IEEE Engineering in Medicine and Biology - vol 26 - nb 03 - May-June 2007

Citation preview

IEEE ENGINEERING IN

MEDICINE AND BIOLOGY Magazine VOLUME 26 • NUMBER 3 ■ http://EMB-Magazine.bme.uconn.edu ■ MAY/JUNE 2007

Accelerating the pace of engineering and science

Sprechen Sie MATLAB? Modeling electric potential in a quantum dot. Contributed by Kim Young-Sang at HYU. This example available at mathworks.com/ltc

®

The language of technical computing.

Image: Kim Young-Sang, Jeong Hee-Jun, Quantum Device Lab, Hanyang Univ. ©2007 The MathWorks, Inc.

Over one million people around the world speak MATLAB. Engineers and scientists in every field from aerospace and semiconductors to biotech, financial services, and earth and ocean sciences use it to express their ideas. Do you speak MATLAB?

IEEE ENGINEERING IN VOLUME 26 • NUMBER 3 MAY/JUNE 2007 http://EMB-Magazine.bme.uconn.edu

MEDICINE AND BIOLOGY Magazine

Exploring Exciting Frontiers in Europe

Themes 12

Biomedical Engineering Trends in Europe Lotfi Senhadji, Maria Siebes, Jos vander Sloten, and Niilo Saranummi

14

Health Technology in Europe Nicolas Pallikarakis and Richard Moore

18

Medical and Biological Engineering and Science in the European Higher Education Area Joachim H. Nagel, Dick W. Slaaf, and Joe Barbenel

©IMAGESOURCE, ARTVILLE, LLC.

26

Biomedical Engineering and eHealth in Europe Ilias Iakovidis, Olivier Le Dour, and Pekka Karp

29

Advanced Wearable Health Systems and Applications Andreas Lymberis and André Dittmar

34

Biomedical Informatics and HealthGRIDs: A European Perspective Victor Maojo and Manolis Tsiknakis

42

A Roadmap for NeuroIT Marc de Kamps and Alois C. Knoll

47

New Technologies Supporting Surgical Interventions and Training of Surgical Skills Jenny Dankelman, Cornelis (Kees) A. Grimbergen, and Henk G. Stassen

53

Engineeering for Health Maria Siebes, Marco Viceconti, Nicos Maglaveras, and C. James Kirkpatrick

Features 60

Improving Corrective Maintenance Efficiency in Clinical Engineering Departments Antonio Miguel Cruz, Cameron Barr, and Elsa P. Pozo Puñales

66

Effects of Simulated Hypergravity on Biomedical Experiments Thais Russomano, Mara R. Rizzatti, Rodrigo P. Coelho, Diogo Scolari, Daniel de Souza, and Paula Prá-Veleda

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

1

Departments NOTES FOR CONTRIBUTORS

4 From the Editor Encouraging Hands-On Experience in BME Education

6 President’s Message Looking Forward to Lyon

7 Around the World Third Kuala Lumpur International Conference on Biomedical Engineering 2006

8 Society News Membership Development Data

10 Student’s Corner Landing a Job in Industry

72 Patents The Expanding World of Prior Art

73 Engineering in Genomics Medline: The Knowledge Buried Therein, Its Potential, and Cost

75 Senior Design Biomedical Engineering/Industrial Design Collaboration in Senior Design Projects

77 Retrospectroscope Who First Performed Cardiac Pacing: Why, When, and Where?

80 Point of View We, Too, Must Evolve

81 A Look at... Shape and Function from Motion in Biomedical Imaging: Part 3

84 Issues in Ethics Ethical Issues in Defibrillator Patients' Quality of Life

88 GOLD Networking: The Five Questions

90 Conference Calendar Mission Statement The Engineering in Medicine and Biology Society of the IEEE advances the application of engineering sciences and technology to medicine and biology, promotes the profession, and provides global leadership for the benefit of its members and humanity by disseminating knowledge, setting standards, fostering professional development, and recognizing excellence.

2

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

IEEE Engineering in Medicine and Biology Magazine is a theme-article publication that covers the full range of fields within biomedical engineering (BME), with each issue covering one theme. Articles are written for technically knowledgeable readers who are not necessarily specialists in the theme topic. A sample list of theme topics of interest includes: biochemical engineering, biocontrols, bioinformatics, biomems, biomaterials, biomechanics, biosignal processing, biotechnology, cellular and tissue engineering, clinical engineering, imaging and image processing, information technology, instrumentation, sensors and measurements, micro- and nanotechnolgy, neural systems and engineering, physiological systems modeling, proteomics, radiology, rehabilitation engineerNOTES FORinCONTRIBUTORS ing, robotics surgery, and telemedicine. In addition to the theme articles, which are invited contributions, the magazine also publishes unsolicited features Coming Attractions that areissues of interest a broad segment IEEE Engineering in Medicine and Future of thetomagazine will haveofthe themes of Teaching Engineering Biology Magazine readers. Tissue Engineering, Biotechnology, and Wearable in Medicine and Biology. IEEE Engineering in Medicine BiologyContributions Magazine also over Sensors/Systems and Their Impact and on BME. onpublishes theme topics 20 scheduled columns for readers interested in industry, academia, and areregularly invited. Other technical articles and feature stories of interest to biomedgovernment. are peer reviewed andare written by experts in the field. ical engineersAll arearticles also welcome. All articles submitted anonymously for On the magazine comprehensive, in-depth tutorial, peeroccasion, review. Letters to the publishes editor, notes, commentaries, and review, other pieces of and survey articles. Letters to the editor, notes, other related pieces personal opinion will be published as such. Wecommentaries, also seek pressand releases of personal in opinion will be published as such. We also seek press releases to activities your company, organization, or school. related to activities your company, school. Manuscripts areinONLY accepted organization, in electronic or format through Manuscript Manuscripts aresite ONLY accepted in electronic format through Manuscript Central at the Web http://embs-ieee.manuscriptcentral.com. Instructions for Central Web and site how http://embs-ieee.manuscriptcentral.com. Instructions for creatingatanthe account to electronically submit a manuscript are available creating an account to original electronically submit aormanuscript available at at the Web site. Doand nothow send submissions revisions are directly to the the Web site. Do Ifnot send or revisions directly to the editorEditor-in-Chief. you areoriginal unable submissions to submit your contribution electronically or in-chief. If you are to submit yourplease contribution or have queshave questions onunable manuscripts style, contactelectronically the Editor-in-Chief: Dr. tions on Enderle, manuscripts style, please contact the editor-in-chief: D. Enderle, John D. Biomedical Engineering Director, UniversityJohn of Connecticut, Program DirectorRoad, for Biomedical Connecticut, 260 Glenbrook Storrs, CTEngineering, 06269-2247.University Voice: +1of860 486 5521.Room Fax: 217, 260486 Glenbrook Road, Storrs, CT 06269-2247 USA. Voice: +1 860 486 5521. +1 860 2500. E-mail: [email protected]. Fax:As +1 860 2500. E-mail: [email protected]. per 486 IEEE policy on standards for publications, review and editorial As per policy are on part standards publications, editorial handling of IEEE manuscripts of the for paper submision review process and to guarantee handling of manuscripts are part of the paper submision process to guarantee quality control. quality control. Make the Deadline Make In orderthe to Deadline have your news published in the magazine in a timely fashion, In order to have news published in the thefollowing magazinedates: in a timely fashion, please submit youryour notices to the editor by please submit your notices to the editor by the following dates: Issue Deadline Issue Deadline Jan/Feb October 1 Jan/Feb September 11 Mar/April December Mar/Apr November1 1 May/June February May/June January July/Aug April 1 1 July/Aug March Sep/Oct June 1 1 Sep/Oct May 1 1 Nov/Dec August Nov/Dec July 1 IEEE Engineering in Medicine & Biology Magazine (ISSN 0739-5175) (IEMBDE) is published Engineering bimonthly by Institute Electrical and Electronics Engineers, Inc., IEEE IEEE in The Medicine andofBiology Magazine (ISSN 0739-5175) (IEMBDE) is Headquarters: 3 Park Ave., Floor, of New York, NY Telephone 212 published bimonthly by The17th Institute Electrical and10016-5997. Electronics NY Engineers, Inc.,+1IEEE 419 7900. NY3Telecopier 212 752 New 4929.York, NY Telex: 236-411 (International messages Headquarters: Park Ave., +1 17th Floor, NY 10016-5997. NY Telephone +1 212 only). IEEE Center (for752 orders, address(International changes, Educational 419 7900. NYService Telecopier +1 212 4929.subscriptions, NY Telex: 236-411 messages Activities, Region/Section/Student 445 Hoes Lane, Piscataway, 08854. NJ only). IEEE Service Center (for Services): orders, subscriptions, address changes,NJEducational Telephone: +1 732 981 0060. Price/Publication Information: Individual copies: IEEE Activities, Region/Section/Student Services): 445 Hoes Lane, Piscataway, NJ 08854. NJ Members $10.00 (first981 copy only), nonmembers $20.00 per copy. (Note: add $4.00 Telephone: +1 732 0060. Price/Publication Information: Individual copies:postage IEEE and handling charge to copy any order $1.00 to $50.00, orders). $5.00 per Members $20.00 (first only),from nonmembers $63.00 including per copy. prepaid Subscriptions: year (included in Society fee) for each member of the IEEE Engineering in Medicine and Biology Society.Nonmember Member and nonmember subscription available on inrequest. Biology Society. subscription prices available onprices request. Available microAvailable in microfiche and microfilm. Copyright and Reprint Permissions: Abstracting fiche and microfilm. Copyright and Reprint Permissions: Abstracting is permitted with is permitted creditLibraries to the source. Libraries are photocopy limcredit to thewith source. are permitted to permitted photocopytobeyond thebeyond limits the of U.S. its of U.S. Law Copyright Law for use of(1)patrons: (1) those post-1977 articles carry Copyright for private useprivate of patrons: those post-1977 articles that carry that a code at athecode at the bottom of the first page, provided the per-copy fee indicated in the code is bottom of the first page, provided the per-copy fee indicated in the code is paid through paid through the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA(2) 01923 the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA; preUSA; (2) pre-1978 For allreprint, other or copying, reprint,information, or republication 1978 articles withoutarticles fee. Forwithout all otherfee. copying, republication write information, write CopyrightsDepartment, and Permission Publishing Services, to: Copyrights andto: Permission IEEEDepartment, Publishing IEEE Services, 445 Hoes Lane, 445 Hoes Lane, Piscataway, NJ 08854 USA. Copyright © 2003 by the Institute of Piscataway, NJ 08854 USA. Copyright © 2007 by the Institute of Electrical and Electronics Electrical Engineers, Inc. All rights reserved. Printed in U.S.A. Periodicals Engineers,and Inc.Electronics All rights reserved. Printed in U.S.A. Periodicals postage paid at New York, postage at New York, NY and at additional mailing offices. Postmaster: Sendtoaddress NY andpaid at additional mailing offices. Postmaster: Send address changes IEEE changes to IEEE Engineering in Medicine & Biology Hoes Lane, Engineering in Medicine and Biology Magazine, IEEE,Magazine, 445 HoesIEEE, Lane, 445 Piscataway, NJ Piscataway, NJ 08854 USA. 08854 USA.

Printed in USA

MAY/JUNE 2007

From the Editor encouraging hands-on experience in BME education John Enderle

think you will find this issue on “biomedical engineering trends in Europe” very informative. I appreciate the efforts of guest editors Niilo Saranummi, Lotfi Senhadji, Maria Siebes, and Jos vander Sloten for putting this issue together. They did a great job! I know that you will enjoy it! Last year we had an issue that focused on developments in Japan, and we plan to have other geographic locations highlighted in the years to come. This column is a continuation of last issue’s column on biomedical engineering accreditation and will focus on an idea for proposed change in Criterion 8 for biomedical engineering programs. The proposal is from

I

John Watson, formerly at the National Institutes of Health, and now a faculty member at the University of California, San Diego. Bioengineering* ABET: adding a hands-on experience for understanding patient needs and clinical applications. The purpose of this communication is to encourage an ABET requirement that all undergraduate bioengineering students have an educational hands-on experience for understanding patient needs and clinical applications. Bioengineering women and men undergraduates are the brightest, most

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE Editor-in-Chief John Enderle University of Connecticut Editorial Board Hojjat Adeli The Ohio State University Howard I. Bassen Food and Drug Administration Krzysztof J. Cios Univ. of Colorado at Denver and Health Sciences Center Pouran Faghri University of Connecticut Limin Luo Southeast University, Nanjing Jasjit Suri Biomedical Technologies Inc. Eugene Veklerov Lawrence Berkeley Laboratory Associate Editors A Look At Jean-Louis Coatrieux University of Rennes, France Book Reviews Paul King Vanderbilt University

Cellular & Tissue Engineering Nenad Bursac Duke University Clinical Engineering Stephen L. Grimes GENTECH COMAR Richard A. Tell Richard Tell Associates, Inc. Emerging Technologies Dorin Panescu St. Jude Medical Faces and Places Andrew Szeto San Diego State University Genomics Harold (Skip) Garner University of Texas Southwestern Medical Ctr. Government Affairs Luis Kun National Defense University Industry Affairs Semahat Demir National Science Foundation Issues in Ethics John Fielder Villanova University

International News John Webster University of Wisconsin, Madison Patents Maurice M. Klee Fairfield, CT Point of View Gail Baura Keck Graduate Institute, Claremont, CA Regulatory Issues Robert Munzner DoctorDevice.com Grace Bartoo Instrumentation for Science and Medicine Retrospectroscope L.A. Geddes Purdue University Senior Design Jay Goldberg Marquette University Society News Jorge Monzon Universidad Nacional del Nordeste Student Activities Jennifer Flexman University of Washington

inspired, and potentially the most creative students studying in schools of engineering. As professors of bioengineering, over the next decade or two, we have perhaps the greatest opportunity in modern history to educate a cadre of bioengineers who could transform medical practice with medical and biological innovations. I suggest that we will fail our constituency in meeting their potential if we do not provide an educational experience that provides a hands-on experience for understanding patient needs and clinical applications. One simply cannot create the most elegant clinical solution without having (continued on page 76)

IEEE PERIODICALS MAGAZINES DEPARTMENT

Senior Managing Editor Geraldine Krolin-Taylor Art Director Janet Dudar Asst. Art Director Gail A. Schnitzer Business Development Manager Susan Schneiderman +1 732 562 3946 [email protected] Fax: +1 732 981 1855 Senior Advertising Production Coordinator Cathline Tanis Production Director Robert Smrek Editorial Director Dawn Melley Staff Director, Publishing Operations Fran Zappulla

Editorial Correspondence: Address to John D. Enderle, Program Director for Biomedical Engineering, University of Connecticut, Room 223 B, 260 Glenbrook Road, U-2157, Storrs, CT 06269-2157 USA. Voice: +1 860 486 5521. Fax: +1 860 486 2500. E-mail: [email protected]. Indexed in: Current Contents (Clinical Practice), Engineering Index (Bioengineering Abstracts), Inspec, Excerpta Medica, Index Medicus, MEDLINE, RECAL Information Services, and listed in Citation Index. All materials in this publication represent the views of the authors only and not those of the EMBS or IEEE.

4

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

President’s Message looking forward to Lyon Donna Hudson

he 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society will be held in Lyon, France, from 23 to 26 August in conjunction with the Biennial Conference of the French Society of Biological and Medical Engineering (SFGBM). This brief overview of the history, culture, and environment of Lyon sets the stage for an exciting event.

T

History

Lyon has a long history, founded as a Roman colony in 43 BCE by Munatius Plancus, a lieutenant of Caesar. The original name was Lugdunum. Burgundian refugees from the destruction of Worms by the Huns in 437 resettled in Lugdunum, which formally became the capital of the new Burgundian kingdom by 461. Lyon was a center for the occupying German forces and a stronghold of resistance during World War II and is now home to a resistance museum. Traboules (secret passages) enabled the local people to escape Gestapo raids. Location

Lyon is set in picturesque Burgundy, along the banks of both the Rhone and Soane Rivers. The conference site is the Lyon Convention Center designed by Renzo Piano in the heart of an exceptional natural setting between the Rhone River and the Tête d’Or Park and within the Cité Internationale, a new urban development covering 22 landscaped hectares (55 acres). Gastronomy

Lyon gastronomy owes much to women, the “Mères” of times gone by. At first, these women cooks served important bourgeois families. They began to work for themselves in the second half of the 19th century. 6

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Culinary tradition is now largely continued by men, including many world-renowned chefs: Bocuse, Lacombe, Orsi, Chavent, Lassausaie, Blanc in Vonnas, Chapel in Mionnay, and Troisgros in Roanne. These chefs, along with a newer generation, have forged the reputation of Lyon

Program Co-Chairs Eric McAdams and Nigel Lovell have designed an outstanding technical program with 12 themes encompassing the broad range of interests that fall under

Greece and Egypt to the present day, with a painting collection including works from the 14th through 20th century. The Musée des Tissus, situated in a 17th century mansion, displays a collection of over 1,000 textiles from both Eastern and Western civilizations. Other attractions include the Place de la Comédie, Roman ruins, Maison des Canuts, and the 17th century City Hall. Getting There

Lyon has a major international airport, Saint Exupéry, which offers flights to over 100 destinations. It is located at about 25 kilometers (15 miles) east of the city center. A shuttle, called Satobus, links the airport to the center of Lyon, Part-Dieu, with departures every 20 minutes, seven days a week. The TGV (high speed train) stops at Part-Dieu and also at the airport. The TGV trip from Paris, leaving from the Charles de Gaulle airport or Gare de Lyon, takes two hours. Bus NR-47 departing from Part-Dieu reaches the Convention Center in ten minutes.

the umbrella of medical and biological engineering. cuisine. The Conference Awards Banquet will be held at the famous restaurant Bocuse. Points of Interest

Major tourist attractions include the Basilique de Notre Dame de Fourvière, known for its unusual architecture and location atop the Fourvière hill. The Cathédrale St-Jean is located at the foot of the hill and is considered one of the most beautiful gothic cathedrals in France. The Musée des Beaux Arts displays art and artifacts from ancient

Conference Details

Conference Chair André Dittmar and Co-Chair John Clark have organized a superb conference in a magnificent setting. Program Co-Chairs Eric McAdams and Nigel Lovell have designed an outstanding technical program with 12 themes encompassing the broad range of interests that fall under the umbrella of medical and biological engineering. Special activities for students are also included. Details can be found at http://www.embc07. ulster.ac. uk/. We hope you are all making your travel plans. The venue is excellent for an outstanding technical event as well as an enriching environment. We look forward to greeting you and wishing you bienvenue à Lyon! MAY/JUNE 2007

Around the World third Kuala Lumpur international conference on biomedical engineering 2006 John Webster

n 11–14 December 2006, the 3rd Kuala Lumpur International Conference on Biomedical Engineering (Biomed) 2006 was held at the Palace of the Golden Horses, Kuala Lumpur, chaired by Fatimah Ibrahim. The conference was officiated by the prime minister of Malaysia, Abdullah Badawi, on 12 December 2006. The Department of Biomedical Engineering of the University Malaya was the organizer, along with the Department of Biomedical Engineering of Inje University, Korea, and the Malaysian Society of Medical and Biological Engineering (MSMBE) as the co-organizers. Healthtronics was the main corporate sponsor. Radibems, Biomodeling Solutions, Tourism Malaysia, Nikon, and Palace of the Golden Horses were the cosponsors. Biomed 2006 was also endorsed by both the International Federation for Medical and Biological Engineering (IFMBE) and the Biomaterials Network. The conference featured five plenary lectures. Makoto Kikuchi, IFMBE president-elect, from National Defense Medical College, Japan, presented “nanotechnology impact towards innovative biomedical engineering.” John G. Webster, from the University of Wisconsin-Madison, United States, presented “electromuscular incapacitating device (Taser) safety.” Metin Akay from Arizona State University, United States, presented “neural engineering: merging neuroscience with engineering.” Marc Madou from University of CaliforniaIrvine, United States, presented “from a Si-centric to a C-centric world.” Yilin Cao from Shanghai 9th People’s Hospital, China, presented “in vivo and in vitro engineering of cartilage.”

O

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

From left: Datuk Rafiah Salim (University of Malaya vice-chancellor), Dato’ Mustapa Mohamed (minister of higher education, Malaysia), The Honorable Dato’ Seri Abdullah Hj Ahmad Badawi (prime minister of Malaysia), Tan Sri Arshad Ayub (University of Malaya Board of Directors, chairperson), and Fatimah Ibrahim (conference chairperson).

In addition, nine invited speakers also presented at the conference: Wan Abu Bakar Wan Abas (University of Malaya, Malaysia), Nigel Lovell (University of New South Wales, Australia), Walter Chang (Chung Yuan Christian University, Taiwan), Y.T. Chew (National University of Singapore), Chi-Woong Mun (Inje University, Korea), Jongman Cho (Inje University, Korea), Dave Singh (University of Puerto Rico, United States), Bart ter Haar Romeny (Eindhoven University of Technology, Netherlands), and Min Wang (University of Hong Kong). Biomed 2006 featured conference tutorials organized by Kwan Hoong Ng on 11 December 2006. John. G. Webster conducted a full-day session on “bioinstrumentation,” Marc Madou

presented “MEMS,” Bart ter Haar Romeny presented “biomedical image analysis,” and Metin Akay conducted a half-day tutorial on “biomedical informatics and neural engineering.” There were 12 exhibition booths during Biomed 2006: Department of Biomedical Engineering, University of Malaya; Healthtronics (M) Sdn. Bhd.; John Wiley & Sons (Asia); Materialise Software (Malaysia); Radibems (M) Sdn. Bhd.; Kriptic Devices Sdn. Bhd.; National Instruments Singapore (Pte). Ltd.; Dynamedix Sdn. Bhd.; Biomodelling Solutions; Bell Communications Technologies Sdn. Bhd.; Healthtronics (M) Sdn. Bhd.; Cahtma. A total of 174 papers appear in the IFMBE Proceedings (volume 15, 2006, ISBN 978-3-540-68016-1, ISSN 17271983), which is published by Springer.

MAY/JUNE 2007

7

Society News membership development data Jorge E. Monzon

s I mentioned previously, we are devoting 2007 to membership development. Reviewing some current statistical data might help us in our commitment to increasing the number of members in our Society. As Table 1 illustrates, EMBS shows a 4.9% positive change in membership for the period December 2005– December 2006, totaling 8,441 members. The net increase of 392 members for the period represents an improved performance over 2005. This 4.9% change places EMBS among the 20 IEEE societies with increased membership in 2006 (Table 2). Overall IEEE membership exhibits a 2% annual gain (Table 3). This marks the first time that the year-to-year

increase in membership has exceeded 1%, a not so insignificant accomplishment considering that back in February 2006, membership was down by 3.3% from the prior year and at a 4-year low. IEEE now stands at the highest level for this time of the year since 2002, with a total of 374,767 members. Although 53.2% of IEEE members belong to an average of 1.6 Societies, there are still 175,311 members without Societies. EMBS geographical statistics follow the general trend of IEEE data. Regions 1–6 (USA) show a decrease in total membership, while Asia-Pacific and Europe show the highest increase. The final Senior Members Admissions Review Panel for 2006 took place in November 2006 in New Orleans, Louisiana. There was a total of 20 new

A

EMBS Senior Members approved at this meeting, and among them were two AdCom members: Ahmed A. Morsy (Africa representative, Egypt) and Kenji Sunagawa (Asia-Pacific representative, Japan). The 2006 Senior Member initiative represented 231 new Senior Members for EMBS; i.e., 3.4% of our higher-grade membership. IEEE has elevated a total of 2,608 Senior Members this year, which surpassed the goal of 2,400 elevations set by the Membership Development Committee for 2006. This is the most Senior Members that IEEE has ever elevated in a single year, and it exceeds last year’s total elevations by more than 15%. Overall, Europe had both the highest number of elevations and the best performance against goal.

Table 1. EMBS membership (Dec. 2005–Dec. 2006). Higher Grade

Student Members

Society

Members

Change

Change

Affiliates

Change

Society Totals

Change

2006

2005

#

%

2006

2005

#

%

2006

2005

#

%

2006

2005

#

%

6,830

6,526

304

4.7%

1,540

1,428

112

7.8%

71

95

−24

+25.3%

8,441

8,049

392

4.9%

Table 2. IEEE Societies with increased membership in 2006.

8

Society Name

Growth

Society Name

Growth

Aerospace and Electronic Systems

2.30%

Intelligent Transportation Systems

8.90%

Broadcast Technology

4.40%

Magnetics

3.90%

Components, Packaging, and Mfg Tech.

0.50%

Nuclear & Plasma Sciences

3.00%

Computational Intelligence

5.10%

Power Electronics

6.20%

Control Systems

0.70%

Power Engineering

5.20%

Dielectrics and Electrical Insulation

1.00%

Product Safety Engineering

5.90%

Education

1.70%

Robotics & Automation

0.30%

Engineering in Medicine and Biology

4.90%

Social Implications of Technology

1.60%

Industrial Electronics

3.30%

Systems, Man & Cybernetics

0.90%

Instrumentation and Measurements

4.90%

Vehicular Technology

3.20%

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

Table 3. IEEE membership (Dec. 2005-Dec. 2006). IEEE Membership Snapshot December 2006

% Change (Over December 2005)

Total membership

374,767

+2.0%

Higher grade

294,276

+0.3%

80,491

+9.0%

337,755

−2.5%

Students Society memberships

Table 4. EMBS renewal data (2005, 2006). AUG. 2006 MEMBERSHIP % of 2006 Society Members

% of 2006

% of

30 August 2006

who

Society

Responding

Active

Renewed

IEEE

Members

Society

Members

IEEE and

Society

Renewed/

who Declined

Total Society

Members who

(Base

Society

Membership

Society

to Renew

Respondents to

Declined to

Membership

Renewed for

for 2007 to

Declined for

Society for

2007 Renewal

Renew Society

Billed for 2007)

2007

Date

2007

2007 to Date

to Date

for 2007

7,891

3,754

48%

354

4%

4,108

9%

EMBS performance in this 2006 initiative compared quite well with other Societies, including those with significant higher memberships like the Computer and Communications Societies. Concerning renewals, it must be pointed out that a significant number of members chose to renew IEEE membership but very sadly did not feel it was valuable to renew their EMBS membership (Table 4). This suggests that we should assess the effectiveness of the advertising campaign for new members and that we reconsider all the services offered to satisfy our members’ needs and as a way of retaining them in EMBS. I am confident that next year will show better statistics for EMBS. All of IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

us should engage in a crusade to increase membership. We need a larger and stronger Society. Every EMBS member should work at their local

level, on a face-to-face basis if necessary, to recruit new members and to show them the benefits of affiliation to our Society.

Correction

In “Machine Learning in the Life Sciences” in the March 2007 issue of IEEE Engineering in Medicine and Biology Magazine, the order of authors was incorrect. The correct order is Lukasz A. Kurgan, Marek Reformat, and Krzysztof J. Cios.

MAY/JUNE 2007

9

Student’s Corner landing a job in industry Jennifer Flexman

Your work is going to fill a large part of your life, and the only way to be truly satisfied is to do what you believe is great work, and the only way to do great work is to love what you do. If you haven’t found it yet, keep looking, and don’t settle. —Steve Jobs, Commencement Speech at Stanford University, 2005 hanks, Steve, but how do I actually get that job? “Landing a job in industry” is the first survey in a three-part series on making the jump from university to various career paths. Look for the next article in July on how to climb the academic ladder.

T

The Big Search

To a student, graduation can be a time of great anxiety and excitement. The anxiety stems from a fear of the unknown, while new opportunities and a major life change drive the feeling of excitement. I researched landing a job in biomedical engineering so that you, as a student, can be equipped with the knowledge you need to face the job search without trepidation. This article surveys industry professionals in the Seattle area, but their pearls of wisdom apply to any job market. Representatives from junior to senior levels and in positions from product development to entrepreneurship weighed in to give you an idea of the many options available to biomedical engineers after graduation, as well as some strategies on how to get the job you want. Where Do You Start?

Starting a job search in industry can be daunting: where are the best opportunities? Recognize that the job search can begin well before you are actually done 10 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

with school. Many jobs come from networking and previous internships. For example, Dawn Jorgenson transitioned easily from her graduate work in bioengineering to a job in medical systems through the industry partners she had worked with in university. Jennifer Osborn, who started as a research associate at NanoString Technologies after graduation with her bachelor’s in bioengineering, had worked with the com-

Starting a job search in industry can be daunting: where are the best opportunities? Recognize that the job search can begin well before you are actually done with school. pany during her senior year. Target your skills toward a particular employer or industry; John Donahue tailored his senior year to make him appealing to Immunex, his target employer, and waited ten months for his ideal job to open up. When it did, his perseverance paid off and he got the job. Of course, not everyone targets a job that far in advance. Perry Hargrave, a newly minted bioengineer, said that he was successful in getting plenty of interviews from applying to jobs he found on the internet. He said that it was helpful to get job information from his previous department and suggested Web sites such as www.sciencecareers.org, www.monster.com, and post-

ings through a local biotechnology association. Other strategies for gaining access to people in industry include noting prominent industry speakers at conferences and targeting the hiring managers themselves as opposed to the human resources department. Go Big or Go Small

Not all work environments are the same, so identify the size of company that suits your personality. Companies come in all shapes and sizes, but for the sake of simplicity let’s categorize them as small or large, based on number of employees and business maturity. Size affects the range of tasks you are expected to accomplish, compensation and benefits you receive, and level of job stability. Naturally, small companies tend to require a greater flexibility in their employees, where the only certainty may be change. Larger companies generally offer narrower job descriptions with more opportunities for formal training. John Donahue reflects from his experience at Amgen that a big company may have more bureaucracy but also job security, a great opportunity to learn and share best practices, and a chance to interface with people from a variety of backgrounds. Jennifer Osborn’s experience at NanoString Technologies, a small company, taught her to play many different roles in her job, with more hands-on learning. Perry Hargrave feels that his current position in a small company gives him a better sense of ownership of his projects than a large company would have. So, You Want to Be an Entrepreneur?

Working in a start-up environment, regardless of your intention to be the entrepreneur yourself, is a different game for graduating students. Joe MAY/JUNE 2007

Eichinger, who has founded four different companies, states that he usually hires students with a master’s or Ph.D., and he prefers at least a small amount of work experience. He lists three essential characteristics for hiring: 1) requisite design skills and education requiring minimal on-the-job training; 2) a high level of motivation; and 3) ability to work well in a team environment. If you want to be the entrepreneur, Joe Eichinger suggests starting in a larger company to get operational experience, the ability to work in mixed teams, and the experience of working in a disciplined project environment. It can be difficult to obtain these skills in a small start-up company, but they will provide a solid foundation for your career. Above all, “experience under good leadership seems to be the best [experience],” Joe states, and “an MBA is great, but not needed,” pointing to Bill Gates as a prime example of entrepreneurial success without formal business training. The Soft Skills: Not So Mushy

Is this someone you’d like to go to lunch with? Employers often ask themselves this during interviews. Technical knowledge is the bare minimum; personality sets you apart in a successful interview. Dorin Panescu lists communication skills and initiative as key characteristics of a potential hire. Joe Eichinger stresses that public speaking is very important in your career, since “one often needs selling or persuasive skills to move an idea forward.” It is important to sound confident and be comfortable talking about yourself favorably. The best way to make this a natural part of your interview is to practice: learn how to articulate your message clearly and persuasively. Remember, you are your own best salesman, and acquiring these skills will serve you well not only in job applications but also throughout your career. To acquire these skills, join a public speaking club or pursue extracurricular activities that allow you to show leadership (for example, start up an EMBS student club or chapter!). IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

How to Get an Edge

How can you stand out in a crowd? Here are some strategies to get an edge on the competition, such as seeking out training and experience particularly valued in an industry. For example, knowledge of clinical or regulatory affairs appeals to a company involved in commercial applications in biomedical engineering. Dorin Panescu notes that students should get “as much hands-on engineering design as you can,” such as through a senior design project, advanced research, or an internship. Further education can give you an edge, but be aware of the norms in the industry in which you would like to work. Having a Ph.D. can mean the difference between pipetting the days away and leading research initiatives; however, it may not be necessary for rising up through the company, and it is pursued at the cost of work experience. In whatever career you pursue, education and technical know-how will only be part of the package you offer; do not underestimate the power of holding a diverse set of skills and being able to work with other people productively. Good luck with your job search! By the way, Mr. Jobs, are you hiring?

➤

➤

➤

➤

Editor’s Note: I would like to thank the following individuals who generously shared their experiences in industry, either through personal correspondence or through the career panel organized by the Biomedical Engineering Society (BMES) at the University of Washington. ➤ Joe Eichinger has a B.S. in mechanical engineering, is the president and director of CoAptus Medical Corporation and AcousTx Corporation, and has over 25 years of experience in the medical imaging and device industries. He is the cofounder of four companies and has experience in venture capital and investment banking. ➤ Dorin Panescu obtained a Ph.D. in electrical and computer engineering. With more than 125 issued U.S.

patents to his credit and more than 15 years of medical device research, his experience covers fields such as keratosplaty, cardiac ablation, cardiac pacemakers, and defibrillators. He is currently a principal staff scientist with St. Jude Medical. Dawn Jorgenson has a Ph.D. in bioengineering. She is a senior research scientist at Philips Medical Systems where she works in product development, clinical and preclinical trials, and postmarket studies with a focus in cardiac electrical therapy. Perry Hargrave is a recent graduate with a B.S. in bioengineering. He currently holds the position of biomedical engineer at Blood Cell Storage, a medical device company, where he has many roles, such as in assay development, prototyping, programming, and manufacturing. Jennifer Osborn has a B.S. in bioengineering and worked as a research associate at NanoString Technologies, where she researched surface chemistry and microfluidic technologies. She is now working in point-of-care diagnostics as a research associate at the University of Washington. John Donahue has a B.S. in chemical engineering and worked for several years as a process development engineer in the Cell Sciences Department at Immunex Corporation, now Amgen. He is currently a senior manager of manufacturing at Amgen’s Washington Cell Culture Facility, which produces therapeutic proteins for clinical trials.

Jennifer Flexman is currently studying at the University of Washington, Department of Bioengineering (Image Computing and Systems Laboratory/ Neuroimaging and Biotechnology Laboratory), toward a Ph.D. in bioengineering. She graduated with a B.Eng. in electrical engineering from McGill University in 2000 and worked as a wireless test engineer for two years. MAY/JUNE 2007

11

EXPLORING EXCITING FRONTIERS IN EUROPE

Biomedical Engineering Trends in Europe Views from the Guest Editors © ARTVILLE, IMAGE SOURCE

BY LOTFI SENHADJI, MARIA SIEBES, JOS VANDER SLOTEN, AND NIILO SARANUMMI

ince the end of the Second World War, European (re-) construction has been based on large-scale projects targeting well-identified challenges. The most symbolic is certainly the European coal and steel project, which stimulated the conception of the European unification and led to the Treaty of Rome of 1957. Other more recent initiatives contributing to the economic and industrial development of Europe include the European agriculture project and the joint European space venture, ESA. A more recent priority is the “Europe of knowledge,” recognizing that the production, diffusion, and utilization of knowledge are the key ingredients for competitive productivity and sustained economic growth. Hence, the creation of a dynamic knowledge-based society within which education and training, research and development, and innovation play a critical role is one of the foremost objectives of Europe’s structural reforms since 2000. A prominent challenge in this endeavor is the health of European citizens and the sustainability of national healthcare systems. Confronted with increasing old age and a declining birth rate, health technologies must deal with the specific needs imposed by the extended age span of the population (from neonatal and pediatric to geriatric care) for support, prevention, diagnosis, and therapy. The need for enhancing the productivity of the working population (also by reducing the number of days for sick leave and curbing early retirement) and improving the quality of life of the elderly has to be balanced by the need for controlling the costs involved in the development of new health technologies, their implementation, and their utilization. Biomedical engineering is the fastest growing engineering field. It is deeply rooted in the culture of interdisciplinary research and collaboration. It opens ways for exploring exciting frontiers in many scientific fields. By establishing collaboration and partnership, biomedical engineering is designated to play a key role in transforming and revolutionizing future medicine and healthcare practices. Biomedical engineering is more than a multidisciplinary approach. It is a new leading engineering discipline of the 21st century. This special issue highlights European efforts in this field. The first three articles outline the regulatory, the biomedical engineering education, and the research and development

S

12 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

environments, respectively. Pallikarakis and Moore present the European regulatory framework for medical devices. The article by Nagel et al. focuses on the biomedical engineering aspects in creating the European Higher Education Area. The contribution by Iakovidis et al. reviews European programs that support research and development in biomedical engineering and highlights its current focus—“biomedical informatics”—at the crossroads of biomedical engineering, medical informatics, and bioinformatics. Hereafter, three examples of activities funded by the European Commission are presented. Lymberis and Dittmar give an overview of selected projects focusing on smart wearable health systems. Maojo and Tsiknakis review activities in biomedical informatics and Grid technologies. After that, de Kamps and Knoll summarize neuro-IT research activities. European Union-funded research and development covers only a small fraction of the research and development done in Europe. The article by Dankelman et al. describes how various complementary technologies play a key role in advancing minimally invasive surgical interventions and training simulators. The section closes with an article by Siebes et al. outlining the benefits of the partnership initiative “Engineering for Health” that is being pursued by the recently created European-wide umbrella organization in our domain, the European Alliance for Medical and Biological Engineering and Science (EAMBES). Lotfi Senhadji is a professor at the University of Rennes 1 with the Department of Electrical Engineering. He is the head of the INSERM research laboratory “Laboratoire Traitement du Signal et de l’Image (LTSI).” He received the Ph.D. from the University of Rennes 1, France, in signal processing and telecommunications in 1993. His main research efforts are focused on nonstationary signal processing with particular emphasis on wavelet transforms and time-frequency representations for detection, classification, and interpretation of biosignals (electrocardiography, electroencephalography, phonocardiography and NMR spectroscopy). He has been investigator of several grants in the field of health technology with public institutions or 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

companies. He has published more than 70 research papers in journals and conferences and he contributed to four handbooks. He is a member of the council of the French Society of Biomedical Engineering (SFGBM), the French Alliance for Biomedical Engineering (AGBM), Senior Member of IEEE Engineering in Medicine and Biology Society, and the IEEEE Signal Processing Society.

elected programme director of the new Master in Biomedical Engineering program. He is a member of the council of the Belgian Society for Medical and Biological Engineering and Computing. In the European Alliance for Medical and Biological Engineering and Science (EAMBES), he served as secretary-general (2003–2004), president-elect (2005), and president (2006).

Maria Siebes received her M.S. (1984) and Ph.D. (1989) in biomedical engineering from the University of Southern California, Los Angeles. She then joined the biomedical engineering faculty at the University of Iowa, Iowa City, and transferred in 1997 to the Academic Medical Center, Amsterdam, The Netherlands, where she currently holds a tenured position at the Department of Medical Physics. Her research interests focus on the assessment of coronary artery disease in humans. Dr. Siebes is a Fulbright Scholar and member of Tau Beta Pi, Sigma Xi, IEEE Engineering in Medicine and Biology Society, ASME, and AHA. She has served on the Council of the European Alliance for Medical and Biological Engineering and Science (EAMBES) since 2003.

Niilo Saranummi received his D.Tech. in biomedical engineering at Tampere University of Technology in 1976. He is currently working as a research professor at VTT Technical Research Centre of Finland. He is co-founder and current chair of HL7 Finland. He is also editorin-chief of the IEEE Transactions of Information Technology in Biomedicine. He has served as president of the International Federation for Medical and Biological Engineering (IFMBE), International Union for Physical and Engineering Sciences in Medicine (IUPESM), and European Alliance for Medical and Biological Engineering and Science (EAMBES). His research interests include pervasive healthcare, innovation, technology transfer, and technology policy setting in health technologies. He is a fellow of Finnish Academies of Technology, International Academy of Medical and Biological Engineering (IAMBE) and American Institute of Medical and Biological Engineering (AIMBE) and a Senior Member of IEEE.

Jos vander Sloten obtained his M.Sc. and Ph.D. in mechanical engineering from the Katholieke Universiteit Leuven in 1985 and 1990, respectively, specializing in biomechanics of the musculo-skeletal system. Currently, he is professor and chair of the Division of Biomechanics and Engineering Design at K.U. Leuven. He is teaching mechanics, problem solving and engineering design, and computer integrated surgery systems. He was

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Address for Correspondence: Niilo Saranummi, VTT Technical Research Centre of Finland, Pervasive Health Technologies, P.O. Box 1300, FIN-33101 Tampere, Finland. Phone: +358 20 722 3300. Fax: +358 20 722 3380. E-mail: [email protected].

MAY/JUNE 2007

13

EXPLORING EXCITING FRONTIERS IN EUROPE

Health Technology in Europe

© ARTVILLE, IMAGE SOURCE

Regulatory Framework and Industry Perspectives of the “New Approach”

BY NICOLAS PALLIKARAKIS AND RICHARD MOORE

iomedical engineering is a dynamic field undergoing rapid evolution over the last decades. Advances in biomedical research and the resulting development of new diagnostic and therapeutic methods, techniques, and equipment have led to a radical change in the way healthcare is delivered today. The impressive progress in the creation of medical knowledge was combined with the broad spectrum and dynamism of other fields of technology, which are very important for medical technologies and provide new possibilities for products. This high technological and medical dynamism leads to shorter product life cycles and creates a tendency toward a shortening of their depreciation period. This makes it necessary for innovative products to reach the markets quickly and in sufficient quantities in order that the high investments in R&D are profitable. However, the arrival in the marketplace of innovative products is less rapid in medical technology compared to some other industry sectors. This is partially due to the complexity of the innovation process and the involvement of multidisciplinary groups, as well as the need to meet regulatory requirements, particularly to guarantee patient and user safety. As a result of rising development costs and the complexity of the innovation process, extensive initial investments are necessary in medical technology, such that financing can present a great barrier for small and new companies, in particular. To complete this picture, the important aspect of the availability and qualification of staff with a wide range of relevant competencies needs to be stressed. Biomedical engineers today should be prepared to adapt to existing or forecasted needs, in the form of knowledge, skills, and attitudes that address the demands of the work environment in the broader healthcare-related sector. Therefore, there is a strong pressure on education, training, and lifelong learning courses to continuously adapt their objectives and programs in order to face new requirements and challenges. In an era of aging populations, healthcare technology can improve the quality of life of citizens; lower the societal costs of stress, disease, and disability by helping patients return more quickly to a contributive role; and increase the efficiency of healthcare systems.

B

14 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Market Figures

The worldwide medical device market in 2002 was valued at over €184 billion. The U.S. market constitutes the largest world market for medical devices, representing a share estimated at 38–40%. The European market, for the same year, was estimated at about €55 billion and, representing almost 30% of the world share, is the second largest market, followed by Japan. The rest of the medical devices world market represents less than 20%. Within Europe, Germany is the leading market, followed by France, Italy, and the United Kingdom. The two largest markets, Germany and France, account for half of the European market, and the four largest ones account for over 70% of it. European countries spend on average 7.8% of gross domestic product on health. This figure is higher for the EU-15 [the 15 countries of the European Union (EU) prior to expansion in 2004] aggregate (8.3%) than for the new member states (6.6%), and compares with a 13.9% for the United States and 7.6% for Japan. For Europe, it is estimated that 6.2% of total health expenditure goes to medical devices. This percentage is higher for new member states than for the EU-15. Both the United States and Japan spend about 5% of total health expenditure on medical devices. The data on per capita expenditure on medical devices show a high degree of heterogeneity between countries and areas. The average annual expenditure for the EU-15 is €134 per person, while for the new member states it is estimated to be under €30. The figures for the United States and Japan are €278 and €158, respectively. The EU Regulatory Framework

Medical devices should provide patients, users, and third parties with a high level of protection and reach the performance levels attributed to them by the manufacturer. The maintenance or improvement of the level of protection, attained in the member states of the EU, is one of the essential objectives addressed by the medical device directives. The EU regulatory framework for medical devices according to the “new approach” is based on the responsibility of the manufacturer and balances free movement of products and protection of health. Broad “essential requirements” for devices are laid down in the medical device directives, as opposed to the detailed and prescriptive “old approach” directives, and 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

The EU regulatory framework for medical devices according to the “new approach” is based on the responsibility of the manufacturer and balances free movement of products and protection of health. European standardization organizations are mandated to prepare harmonized standards, with a presumption of conformity to relevant essential requirements, if devices comply with these harmonized standards. The scope of Directive 93/42/EEC [1] applies to all medical devices and their accessories, except from the active implantable and the in vitro diagnostic medical devices, which are covered by 90/385/EEC [2] and 98/79/EC [3], respectively. Medical device means any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: ➤ diagnosis, prevention, monitoring, treatment, or alleviation of disease ➤ diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap ➤ investigation, replacement, or modification of the anatomy or of a physiological process ➤ control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its function by such means. Similar definitions hold for active implantable and in vitro diagnostic medical devices. It is therefore clear that the three above-mentioned medical device directives are covering an extremely wide range of products, from syringes and sutures to complex patient monitoring and imaging systems or implantable pacemakers and reagents. This universe of products has now been classified in more than 7,000 generic groups according to the global medical device nomenclature. According to the “new approach,” member states shall not create any obstacle to the placing on the market, or the putting into service within their territory, of devices bearing the CE marking, which indicates that they have been subject to an assessment of their conformity. Placing on the market means first making available, in return for payment, or free of charge, a device (other than a device intended for clinical investigation) with a view to distribution and/or use on the community market, regardless of whether it is new or fully refurbished. Putting into service means the stage at which a device has been made available to the final user as being ready for use on the community market for the first time for its intended purpose. Member states shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users, and, where applicable, other persons when properly installed, maintained, and used in accordance with their intended purpose. These tasks belong to the responsibilIEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

ities of the competent authorities (CAs) of the member states. Within this scope, national authorities maintain a registration of manufacturers or persons responsible for placing devices on the market, verify the CE-marked devices in regard to their compliance with the relevant requirements of the applicable directive, take the appropriate measures when the CE marking has been affixed unduly in order to restrict or prohibit the placing on the Community market of the product in question, or to ensure that it is withdrawn from the market. They are also responsible for the monitoring of clinical investigations and the maintenance of an appropriate vigilance system for medical devices. The other parties involved under this regulatory scheme are the notified bodies (NBs), the manufacturers or their authorized representatives, and the standardization bodies. The overall monitoring and coordination activity is assured by the Commission through the regulatory committees and expert working groups established under the directives. Notified bodies are designated by the CAs and carry out conformity assessment and verification operations. These operations include examination of the design dossier, verification of quality systems, classification and testing of products, leading to delivery (or to suspension or withdrawal) of certificates, allowing manufacturers to affix the CE mark. NBs must comply with criteria of: ➤ independence ➤ sufficiency of staff and facilities ➤ a high degree of professional integrity and competence ➤ liability insurance in order to be designated by the relevant national authority. There are today more than 70 designated NBs for medical devices in the EU with various scopes and fields of action regarding the certification of manufacturers and products, mainly focused on safety issues concerning their use. Medical devices are divided into Classes I, IIa, IIb, and III [4]. Classification is made according to a number of criteria, related to the risks associated with the use of the device such as: ➤ the time during which the device is in contact with the human body ➤ the vulnerability of the human body to noninvasive, invasive, surgically invasive, and implantable devices and their active or nonactive way of function. Special rules apply to specific cases, like blood bags or devices incorporating material of animal origin. Classification rules are described in the medical device classification guidelines that may be adapted in the light of technical progress and any information. Manufacturers, prior to affixing the CE marking to their products and putting them on the market, must: ➤ correctly classify the device ➤ ensure that the product is a medical device according to the definition and that it fulfills the essential requirements MAY/JUNE 2007

15

There are today more than 70 designated notified bodies for medical devices in the EU with various scopes and fields of action regarding the certification of manufacturers and products, mainly focused on safety issues concerning their use. ➤ provide adequate risk analysis and, where necessary, clini-

cal data, correct labeling, and technical documentation ➤ perform the conformity assessment procedure with or without an NB ➤ make a declaration of conformity. Manufacturers should also maintain a postmarket surveillance system that allows them to be informed about any adverse event or problem associated with the use of their devices. The European Standardization Bodies

There are three European standardization bodies (ESBs), namely: ➤ CEN: the European Committee for Standardization ➤ CENELEC: the European Committee for Electrotechnical Standardization ➤ ETSI: the European Telecommunications Standards Institution. Each of these ESBs may be requested by the European Commission to prepare voluntary standards in support of European directives by way of an official “mandate.” Only standards that have been mandated can subsequently have their references published in the Official Journal of the European Communities (OJEC) as “harmonized European Standards” and can provide a presumption of conformity with relevant essential requirement. Harmonized standards have a so-called “Annex ZA,” which details the relationship between their provisions and the essential requirements addressed. Standards are always “voluntary” in the sense that a manufacturer can choose to use them or not. However, if compliance with a standard is claimed, then the requirements of that standard have to be followed. Extensive standardization programs in support of the three directives have been conducted by CEN and CENELEC and

Competent Authority

Medical Device Vigilance System

Manufacturer

User Reporting System

Post Market Surveillance

User

Fig. 1: Schematic diagram of the parties involved in the medical directives vigilance procedures.

16 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

several hundreds of harmonized standards have been published. CEN and CENELEC additionally have formal methods of cooperation of standards-writing with their international counterparts, the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC), respectively. Under these agreements, e.g., the “Vienna Agreement” between CEN and ISO, one organization (usually ISO) can take the lead in standards-writing with the possibility of parallel voting on the approval of drafts between the two organizations. This results in the ideal situation of having an international standard that can, at the same time, also be suitable to support European regulatory needs as an identical European standard. The European Medical Devices Vigilance System

One of the most important tasks under the new approach is the implementation of vigilance procedures concerning medical devices [5], [6]. The regulations covering medical devices concentrate primarily on premarketing requirements but do not always ensure that the products will be either safe or effective during their use. From the perspective of the healthcare facility, a medical device should be subject to continuous monitoring and quality control of its functional status in the postmarketing life cycle. On the other hand, the responsibility of the manufacturers should not stop when the device is put on the market. They must also encourage the correct application of their products through appropriate guidance or user training and monitor that their performance is according to their specification. Early warning of unexpected adverse effects can be obtained by the users reporting either back to the manufacturers (postmarket surveillance) or to the competent authorities (user reporting system) for any problem resulting from their use. Postmarket surveillance is of extreme importance for the manufacturers, since they obtain feedback from the users, in order to continuously improve their product. The EU Directives contain some provisions regarding postmarket surveillance. The AIMD Directive contains requirements for reporting device incidents, with a provision for “a systematic procedure to review experience gained from devices in the post production phase and to implement appropriate corrective action” that the manufacturers have to comply with (Figure 1). Even if the manufacturer is assigned such a surveillance task, the follow-up of maintenance schemes remains the responsibility of healthcare facilities and health care professionals. The healthcare facility should make the necessary arrangements for ensuring that devices are maintained and used properly. Unfortunately, there is no direct reference in the directives formalizing this responsibility. However, member states are responsible for introducing appropriate measures in order to meet the user’s safety requirements. Confidentiality is also an important issue. The initial reports received by a CA are confidential, but when there is an MAY/JUNE 2007

outcome of the investigation this should be made known to the rest of the CAs, in order to prevent the occurrence of other similar incidents. On the other hand, dissemination of information that has not been verified can result in serious negative consequences for both manufacturers and patients, and for that reason special care is required. In order to meet these requirements, most member states have or are in the progress of implementing their national medical device vigilance systems. Since 2004, the CEU implemented the EUDAMED system in order to facilitate the information exchange between CAs and improve confidentiality. Several hundreds of vigilance reports have already been submitted through this system, which seems very successful, but with access limited to the CAs only. Industry Perspectives

Industry has been a very strong supporter of the “new approach” regulatory system. The three medical device directives, by virtue of their broad essential requirements, supporting voluntary standards, and lack of a prescriptive approach, allow considerable flexibility in technical solutions and are considered to be “innovation-friendly,” while maintaining a high level of patient safety. Industry has contributed hundreds of experts toward the production of several hundreds of harmonized standards. With the advent of a number of innovative enabling technologies such as nanotechnology, which has the potential for enormous application in the medical technology field, and the trend toward “convergence” of existing technologies (e.g., advanced materials science, cell biology, informatics, miniaturization) to produce new generations of products, industry is very keen on maintaining the principles of the new approach in the future regulation of novel medical technology products incorporating innovative or hybrid technologies. Industry’s view is that, unless innovation-friendly, adaptable, and flexible regulation is applied to such products, there will be a strong disincentive toward investment in the necessary research and development in Europe. Conclusions

It can be generally accepted, and indeed it is formally recognized by the Council, that the “new approach” system of regulation as applied to medical devices has been highly successful and effective since its inception and has facilitated a high level of device development and placement on the market in Europe while, at the same time, providing a high level of patient safety. Challenges remain, in particular the adaptation of existing directives toward new generations of technologies and products and greater efficiency and responsiveness in the production of supporting tools such as European standards. However, the basic infrastructure has been set in place for an efficient, flexible, responsive, and innovation-friendly regulation of medical technology products. Nicolas Pallikarakis studied physics, biophysics, and medical physics in Greece, the United Kingdom, and Belgium. He is currently a professor of medical physics at the University of Patras, Greece, and chairman of the board of the Institute of Biomedical Technology (INBIT). For the last 25 years he has been actively engaged in the field of medical technology. He is IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

the director of the European Erasmus postgraduate course on biomedical engineering, running the Department of Medical Physics at the University of Patras since 1989. He is the author of more than 70 scientific papers and three books. He has been project coordinator of many national and European R&D projects such as BEAM I and II (biomedical equipment assessment and management) in the Health Care Telematics program of the CEU and the European Medical Device Information Exchange System (EUROMEDIES) and a Concerted Action addressing medical device vigilance in Europe. He was the president of the board of the Clinical Engineering Division (CED) of the International Federation for Medical and Biological Engineering (IFMBE) (1994–1996), Greek delegate for the Medical Device Standing Committee (MDEG) of DG Enterprise of the CEU, and member of the Health Care Forum of CEN (CHeF). He was recently elected a member of the International Academy of Medical and Biological Engineering (IAMBE) of the IFMBE. Richard Moore received his B.Sc. (Honours) in botany at the University of Reading in 1974. Since 1997, he has been the the scientific director (science, innovation, and horizontal regulation) of Eucomed, a nonprofit European association representing 4,500 designers, manufacturers, and suppliers of medical technology used in the diagnosis, prevention, treatment, and amelioration of disease and disability. In Eucomed he is responsible for the direction of Eucomed programs in the fields of: innovation and new technologies, including medical nanotechnology, new medical technology/regulatory interface, R&D projects at the European Commission level, human tissue-engineered products and regenerative medicine, environmental affairs, European and international standardization, and specific key product sectors. Previous work history includes project manager of healthcare for the European Committee for Standardization and project manager of the Chemical and Health Department of the British Standards Institution. He is a Fellow of the Linnean Society of London (FLS), a Chartered Biologist (CBiol), a Member of the Institute of Biology (MIBiol), a European Professional Biologist (EurProBiol), and a Fellow of the Institute of Nanotechnology (FIoN) where he now works as a manager of nanomedicine and lifesciences. Address for Correspondence: Nicolas Pallikarakis, Department of Medical Physics, School of Health Sciences, University of Patras, 26500, Rio–Patras, Greece. Phone: +30 2610 997702. Fax: +30 2610 992496. E-mail: [email protected]. References [1] “Medical devices,” Council Directive 93/42/EEC, Official J. Euro. Commission, p. L-169, 1993. [2] “Active implantable medical devices,” Council Directive 90/385/EEC, Official J. Euro. Commission, p. L-189, 1990. [3] “In vitro diagnostic medical devices,” Council Directive 98/79/EC, Official J. Euro. Commission, p. L-331, 1998. [4] Guidelines to the Classification of Medical Devices, 4th draft, Commission of the European Communities, July 1994. [5] Guidelines on a Medical Device Vigilance System, Commission of the European Communities, May 1993. [6] N. Pallikarakis, N. Anselmann, and A. Pernice, Information Exchange for Medical Devices. Amsterdam: IOS Press, 1996.

MAY/JUNE 2007

17

EXPLORING EXCITING FRONTIERS IN EUROPE

Medical and Biological Engineering and Science in the European Higher Education Area © ARTVILLE, IMAGE SOURCE

Working Toward Harmonization of Biomedical Programs for Mobility in Education and Employment BY JOACHIM H. NAGEL, DICK W. SLAAF, AND JOE BARBENEL

ardly anybody in Europe paid much attention to the harmonization of education until the recent rapid development of the European Union (EU) raised the issue of mobility and the related problems of mutual recognition of academic degrees. The Europe-wide harmonization and quality control of higher education were the objectives of the Bologna Declaration [1], demanding the creation of a European Higher Education Area (EHEA) and originally signed in 1999 by 29 European countries, including 14 nonmembers of the EU. The implementation of the ideals in the Declaration led to the Bologna Process [2]. The number of countries participating in the Bologna Process grew rapidly and now includes 45 European countries while the EU expanded in 2004 to incorporate a total of 25 countries. In parallel to the Bologna Process and in its support, the European Council, which brings together the heads of state or government of the European Union countries and the president of the European Commission, who is the European head of government, called in 2000 for the formation of the “Europe of Knowledge,” which would become a most competitive and dynamic knowledge-based economic union by realizing a harmonized European Education and Research Area. For most of the European countries these initiatives cause major, in some cases even fundamental, changes in the national systems for higher education. The Bologna Declaration asks for the promotion of European cooperation in quality assurance with a view to developing comparable criteria and methodologies and the promotion of the necessary European dimensions in higher education, particularly with regards to curricular development, interinstitutional cooperation, mobility schemes and integrated programs of study, training, and research. A system of credits should be established, such as in the European Credit Transfer System (ECTS) [3], as a proper means of recognizing and promoting student mobility. Credits could also be acquired in nonhigher-education contexts, including lifelong learning, provided they are recognized by the receiving universities concerned. In order to achieve their goals, the governmental authorities intend to pursue intergovernmental cooperation and cooperation with nongovernmental European organizations with competence on higher education. They expect the universities to contribute actively to the success of their endeavor.

H

18 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

The Declaration involves six actions related to employability, mobility, compatibility, and quality assurance to be completed by 2010: ➤ adopt a system of easily readable and comparable degrees ➤ adopt a system with two main cycles (undergraduate/graduate), which was in 2005 expanded to include doctoral degrees as a third cycle ➤ establish a system of credits ➤ promote mobility by overcoming obstacles ➤ promote European cooperation in quality assurance ➤ promote European dimensions in higher education. The aim of the process is to make the higher education systems in Europe converge toward a more transparent system where the different national systems would use a common framework based on three cycles with the bachelor’s, master’s, and doctorate degrees replacing the traditional national degrees, such as the Diploma degrees. But who will implement EHEA, and how will it be done? How will biomedical engineering education change through these developments, and how can the community of biomedical engineers influence them? As a unique opportunity to promote medical and biological engineering and science (MBES), the Bologna movement has triggered an initiative by the European MBES community to establish their Higher Education Area by harmonizing the educational programs, specifying minimum qualifications, and establishing criteria for an efficient quality control of education, training, and lifelong learning, which is very high on the list of priorities for the EU. The main objective of the current initiatives within MBES is to establish a general European consensus on guidelines for the harmonization and accreditation of high-quality MBES programs and for the certification and continuing education of professionals working in the healthcare systems. Adoption and adherence to these guidelines will allow mobility in education and employment. Implementing the EHEA for MBES in cooperation with all relevant groups will also further the professional standing of MBES and the competitiveness of European education, industry, and healthcare systems. A survey of the current status of the EHEA for MBES demonstrates that its implementation is steadily progressing and that its impact will benefit the quality of education and training [4]. 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

European harmonization of higher education programs, a prerequisite for student and teacher mobility, is an important political goal of the EU, which sooner or later all academic disciplines will adopt, although for most of them there is no inherent reason to do so. For MBES, this young discipline that is expanding so fast that today hardly any European university is able to cover all areas of MBES, it is more: it is actually an important prerequisite for students to be able to select the MBES specialties of their choice, no matter where they come from and what the specialties of their home university are. In the traditional academic disciplines consensus about the necessary content of higher educational programs and the required qualifications of professionals has been established over many decades, but MBES as a briskly growing discipline has, in contrast, not yet achieved consensus. Today, more than 200 universities, universities of applied science, polytechnic schools, academies, and other institutions in Europe offer educational programs in MBES at all academic levels, but with only little international coordination of contents and required outcome qualifications. Until recently, not even comprehensive knowledge has been available as to which institutions are involved and which programs they are offering. Since 1999, the International Federation for Medical and Biological Engineering (IFMBE), its European member societies, and numerous European universities with an interest in MBES, as well as the European Alliance for Medical and Biological Engineering and Sciences (EAMBES), an alliance of European national and transnational societies and academic institutions that was founded in 2003 on the initiative of IFMBE, have been engaged in projects aiming at creating a comprehensive survey of the status of MBES education and research in Europe. They have also been charting the MBES community; developing recommendations on harmonized MBES education, training; and certification; and establishing criteria for the accreditation of MBES programs in Europe. Implementing EHEA

Harmonizing the European education systems and making European education policies more dynamic are high on the list of European political priorities, but there are strict regulations and limitations on what is possible and who can decide which way to go within the EU. The 1997 Amsterdam treaty [5] clarifies which activities of the European Commission in the area of education are allowed in cooperation with the member countries in order to reach the common goal of high-quality educational systems in all regions of the EU. The treaty emphasizes the European dimension of education but nevertheless insists on subsidiarity that limits the power of the Union and leaves full and unrestricted responsibility for the structuring of educational systems as well as for curricula with the individual member state. The responsibility of the Union is to support and supplement activities of the member states in the area of education. The treaty does, explicitly, not allow harmonization of national laws and administrative procedures by unilateral decisions of any European entities. Thus, implementation of the EHEA cannot be decided or dictated by the European Commission but can only be achieved by European bodies that include all member states and that are able to reach unanimous decisions. Therefore, the aim of the Bologna process, i.e., the realization of the EHEA through the consensus of all 45 Bologna signatory states, is very important and needs the full support of the MBES comIEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

munity. For this purpose, a Europe-wide participation project, BIOMEDEA, was launched in 2004 by Joachim Nagel in cooperation with Dick Slaaf and Jan Wojcicki (International Centre of Biocybernetics of the Polish Academy of Sciences in Warsaw) as well as colleagues from 32 European countries, aiming at contributing to the realization of the EHEA in MBES. The project coordinates previous initiatives, using the available synergies to facilitate the implementation of the EHEA in the field of medical and biological engineering and sciences for the benefit of the universities, the students, and last but not least the European people. The project aims at establishing Europe-wide consensus on guidelines for the harmonization of high-quality MBES programs, their accreditation, and for the training and certification or even registration and continuing education of professionals working in the healthcare systems. Improved quality assurance of MBES education and training is a vital component and is also directly related to the issues of healthcare quality. It offers the advantages of providing confidence for the employer that the employee has the necessary education, training, and responsible experience, and the reassurance for the user of the service, meaning the patients, that those providing the service are effective and competent. Adherence to these guidelines will ensure mobility in education and employment and improved competitiveness of the European biomedical industries. Keeping in mind that, in addition to the Bologna process, innovative MBES teaching strategies and methods as well as new educational programs are emerging throughout Europe, filling the gap between engineering and life sciences with a variety of new specializations, it is no surprise that Nature stated in its September 2003 “careers and recruitment” section [6] that “Europe chips in for training. The United States may have more coordinated funding, but Europe is taking the lead in training biomedical engineers.” This development may be due to the diversity of the European education systems and the extra efforts it has cost the European educators to harmonize their programs, which is in complete contrast to the United States with its homogeneous higher education system. Nevertheless, there have been strong interactions between Europe and the Unites States in the biomedical engineering education, with strong European participation in the Whitaker Summits on biomedical engineering education where new methods, best practices, and contents have been discussed and accepted in trans-Atlantic agreement. The educational environments are, however, different. In the United States the universities are autonomous and in full control of the higher education system; in some European countries higher education systems are controlled by the governments. As a drawback, Europe has not experienced the huge grants from the Whitaker Foundation for the initiation of new biomedical engineering programs and research, and there is no generally accepted accreditation agency like ABET taking care of many aspects of quality assurance. Implementing EHEA requires structures and procedures as well as instruments warranting the transparency and mutual recognition of qualifications (see the “Instruments for the Implementation of the European Higher Education Area Warranting the Transparency and Mutual Recognition of Qualifications” sidebar). One of the major obstacles for people wishing to work or to study in a European country other than their country of origin is that their qualifications and competences may not be accepted. To remove these obstacles, the EU MAY/JUNE 2007

19

has introduced several instruments [7], aiming at facilitating the transfer of qualifications and competences for academic and professional purposes as they are outlined in the sidebar, including continuing education, the so-called area of lifelong learning, structures to provide transparency and recognition for academic and professional purposes, and instruments for professional recognition in regulated professions that are of interest for the biomedical engineering community with regard to a future regulation of the clinical engineering profession. Most of these instruments are not really new and they do not necessarily lead to a harmonized education area. Even if all European countries were to formally satisfy the requests of the Bologna declaration, such as two-cycle bachelor’s/master’s programs, this does not automatically guarantee comparability and compatibility of degrees and competencies, and thus it does not necessarily mean that the EHEA has been fully implemented.

It is obvious that the most urgent issues in realizing the demand for employability, mobility, compatibility, and quality assurance are to harmonize and to generate agreement on the recognition and transparency of qualifications, specifically accreditation of educational programs, training, continuing education, certification of individuals, and a regulation of safety-critical professions (Figure 1). Language is also a major problem impeding mobility. Except for some countries that are offering courses in English, although it is not their official language, most of the EU countries use their own languages as the teaching language and thus graduate and undergraduate student exchanges between, for example, Spain and Finland or Denmark and France, are not easy. The same holds for teachers. The need for quality assurance of academic programs is well understood by the national governments, which are striving to set up the structures for accreditation or at least

INSTRUMENTS FOR THE IMPLEMENTATION OF THE EUROPEAN HIGHER EDUCATION AREA WARRANTING THE TRANSPARENCY AND MUTUAL RECOGNITION OF QUALIFICATIONS The European Area of Lifelong Learning

achievements and a description of his or her national

The broader long-term aim outlined by the Commission in

higher education system.

its Communication on “Making a European Area of Lifelong Learning a Reality” [8] is to enable people to meet

Transparency and Recognition for Professional Purposes

the challenges of the knowledge-based society by pro-

A network of National Reference Points for vocational qual-

moting the development of their knowledge and compe-

ifications is being set up in the EU member states and will

tences at all stages of their lives. The validation of

be the first point of contact for questions relating to voca-

“nonformal learning” is a crucial element of lifelong learn-

tional qualifications.

ing, enabling people to build on knowledge and skills

The Certificate Supplement for vocational qualifications

wherever they are acquired. The European programs

has been developed in parallel to the Diploma Supplement

Leonardo da Vinci and Socrates/Grundtvig are the key

in higher education and is currently being tested in the

programs supporting lifelong learning and the develop-

member states.

ment of transnational vocational education and training.

A common European Format for Curriculum Vitae (CV) has been recommended by the Commission, aiming at a

Transparency and Recognition for Academic Purposes

simple and efficient presentation of individual qualifica-

The network of National Academic Recognition

tions and competences.

Information Centres (NARIC), created at the Commission’s

The Europass assists and promotes mobility within work-

initiative in 1984, covers all EU and European Economic

linked training by providing a voluntary Europe-wide

Area member states and all the associated countries in

means of recording periods of training outside the “home”

Central and Eastern Europe. These centers provide

member state.

authoritative advice and information on the academic recognition of diplomas and periods of study undertaken

Instruments for Professional

abroad. A parallel network, European Network of

Recognition in Regulated Professions

Information Centres (ENICs), was set up by the Council of

Professional recognition in the regulated professions is cov-

Europe and UNESCO-CEPES. The joint NARIC-ENIC network

ered by a set of directives specifying the rights of individual

covers a broad framework of countries.

citizens in the field of qualifications. This set of directives will in

The European Credit Transfer System (ECTS) was

the near future be replaced by one single directive covering

introduced by the Commission more than 10 years ago

all regulated professions. (In contrast to EU-Regulations,

as a common basis for recognizing students’ study peri-

which are immediately binding for all member states, EU-

ods abroad. The Commission, the Council of Europe,

Directives need to be implemented as binding national laws

and UNESCO have jointly developed a Diploma

or regulations to become effective. The member states must

Supplement that includes both a graduate’s personal

pass the necessary laws within a defined time limit.)

20 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

evaluation where they do not yet exist. In addition to, or perhaps even in contrast to, what the national governments are implementing, there is an urgent need for subject-based evaluation at the European level, a type of evaluation that is not based on national systems or institutions but on subject areas, disciplines, or professions. A missing element in Europe is that institutions do not have independent European bodies to which they could turn for an evaluation of their curricula that would not be restricted by national interests. There is a need in Europe to fill this vacuum with detailed requirements for specific disciplines, such as MBES, with regard to accreditation and evaluation of academic programs, including European subject-based evaluation, as well as continuing education, certification, and regulation of professions. By gaining influence on these processes, the MBES community can achieve much for the positive development of its discipline [9]. The continuing, dynamic development of MBES and the consequential fast expansion and changes of educational programs require that the scientific and professional societies in the field of MBES face the challenges of actively participating in shaping the future of this highly successful discipline by leading and guiding the further development of higher MBES education. It should not be forgotten that special attention must be directed toward the impact that the Bologna Process will have on MBES research within the harmonized two-cycle bachelor/master programs and even more within the Ph.D. programs, which, according to the decision of the Bologna signatory states, should be structured doctoral programs of at least three years’ duration. So far the doctoral programs in most European countries have had no specific structure and are essentially limited to supervised research projects. Present Situation and Expectations for the Future

A very important question regarding the implementation of EHEA is, of course, what impact it will have on the quality of education, training, and research in European universities. A recent survey on master’s and joint (international) degrees in Europe [10] shows that in general the development of the twocycle programs as requested by the Bologna Process, normally leading to bachelor’s and master’s degrees, does not have systematic negative impacts on the quality of education. On the contrary, expectations are that adding the advantages of harmonized or even international programs, the European educational systems will gain in quality and international competitiveness. The main conclusion of the survey is that there is still significant variety with regard to the duration and architecture of degrees in the EHEA, but there is a dominant trend toward a two-cycle structure cumulating in master’s level degrees that require the equivalent of 300 ECTS credits; i.e., five years, with one full-time academic year being counted as 60 credits and thus one credit being equivalent to about 30 work hours. As an EAMBES and IFMBE recommendation, these should contain at least 60 credits at the graduate level in the area of specialization; i.e., MBES. But there is no agreement yet among the European countries on how to stagger the two cycles. Most common is the 3+2 year model although some countries prefer 3.5+1.5 year and a few countries even opt for the 4+1 year solution, leaving only one year for the master’s program. It is obvious that in this situation only outcomebased accreditation of the programs can warrant the necessary IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Realizing the Requests for Employability, Mobility, Compatibility, and Quality Assurance Requires European Agreement on: Accreditation of Educational Programs Training Continuing Education Certification of Individuals Regulation of Professions Management Structures for the Harmonized Education Fig. 1. Requirements for the MBES EHEA.

European harmonization of education. Credit systems have been, or are being introduced, in almost all countries and there is a clear trend to use ECTS. Also, the Diploma Supplement is used or being introduced in a majority of countries. The general requirement for access to a master’s program is usually the completion of an undergraduate degree at the bachelor’s level, but a growing number of countries are allowing access to holders of equivalent, often less formal, qualifications and provide more bridges between the professional higher education sector and the universities. Only a few higher education institutions feel the need to seek accreditation from foreign agencies, since national and regional accreditation agencies either exist or are developing rapidly in most parts of Europe. In short, the European situation can be characterized by regional differences as to the realization of the Bologna Process. While those countries with higher educational systems based on the Anglo-Saxon tradition are less eager to change and harmonize their systems, the Baltic countries are well advanced in the reform process, the Nordic countries are deepening the reform, in Western and Southern Europe the Bologna Process gives a boost to reforms, and in Central and Eastern Europe the reforms continue and gain speed after some initial resistance to change. MBES

Information on the post-Bologna developments of education, training, and accreditation in the area of biomedical engineering has been gathered in the IFMBE/EAMBES White Paper on the status of MBES in Europe [4], organized and edited by Joachim Nagel. Information has been obtained about the situation and practice in 28 European countries and it contains an overview, written by Joe Barbenel, attempting to compare and contrast the different national models. When looking at all the information, it is necessary to bear in mind two important constraints. The field of biomedical engineering is changing and growing rapidly, which means that some of the information was out of date almost as soon as it was written. The sections on different countries also show the very great national variability in both educational practice and nomenclature that makes comparison difficult. It is to be hoped that the implementation of the ideas and aims of the Bologna Declaration will lead to more consistency and simplicity in the future. The Bologna Declaration envisages two main educational cycles, undergraduate and graduate. The first cycle will last a minimum of three years and leads to the award of a degree that is, in the words of the Declaration, “relevant to the European labor market as an appropriate level of qualification.” In contrast to the United States, this first level of professional qualification is not yet accepted by the employers in MAY/JUNE 2007

21

In the United States the universities are autonomous and in full control of the higher education system; in some European countries higher education systems are controlled by the governments. most European countries, and nearly 100% of the graduates are enrolling in the second cycle, though some countries are intending to limit access to the second cycle to a certain percentage of first-cycle graduates. The successful completion of the first-cycle degree is required for access to the second-cycle degree that “should lead to the master and/or doctorate degree” [1]. The implementation of the Declaration has led to the situation where the minimum of three years for the first cycle is becoming the standard duration. With two exceptions biomedical engineering education is available in all the countries covered by the White Paper. The biomedical engineering programs are based on two models, one in which biomedical engineering is a component of a mixed degree and the second in which the degrees are nominally in biomedical engineering. There are many undergraduate degree programs in conventional engineering subjects—particularly electrical, mechanical, and chemical—that contain biomedical engineering options or electives. The biomedical content appears not to be a route to practice as a professional biomedical engineer but has an educational aim; i.e., to provide examples of the application of the conventional engineering that forms the majority of the degree content in an unusual but interesting and demanding context. Biomedical applications appear to be particularly popular in electrical engineering, with an emphasis on biomedical electronics, instrumentation, as well as signal and image analysis. The situation with postgraduate degrees is less clear, but there are some M.Sc. degrees in electrical and mechanical engineering that are awarded with a major in biomedical engineering. First-cycle programs that lead to a biomedical engineering degree are either stand-alone programs or the first stage of a two-cycle degree. Both types are generally of three-years’ duration. The stand-alone programs usually lead to technical/ technician-level qualification. As with the mixed undergraduate courses, there is a strong emphasis on electronics and instrumentation, but there is also an industrial bioengineering qualification in Italy. The situation in Ireland is rather different, where the course duration may be four years, leading to a professional level rather than a technician level degree, although some graduates are employed in technical-level posts. In The Netherlands, the Universities of Eindhoven and Twente provide two-cycle (3+2) fully integrated biomedical engineering programs; i.e., life sciences integrated from the start. The structure of second-cycle biomedical engineering degrees is particularly variable and even within one country there are often major differences. There are, however, three common models, as described in the following paragraphs. The second cycle follows the first cycle as an integrated course leading to a single degree. The second-cycle components last either one or two years, commonly producing a 522 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

year degree, although four years is more usual in England, where the resulting qualification is generally called an undergraduate master’s degree. A wholly biomedical postgraduate master’s degree, with completion of a first-cycle degree as an essential entry requirement. The nature of the first-cycle degree is, once again, very variable. In many cases the first-cycle degree must be in engineering or a physical science, but there are also degree courses that will accept those with life science, medical, or paramedical degrees. The degrees are of 1- or 2year duration and generally contain both instructional and research components, although the balance of components appears to extend from virtually all instruction to virtually all research. There is a lack of common degree names, although master of science is widespread. Third-cycle biomedical engineering degrees. The Bologna Declaration originally envisioned only two educational cycles, the second cycle being a master’s or doctoral degree. In practice students can, and often do, progress from a master’s degree to a separate doctoral degree, usually Ph.D., which represents a third- rather than a second-cycle degree. Entry conditions often, but not always, require the candidate to have a second-cycle degree. The Ph.D. in Europe has traditionally been rather like a research apprenticeship, being almost entirely research based. There is a growing tendency for the degree to contain instructional material, often with credit for prior material; e.g., in a preceding master’s degree. The usual minimum duration of study is three years. Accreditation of Degrees and Programs

Biomedical engineering degrees are accredited or approved by a variety of mechanisms. By far the most common agency is a government ministry or department, usually of health, science, or technology. In Israel the approving agency is the Higher Education council, a government-supported public body. There is no comment on degree accreditation in more than half of the national returns, but in many of these countries the universities are autonomous and degree courses do not need external authorization, being a matter for the university itself. Accreditation of program content is less common than degree accreditation. Government agencies are the most common source of accreditation although in the United Kingdom professional societies are a source of accreditation. The United Kingdom method is particularly complex because the engineering institutions accredit the conventional engineering content of some mixed degrees with biomedical engineering content. The United Kingdom biomedical engineering society accredits some postgraduate M.Sc. degrees with an instructional content matching a notional syllabus defined by the society. MAY/JUNE 2007

Provision and Accreditation of Training

There appears to be little provision for the training of those entering healthcare in a hospital setting. There are, however, training schemes reported for Denmark, the United Kingdom, The Netherlands, and Ireland. In Denmark, there is a threeyear integrated postgraduate educational and training program. The course is organized and delivered by Odense University Hospital, apparently under the auspices of the Danish Health Council, and leads to certification as a clinical engineer. There is a similar two-year program for clinical technicians. In the United Kingdom the trainees are employed in the National Health Service at an appropriate training grade. The training scheme normally lasts for six years, being divided into three training periods. Basic training that combines both training and education is normally the entry into the profession and is for two years, reduced to at least 15 months for trainees with an M.Sc. accredited by the national society (see above). Successful completion of the basic training scheme leads to the award of a Diploma of the national society and an M.Sc. Basic training is followed by a four-year program of advanced training and responsibility. Training takes place in centers that have been accredited by

the national society, which also has a syllabus of the competencies to be developed by the trainee. Registration

Registration is possible in very few European countries. There is a voluntary register organized and administered by the national biomedical engineering society in Ireland, Norway, and Sweden. In the United Kingdom, voluntary registration organized by the national biomedical engineering society (IPEM) has been replaced with compulsory registration. All those who interact with patients, either directly or indirectly, must be registered with the Health Professions Council as clinical scientists. Applicants for registration must show that the applicant has achieved the competences required after four years of participation in the IPEM training scheme, although these may be obtained by alternative, nonIPEM routes. Continuing professional development will be a requirement for continuing registration. There is widespread recognition of the need for biomedical engineering education, training, and accreditation/certification throughout Europe. Many schemes are being developed or are awaiting implementation, but there has

BIOMEDEA WORKSHOPS IN 2004 AND 2005 The 2004 Eindhoven meeting (http://www.bmt.tue.nl/biomedea) consisted of four workshops:

Specify? The goal of the workshop was to specify the general requirements of the guidelines.

• The Undergraduate Biomedical Engineering Curriculum.

• BME/CE Training – a European Training Scheme. The

The goals were to delineate the core topics in biomed-

goal here was to establish a European Protocol for the

ical engineering science that all biomedical engineer-

formation and training of biomedical or clinical engi-

ing students should understand, the biomedical

neers working in a hospital environment.

engineering science topics, underpinning areas of bio-

• BME core competencies and specializations that should

medical engineering specialization, and the critical skills

be recommended in the guidelines for the accredita-

expected of all undergraduate biomedical engineers.

tion of BME programs in Europe.

• The Biomedical Engineering Master Curriculum. The

• Guidelines for curricula, specifying a flexible framework

goals were to delineate at the graduate-level intellec-

of biomedical engineering curricula as a guide for the

tual underpinnings for the future of biomedical engi-

accreditation of biomedical engineering programs.

neering, integration of the engineering sciences and

• Basic competencies in engineering/science, biology

modern biology, engineering opportunities in the hospi-

and medicine, and general competencies including

tal, and critical skills.

“soft skills” as minimum output requirements for accred-

• Educational Methods and Best Practices. The goals of the

ited biomedical engineering programs.

workshop were to discuss educational methods and to illustrate best practices adapted to teaching biomedical

The 2005 Stuttgart meeting (http://biomedea.org) included

engineers how to solve clinical and biological problems.

workshops on:

• Training. The goal of this part of BIOMEDEA was to gather

• Criteria and Guidelines for the Accreditation of

the information necessary to write a survey on biomed-

Biomedical Engineering Programs in Europe

ical engineering/clinical engineering training in Europe

• European Protocol for the Training of Clinical Engineers

and to establish guidelines for the minimum require-

• European Protocol for the Certification of Clinical Engineers

ments for the training of clinical engineers in Europe.

• European Protocol for the Continuing Education of Clinical Engineers

The 2005 Warsaw meeting (http://hrabia.ibib.waw.pl/

• IFMBE International Register of Clinical Engineers and an

Biomedea) included workshops on:

international symposium on Patient Safety –

• Guidelines for the Accreditation of BME Programs in

Biomedical/ Clinical/Hospital Engineering Providing a

Europe: Why Do We Need Them and What Should They

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Safe Health Care Environment.

MAY/JUNE 2007

23

The BIOMEDEA project aims at establishing Europe-wide consensus on guidelines for the harmonization of high-quality MBES programs, their accreditation, and for the training and certification or even registration of professionals. been little harmonization. The continuing national differences are a serious problem that can hinder and limit transnational education, training, employment, and cooperation. The BIOMDEA project aims at changing this situation by developing European standards that will be recognized in all 45 Bologna signatory countries. BIOMEDEA

The project aims at establishing Europe-wide consensus on guidelines for the harmonization of high-quality MBES programs and their accreditation and for the training and certification or even registration and continuing education of professionals working in the healthcare systems. Adherence to these guidelines will ensure mobility in education and employment as well as the necessary safety for patients. Targets for the dissemination of results will be the European universities, political decision makers at European and national levels, the European Accreditation Council as well as the accreditation councils of all European countries, European quality assurance and accreditation agencies, healthcare providers, and students. BIOMEDEA is moving ahead very successfully. There have been three meetings with the participation of 80 European academic institutions that took place in Eindhoven (The Netherlands), Warsaw (Poland), and Stuttgart (Germany) with numerous workshops (see the “BIOMEDEA Workshops in

2004 and 2005” sidebar). As a result, there has been agreement on the Criteria and Guidelines for the Accreditation of Biomedical Engineering Programs in Europe [11] and a European Protocol for the Training of Clinical Engineers [12]. European Protocols for the Certification and Continuing Education of Clinical Engineers have been discussed and are currently being written. IFMBE, the main sponsor of BIOMEDEA, will, in cooperation with the World Health Organization (WHO), as a part of the initiatives for the World Alliance for Patient Safety (www.who.int/patientsafety), set up a global registry of certified clinical engineers with the goal of international mutual recognition of certification and strive toward making certification and/or registration of clinical engineers mandatory everywhere in the world, based on the same criteria. This would substantially improve mobility of clinical engineers but would also contribute to increasing patient safety. In order to realize the principles of the European Protocol for the Training of Clinical Engineers, adequate structures for the management of the training scheme as they are shown in Figure 2 must be put in place. Future Developments BIOMEDEA and EUR-ACE

With broad support from the European bodies, a new project, EUR-ACE (Accreditation of European Engineering Programs and Graduates), has been entrusted by the Bologna countries with the task of establishing National Society or European standards and procedures for Engineering Professional Body Medical Equipment Educational Institutions quality assurance and accreditation in Suppliers higher education. EUR-ACE aims at setting up a European system for accreditaClinical Engineering Professional Biomedical Clinical Engineering Development Panel Industry tion of engineering education [13] with Professionals Manufacturers the following main goals: ➤ provide an appropriate “European Employer label” to the graduates of the accreditBoard of European Training Coordinator Representatives ed educational programs Examiners (IFMBE) ➤ improve the quality of educational programs in engineering Training Coordinator ➤ facilitate transnational recognition by (1 per Training Center) the label marking ➤ facilitate recognition by the competent authorities, in accord with the Training Supervisor (1 for Each Trainee) EU directives ➤ facilitate mutual recognition agreements. The system will be based on a set of Trainee common European standards that will be proposed, tested in a number of countries, Fig. 2. Structure for the management of clinical engineering training and certificarefined and tuned, and then tested again in tion in Europe. order to achieve the largest consensus. A

24 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

detailed proposal will also be formulated on how to set up and run the system that must become self-supporting within the five years. The project will thus interest several target groups, from higher education decision-makers at the European level to governing bodies of higher education institutions, from national and local higher education authorities to engineering teachers, from professional organizations to employers of engineers. It will be a significant contribution to the harmonization of the European higher education and possibly pave the way for analogous initiatives in other professional fields. BIOMEDEA will represent the specific biomedical engineering issues and interests within EUR-ACE and will test its specific criteria for accreditation within the project.

in electrophysiology from the same university in 1977. He joined the Department of Biophysics at Universiteit Maastricht in 1975. He was appointed professor of physics of the microcirculation in 1997 and professor of vital microscopy and imaging at the Faculty of Biomedical Engineering of the Eindhoven University of Technology in 2003. He is a member of the Dutch, European, German, and American Microcirculatory Societies; the Dutch and American Physiological Societies; the European Alliance for Medical and Biological Engineering & Sciences (EAMBES; chair, Academic Division); and president of the Dutch Society for Biophysics and Biomedical Engineering.

Global Aspects

MBES is not isolated from the rest of the world in the EHEA. The BIOMEDEA meetings have attracted international interest and participation in its activities. Global exchange of experiences and harmonization of MBES education and training, specifically in the field of clinical engineering, does not only contribute to the mobility of students, teachers, and those employed in the various MBES professions but also contributes to the improvement of the healthcare systems and specifically patient safety. Through the IFMBE, BIOMEDEA is participating in two major WHO initiatives, the World Alliance for Patient Safety and the Global Alliance for the Health Workforce. Experiences gathered in these international activities will in the future permit further development of the guidelines and protocols for biomedical and clinical engineering education and training for the benefit of the discipline and the well being of people not only in Europe but worldwide.

Joe Barbenel qualified in dentistry (University of London) in 1960. After general dental practice he graduated in physics (St. Andrews) in 1966 and became a lecturer in dental prosthetics at the University of Dundee. He graduated with the M.Sc. and the Ph.D. in bioengineering from the University of Strathclyde, where he subsequently became a member of the academic staff, becoming head of the Bioengineering Unit before retiring in 1999. Since then he has been based in the Centre for Ultrasonic Engineering, University of Strathclyde. He is a fellow of the Institute of Physics (UK), of the Institute of Biology and Institute of Physics and Engineering in Medicine (UK), and of EAMBES. He remains involved in the recognition and development of MBES at the national and international levels.

Conclusions

Address for Correspondence: J.H. Nagel, Department of Biomedical Engineering, University of Stuttgart, Seidenstrasse 36, 70174 Stuttgart, Germany. Phone: +49 711 685 82370. Fax: +49 711 685 82371. E-mail: [email protected].

The evolving EHEA will substantially influence the development of educational aspects of medical and biological engineering and sciences. These developments will be beneficial to the biomedical engineering profession and to society as a whole. The biomedical engineering community must grasp this opportunity through focused national and European actions and cooperation with the relevant bodies.

Joachim H. Nagel is a professor and chairman of the Biomedical Engineering Department at the University of Stuttgart, Germany, following more than a decade as a professor of biomedical engineering, radiology, and clinical psychophysiology at the University of Miami, Florida. He is the president of the International Federation for Medical and Biological Engineering (IFMBE), the designated president of the International Union for Physical and Engineering Sciences in Medicine (IUPESM), a member of the Council of the European Alliance for Medical and Biological Engineering and Science (EAMBES), and the immediate pastchairman of the Division of Academic and Research Institutions of EAMBES. Dr. Nagel is the founder and leader of the European BIOMEDEA project: Biomedical Engineering Preparing for the European Higher Education Area. Dick W. Slaaf studied experimental physics at the University of Utrecht, where he graduated in 1972. He obtained his Ph.D. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

References [1] European Higher Education Area, “The Bologna Declaration of 19 June 1999,” [Online]. Available: http://www.bologna-berlin2003.de/pdf/bologna_declaration. pdf [2] From Berlin to Bergen [Online]. Available: http://www.bologna-bergen2005. no/ [3] ECTS User’s Guide [Online]. Available: http://www.hrk.de/de/download/ dateien/ECTSUsersGuide(1).pdf [4] J.H. Nagel, Ed., Biomedical Engineering Education in Europe—Status Reports [Online]. Available: http://www.biomedea.org/Status%20Reports%20on% 20BME%20in%20Europe.pdf. [5] Treaty of Amsterdam [Online]. Available: http://www.eurotreaties.com/ amsterdamtext.html [6] R. Jox, “Europe chips in for training,” Nature, vol. 425, p. 326, Sept. 2003. [7] The European Commission, “Recognition and transparency of qualifications” [Online]. Available: http://europa.eu.int/comm/education/policies/rec_qual/ rec_qual_en.html [8] The European Commission, “Making a European Area of Lifelong Learning a reality” [Online]. Available: http://europa.eu.int/comm/education/policies/ lll/life/index_en.html [9] J.H. Nagel, “Biomedical engineering in a European Higher Education and Research Area,” Lecture Notes of the ICB Seminars, pp. 11–35, 2002. [10] C. Tauch and A. Rauhvargers, “Survey on master degrees and joint degrees in Europe” [Online]. Available: http://www.eua.be:8080/eua/jsp/en/upload/ Survey_Master_Joint_degrees_en.1068806054837.pdf [11] “International Federation for Medical and Biological Engineering,” Criteria and Guidelines for the Accreditation of Biomedical Engineering Programs in Europe. [Online]. Available: http://www.biomedea.org/Documents/Criteria% 20for% 20Accreditation%20Biomedea.pdf [12] “International Federation for Medical and Biological Engineering,” European Protocol for the Training of Clinical Engineers [Online]. Available: http://www.biomedea.org/Documents/European%20CE%20Protocol%20Stuttgart.pdf [13] EUR-ACE, Accreditation of European Programmes and Graduates [Online]. Available: http://www.feani.org/EUR_ACE/EUR_ACE_Main_Page.htm

MAY/JUNE 2007

25

EXPLORING EXCITING FRONTIERS IN EUROPE

Biomedical Engineering and eHealth in Europe Outcomes and Challenges of Past and Current EU Research Programs © ARTVILLE, IMAGE SOURCE

BY ILIAS IAKOVIDIS, OLIVIER LE DOUR, AND PEKKA KARP

iomedical engineering and information and communication technologies (ICTs) for health, in short biomedical engineering and eHealth, are interdisciplinary sciences that are growing fast and have a significant social and economic impact. The European Commission (EC) has promoted closer collaboration between the disciplines for several years [1] by creating new application areas, such as personal health monitoring systems integrating advanced biomedical sensors. Indeed, biomedical engineering has been a pioneer field in European Community research related to health. The synergy and collaboration is a natural consequence of the pervasive nature of the information technologies in all aspects of life, including the new generation of medical technologies and devices. However, stronger collaborations are needed across disciplines and research areas such as biology, physics, medicine, engineering, nanotechnologies, and ICTs in order to address the important challenges in healthcare and market opportunities. The EC has supported research and development related to the biomedical engineering and ICT for health for over 20 years. In 1987 it accounted for 45% of the medical research program and has maintained a significant presence, albeit with a variable visibility, over successive Framework Programmes (FP). Examples of focused programs include the BIOMED1 and AIM (Advance Informatics in Medicine) programs. The consolidation of the medical devices market, which demanded from the EU a stronger regulatory framework; the rapid evolution of information technologies; and the phenomenal growth of genomics research have resulted in a diffusion of the research related to biomedical engineering and ICT for health within other programs and research priorities since the late 1990s. Health-related research, including health technologies, accounts in sixth EC Research and Technology Development Framework Programme (FP6) for approximately €4 billion (25%). The funding for biomedical engineering and eHealth amounts to approximately €500 million. It has been provided mainly by three priorities (programmes) of FP: life sciences, information society technologies, and nanotechnologies and nanosciences.

B

26 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

European Commission Support to Biomedical Engineering and eHealth

The total yearly budget of the EU is around €100 billion, corresponding to roughly 1% of the gross domestic product (GDP) of its member states. Research is, in budgetary terms, the third policy of the European Community. The first two are the Common Agricultural Policy (45% of the EC expenditures) and Structural Funds (35%), aimed at assisting the lesser economically developed regions and member states. Since 1984, research and development activities of the EU are presented within an overall Framework Programme for Research and Technological development that normally has a duration of five years. Seventh FP has a duration of seven years, so that it matches the EU budgetary planning for 2007–2013. With a proposed funding of almost €55 billion, it accounts for about 4% of EC expenditures. Past Research and Developments Programs

Biomedical technology and engineering was addressed by the EC during the late 1980s by health research programs. This continued up to the biomedicine and health program in the Fourth Framework Programme (1994–1998); see, e.g., [2]. In BIOMED2, 50 collaborative research projects in the area of biomedical engineering were funded. Since the beginning of the Fifth Framework Programme (1998–2002), there is no longer a single framework identified as a “biomedical engineering and technologies research programme” at the EC level. Instead, a fragmented and a dynamic landscape exists with programs or subprograms calling for biomedical engineering expertise appearing (and disappearing). In the FP6 biomedical engineering topics could be found in personal (wearable and implantable) eHealth systems, assistive and rehabilitation technologies, micro- and nanosystems, and bio-inspired information technologies in the Information Society Technologies Programme; neurosciences research, radiotherapy and medical imaging as part of the Life Sciences, Genomics, and Biotechnology for Health Programme; and biosensors in the Nanotechnologies Programme. The scientific community in the field has, with time, learned to identify the appropriate Programme to be submitted with the relevant proposal. This might have created some confusion and caused some lack of visibility for the sector, as compared to well-identified “desks” 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

for research dealing, for example, with telecommunications technology or pharmaceuticals. ICT for health-related research started in 1988 with an exploratory action. In FP3 (1991), a three year programme started called Advanced Informatics in Medicine (AIM) with a European Community (EC) contribution of €111 million. This program has seen a move from prototype development to commercial product creation and an increase in funding to €150 million and €200 million in the Fourth and Fifth Framework Programmes, respectively [3]. The terms and focus have evolved since 1994 from medical informatics to health telematics, now evolved into eHealth, with special emphasis on biomedical informatics. [While the term biomedical informatics in the current IST program is used to represent a scientific area that builds on synergy between medical informatics and bioinformatics (http://bioinfomed.isciii.es/), in this article the terms biomedical informatics, medical informatics, eHealth, and ICT for health are used interchangeably.] For some years these programs formed a “unique” research and development program in the world that focused on health telematics. They created a strong European community in the field, demonstrated the benefits of many eHealth solutions, and supported EU industry in its drive to become competitive internationally. Many of these research results have now been tested and put actively into practice. The Advanced Materials and Industrial Technologies scheme (the so-called Brite-Euram) and consequently the Growth Programme have supported research related to biomaterials and predecessors of what, in the Sixth Framework Programme, has become the Nanotechnologies and Nanosciences Programme. This program supports research in nanotechnologies and nanobiotechnologies including applications in healthcare such as biosensors, biomaterials, and new breeds of biochips for treating life-threatening conditions, including cancer and heart disease. Other research areas include development of bioengineered devices, in the form of body implants that deliver smart drugs or carry new cells to repair damaged tissue that combine nanoscale engineering with biology to manipulate either living systems or to build biologically inspired materials at the molecular level. Sixth Framework Programme (2002–2006)

The situation in FP6 is not very different from that of FP5. There are again three main axes in three research priorities addressing biomedical engineering and ICT for health. Priority 1 – Life Science, Genomics, and Biotechnology for health has a heavy emphasis on genomics, biotechnology for health, cancer research, and vaccines against poverty-related diseases (HIV-AIDS, malaria, tuberculosis). Nevertheless, within this priority, one could estimate that globally €100 million to €120 million were dedicated to biomedical engineering-related projects in the following fields: bioinformatics, molecular imaging, radiation therapy for cancer, and brain functional imaging.

➤ Micro- and nanosystems: Miniaturized implantable devices

with microfluidic controls that can deliver treatment in a controlled manner; artificial organs; new biomedical sensors with in vitro testing; smart textiles; e.g., [5] ➤ Future and emerging technologies (FET) [6]: A specific aim of the FET actions is to sponsor novel multidisciplinary research in the area of bio-inspired information technologies. For instance, brain-computer interface, neurons-on-silicon, and nanobiosensor research is funded via this scheme; e.g., [7]. Priority 3 – Nanotechnologies and nanosciences priority supported research projects with approximately €70 million for medical instruments and equipment for better surgery and diagnosis systems, tissue engineering, new biosensors, biomimetic and biohybrid systems, and others. There are other international programs as well; for example, Eureka, an intergovernmental initiative that was launched in 1985 for 35 European countries. The Eureka scheme is open to all scientific sectors. There are currently 145 ongoing projects, for a total budget of roughly €370 million, in the medical and biotechnology areas, up to a third of which is related to biomedical engineering and technologies. Seventh Framework Programme (2006–2013)

The funding in the Seventh Framework Programme [8] has significantly increased to approximately €54.5 billion. It includes again major programmes (called themes) on health, ICT, and nanotechnologies. New research activities related to biomedical engineering and eHealth will be supported by these themes. For example, within the health theme, new activities relate to detection, diagnosis, and monitoring with emphasis on noninvasive or minimally invasive approaches; innovative therapeutic approaches; and intervention. The ICT theme of the Programme is presenting new plans for its ICT for health activities focusing on ICT-based systems and services for improved prevention, personalization of care, and new activities related to modeling and simulation for support of predictive medicine. The FET area will support research at the frontier of knowledge in core ICTs and in their combination with other relevant areas and disciplines. In areas related to biomedical engineering, FET will aim at exploiting synergies between biology and ICTs, in a variety of areas such as neuromorphic information processing, biohybrid interfaces and systems, modeling, and simulation. Similarly, new research topics are included in the nanotechnologies theme. In addition to the traditional (collaborative) programmes, there is an opportunity for single individuals (ideas specific programme). Outside of the setting of FP7 there are also many other smaller programmes such as Competiveness and Innovation (CIP) programme that will support larger scale deployment activities in the area of eHealth. Conclusions

Priority 2 – Information Society Technologies devoted to biomedical engineering and eHealth-related fields approximately €300 million. The most relevant areas include: ➤ ICT for health: Intelligent and communicating wearable health systems integrating the latest biomedical sensors; software tools supporting health professionals; biomedical informatics. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

The biomedical engineering and ICT for health (eHealth) areas have been funded by EU research programs during the last 20 years. During the last two Framework Programmes (1998–2006) biomedical engineering has been diffused in several programs and priorities, but the total amount of funding has not diminished and has followed the overall growth of the EU funds for research. Many good results have been achieved MAY/JUNE 2007

27

that have led not only to new diagnostic and treatment methods and devices but also have contributed to the growth of one of the largest industries worldwide. For example, the ICT for the health industry became the third-largest industry of the health sector that has tripled in size during the last 10 years [9]. The current FP7 will support innovative research at the crossroads of medicine, biology, engineering, and information sciences and contribute to worldwide state-of-the-art technology through the full span of the innovation chain from foundational to applied research. New opportunities will appear for the biomedical engineering and health informatics community due to the convergence of many technologies and methods within the health domain. The focus on the ultimate benefits to all citizens, such as improved health access to quality healthcare and the efficiency of new citizen-centered healthcare delivery systems, will put health technologies center stage for innovative research, technological assessment, and clinical validation. The synergy of areas such as medical informatics and bioinformatics will give rise to research that supports molecular- and genomics-based medicine. The advances in computational tools and infrastructures will enable one to address new challenges such as multilevel modeling and simulation of the human anatomy and physiology that will enable in silico testing and modeling of biological processes related to diseases and treatments [10]. In the new program the traditional areas of biomedical engineering and eHealth will be expanded due to overall convergence of info-bio-nano technologies and cognitive sciences. For example, the clearly defined biomedical engineering disciplines (e.g., physiological measurements, medical imaging) will be accompanied by others emerging areas of transdisciplinary expertise (such as nano-bio-IT, systems and synthetic biology, complex systems). The biomedical engineering and eHealth area represents one of the most dynamic and leading research fields and areas of innovation. It has a huge existing and emerging industrial base. The social and economic impact of innovation and progress is unquestionable. This multidisciplinary research area, with healthcare as a common traditional application area, is also extending to cover new areas of cooperation. The selection of research themes and priority setting in the Framework Programme takes place through consultations with the research communities. The relevant research community is expected to contribute to the process of setting priorities. Indeed, a necessary condition for future progress in this exciting cross-disciplinary area depends on improved communication and synergy between all the research disciplines and their concerted effort with industry and relevant authorities. Acknowledgments

The views presented in this article are those of the authors and do not necessarily represent the views of the European Commission. Ilias Iakovidis is deputy head of the ICT for Health unit of the European Commission. He is responsible for the research strategy and international cooperation. He is also working on the follow-up of the eHealth Action Plan COM (2004) 356, of which he was the main co-author. Beyond the office duties he continues to 28 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

publish, teach, and give lectures at major international conferences. In 2001 he was elected fellow of the American College of Medical Informatics for his contribution to the field. Olivier Le Dour is assistant to the Health Research Director of the European Commission at the Research Directorate General, a task that involves both giving advice and internal coordination for a department of 140 people. His background is in medical imaging. Over the years as a Commission official, he has been a project officer for the biomedical engineering area and for demonstration projects in health research as well as a policy officer in health research. Pekka Karp is the deputy head of the Future and Emerging Technologies unit in the Directorate General for Information Society and Media of the European Commission. He acts as the program manager in the areas of bio-inspired information technologies and robotics. He received his Dr.Tech. degree in electronics from the Helsinki University of Technology, Finland, in 1977. His research topics included measurements and analysis of biomagnetic fields. He was associate professor of physics at the University of Kuopio, Finland, from 1979 to 1981. In 1982 he joined the Finnish Centre for Metrology and Accreditation. From 1987 until 1994, he worked as the technical director of the Helsinki University Central Hospital and from 1995 as research professor and the director of the Finnish Office for Health Care Technology Assessment until joining the European Commission in 1996. Address for Correspondence: Ilias Iakovidis, European Commission, Information Society and Media DirectorateGeneral, Avenue de Beaulieu 31, 1160 Brussels, Belgium. E-mail: [email protected].

References [1] I. Iakovidis, “Collaboration of biomedical engineering and medical informatics on the road to citizen-centred care,” presented at VIII Mediterranean Conf. on Medical and Biological Engineering and Computing (MEDICON ‘98), Lemessos, Cyprus, June 1998. [2] “Biomedicine and Health (BIOMED 2) 1994–1998” [Online]. Available: http://www.cordis.lu/biomed/src/ab-2.htm#2 [3] I. Iakovidis, “From medical informatics to eHealth and biomedical informatics: Overview of EU activities and achievements,” in Proc. MIE2004-STC Conf., Munich, Germany, June 2004. [4] V. Maojo and M. Tsiknakis, “Biomedical informatics and HealthGRIDs: A European perspective,” IEEE Eng. Med. Biol. Mag., vol. 26, pp. 34-41, May 2007. [5] A. Lymberis and A. Dittmar, “Advanced wearable health systems and applications: Research and development efforts in the European Union,” IEEE Eng. Med. Biol. Mag., vol. 26, pp. 29-33, May 2007. [6] “Future and Emerging Technologies” [Online]. Available: http://cordis. europa.eu/ist/fet/home.html [7] M. de Kamps and A. Knoll, “A Roadmap for NeuroIT: Challenges for the next decade,” IEEE Eng. Med. Biol. Mag., vol. 26, pp. 42-46, May 2007. [8] Seventh Research Framework Programme (FP7) homepage [Online]. Available: http://cordis.europa.eu/fp7/home_en.html [9] “Making healthcare better for European citizens: An action plan for a European eHealth Area” [Online]. Available: http://www.europa.eu.information_ society/activities/health/policy_action_plan/index_en.htm [10] “Towards Virtual Physiological Human: Multilevel modeling and simulation of the human anatomy and physiology” [Online]. Available: http://europa.eu/ information_society/activities/health/docs/events/barcelona2005/ec-vph-whitepaper2005nov.pdf

MAY/JUNE 2007

Research and Development Efforts in the European Union © ARTVILLE, IMAGE SOURCE

BY ANDREAS LYMBERIS AND ANDRÉ DITTMAR

edicine has traditionally focused on treatment using molecules, drugs, mechanics, prosthesis, and surgery. More recently, the healthcare community’s investments and expectations have shifted more toward early detection of diseases, health status monitoring, healthy lifestyle, and overall quality of life. Healthcare providers are looking for cheaper and more responsive ways of delivering services than through large centralized institutions [1]. Healthcare and health services have to be accessible to everyone, at low cost, whenever and wherever they need them. The evolution that is underway in healthcare and health delivery in Europe and worldwide is mainly driven by: ➤ demographic changes [1], including the increase of the aging population and chronic diseases and the need for further integration of handicapped ➤ steadily increasing healthcare costs [2] ➤ cultural changes; e.g., people becoming more eager to participate actively in their own health management ➤ the remarkable progress in sciences and technologies, like biomedicine and micro/nano technologies (MNT), offering new solutions based on integrated, smart, cost-efficient systems. In particular, the strong market demand for microsystems and nanotechnologies in medical applications has significantly contributed to the continuous technological innovation [3]. Europe has driven substantial developments in medical technology and eHealth since the early 1990s. In particular, research & development support under the Information Society Technologies (IST) activities of the Fifth Research and Development Framework Program (FP5, 1999–2002) of the European Commission (EC) has achieved significant results in integrated ICT systems and applications to support mobile and personal health. Special research and development effort was placed on smart wearable health systems and applications (SWHSA) [4]. This work was further advanced in FP6 (2002–2006) with more integrated multifunctional wearable systems like smart textiles, body sensor networks, and context-aware sensor systems enabling physiological, biochemical, and physical monitoring of the individual. Research and development projects in SWHSA face several common issues, technological and nontechnological, which

M

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

EXPLORING EXCITING FRONTIERS IN EUROPE

Advanced Wearable Health Systems and Applications

are usually addressed in the user-requirements phase of a project. This article discusses these aspects as well as the major achievements and ongoing research and development on SWHSA in Europe (and worldwide) and future challenges. User Requirements for Wearable Health Systems and Applications

Communicative wearable health systems [4]–[6] are recognized as one of the most promising platforms for minimally obtrusive and individualized health services at the point of need. In addition to improving the quality of life, the strong interest in developing and implementing such solutions is guided by the considerable direct and indirect annual medical costs [2]. SWHSA could contribute to a significant reduction of the total healthcare expenditure by, for example, avoiding unnecessary hospitalizations and ensuring that those who need the urgent care get it sooner, and reducing medical errors by enabling interaction between patient and health professional any time it is needed. One of the most important development phases of a SWHSA is the analysis of the user needs. The experience acquired within the European project research activities shows that these issues are numerous and complex [4]; e.g., usability and wearability, data storage, embedded decision support, power supply (i.e., power scavenging and storage), telecommunication, and interoperability and eHealth service. Sensing capabilities and biomedical sensors play a key role in the design, performance, and acceptance of SWHS. The new generation of biomedical sensors presents a large spectrum bandwidth allowing new measurements on humans and new approaches for diagnosis, ambulatory healthcare, and care at the point of need, any time [7]. The non-invasive sensors are particularly suitable for humans (offering painless measurement, no risk for infection, and user-friendliness) but present usually a high complexity of principle and system design, due to the difficulty to measure deep phenomenon from the surface of the skin. The choice of the localization of noninvasive devices has to satisfy several criteria and limitations (e.g., obtaining the best signal/noise ratio, fixing, and ergonomics) but also unobtrusiveness. Several solutions are available such as independent sensors and devices, perimetric fixing using the body segments and the circular body parts (e.g., head, arm, 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

29

One of the major challenges today for this rapidly growing field is to fuse the research work and consumer insights on smart clothing and create multidisciplinary teams of product designers and engineers. wrist, leg and ankle) as well as networked body sensors. However, the limited number of available sensors and the long life cycle of development and validation constitute a bottleneck for further progress of wearable biomedical devices. Other major issues to be addressed in the user requirements analysis are: ➤ clinical validation planning; e.g., possible clinical scenarios that have to be tested with respect to normal and abnormal medical values (diagnostic and screening tests) ➤ legal and ethical issues; e.g., personal medical data protection, user confidentiality measures, and risk analysis ➤ manufacturability, maintainability, and connectivity, which are particularly important for smart fabrics technology. Achievements In Wearable (Nontextile) Health Systems

Remote monitoring of multiple vital signs has been too complicated to achieve either because the required specialized measurement devices were unavailable or too expensive or too unfriendly to be employed. Therefore, almost all past and current commercial portable/wearable applications of health monitoring have been limited to the registration of a single physiological parameter, resulting in incomplete information about other relevant physiological and environmental factors likely to contribute to the wearer’s health status. The reluctance of health professionals to include the analysis of the (large amount of) transmitted data in their daily practice has been another barrier to the expansion of ambulatory health monitoring. One of the main objectives of recent and ongoing research in SWHSA, in Europe and worldwide, is to increase system

functionality and autonomy with embedded decision support, as well as to enhance user-friendliness and multiparameter monitoring capabilities. More than 35 EC projects with an approximate total funding of €60 million were supported from 1999 until 2002 in the area of ambulatory and wearable Information and Communication Technologies (ICT)-based health monitoring systems and medical devices [8]–[12]. Projects contributed to these results mainly by following two complementary approaches: the “application pull” approach (supported by the “eHealth” sector) and the “technology push” approach (supported by the “micro and nanosystems” sector). Representative examples of such prototype systems and applications include: ➤ continuous measurement and control of glucose concentration in subjects with type 1 diabetes, enabling the provision of better adjustment of insulin dosage [8] ➤ personal ECG monitoring [9] for early detection and management of cardiac events, including recording, storage, and synthesis of standard 12-lead ECGs, self-adaptive data processing, decision support, and alarm generation ➤ a wrist multisensor device for continuous monitoring of health status and alert, integrating biomedical sensors for heart rate, 1-lead ECG, blood pressure, oxygen blood saturation, and skin temperature measurement [10] ➤ a personal mobile health service platform for vital signs monitoring based on a body area network, utilizing the next generation of public wireless networks [11] ➤ an ambulatory bio-sensing microsystem for continuous evaluation of organ feasibility both during transport and during the initial postoperative period [12].

Marsian Project

1 min Skin Temperature Skin Blood Flow Skin Potential

No Ventilation

Ventilation

Vasoconstriction

Skin Resistance Respiration

(a)

(b)

Fig. 1. (a) Marsian: An ambulatory instrumentation composed of clothes, gloves, and wrist device. (b) Autonomic nervous system reaction to ventilation stimulation. The ventilation localized on the face of the subject induces a thermal and sensorial discomfort. The decrease of skin microcirculation, the increase in respiration rate and amplitude, and the pattern of skin resistance and potential are related to a negative stimulation (thermal discomfort).

30 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

There are also other approaches that aim at developing biosensing patches, adapted to different body fluids (e.g., sweat, blood), where the textile itself is the sensor.

Other relevant prototype systems developed in Europe during the same period include: ➤ a wrist system providing continuous monitoring of physiological signs, changes in the user’s normal activity [13], and overall well-being by measuring skin temperature, heart pulse and rate, micro/macro movement, and fall detection [14] ➤ a smart glove [15] for noninvasive multiparametric measurements of the autonomous nervous system, enabling the study of cognitive and physical status; the response to odor, speech, and vision; and the comparison with conscious and verbal indications as well as mental training (Figure 1) ➤ a multichannel portable chrono-programmable pump based on the principle of chrono-adapted administration of drugs; i.e., adaptation to the changes of the pharmacological effect of a drug according to the biorhythms [16]. New promising research recently emerged from the miniaturization of electronics and materials processing, making possible the integration of multiple smart functions into textiles without being a burden. The advantages of this integration are obvious: first, about 90% of the skin can be in contact with textile, which is the most “natural” interface to the body, and, second, fabrics are flexible and fit well with the human body and they are also cheap and disposable. Intelligent biomedical clothing (IBC), presented below, is a special example of SWHS. Intelligent Biomedical Clothing: State of the Art and Ongoing Research

Intelligent biomedical clothing [17] refers usually to clothes with sensors that are close to or in contact with the skin. The sensors are enclosed in the layers of fabric, or it is the fabric itself that is used as the sensors [18]–[25]. Such sensors can be piezo-resistive yarns, optic fibers, and colored multiple layers. IBCs have several advantages, starting with removing the task of placing the sensors by a nurse or a physician, providing a “natural” interface with the body. Commonly, IBC is understood as the integration, into textile, of sensors, actuators, computing, and power source, with the whole being part of an interactive communication network. Such systems could only be conceived through a combination of recent advances in fields as diverse as polymer and fiber research, advanced material processing, microelectronics, sensors, nanotechnologies, telecommunication, informatics, biochemistry, and medicine. The fist results in IBC have been achieved recently mainly by research teams in Europe and the United States. Five major prototypes are presented below: VTAMN, WEALTHY, magIC (Europe), and the SmartShirt and LifeShirt (USA). ➤ VTAM is a t-shirt made from textile with woven wires, incorporating four smooth, dry ECG electrodes; a IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

breath rate sensor; a shock/fall detector; and two temperature sensors [18]. ➤ WEALTHY (EC, FP5 Project) is a wireless-enabled garment with embedded textile sensors for simultaneous acquisition and continuous monitoring of biomedical signs like ECG, respiration, EMG, and physical activity [19]. The “smart cloth” embeds a strain fabric sensor based on piezo-resistive yarns and fabric electrodes realized with metal-based yarns (Figure 2). The project terminated in March 2005, and the prototype has since been further validated; market exploitation effort is under way. ➤ MagIC [20], is a sensorized vest including fully woven textile sensors for ECG and respiratory frequency detection and a portable electronic board for motion assessment, signal preprocessing, and Bluetooth connection for data transmission. ➤ SmartShirt [21] is a wearable sensorized garment that measures human heart rhythm and respiration using a threelead ECG shirt. The conductive fiber grid and sensors are fully integrated (knitted) in the garment. ➤ LifeShirt [22] is a miniaturized, ambulatory version of respiratory inductance plethysmography. The garment is a lightweight, machine washable, form-fitting shirt with embedded sensors to measure respiration. A modified limb two-lead ECG quantifies cardiac performance and a three-axis accelerometer measures posture and activity. The above prototype systems have reached a mature technological status and currently pursue (without an EU or other public funding) either further performance validation in healthcare and other applications or a commercialization route. Several other research activities are in progress at the European and national levels. Within the FP6, a cluster of projects dealing with smart fabrics, interactive textile, and flexible systems regroups research and development activities from the following sectors: 1) “micro & nano systems”: the projects’ main objective is the full integration of sensors/actuators, energy sources, processing and communication within the clothes enabling health applications but also personal protection and disaster situation management 2) “ICT for health”: the projects aim at personal health management through integration, validation, and use of smart wearable systems/solutions; i.e., smart clothing and other networked mobile devices. In the first category, the projects focus more on research and development and integration of advanced fibers and materials at the fiber core (microelectronics components, user interfaces, power sources, and embedded software) toward more functionalized, user-friendly, and autonomous wearable systems. These projects are biosensing textiles to support MAY/JUNE 2007

31

E W

E

Electrodes P

W S

B Piezoresistive Sensor

S P

E

B Piezo Resistive Sensor Electrodes W R E G G

(a)

(b)

Fig. 2. (a) Wealthy prototype model: E = Einthoven, W = Wilson, R = referee, P = precordial leads, B = breathing sensors. (b) Wealthy movement sensors.

health management (BIOTEX), contactless sensors for body monitoring incorporated in textiles (CONTEXT), protection e-textiles: micro/nanostructured fiber systems for emergency disaster wear (PROETEX) and stretchable electronics for large area applications (STELLA). Examples of projects in the second category are MyHeart [23], aiming at the systematic fighting of the origin of cardiovascular diseases (i.e., sedentary lifestyle, sleep disorders, stress, weight, and acute events) by developing and validating specific wearable applications, and OFSETH (aiming at the integration of optical fiber-based sensors into functional textiles for extending the capabilities of wearable solutions for health monitoring). One of the major challenges today for this rapidly growing field is to fuse the research work and consumer insights on smart clothing and create multidisciplinary teams of product designers and engineers. Future Challenges and Conclusions

Research and development on SWHSA was motivated by the need to respond successfully to the healthcare challenges of reducing healthcare costs while maintaining a high quality of care, providing ubiquitous easy access to care, and shifting the focus of healthcare expenditure from treatment to prevention through wellness programs. It goes without saying that this final objective raises great challenges. Physiological monitoring with SWHS has so far dealt mostly with measurement of vital signs like ECG, heart rate, respiratory rate, skin temperature, and posture. There is a trend to extend monitoring capabilities toward biochemical variables. Sampling body fluid analytes, like glucose, lactate, and other proteins, will enable more thorough assessment of a person’s health status, the state of his/her immune system, stress condition, etc. There are several promising techniques for achieving this type of monitoring in a purely noninvasive, painless way. One could thus envisage the integration of noninvasive transdermal biosensors in SWHS; e.g., in biomedical 32 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

clothes [24]. There are also other approaches that aim at developing biosensing patches, adapted to different body fluids (e.g., sweat, blood), where the textile itself is the sensor; e.g., the BIOTEX project mentioned earlier. The future development of IBC based on full integration of sensors/actuators, energy sources, processing, and communication within the clothes could overcome barriers to existing wearable health systems. Among the most important challenges are the production of higher conductivity textile materials according to current industrial processes, as well as skin interfacing and packaging. Along with these challenges, cleaning and washing issues have to be solved. Further research is required also in signal processing and improvement of signal quality during the wearer’s physical activity and data interpretation. Also, business models for network services as well as standardization at all levels and personalization are widely considered as criteria for success. Finally, clinical validation as well as costeffectiveness have to be further assessed in order to provide a critical mass of data that would convince decision makers, third-party payers, health providers, and citizens. The international community recognizes the huge development of wearable health technology and its potential role in the new healthcare-delivering landscape. For example, the IEEE Engineering in Medicine and Biology Society established a technical committee for wearable biomedical sensors and systems (WBSS) in 2004. The purpose is to raise awareness of the community in this subject and to encourage collaboration to progress research and development. The area of SWHSA is further developed in FP6 of the EC, through significant support of new functionalized systems based on the integration of several technologies and disciplines such as micro/nanotechnologies, textile materials, physiology, biology/biochemistry, and ICT as well as data integration and decision support (see cluster of EC-funded projects on Smart fabrics, interactive Textile) [25]. This area is expected also to be further developed within FP7. MAY/JUNE 2007

Andreas Lymberis was born in Patras and graduated with a B.Sc. in Applied Physics from Paris VI, in 1985. After a postgraduate degree (D.E.A.) on Magnetic Resonance Imaging in 1987, he obtained his Ph.D. in biomedical sciences with thesis on human tissues characterisation by ultrasounds in 1990. After completing his military service, he worked in France as a post-doc engineer on the applications of ultrasounds for health monitoring in space. From 1993–1999 he worked in the biomedical technology area, especially in management and assessment of biomedical equipment, in R&D on diagnostic techniques and in Health telematics, as R&D manager in IT companies. In 1999 he joined the European Commission, Directorate General Information Society and Media, in Brussels, Belgium, as a Scientific Officer in the eHealth sector where he coordinated a group of R&D activities on “smart wearable health management systems and biomedical clothing.” Since 2004 he is appointed as scientific officer to the “Integrated Micro-Nano Systems” sector where he is mainly involved in the R&D activities relating to the integration of micro-nano systems and smart textile and to the interaction of micro-nano systems with the living world. He is visiting faculty in several graduate and post-graduate courses on Biomedical Engineering and has published over 30 articles in journals and conference proceedings. He has co-edited two books on wearable e-Health systems and one book on mobile Health.

[2] S. Weingarten, J. Henning, E. Badamgarav, K. Knight, V. Hasselblad, A. Gano Jr., and J.J. Ofman, “Intervention used in disease management programs for patient with chronic illness—Which ones work? Meta analysis of published reports,” BMJ, vol. 325, pp. 925–928, 2002.

André Dittmar is the Director of the Department of Biomedical Microsensors and MicroSystems of the CNRS LPM of the INSA of Lyon (France). He is active in the research field of micrononinvasive sensors for the thermo-neuro-microvascular parameters of the human body and microtechnologies in biomedical engineering and the study of vigilance, emotional response, mental work load, and thermal comfort in humans for local metabolism and microcirculation. Recently, he was an associate editor for the IEEE Transactions on Biomedical Engineering; co-chair of the IEEE-EMBS annual meeting on biomedical microtechnologies; coordinator of the Euro-BME Network; in charge of the French CNRS program on “Smart Sensors, Clothes and Houses”; an expert for the European programs IST, FET, and MNT; and member of the World Academy of Biomedical Technologies (UNESCO). He is chairman of the 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (2007), to be held in Lyon, France. He is also active in bio-inspired research for the biomedical field.

[14] Aphycare homepage [Online]. Available: http://www.aphycare.com.

Address for Correspondence: Andreas Lymberis, European Commission, Information Society and Media DirectorateGeneral, Avenue de Beaulieu 31, 1160 Brussels, Belgium. Phone: +32 2 2996978. Fax: +32 2 2998249. E-mail: [email protected].

[3] J.M. Wilkinson, “Medical market for microsystems,” Int. Newsletter Microsyst. MEMS, no. 4/02, p. 37, Sept. 2002. [4] A. Lymberis, “Smart wearable systems for personalised health management: Current R&D and future challenges,” in Proc. 25th Ann. Int. Conf. IEEE EMBS, vol. 4, Sept. 2003, pp. 3716–3719. [5] P. Bonato, “Wearable sensors/systems and their impact on biomedical engineering,” IEEE Eng. Med. Biol. Mag., vol. 22, no. 3, pp. 18–20, May/June 2003. [6] N. Saranummi, “Information technology in biomedicine,” IEEE Trans. Biomed. Eng., vol. 49, no. 12, pp. 1385–1386, 2002. [7] F. Axisa, P.M. Schmitt, G. Delhomme, E. McAdams, and A. Dittmar, “Flexible technologies and smart clothing for citizen medicine, home healthcare, and disease prevention,” IEEE Trans. Inform. Technol. Biomed., vol. 9, no. 3, pp. 325-336, 2005. [8] R. Hovorka, “Closing the loop: The Adicol experience,” Diabetes Technol. Therapeut., vol. 6, no. 3, pp. 307–318, June 2004. [9] P. Rubel, F. Gouaux, J. Fayn, D. Assanelli, A. Cuce, L. Edenbrandt, and C. Malossi, “Toward intelligent and mobile systems for early detection and interpretation of cardiological syndromes,” in Computers in Cardiology 2001, A. Murray, Ed. Piscataway, NJ: IEEE Computer Society Press, pp. 193–196, 2001. [10] P. Lukowicz, U. Anliker, J. Ward, G. Tröster, E. Hirt, and C. Neufelt, “AMON: A wearable medical computer for high risk patients,” in Proc. ISWC 2002, 6th Int. Symp. Wearable Computers, 2002, pp. 133–134. [11] A. Van Halteren, R. Bults, K. Wac, N. Dokovsky, G. Koprinkov, I. Widya, D. Konstantas, and V. Jones, “Wireless body area networks for healthcare: The MobiHealth project,” Stud. Health Technol. Inform., vol. 108, pp. 181–193, 2004. [12] Microtrans homepage. Available: http://www.cnm.es/~mtrans/ [13] Cambridge Neurotechnology Ltd. homepage [Online]. Available: http://www. camntech.co.uk

[15] A. Dittmar, F. Axisa, and G. Delhomme, “Smart clothes for the monitoring in real time and conditions of physiological, emotional and sensorial reactions of humans,” in Proc. 25th Ann. Int. Conf. IEEE EMBS, vol. 4, 2003, pp. 3744–3747. [16] Aguettant homepage [Online]. Available: www.aguettant.com/melodie/ index_en.html [17] A. Lymberis and S. Olsson, “Intelligent biomedical clothing for personal health and disease management: State of the art and future vision,” Telemed. J. e-Health, vol. 9, no. 4, pp. 379–386, 2003. [18] AL. Weber, D. Blanc, A. Dittmar, B. Comet, C. Corroy, N. Noury, R. Baghai, S. Vaysse, and A. Blinowska, “Telemonitoring of vital parameters with newly designed biomedical clothing VTAM,” Stud. Health Technol. Inform., vol. 108, pp. 260–265, 2004. [19] R. Paradiso, A. Gemignani, E.P Scilingo, and D. De Rossi, “Knitted bioclothes for cardiopulmonary monitorining,” in Proc. 25th Ann. Int. Conf. IEEE EMBS, vol. 4, 2003, pp. 3720–3723. [20] M. Di Rienzo, F. Rizzo, G. Parati, G. Brambilla, M. Ferratini, and P. Castiglioni, “MagIC system: A new textile-based wearable device for biological signal monitoring. Applicability in daily life and clinical setting,” in Proc. 27th Ann. Int. Conf. IEEE EMBS, Shanghai, Sept. 2005, pp. 7167–7169. [21] D. Marculescu, R. Marculescu, N.H. Zamora, P. Stanley-Marbell, P.K. Khosla, S. Park, S. Jayaraman, S. Jung, C. Lauterbach, W. Weber, T. Kirstein, D. Cottet, J. Grzyb, G. Troster, M. Jones, T. Martin, and Z. Nakad, “Electronic textiles: A platform for pervasive computing,” Proc. IEEE, vol. 91, no. 12, pp. 1991–2016, Dec. 2003. [22] P. Grossman, “The LifeShirt: A multi-function ambulatory system monitoring health, disease, and medical intervention in the real world,” Stud. Health Technol. Inform., vol. 108, pp. 133–141, 2004. [23] J. Lauter, “MyHeart: Fighting cardiovascular disease by preventive and early diagnosis,” Stud. Health Technol. Inform., vol. 108, pp. 34–42, 2004.

References

[24] P. Connolly, C. Cotton, and F. Morin, “Opportunities at the skin interface for continuous patient monitoring: A reverse iontophoresis model tested on lactate and glucose,” IEEE Trans. Nanobioscience, vol. 1, pp. 37–41, Mar. 2002.

[1] M. Scholtz, “Addressing the global demands for improved healthcare,” in Proc. Telemedicine 21st Century, Opportunities Citizens, Society, Industry, 1999, pp. 11–18.

[25] Smart Fabric Interactive Textile (SFIT) cluster of EU projects homepage [Online]. Available: http://www.csem. ch/sfit/

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

33

EXPLORING EXCITING FRONTIERS IN EUROPE

Biomedical Informatics and HealthGRIDs: A European Perspective © ARTVILLE, IMAGE SOURCE

Past and Current Efforts and Projects in the Synergy of Bioinformatics and Medical Informatics

BY VICTOR MAOJO AND MANOLIS TSIKNAKIS

edical informatics (MI) and bioinformatics (BI) are two recognized informatics disciplines with different and independent backgrounds, training, and research and development agenda. Only recently have proposals for joint efforts between BI and MI been pointed out regarding training and specific research projects and activities [1], [2]. Capitalizing on the opportunities apparent as a result of these developments requires the integration and exploitation of data and information generated at all levels, from molecular to organ and disease to the population, by the disciplines of BI and MI, including medical and molecular imaging. Thus, the new interdisciplinary scientific field of biomedical informatics (BMI) is evolving. One of the first European efforts related to BMI was the BIOINFOMED study [3], supported by the European Commission (EC). At the same time, a seminal conference, “Access and Integration of Remote Genetic and Medical Databases: Knowledge Empowering Individualised Healthcare and Well-Being,” was held in Brussels in December 2001 [4]. Its main objective was to establish the basis for a dialog among researchers in MI, BI, and neuroinformatics. As a result of the BIOINFOMED study, a white paper was delivered to the EC. Recently, a number of European Networks of Excellence (NoE) in biomedical informatics have been launched [5]–[7] based on the recommendations of the BIOINFOMED study. The EC has led various specific initiatives to consolidate BMI as a multidisciplinary scientific discipline, by actively supporting a number of NoEs, projects, studies, and workshops. In some of these events, invited representatives of the U.S. National Science Foundation (NSF) have participated. In fact, there are ongoing initiatives to establish initiatives in the BMI area, both in Europe and the United States, following these preliminary steps taken at the European level. In June 2006, a conference took place to celebrate the five-year anniversary of the previously mentioned conference and to present the main research and development directions in the domain of BMI within the 7th Framework Programme of the European Union (EU) [8]. Numerous projects are linking BMI initiatives to GRID technologies. The GRID is probably one of the most promising and dynamic concepts under development in the information technology community [9]. GRID systems and applications aim to

M

34 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

integrate, virtualize, and manage resources and services within distributed, heterogeneous, dynamic “virtual organizations.” On the biomedical side, GRID applications and services may have an impact on biomedical research, facilitating the implementation of new methodological approaches such as nonhypothesis-based medicine [10], which will complement and extend the current evidence-based medicine. In the next sections, we provide a review of the background and challenges regarding BMI and HealthGRIDs, focusing on the European activities in the area. Background Genomic Medicine

Various genome-wide sequencing projects have been already completed, including the Human Genome Project [11]. The completion of the Human Genome Project sparked the development of many new tools to be used in finding the mechanism behind disease. Based on these projects, a future where genetic profiling or patient stratification based on genetic variance is routine is not that difficult to imagine. Diagnosis based on genotypic and integrated phenotypic data (i.e., clinical genomics) will result in more effective treatments earlier, prolonging the life of the population and improving quality of life. Readily available, integrated patient data will help to identify patients at risk for adverse drug reactions, improve clinical trials and drug discovery, and tailor individualized treatment for a variety of diseases [12]. These developments support the vision of genomic medicine. Genomic medicine integrates molecular medicine, which aims to explain life and disease in terms of the presence and regulation of molecular entities, and individualized medicine, which applies genotypic knowledge integrated with corresponding phenotypic data to identify predisposition to disease and develops therapies adapted to the genotype of a patient. The former is driven toward gaining knowledge about the disease, while the latter tries to identify and clinically utilize individual genetic information. Today, there are solid expectations that genomic medicine will improve patient care in issues such as genetic epidemiology and public health, with the creation of biobanks and new 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

For genomic medicine to succeed, new methods for integrating clinical and genomic data and novel methods and common tools for efficient extraction of new knowledge are required.

population studies [13], [14]; disease reclassification; modifying traditional categories; drug discovery and improved clinico-genomic trials [15]; and patient diagnosis and management (e.g., biochips, identification of people with genetic predispositions, and monitoring). While the goal is clear, the path to such discoveries has been fraught with barriers in terms of technical, scientific, and sociological challenges. Over 800 public databases are currently available to researchers, including information from genes, proteins, and diseases, among others. An increasing number of BI tools are also available to extract and correlate information. But, much of the genomic data of clinical relevance generated so far are in a format that is inappropriate for diagnostic testing. Up to now, the lack of a common infrastructure has prevented clinical research institutions from mining and analyzing disparate data sources. This inability to share technologies and data can therefore severely hamper the research process. As a result, for genomic medicine to succeed, new methods for integrating clinical and genomic data and novel methods and common tools for efficient extraction of new knowledge are required. The analysis of “omics” data and their seamless correlation with phenotypical data will facilitate understanding the molecular basis of complex diseases and thus enable the development of novel drugs or diagnostic tests [12]. In this regard, biomedical professionals and researchers should be reminded that the history of medicine shows that applying basic scientific results to patient care and management is not a straightforward and immediate process [13]. The BMI research community, which is gradually evolving, is already developing specific actions and research and development agendas to address the open methodological and technological issues. One of the most challenging technical issues is the development of new service-oriented architectures to fulfill the computing requirements that many clinico/genomic applications will demand. GRID technologies are promising to deliver the required processing power with improved efficiency and lower costs compared to traditional approaches as well as improving information access and responsiveness and adding flexibility, all crucial components of solving the multilevel data integration problem. HealthGRIDs

HealthGRIDs are GRID infrastructures addressing the specific problems and applications needed in biomedicine [16]. Resources in HealthGRIDs are biomedical databases, computing power, medical expertise, and even medical devices. Applications include areas such as microarray analysis, image analysis, in silico simulation, distributed database integration, and data mining, among others. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

There are ongoing initiatives to build extended HealthGRIDs both in Europe and the United States. For instance, in Europe, an organization called HealthGRID [17] has been created. It regularly organizes conferences and has supported the elaboration, by a group of experts at a European level, of a white paper in the area. HealthGRID [18], with the active participation of the EC, has been promoting the development of new GRID initiatives in Europe. Such a GRID initiative in Europe is EGEE (Enabling GRIDS for e-Science) [19], which is funded by the EC and aims to build on recent advances in GRID technology and develop a service GRID infrastructure that is available to the wider scientific community 24 hours a day. With respect to GRID projects in the domain of biomedicine, there are many examples, such as GenoGRID [20], Gripps—GRID Protein Pattern Scanning [21], CancerGRID [22], MyGRID [23], eDiamond [24], and others, funded by the EC or by national agencies. Recently a new integrated project with the acronym ACGT (Advancing Clinico-Genomic Clinical Trials) [25] has been funded. Its objective is to provide an open European GRID infrastructure and open GRID services in support of postgenomic, multicentric clinical trials on cancer. In the United States, an example is the Biomedical Informatics Research Network (BIRN) [26], which is building an infrastructure of networked high-performance computers, data integration standards, and other emerging technologies to pave the way for medical researchers to transform the treatment of disease. It was launched in 2001 as an initiative of the National Institutes of Health (NIH). Another one is caBIG [27], also funded by the NIH, which is developing a cancer biomedical informatics GRID for cancer research in the United States. For the successful application of GRID technologies in BMI, a series of challenges must be successfully addressed by such research and development projects in the area. The next section presents the main challenges. Current Research Challenges in BMI and Biomedical GRIDS

The recent white paper in the HealthGRID area [18] has pointed out the areas where GRID technologies are expected to provide the computing infrastructure and processing power needed for postgenomic biomedical research. Based on this, we have the following list of priorities: ➤ “omics” areas for identifying genes and proteins and for the automatic annotation of genomic information, among other areas ➤ building virtual models of molecules, cells, and organs based on data from the Visible Human and other related projects [28] MAY/JUNE 2007

35

➤ molecular imaging, developing in vivo visualizations of

cellular and genetic processes ➤ three-dimensional (3D) modeling and visualization, prediction of 3D protein structures, or image storage and transmission require an underlying computing infrastructure that traditional networks and techniques cannot support ➤ pharmacogenomics; the design of new drugs requires advanced computational methods and tools ➤ multimodal image fusion and real-time visualization and image manipulation are needed for creating realistic models of surgical interventions, for use in training, diagnosis, and surgery. While GRID technologies promise to provide the middleware, infrastructures, and standards needed, there are still many technological challenges in related areas. Of particular importance is the issue of domain ontologies, since formalized knowledge representations, i.e., ontologies, will play a key role in all future biomedical GRIDs. In the following subsection we detail some of these issues, where BMI research can decisively contribute to the advancement of the overall domain. Heterogeneous Database Integration

Today, databases around the world contain biomedical data ranging from the clinical findings for an individual patient to the genetic structure of our species. In aggregate, these data encompass information and knowledge that can significantly improve patient care, public health, basic research, and administrative efficiency. However, the wonderful volume and availability of these data has grown through a largely decentralized process without any coordinated and standardized approach to database implementations. This process has resulted in a patchwork of diverse, or heterogeneous, database implementations, making access to and aggregation of data across implementations very difficult from a practical perspective. The practical problems of heterogeneous database integration create a large gap between the potential and the realized value of

electronically stored clinical (i.e., phenotypic) and genetic (i.e., genotypic) data. Very significant theoretical barriers impede the integration of heterogeneous data sources. The foremost of these barriers is the representational heterogeneity of the data themselves; i.e., the differences in data models, schemas, naming conventions, and levels of abstraction used to represent data that are conceptually similar. Additional theoretical challenges include performance optimizations for translating queries and executing them across multiple distributed databases and methods to efficiently maintain mappings among databases that are autonomously managed and frequently changed. Database integration requires establishing links among the syntactic and semantics structures of different data sources. Classical approaches to database integration include techniques such as wrappers or virtual conceptual schemas. Ontologies [29] are a relevant method for database integration and, in fact, many current projects and proposals are evolving toward ontology-based methods. By using these ontology-based approaches, developers can map, for instance, objects belonging to a specific database to concepts of a shared ontology or biomedical vocabulary. Following this method, two different databases containing the same concept, but expressed with different names, can be mapped using domain ontologies. Two recent and relevant examples of database integration systems using ontologies in the biomedical domain include: ➤ SEMEDA (SEmantic MEta-DAtabase), a system for semantic integration of biological databases and querying federated databases [30] ➤ OntoFusion, an information access workstation (see Figure 1) developed within the INFOGENMED project that allows biomedical professionals to access private and public databases (e.g., Genbank, OMIM, Swiss-Prot, PDB, and others) as well as biomedical ontologies in a transparent, integrated, and uniform way [31]. A workshop on semantic interoperability and biomedical ontologies, held in Brussels in December 2004, reflected various approaches and projects related to ontologies [32]. This workshop focused on one of the most significant goals of the EC for the Sixth Framework Programme; i.e., the interoperability of eHealth systems. The possibilities for developing realistic approaches related to the issue of seamless interoperability with clinical applicability were analyzed. Special emphasis was placed on semantic interoperability and the further research and development needed in the area of biomedical ontologies. The final workshop summary considers the need to create more formal methods for building biomedical ontologies and training biomedical developers in the area, providing them with the background and skills needed for ontology development. Ontologies in Biomedicine

Fig. 1. A screenshot from the OntoFusion system.

36 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

The huge amount of heterogeneous data that genomic and epidemiological researchers share has generated important challenges for information access, integration, and analysis that biomedical informaticians must address. MAY/JUNE 2007

Readily available, integrated patient data will help to identify patients at risk for adverse drug reactions, improve clinical trials and drug discovery, and tailor individualized treatment for a variety of diseases. As stated earlier, biomedical ontologies will play a central role in responding to one of the most urgent challenges in BMI; i.e., heterogeneous data integration. Ontologies are more than controlled vocabularies or taxonomies. They represent the underlying meaning of a scientific domain. In biomedicine, there are no current ontologies that integrate both genomic and clinical data as they are actually needed in topics such as information retrieval or data mining. In this regard, previous experiences with the Unified Medical Language System (UMLS), the Systematized Nomenclature of Medicine (SNOMED), Gene Ontology or the International Classification of Diseases (ICD)-10 will be the basis for the elaboration of more formal, scientifically based ontologies that can contribute to tasks such as database integration, information retrieval, or heterogeneous systems interoperability. Currently, the ontologies (or vocabularies, more strictly) used (such as the UMLS, which now includes Gene Ontology) in biomedical informatics are plagued with technical problems that need to be solved by software engineers. Given these constraints, there is a vast amount of real problems that can benefit from using these ontologies or vocabularies. For instance, designing new models for biobanks (i.e., databases that include both clinical and genomic data); the unification of databases, including information such as single nucleotid polymorphisms (SNPs); using clinical data in drug discovery; creating ontologies in the “omics” areas; improving data mining and searching; and many others. It is doubtful that ontological research will have a significant impact per se in achieving outstanding scientific advances in biomedical informatics. To have realistic chances of success, it will need to link achievements in ontological research to BMI methods and procedures as well as to consider and address actual BMI and cognitive research issues [33]. As Kulikowski, an MI pioneer, has pointed out, researchers should “rethink how to design not only declarative but also procedural and updatable computational ontologies for biomedicine, which connect with biomathematical analysis, simulation, and interpretation models” [34]. Ontologies are increasingly being used to integrate and facilitate access and retrieval from remote sources over the Internet. The large amount of public databases (currently over 800) and local databases that must be accessed and navigated by researchers in order to retrieve the information needed demands new approaches of database integration. Classical approaches such as schema matching are being redesigned to incorporate hybrid approaches, including domain ontologies [35]. Various architectures have been proposed, with different middleware options, using, for instance, intelligent agents, Web services, or GRID technologies. But several challenges related to linking and mapping clinical and biological information still exist [36]. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Information Retrieval

Information retrieval is a branch of informatics dealing with storing, recovering, and maintaining information [37]. It is commonly related to the processing of sets of documents that contain unstructured text. In the biomedical domain this issue includes medical and lab reports, memos, clinical records, scientific literature, etc. The semantic Web research community develops new models to search and access information that can be located at remote and disparate locations, which are of relevance to some of the challenges in BMI. Considering information retrieval, information objects need some description. With respect to this task, two main approaches can be adopted: keyword- and ontology-based information retrieval models. For keyword-based information retrieval, keyword lists describe the contents of information objects, without considering the semantic relationships among keywords. Ontology-based approaches allow users to consider such semantic links. Ontologies are particularly important when there is a concept overlapping, e.g., in biological and medical sources, and both are included in the same system. In this kind of clinico/genomic information systems, ontologies can be also used to annotate different information from a wide variety of databases (e.g., genomic, proteomic, biomedical images) and improve information retrieval. A research approach is to replace developers in ontology construction by automatic learning processes. At this moment, human supervision is still needed. Distributed Data Mining

The field of data mining explores how to extract useful knowledge from raw data, using a methodology that is commonly known as “knowledge discovery in databases” (KDD). This becomes very important in the domain of BMI, since basic research in the biological areas, and BI, too, has been usually carried out in the laboratory. Today, experiments are being transferred to the computer, becoming “in silico.” Data from these experiments and from all the advances in the “omics” areas are producing enormous amounts of data, which are difficult to manage using traditional statistical methods and approaches. Outcomes from these experiments could generate scientific hypothesis that can be tested, clinical prediction and association rules, decision trees, etc. In biomedicine, in spite of numerous claims and journal articles about the topic, few of these data mining systems have been widely accepted and adopted [38]. In contrast, data mining has obtained considerable success in recent genomic research, contributing to the huge tasks of data analysis linked to the Human Genome Project and related research in areas such as gene sequencing or protein structure prediction [39], [40]. In a new clinico-genomic scenario, novel ideas are been considered: MAY/JUNE 2007

37

Up to now, the lack of a common infrastructure has prevented clinical research institutions from mining and analyzing disparate data sources. This inability to share technologies and data can therefore severely hamper the research process. ➤ new methodologies for study designs, using the lessons

➤ ➤ ➤

➤

learned in the area, including epidemiological concepts [38], [41] cognitive approaches, analyzing the characteristics of medical reasoning [33], [42] ontology-based approaches to data selection, preprocessing, and evaluation mapping biological and medical terms and checking the consistency of the biobanks and various databases that are being built for gathering biological and medical information; e.g., the Iceland database [15] or a project carried out at the Mayo Clinic in Rochester, Minnesota [43], aiming at linking clinical and genomic information using GRID technologies to improve data processing needed in many data-mining tasks (e.g., in image-based pattern recognition or analysis of microarray data) that are hardly managed by traditional technologies.

Similarly, with support from the IBM Life Sciences Department at Haifa, Israel, a new interest group to specify clinico/genomic information within HL7 has been developed [50]. The focus of clinical genomics work is the personalization of the genomic data and linking these with relevant clinical information. Genomics formats such as BSML (Bioinformatics Sequence Markup Language), MAGE-ML (Microarray and GeneExpression Markup Language), and LSID (Life Science Identifier) are being reviewed in this initiative. For phenomics to become an “omics” discipline, new standards must be developed to create phenotype data models. The challenge of creating informatics support for phenomics research can be viewed as the need to create an effective database system for phenotype data. In this regard, over 60 institutions are currently involved in the PhenoFocus project [51], with the goal of discussing problems and forming consensus solutions. A relevant player in this series of activities is the Global Open Biology Ontology network [52].

Creating New Clinical/Genomic Data Models

Regarding the electronic health record, there have been various international efforts related to standardization, including CENTC251 in Europe [44], HL7 in USA [45], the Healthcare task force of the Object Management Group [46], International Standards Organization [47], and OpenEHR [48]. Classical models of electronic health records must be updated to include genomic and other “omics” information. In this sense, new data models and standards are needed to link genotype and phenotype information that can be useful for research tasks. As an example, a consortium of industry and academic centers is developing a new standard data/domain model for polymorphic data. This model incorporates different forms of DNA variation as well as its description at the DNA level. A new markup language for polymorphisms has been developed and is being currently extended to include phenotype data and ontology concepts [49].

European Initiatives in BMI

As stated above, the “official” initiatives to launch the BMI efforts in Europe began with the BIOINFOMED study and the Brussels meeting carried out in December 2001. Following this, a number of initiatives have been launched. Some of the initiatives launched at the European level in areas such as GRID or biomedical ontologies or other related standards have been mentioned earlier, whereas others have been parts of national research and development agendas. In this section, the main EU-funded research and development projects and other significant initiatives will be very briefly presented. These concerted actions are contributing to placing the EU in a predominant position within this emerging field of scientific research and development. Recently, the European Research Consortium in Informatics and Mathematics (ERCIM) created a working

Table 1. Main Networks of Excellence funded by the IST directorate in the eHealth sector in the Sixth Framework Programme. Project Acronym INFOBIOMED

Topic Network of Excellence in Biomedical Informatics Structuring

Web Address www.infobiomed.org

European biomedical informatics to support individualized healthcare BIOPATTERN

Network of Excellence in Computational Intelligence for

www.biopattern.org

biopattern analysis in support of eHealthcare Semantic Mining

Network of Excellence in semantic interoperability and

www.semanticmining.org

data mining in biomedicine

38 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

group on biomedical informatics. This working group intends to promote interaction and collaboration between ERCIM research and development groups active in the area and facilitate cross fertilization and synergies between distant scientific disciplines. The overall aim is to consolidate and advance this new field of research, enabling a better level of individualized healthcare in the postgenomic era [53]. The working group places particular emphasis on understanding the link between genes, disease, and the environment, and on the development of predictive models for diseases linked to genetic and environmental risk factors. Regarding the support of the EC in the area, Table 1 shows a summary of the main NoE funded by the IST directorate in the eHealth sector in the Sixth Framework Programme. Subsequently, a number of specific support actions, such as SYMBIOMATICS, and projects have been funded. These are presented in Table 2. Given the lack of space to detail all of these projects, we simply provide the main objective of each project and encourage readers to visit the corresponding Web site for detailed information about each project. These projects are particularly representative of the objectives and the research

and development agenda in the domain of biomedical informatics of the EC. Conclusions and Future Challenges

In this article we have provided an overview of current approaches related to BMI, GRID, and genomic medicine, particularly in Europe. Research on areas such as ontologies, data mining, information retrieval, or semantic interoperability is redefining current informatics methodologies to support biomedical research. While traditional disciplines such as BI, MI, and neuroinformatics will keep their characteristics and independence, some initiatives are being supported, such as in BMI, to enhance synergy among them and other “omics” disciplines, going beyond the actual vision of interdisciplinary research. This synergy, currently addressed by BMI and GRID projects, is being extended, at a conceptual level, to include other areas. In this regard, workshops and activities have been supported by the Directorate General Information Society of the EC since 2004 [54]. These have discussed the visions and challenges in an intersecting area at the boundary between informatics, biotechnology, nanotechnology, and cognitive science. Three areas have been identified:

Table 2. Support actions and projects funded through the Sixth Framework Programme. Project Acronym

Topic

Web Address

SYMBIOMATICS

Synergies in medical informatics and bioinformatics

www.symbiomatics.org

ACGT

Advancing clinico-genomic clinical trials on cancer

www.eu-acgt.org

@neurIST

Integrated biomedical informatics for the management

www.cilab.upf.edu/aneurist

of cerebral aneurysms ASSIST

Association studies assisted by inference and semantic

www.assist.iti.gr

technologies DESSOS

Decision support software for orthopedic surgery

www.dessos.org

EuResist

Integration of viral genomics with clinical data to predict

www.euresist.org

HealthAgents

Agent-based distributed decision support system for brain

response to anti-HIV treatment http://groups.inf.ed.ac.uk/HealthAgents

tumor diagnosis and prognosis Health-e-Child

An integrated platform for European pediatrics based on a

HEALTH PLUS

Improving knowledge and decision support for healthy

www.health-e-child.org

GRID-enabled network of leading clinical centers www.health-plus.eu

lifestyles HEARTFAID

A knowledge based platform of services for supporting

http://lis.irb.hr/heartfaid

medical-clinical management of heart failure within elderly population I-Know

Integrating information from molecule to man: knowledge

www.cfin.au.dk

discovery accelerates drug development and personalized treatment in acute stroke Immunogrid

The European Virtual Human Immune System Project

www.immunogrid.org

K4CARE

Knowledge-based homecare eServices for an ageing

www.k4care.net

Europe (Continued)

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

39

Table 2. (Continued . . . ) Project Acronym

Topic

Web Address

LHDL

Living Human Digital Library

www.livinghuman.org

MATCH

Automated diagnosis system for the treatment of colon

www.match-project.com

cancer by discovering mutations on tumour suppressor genes MULTI-KNOWLEDGE

Creating new knowledge in networks of medical research

www.multiknowledge.org/page.asp

OFSETH

Optical fiber sensors embedded into textile for healthcare

www.ofseth.org

Q-REC

European quality labeling and certification of electronic

www.eurorec.org

health record systems RIDE

A roadmap for interoperability of eHealth systems in support

www.srdc.metu.edu.t

of COM 356 with special emphasis on semantic interoperability RIGHT

Reducing diagnosis and treatment risks by leveraging

www.mip.polimi.it

knowledge and practices of healthcare professionals SAPHIRE

Intelligent healthcare monitoring based on

www.srdc.metu.edu.tr

Sealife

semantic interoperability platform A semantic grid browser for the life sciences applied

www.biotec.tu-dresden.de/sealife

to the study of infectious diseases SIMAP

Simulation modeling of the MAP kinase pathway

www.cgen.com

SMARTHEALTH

Development of a next generation of smart diagnostic

www.smarthealthip.com

systems fully integrated into healthcare systems in Europe STEP

A strategy for the EuroPhysiome

www.europhysiome.org

VIROLAB

A virtual laboratory for decision support in viral disease

[email protected]

treatment WOUNDMONITOR

Mobile system for noninvasive wound state monitoring

➤ interdisciplinary research at the crossroads of MI, BI, sys-

tem biology, and neuroinformatics ➤ research on new information and communications technology (ICT) systems inspired by nature, ranging from the use of biomolecular structures in electronic devices to the exploitation of cognitive concepts from living systems into man-made systems ➤ interdisciplinary research toward integrated systems based on emerging convergence of ICT, nano-, and biotechnologies and their integration and interface with the living world. This convergence, whose origins can be traced back to workshops held in the United States with support from the NSF [55], is a clear example of the numerous initiatives to bridge the traditional boundaries between classical, informatics-related disciplines. In times of rapid technological changes, young disciplines such as MI and BI are already finding their synergies within BMI. Other disciplines such as nanotechnology, cognitive science, and the engineering disciplines are finding new and linked exchange areas. GRID technologies will contribute to reduce the distance and differences between remote and separate partners that can actually share data and computing infrastructures, 40 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

www.manchestr.ac.uk/woundmonitor

enhancing the collaborative efforts already in place in areas such as genomics. Acknowledgments

Drs. Maojo and Tsiknakis are funded by the European Commission through the INFOBIOMED NoE (contract no. IST-507585), the ACGT Integrated Project (contract no. FP6-2004-IST-4-026996), and other relevant national research and development projects (Spain, INBIOMED network, and Greece). Victor Maojo received his M.D. at the University of Oviedo (Spain) in 1985 and his Ph.D. in computer science at the Universidad Politecnica de Madrid (UPM) in 1990. At the UPM, he is currently an associate professor and associate director of the Artificial Intelligence Lab. Before entering the faculty of the UPM, he was a postdoctoral researcher and consultant at the Georgia Institute of Technology, Atlanta, from 1990–1991 and a research fellow at the Decision Systems Group of Harvard MAY/JUNE 2007

University-MIT, Boston, Massachusetts, from 1991–1993. He has been the principal investigator in more than 20 national and international projects and has authored more than 100 scientific papers and books. He has been a member of numerous committees at international conferences and journals and served as an expert for the Fourth and Fifth Framework Programmes of the European Commission. Manolis Tsiknakis received a B.Eng. in electronic engineering, an M.Sc. in microprocessor engineering, and a Ph.D. in control systems engineering from the University of Bradford, United Kingdom. In 1992, he joined FORTH-ICS, where he is currently a principal researcher and head of the eHealth laboratory. He has been the principal researcher in many collaborative research and development projects and is currently coordinating the development of HYGEIAnet, the integrated health information network of Crete. He is the initiator and chair of the ERCIM Biomedical Informatics Working Group. He was a member of the Programme Committee of HealthGRID (2003–2005) and the IEEE CBMS 2005 International Conferences. His current research interests are in the areas of biomedical informatics, component-based software engineering, information integration, ambient intelligence in eHealth and mHealth service platforms, and signal processing and analysis. He is a member of IEEE and ACM. Address for Correspondence: Victor Maojo, Biomedical Informatics Group, Artificial Intelligence Laboratory, School of Computer Science, Universidad Politecnica de Madrid, 28660 Boadilla del Monte, Madrid, Spain. Phone: +34 91 336 6897. Fax: +34 91 352 4819. E-mail: [email protected].

References [1] R. Altman, “The interactions between clinical informatics and bioinformatics,” J. Am. Med. Inform. Assoc. vol. 7, no. 5, pp. 439–443, 2000. [2] V. Maojo and C.A. Kulikowski, “Bioinformatics and medical informatics: Collaborations on the road to genomic medicine,” J. Am. Med. Inform. Assoc., vol. 10, no. 6, pp. 515–522, 2003. [3] F. Martin-Sanchez, I. Iakovidis, S. Norager, V. Maojo, P. de Groen, J. Van der Lei, T. Jones, K. Abraham-Fuchs, R. Apweiler, A. Babic, R. Baud, V. Breton, P. Cinquin, P. Doupi, M. Dugas, R. Eils, R. Engelbrecht, P. Ghazal, P. Jehenson, C. Kulikowski, K. Lampe, G. De Moor, S. Orphanoudakis, N. Rossing, B. Sarachan, A. Sousa, G. Spekowius, G. Thireos, G. Zahlmann, J. Zvarova, I. Hermosilla, and F.J. Vicente, “Synergy between medical informatics and bioinformatics: Facilitating genomic medicine for future health care,” J. Biomed. Inform., vol. 37, no. 1, pp. 30–42, Feb. 2004. [4] “Knowledge empowering individualized healthcare and wellbeing,” in Proc. Conf. Synergy Between Research Medical Informatics, Bioinformatics, NeuroInformatics [Online]. Available: http://14dec2001.ramit.be/program.html [5] INFOBIOMED homepage [Online]. Available: http://www.infobiomed.org/ [6] BIOPATTERN Network of Excellence homepage [Online]. Available: http://www.biopattern.org/ [7] “Semantic mining” [Online]. Available: http://www.semanticmining.org// [8] ICT for Biomedical Sciences Conference homepage [Online]. Available: http://europa.eu.int/information_society/events/ict_bio_2006/index_en.htm [9] I. Foster, C. Kesselman, and S. Tuecke, “The anatomy of the GRID: Enabling scalable virtual organizations,” Int. J. High Perform. Comput. Applicat., vol. 15, no. 3, pp. 200–222, 2001. [10] J. Pittman, E. Huang, H. Dressman, C.-F. Horng, S.H. Cheng, M.-H. Tsou, C.-M. Chen, A. Bild, E.S. Iversen, A.T. Huang, J.R. Nevins, and M. West, “Integrated modeling of clinical and gene expression information for personalized prediction of disease outcomes,” Proc. Natl. Acad. Sci. USA, vol. 101, no. 22, pp. 8431–8436, 2004. [11] E.S. Lander, “Initial sequencing and analysis of the human genome,” Nature, vol. 409, no. 6822, pp. 860–921, Feb. 2001. [12] F.S. Collins and V.A. McKusick, “Implications of the Human Genome Project for medical science,” JAMA, vol. 285, pp. 540–544, 2001.

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

[13] D. Weatherall, Science and the Quiet Art. Medical Research & Patient Care. Oxford, U.K.: Oxford Univ. Press, 1995. [14] V. Maojo and F. Martin-Sanchez, “Bioinformatics: Towards new directions for public health,” Meth. Info. Med., vol. 43, no. 3, pp. 208–214, 2004. [15] G.J. Annas, “Rules for research on human genetic variation: Lessons from Iceland,” N. Engl. J. Med., vol. 15;342, no. 24, pp. 1830–1833, June 2000. [16] Expert Group Report, “Next Generation GRID(s),” European GRID Research 2005–2010, June 2003 [Online]. Available: http://www-unix.GRIDforum.org/ mail_archive/ogsa-wg/pdf00024.pdf [17] HealthGrid homepage [Online]. Available: http://www.healthgrid.org/ [18] HealthGRID White Paper [Online]. Available: http://www.whitepaper. healthgrid.org/ [19] Enabling Grids for E-sciencE homepage [Online]. Available: http://public. eu-egee.org/ [20] GenoGrid Project, “Genome analysis and annotation via Grid computing,” [Online]. Available: http://gmod.org/genogrid [21] Grid Protein Pattern Scanning homepage [Online]. Available: http:// gripps.ibcp.fr/index.php [22] Cancer-grid [Online]. Available: http://lists.nottingham.ac.uk/mailman/ listinfo/cancer-grid [23] MyGrid homepage [Online]. Available: http://www.mygrid.org.uk/ [24] eDiaMoND homepage[Online]. Available: http://www.ediamond.ox.ac.uk/ [25] ACGT homepage [Online]. Available: http://www.eu-acgt.org/ [26] Biomedical Informatics Research Network homepage [Online]. Available: http://www.nbirn.net/ [27] caBIG Community Web site [Online]. Available: https://cabig.nci.nih.gov/ [28] M.J. Ackerman, “The Visible Human Project: A resource for education,” Acad. Med., vol. 74, no. 6, pp. 667–670, June 1999. [29] T.R. Gruber, “A translation approach to portable ontology specifications,” Knowl. Acquisition, vol. 5, no. 2, pp. 199–220, 1993. [30] J. Köhler, S. Philippi, and M. Lange, “SEMEDA: Ontology-based semantic integration of biological databases,” Bioinformatics, vol. 19, no. 18, pp. 2420–2427, 2003. [31] D. Pérez-Rey, V. Maojo, M. García-Remesal, R. Alonso-Calvo, H. Billhardt, F. Martin-Sánchez, and A. Sousa, “ONTOFUSION: Ontology-based integration of genomic and clinical databases,” Comput.Biol. Med.,vol. 36, no. 7-8, pp. 712-730, Jul.-Aug. 2006. [32] “Ontology and Semantic Interoperability of Systems Sharing Biomedical Information,” Brussels, Belgium, Nov. 2004 [Online]. Available: http://www. ecor.uni-saarland.de/announce/eurorecontologyworkshop.html [33] D. Evans V. Patel, Eds., Cognitive Science in Medicine. Biomedical Modelling. Cambridge, MA: MIT Press, 1989. [34] C. Kulikowski, private communication, 2005. [35] W. Sujanski, “Heterogeneous database integration in biomedicine,” J. Biomed. Inform., vol. 34, no. 4, pp. 285–298, 2001. [36] R. Stevens, C. Goble, N. Paton, S. Bechhofer, G. Ng, P. Baker, and A. Brass, “Complex query formulation over diverse information sources using an ontology,” in Proc. Workshop Computation Biochemical Pathways Genetic Networks, European Media Lab (EML), Aug. 1999, pp. 83–88. [37] W.R. Hersh, Information Retrieval: A Health Care Perspective. Berlin: Springer-Verlag, 1996. [38] V. Maojo, “Domain-specific particularities of data mining: Lessons learned,” in Lecture Notes in Computer Science, vol. 3337. Berlin: Springer-Verlag, 2004, pp. 235–242. [39] P. Baldi and S. Brunak, Bioinformatics: The Machine Learning Approach, 2nd ed. Cambridge, MA: MIT Press. 2001. [40] A.D. Baxevanis and B.F. Ouellette, Eds. Bioinformatics: A Practical Guide to the Analysis of Genes and Proteins. New York: Wiley, 1998. [41] P.J.G. Lisboa, “A review of evidence of health benefit from Artificial Neural Networks in medical intervention,” Neural Netw., vol. 15, pp. 11–39, 2002. [42] M. Pazzani, “Knowledge discovery from data?” IEEE Intell. Syst., vol. 15, no. 2, pp. 10–13, 2000. [43] P.C. de Groen, “A healthy database; IBM creating a system for millions of Mayo Clinic patient files,” Post-Bulletin (Rochester, MN), p. 1A, Mar. 25 2002. [44] CEN/TC 251 European Standardization of Health Informatics homepage [Online]. Available: http://www.centc25l.org [45] Health Level Seven homepage [Online]. Available: http://www.hl7.org [46] OMG Healthcare Domain Task Force homepage [Online]. Available: http://healthcare.omg.org [47] International Organization for Standardization homepage [Online]. Available: http://www.iso.ch [48] openEHR homepage [Online]. Available: http://openehr.org/ [49] A. Brookes, “Data models,” INFOBIOMED NoE. internal report. 2004. [50] HL7 Clinical Genomics Web page [Online]. Available: http://www.h17.org/ special/committees/clingenomics/index.cfm [51] PhenoFocus homepage [Online]. Available: http://www.phenofocus.net [52] Open Biomedical Ontologies homepage [Online]. Available: http://obo. sourceforge.net [53] European Research Consortium for Informatics and Mathematics homepage [Online]. Available: http://www.ercim.org/ [54] Information Society Technologies homepage [Online]. Available: http://www.cordis.lu/ist/ictbio/home.htm [55] M. Roco and W.S. Bainbridge, Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnology, Information Technology and Cognitive Science. Berlin: Springer-Verlag, 2003.

MAY/JUNE 2007

41

EXPLORING EXCITING FRONTIERS IN EUROPE

A Roadmap for NeuroIT Challenges for the Next Decade

© ARTVILLE, IMAGE SOURCE

BY MARC DE KAMPS AND ALOIS C. KNOLL

hat is NeuroIT? And why does it need a roadmap? After all, there is something called “neuroinformatics,” which has been around for a while and which is growing rapidly. The term neuroinformatics is often used to refer to the application of information technology (IT) to the “brain sciences.” Almost all of the brain sciences have become considerably more complex, and recording and managing the results from experiments entails the use of ever-more complex and larger databases and analysis tools. Examples are the large heterogeneous data sets produced by fMRI machines, the complex electro-chemical mechanisms and genetic factors that determine neuron function, and so on. To understand these data, increasingly complex and time-consuming models are necessary, which run on ever-larger computers, which sometimes need novel architectures to run efficiently. An interesting overview of the activity in this area can be found in two reports published by the Organization for Economic Cooperation and Development (OECD) [1], [2]. Where our knowledge of the brain and brain function is expanding rapidly, our ability to make use of this information has somehow not increased at the same rate. Living creatures still outperform computers in a large range of skills, many of which are considered to be “simple.” Computer scientists can only dream of the object-recognition skills of humans, and roboticists would love to create service robots with the same degree of autonomy as an ant. The possibility for the development of artifacts that are able to learn over their lifetime and are able to adapt their behavior in the face of changing circumstances seems even more remote. In general, every complex artifact has to be programmed carefully, by hand, and for a new range of applications this has to be done again, from scratch. The relatively slow progress in the creation of bio-inspired artifacts and IT applications is a source of frustration for policy makers, scientists, and engineers alike. Scientists and engineers that try to emulate methods used by nature find that their bio-inspired approaches work very well on some problems, while failing on other, seemingly related ones. Or they find that approaches that are promising on toy problems do not scale well with the problem size. Behind these problems is a lack of systematic understanding of how nature accomplishes things, which, as we will see, is one of the central

W

42 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

issues in the roadmap. This makes bio-inspired engineering difficult and solutions to many problems can only be found by trial-and-error. The haphazard development of bioinspired engineering is also undesirable from a political point of view: clearly there is great economic potential in some fields of research and in order to stay competitive it is important to know which research to fund. Moreover, the impact of new technology on society can be considerable, as we have seen recently with the Internet. These considerations have led to the creation of nEUroIT.net (http://www.neuro-it.net), a thematic network in the area of NeuroIT. NeuroIT has here been defined loosely as “neuroscience for IT,” whereas in “neuroinformatics” the emphasis has more been on “IT for neuroscience.” The distinction, therefore, is not so much in the field of study, or in the techniques used, but rather in the long-term objective of the research. nEUro-IT.net is funded by the Future and Emerging Technology (FET) arm of the Information Society Technology (IST). One of its most important activities is the creation of a roadmap. The reasons for a roadmap have been stated implicitly already: it tries to develop a vision for where the field will be in the next decade. It tries to identify problems that affect the field as a whole and how they can be solved. It serves as a reference for the state-of-the-art research in various fields for researchers and for decision makers. This is perhaps even more important for NeuroIT than for other fields, since it is highly interdisciplinary: a computer scientist cannot be expected to know about the latest developments in primate vision, and yet these developments may provide crucial inspiration for new approaches in computer vision. The Creation of a Roadmap

The NeuroIT community is very heterogeneous and the creation of a roadmap entails a number of practical problems. First of all, a constituency must be formed in a field that does not yet exist. The FET’s systematic funding of NeuroIT proved instrumental here: although mostly unaware of each other’s existence, quite a large group of people had been working in multidisciplinary projects for some years. They were first brought together in a kick-off meeting in 2002 December in Leuven, Belgium. Second, people must be convinced that 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

Since nature has solved this problem very efficiently in the course of evolution, it is necessary to look to nature for guidance on how to design complex artificial systems.

roadmapping is worth their time. At first, this was a difficult process. After a “start-up” meeting it was simply decided that each of the attendees write a “grand challenge.” The “challenges” together constituted the first version, which was published on the nEUro-IT.net Web site. After a Web consultation, which was supported by FET, the document had generated considerable attention and it became easier to ask for contributions, especially since the document had since been used in the formulation of several funding call texts. The Roadmap: Topics in NeuroIT

We briefly discuss the topics of the roadmap here, the expected benefits, the resources required, and the most important obstacles that stand in the way of their realization. The discussion is necessarily brief, but the interested reader can always obtain the roadmap at the nEUro-IT.net Web site. References can be found there. “Brainship”: Human–Machine Interaction

Controlling machines by mere thought is an old engineering dream. It has obvious applications; for example, controlling prosthetics in the form of artificial limbs. Another possibility would be teleoperation of remote exploratory vehicles, equipped with artificial sensors, ranging from microendoscopes to deep-sea vehicles. Yet another application would be a direct interface with information systems. Although this sounds like science fiction, recent progress in the use of multielectrodes implanted in the brain suggests that this is a real possibility. A major breakthrough is the discovery that the brain has enough plasticity to adapt its signals to communication over a limited number of channels, and it has therefore become possible to predict limb movements from the activity of multiple single-neuron recordings in the motor cortex [3]. This was first demonstrated on rats and later in monkeys. An impressive demonstration was given in two experiments [4], [5], where brain signals directly control the position of a cursor, using visual feedback from the screen. While important as proof of principle, a major problem in controlling a prosthetic device is the lack of somato-sensory feedback in current experimental designs. There is still a long way to go in this area: a better understanding of principles of neural coding is needed, in particular how the brain integrates sensory and motor systems, both in fast motor control and in decision. To name a few problem areas: one needs stimulation multielectrode arrays to allow for a direct input of sensory information. It is important to find out if there are alternatives to implanting electrodes in the brain, and, as long as this is not the case, to improve the durability of electrodes implanted and to reduce the impact that they have on brain tissue. Important ethical issues are the possibility of brain damage caused by invasive techniques: under what circumstances is this acceptIEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

able, if at all? And for invasive and noninvasive techniques alike, there is the possibility that the induced brain plasticity interferes with normal brain function. Factor X: A Machine that Grows by a Factor of 10 in Size, Strength, and Cognitive Abilities

Inspired by the possibilities that new materials and nanotechnology offer, some roboticists dream about machines that coevolve their brains and bodies in continuous interaction with the environment over a limited period of time. This vision is largely inspired by the development of living organisms and the theory of action-centered cognition [6]. One may think of a self-assembling robot, based on “genetic” information, under the influence of the environment. Such robots would be autopoietic (built from the inside out) as opposed to the current generation of robots, which is allopoietic (built from the outside in). A possible starting point for such robots would be a (modified) biological substrate. This has several disadvantages: the creation of new organisms, which is the implication, would be a major ethical problem. The size of such artifacts and the capabilities of its sensors and actuators would be limited to biological ranges. It seems more realistic to look at the possibilities that recent developments in material science offer. Currently there are a few developments that could be taken as a starting point for this challenge: Modular robots are built from a certain number of identical motor modules and can be combined into different shapes and macro structures, evolutionary and epigenetic robotics, and nanoscale self-assembling structures. From today’s perspective there are four lines of research that could be considered to bring a project like this underway. First is molecular robotics, which is the exploration and design of materials and substrates that lend themselves to build “cells” that can be made to meet the different requirements for various body areas. Second are distributed growable sensors for distributed areas of sensor cells. Here it will be necessary to investigate how they can be coordinated and produce sensible results when they are distributed over a large surface of the outer body (“skin”) and are physically connected by a medium that has a high degree of flexibility (“body”). Third is growable distributed information processing, which is a demanding research area because the information processing has to control the artifacts from the moments of “inception.” Hence, this system not only has to control its actuators and sensors but it must interact with the environment to control the growth of the artifact and co-evolve with the increasing capabilities of its sensors and actuators. Fourth are growable motor entities and spatially distributed actuators. The actuators must be controllable as they develop their actuator part and their support structure. The development must be in sync with the growth of the size of the artifact. MAY/JUNE 2007

43

The benefits of this kind of construction method are quite clear, but it will take considerable research to see if basic building blocks can be designed that are cheap and have the required properties. Conscious Machines

From the point of view of NeuroIT, three motivations to study consciousness in relation to IT artifacts appear repeatedly in the literature. First of all, it has proved to be far more difficult than expected to deliver artifacts that are truly autonomous and that are able to learn over their lifetime. Artifacts still have to be programmed very carefully for every new task that they have to perform. Such programming is obviously limited, since new and unforeseen situations can not be preprogrammed. This is turn sets severe limitations on the autonomy of the artifact. The second motivation has to do with the way that humans interact with artifacts and how they perceive them. The third motivation has to do with the fact that the neurosciences start to present the outline of a systems-level understanding of the brain. Still, there is much to be understood on this level, and given the experimental difficulties that are involved (see the “Brainprobe Project” section), it is widely believed that building artifacts is actually an interesting way to study aspects of higher-level cognition, including consciousness. It is generally assumed that complex autonomous artifacts need a sense of “self” [6], [7] to monitor the effect of their actions, in past and present, on the world, and to be able to “learn” from this in a way that is not preprogrammed. Many people also believe that emotions, awareness, and attention play an important role in such processes, and so there is a considerable interest in a more rigorous definition of these concepts and in the way humans and animals use them. An interesting problem that relates to consciousness is how it emerges: a living creature is specified by a genetic code, which is rather limited and cannot prescribe the development of an organism in detail. This raises the question of how consciousness emerges in a growing organism, and if lessons can be learned concerning the construction of artifacts from this. Other questions are how the embodiment of an organism or artifact influences its mental representations. The interest in several fields of engineering and IT for concepts, which used to be studied exclusively by psychologists (e.g., [8]) is relatively new; e.g., [9]–[11]. To make progress, other challenges in the roadmap are instrumental. Ethical issues involved first of all relate to humans. Truly autonomous service robots may replace humans, for instance. If progress in this field is really successful, however, we might have to extend such considerations to machines. Successful in the Physical World

This challenge analyzes the reasons for why artificial systems perform so poorly compared to living ones from a slightly different perspective. For the creation of an intelligent system, a designer has options that basically can be classified as the choice for computation and control strategies, the choice for morphology, the choice of materials, and using the environment. The hypothesis behind this challenge is that living creatures are optimized with respect to all of these options, as opposed to conscious machines, where the emphasis was on the assumption that living creatures have 44 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

computational capabilities for reasoning, planning, etc., that are vastly superior to man-made algorithms devised to reproduce these skills. Significant simplifications in the control loop of an agent can be achieved if its computational capabilities are distributed over the central nervous system, the peripheral system, the materials of its body, and its interaction with the environment. A well-integrated periphery may be the key in lowering the difficulty of a task to a point where it becomes feasible as well as take the load off a central processing module. Prime research objectives for this challenge are, therefore: intelligent periphery, system integration, morphology and materials, and “environment models” used to codify task/world knowledge. Despite the fact that neural processing will remain an integral part of agent construction, the focus of this challenge is on making the periphery smarter and integrating it better with central computations. An important aspect of this is the development of universal standards (“bus standards”) for smart reusable peripherals, which would facilitate cooperation between different projects and would facilitate the introduction of new technology into product design. This would then create building blocks for individual systems but also allow capabilities for robot interaction and collaborative behaviors. Automated Design of Artificial Cognitive Systems

In this chapter of the roadmap, it is argued that the reason that artificial intelligence in its various guises has been unsuccessful in modeling and explaining sophisticated cognitive functions is the fact that sophisticated cognitive algorithms are complex in the technical sense that they cannot be compressed into a compact piece of code [12]. The question of how to design artificial cognitive systems then arises. Since nature has solved this problem very efficiently in the course of evolution, it is necessary to look to nature for guidance on how to design complex artificial systems. The aim is therefore to create a theory of the evolution of complex systems in nature and to apply the theory to generate biologically inspired techniques for the automated design of artificial cognitive systems. A key reason that is cited for lack of progress so far is the fact that the biological processes that artificial evolution has to emulate are incredibly hard to model. As a result, the main thrust of recent biological research is toward the investigation of specific organisms and systems rather than broad theory. Traditional evolutionary theory lent itself naturally to mathematical modeling, whereas more recent research has generated a vast wealth of disjointed information that has yet to be adequately organized. To solve this problem, one needs a theory of the evolution of complex systems. In the challenge, various lines of research are proposed that include evolutionary techniques together with a realistic modeling of the physics and the chemistry that is involved. Importantly, a set of benchmark problems must be included: projects that are too difficult to solve by contemporary software techniques but sufficiently simple to give developers a real hope of success. Constructed Brain

In this challenge the possibilities for the “complete” simulation of a brain are investigated. There are at least three major problems that hamper the understanding of the brain. The first MAY/JUNE 2007

beyond the single neuron level for NeuroIT, it attempts to is the sheer complexity of the brain, in terms of number of identify the most important obstacles for such an undercomponents and in terms of the physical and chemical standing from the point of experimental neuroscience, and processes that control its function. The second is that the brain it suggests several lines of research to overcome them. It is hard to divide in modules with a well-defined function and starts with an extensive review of the current experimental that many aspects of the brain are hard to study in isolation. techniques to measure brain activity: PET, fMRI, (multiple) The third is that a large number of disciplines are involved in single electrode measurements, multielectrode measurethe study of the brain, each with its own methodology, termiments, and optical techniques. It discusses the (combinanology, and traditions. tions of) relative strengths and limitations of these To overcome these problems it is suggested to create a techniques and how they relate to unresolved issues conframework that allows a large-scale, coarse simulation of the cerning the interpretation of neuroscientific data and, as brain, with sufficient flexibility to create more detailed simulasuch, contains a valuable comprehensive review of the tions locally, where needed, or to increase overall sophisticaexperimental state-of-the-art in neuroscience. tion when computer power increases. Theoretical methods are reviewed that could be important for the creation of such a framework. It is clear that the simulation of the 100 billion neurons of the human brain is not currently possible, and even if this were possible, one would still need to find the correlates of cognitive states and behavior. Spatial Maps Special consideration is therefore given to tech(Winner-Take-All) niques that yield a “mesoscopic” or “thermodynamic” description of groups of neurons; e.g., [14], [15]. Another area that is important is the identification of computational architectures; e.g., [16], [17]. The large-scale organization of the cortical netWorking Memory (Blackboard) works is starting to emerge from a combination of Display imaging data, psychophysical experiments, and theFeature Maps oretical modelling (see Figure 1). At the same time, (Shape, Color) Retinotopic Areas multi-electrode arrays provide new insights in the (Visual Blackboard) function of the local cortical circuits, which are repeated over the entire brain (see Figure 2). To find organizational principles that are repeated over and over again, and which explain how a massively parallel network of relatively slow elements can perform complex computations, is extremely Fig. 1. We slowly start to understand how local networks are organized important for NeuroIT. into large-scale cortical networks. Can we organize massively parallel There are many issues involved in the start of computers in a similar way? such a project, too many to mention here, but one of the most important is software engineering. It is obvious that in such a project many software Feedback libraries have to be integrated in a flexible way. Taking this one step further, it will be necessary, Interaction: Local Microcircuit given the complexity of the project, to invent (Disinhibition) new ways of publishing models in addition to journal articles. The publication of models in itself would be an interesting issue in software engineering as well. i i It is hard to overestimate the potential benefits of such a project. Modeling and software development in brain science is primitive compared to disciplines such as high-energy physics, which have established traditions of software engineering. This is odd, given the heterogeneous data and Interaction models in “brain science” and the inherent complexity of models of the brain. It is probably necessary to establish an agency to start up this project, since it is beyond the capabilities of indiFeedforward vidual research groups. The Brainprobe Project

The Brainprobe Project starts with a few observations on the importance of an understanding IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Fig. 2. Detailed simulations of local microcircuits are sometimes necessary to understand the big picture. The interaction between local and global structures is a characteristic of most natural systems and this seems to apply to successful bio-inspired artifacts as well.

MAY/JUNE 2007

45

There are several experimental issues that hold the promise for progress. The combination of different techniques in one experiment (fMRI with EEG, for instance) would enable the use of the good spatial resolution of the former and the good temporal resolution of the latter. Multielectrode measurements consisting of several hundreds of electrodes, implanted in several brain regions, would offer the possibility to observe synchrony between different brain areas, to study functional architecture, and to input signals into the areas. Finally, the development of new mathematical tools to interpret the new data is essential. Conclusions

It is clear that the challenges presented here are very ambitious, and that some of them can only be started in the future. It is also clear that there are strong interrelations. “Conscious Machines,” for instance, will need some of the research that was described in the “Constructed Brain” and the “Brainprobe Project” sections. Very interesting is the fact that in at least three challenges the need was recognized for collaborations that extend beyond small research groups. This is true for the “Acting” challenge, which calls for standardization of peripherals; for “Constructed Brain,” which claims that models created by individual research groups cannot capture the complexity of the brain and calls for a framework to connect such models; and also for the “Brainprobe Project.” This shows the need for a NeuroIT community and also for more permanent funding initiatives in these areas that would allow the creation of communities and institutes that would tackle these standardization and collaboration issues in a more systematic way than is currently the case. Recently, a new version of the roadmap was published (version 2.0). It includes a new chapter on bio-inspired hardware, which describes VLSI design of neuromorphic chips and evolvable hardware, among others. Nearly all chapters have been updated to the state-of-the-art of summer 2006. Acknowledgments

Contributors to the roadmap are Marc de Kamps (Constructed Brain), Alois Knoll (Factor X, Conscious Machines), Rolf Müller (Successful in the Physical World, together with John Hallam and Herbert Peremans), Guy Orban (The Brainprobe Project, with contributions from Giacomo Rizzolatti), Giulio Sandini (Conscious Machines, with contributions from Ricardo Manzotti and Vincenzo Tagliasco), Erik de Schutter (Brain Ship), and Richard Walker (Automated Design of Artificial Cognitive Systems). The Conscious Machines chapter of the roadmap is currently being reviewed and extended by Igor Alkesander, John Taylor, and Ricardo Sanz. New contributors to version 2.0 were: Anders Lansner (Constructed Brain), Eduardo Ross, Fransisco Pelayo, Giacomo Indiveri, and Tobi Delbrück (Bio-Inspired Hardware). Marc de Kamps studied theoretical physics at the University of Amsterdam. He obtained a Ph.D. in 1996 in experimental high-energy physics. After finishing his thesis, he worked at the Psychology Department of Leiden University, modelling the neural substrate of attention. He then worked at the

46 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Technical University of Munich, modelling visual attention and combinatorial productivity in neural networks and assisting Alois Knoll in the coordination of nEUro-IT.net. He is now a lecturer in the Biosystems Group of the School of Computing at the University of Leeds.

Alois C. Knoll received the diploma (M.Sc.) degree in electrical engineering from the University of Stuttgart, Germany, in 1985 and his Ph.D. (summa cum laude) in computer science from the Technical University of Berlin, Germany, in 1988. Since 2001 he has been a professor of computer science at the Computer Science Department of the Technical University of Munich. His research interests include sensor-based robotics, multiagent systems, data fusion, adaptive systems, and multimedia information retrieval. He is currently coordinator of nEUro-IT.net. Address for Correspondence: Marc de Kamps, Biosystems Group, School of Computing, University of Leeds, LS2 9JT Leeds, United Kingdom. E-mail: [email protected].

References [1] Biological Informatics Group, “Neuroinformatics: A developing field, uniting the neurosciences and interfacing it to the medical and information technology domains (version 6),” in Proc. OECD Megascience Forum, Neuroinformatics Subgroup, 1998 [Online]. Available: http://www.oecd.org/dataoecd/ 24/32/2105199.pdf [2] Report on Neuroinformatics from the Global Science Forum Neuroinformatics Working Group of the OECD, 2002 [Online]. Available: http://www.oecd.org/ dataoecd/58/34/1946728.pdf [3] J.K. Chapin, K.A. Moxin, R.S. Markowitz, and M. Nicolelis, “Real-time control of a robot arm using simultaneously recorded neurons in the motor cortex,” Nature Neurosci., vol. 2, pp. 664–670, 1999. [4] M.D. Serruya, N.G. Hatsopolous, L. Paninski, M.R. Fellows, and J.P. Donoghue, “Instant neural control of a movement signal,” Nature, vol. 416, pp. 141–142, 2002. [5] M.D. Taylor, S.I. Helms-Tillery, and A.B. Schwartz, “Direct cortical control of 3D neuroprostethic devices,” Science, vol. 296, pp. 1829–1832, 2002. [6] I. Aleksander, “The self ‘out there’,” Nature, vol. 413, pp. 23–23, 2001. [7] I. Aleksander, How to Build a Mind. London: Weidenfeld & Nicolson, 2000. [8] B.J. Baars, A Cognitive Theory of Consciousness. Cambridge, U.K.: Cambridge Univ. Press, 1988. [9] S. Grosberg, “The link between brain learning, attention, and consciousness,” Consciousness Cognition, vol. 8, pp. 1–44, 1999. [10] S. Harnard, “Can a machine be conscious? How?,” J. Consciousness Studies, vol. 10, pp. 67–75, 2003. [11] J.G. Taylor, “Paying attention to consciousness,” Trends Cognitive Sci.,” vol. 6, pp. 206–210, 2002. [12] G.J. Chaitin, “Randomness and mathematical proof,” Sci. Amer., vol. 232, pp. 47–52, May 1975. [13] J. Hertz, A. Krogh, and R.G. Palmer, Introduction to the Theory of Neural Computation. Reading, MA: Addison-Wesley, 1991. [14] J. Eggert and J.L. van Hemmen, “Modeling neuronal assemblies: Theory and implementation,” Neural Computat., vol. 13, pp. 1923–1974, Sept. 2001. [15] B.W. Knight, D. Manin, and L. Sirovich, “Dynamical models of interacting neuron populations in visual cortex,” in Symp. Robotics and Cybernetics: Computational Engineering in Systems Applications, E.C. Gerf, Ed. Lille, France: Cite Scientific, 1996. [16] F. van der Velde, “On the use of computation in modelling behavior,” Netw. Computation Neural Syst., vol. 8, pp. R1–R32, 1997. [17] F. van der Velde and M. de Kamps, “Neural blackboard architectures of combinatorial structures in cognition,” Behav. Brain Sci., vol 29, no. 1, pp. 37–70, 2006.

MAY/JUNE 2007

© ARTVILLE, IMAGE SOURCE

A Look at Projects in Europe Supporting Minimally Invasive Techniques

BY JENNY DANKELMAN, CORNELIS (KEES) A. GRIMBERGEN, AND HENK G. STASSEN

ith the introduction of new technology for surgical and interventional procedures, more complex operations can be performed. The goals are to increase the accuracy and safety of interventions and to reduce their invasiveness and discomfort to patients. If properly engineered, technology can reduce human limitations in dexterity and stability, while still leaving clinical decisions and high-level control to the medical doctor [1]. The technology supporting surgery can be roughly divided into 1) technology for the improvement of manipulation, directly performed by the surgeon himself focusing on minimally invasive procedures, including teleoperated surgical robots, surgical assistants, and other augmented devices and 2) technology that enhances precision, focusing on preoperative planning, image guidance, and including autonomous robots. A broad overview of medical robotics can be found in [1]–[3]. The developed instrumentation should be used by surgeons/interventionists. They have to implement the new method and the new instrumentation in their clinical practice. To limit training on patients, alternative solutions for training surgical skills are searched for. This article will end with a discussion on problems with the development of instruments to be used in the clinic and the clinically driven approach that may support this process.

W

Tools and Systems Supporting Manipulation Controlled by the Surgeon

Minimally invasive operation techniques are based on the access to the body of a patient via a limited number of cylindrical cannulas (trocars), inserted via small incisions in the skin. Despite many benefits for the patient, minimally invasive procedures yield a series of disadvantages to the surgeon [4], [5]. The surgeon has no direct three-dimensional (3D) view on the operation field, the instruments have limited degrees of freedom and limited force feedback, and there are hand–eye coordination problems [6]. Surgical Robotic Systems and Manipulators

Recently, computer-assisted surgery has entered the operating room, bringing opportunities for new advancements and improvements. In robotic manipulators, a computer is placed between the hands of the surgeon and the end-effector of the instruments. The initial work in this field has been performed IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

EXPLORING EXCITING FRONTIERS IN EUROPE

New Technologies Supporting Surgical Interventions and Training of Surgical Skills

in Karlsruhe and Tuebingen (see Table 1 for a description of the research institutions) [7]. The most common surgical robotic system currently on the market is the DaVinci system (Intuitive Surgical, Figure 1). This system consists of a master console, where the surgeon sits and is looking at a 3D binocular display of the operative field. A three-armed robotic system is placed next to the operation table, with two arms for manipulating the instruments and the middle arm for controlling the two-channel optical system. The main advantage of this master–slave system is the introduction of extra degrees of freedom to control the instruments inside the body, the socalled endo-wrist approach. The surgeon’s movements of the hand and fingers are transferred to the tip of the instruments, allowing the surgeon to control the tip of the instruments intuitively [8]. The main disadvantages of using currently available robotic systems are their high price, the time loss during set-up of the equipment, and the lack of force feedback. Based on the know-how of the lightweight robot and dexterous hand developments, the DLR institute is designing and constructing a universal surgical robot with an independent gripping force sensor to detect manipulation reactions [9]. A mechanical minimally invasive manipulator (MIM) was designed at the Academic Medical Center (AMC) in Amsterdam [10] (Figure 2) as a small, economical, and mechanical alternative for the computer-assisted “robotic” systems. The instrument is coupled by a mechanical link to the manipulator’s handle in such a way that movement directions of the handle correspond to identical movement directions of the instrument tip in all degrees of freedom. Although the manipulator is completely balanced, the total mass (5.5 kg) should be reduced to lower the inertia of the system and to enable even more precise manipulation. Since the robotic systems are too complex and costly for daily use, several groups are working on deflectable instruments having more degrees of freedom than standard instruments. At TuebingenSc, a handheld manipulator (Radius System) was developed [11] that was recently introduced on the market (Figure 3). At IMM a deflectable and rotatable endoscopic instrument was developed based on a miniaturized spheric articulation that can be manipulated by a single control wheel [12]. At Delft, a miniature steerable mechanism was developed for use in endoscopes, instruments, and catheters. 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

47

The steerable mechanism consists only of standard parts such as cables, coil springs, rings, and tubes and was inspired by the tentacles of a squid (Figure 4) [13]. The handheld instruments are simple but still have control problems in that manipulation is less intuitive compared to the robotic systems. Many other instruments have been developed supporting the minimally invasive approach. At Dundee, the Dundee MultiTool (DMT) was designed to enable the internal deploy-

Fig. 1. The da Vinci system (Intuitive Surgical, Santa Barbara, California).

ment (by thumb extrusion) of a small dissecting forceps (pickup), needle driver, and scissors [14] and a new grasper enabling prehensile grasping by finger-like jaws [15]. More fundamental research on grasping safely has been performed at Delft and can be found in [16], [17]. Camera Holders to Support the Minimally Invasive Techniques

During minimally invasive procedures an assistant is controlling the endoscope. Camera holders are able to return camera control to the surgeon and stabilize the endoscopic image [18]. At Karlsruhe, a passive camera holder with a stationary point and electromechanical brakes, called the Tiska [19], was developed. The AMC developed another design based on a parallelogram mechanism with stationary point balancing with a spring and adjustable friction (Passist) [20], [21]. A handcontrolled motorized active endoscope positioner was developed at Karlsruhe (Felix) [22]. The PER is an active system for endoscopy developed at TIMC/IMAG [23]. The positioning mechanism is fixed to the endoscope and strapped to the patient at the incision location, so no rigid base is necessary. The manipulator moves with the patient during breathing, repositioning by the surgeon, motions of other instruments, or any other displacement of the abdominal wall. PER relies on cable actuation using electrical motors. The surgeon may interact with the system using a joystick.

Table 1. Institutions mentioned in text. AMC

Instrument Development Department, Academic Medical Center, Amsterdam, The Netherlands

CRIM

CRIM laboratory, Scuola Superiore Saint’Anna, Pisa, Italy

Delft

Department of BioMechanical Engineering, Delft University of Technology, Delft, The Netherlands

DLR

Institute of Robotics and Mechatronics of the German Aerospace Center, Wessling, Germany

Dundee

University of Dundee, Ninewells hospital, United Kingdom,

EPFL

EPFL Institute, Lausanne, Switzerland

Karlsruhe

Institute of Medical Technology and Biophysics Forschungscentrum Karlsruhe, Germany

IMM

Institute Mutualiste Montsouris, Paris, France

Imperial

Mechatronics in Medicine Laboratory at Imperial College in

College

London, United Kingdom

IRCAD-EITS

IRCAD-EITS Institute, Strasbourg, France

Leuven

Leuven at the Katholic University of Leuven, Belgium

LIRMM

Laboratory of Computer Science, Robotics, and Microelectronics (LIRMM), Montpellier, France

München

Technical University of München, Germany

Oslo

Ulleval University Hospital, Oslo, Norway

TeubingenSc

Teubingen Scientific, Germany

TIMC/IMAG

TIMC/IMAG institute, La Tronche Cedex, France

Trondheim

SINTEF Health Institute in Trondheim, Norway

Tuebingen

University of Tuebingen, Germany

48 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Enhancing Vision and Touch

Although tools with haptics are not clinically used, many augmented devices have been developed to measure properties of living tissues. The systems provide sensing and display functions to improve the surgeon’s ability to sense tactile or haptic phenomena. At CRIM, a prototype of a new mechatronic tool was developed, integrated in a system for computer-assisted arthroscopy [24], [25]. The tool has a cable-actuated steerable tip and incorporates sensors for the detection of the tip position and contact with the surrounding tissue. A semi-automatic collisionavoidance mechanism prevents contact between the tip and some anatomical regions selected preoperatively (active constraints). DLR is developing novel instruments with additional degrees of freedom at the distal end (to retain full dexterity) and integrated force torque sensors. The use of force-feedback input devices together with advanced control algorithms enables the generation of realistic contact impressions [26]. At EPFL the BiopsyNavigator was developed that combines visualization with haptic rendering in order to provide haptic feedback to the surgeon during a biopsy using patient-specific data [27]. At München, an experimental endoscopic robot system was developed that is capable of both measurement and reflection of forces [28]. Finally, in Leuven a 5-mm diameter tri-axial force sensor has been developed for minimally invasive robotic surgery using strain gauges. The new MAY/JUNE 2007

sensor is based on a flexible titanium structure of which the deformations are measured through reflective measurements with three optical fibers [29]. An alternative approach without sensors was used at Delft. To be able to feel the forces applied to the tissue, a frictionless gripper was designed using rolling links [30]. To safely manipulate tissue, optimal visual feedback is also required. A flexible endoscope was developed at Delft improving the depth perception and eye–hand coordination (Endo-Periscope). The steerable tip can also be used to look behind organs and to observe places and cavities that are difficult to reach with conventional rigid endoscopes [31]. Systems to Enhance Precision

Geometric precision is often important especially in orthopedics and neurosurgery. Hence, these systems have as characteristics that the movements are guided by pre- and peroperative images. The ROBODOC is one of the first robots to be successfully introduced for joint replacement surgery. Since then, several other systems have been developed; however, most are not (yet) in clinical use. A pioneering research group at Imperial College developed Probot to aid in transurethral resection of the prostate [32]. A special-purpose robotic frame was designed to hold the surgical instrument. The geometry of the system is designed to allow a cavity to be hollowed out from within the prostate and restrict movements outside an allowable range. This restriction provides an additional margin of safety. Another special-purpose robot called Acrobot (from Active Constraint Robot) has been developed for safe use in the operating room for total knee replacement surgery. The surgeon guides the robot using a handle with feedback from a force sensor attached to the robot tip [33].

At LIRMM, a computerized system called SCALPP was developed for the harvesting of skin to be used in surgical procedures for burn victims and in orthopedic surgery [34]. At TIMC/IMAG, a robot for tele-echography called TER was developed. Performing an ultrasound examination involves good eye-hand coordination and the ability to integrate the acquired information over time and space. These specialized skills are not always present; therefore, teleconsultation is seen as an interesting alternative to conventional care. The teleoperated TER system [35] allows the expert physician located in the master site to move the virtual probe placed on a haptic device (Phantom) and to control the real echographic probe placed on the slave robot. The slave robot architecture is a lightweight, parallel, uncoupled robot placed on the patient’s body. The PADyC of TIMC/IMAG is a passive arm with dynamic constraints [36]. The concrete objective for PADyC’s development was to build a general-purpose mechanical device to be held by the surgeon that allows him to feel the virtual world of patient data (including safety regions around anatomical obstacles to be avoided), while moving in the real

Fig. 3. The Radius System, which is a hand-held manipulator (Tübingen Scientific, Germany). It is a simple instrument with a steerable tip with seven degrees of freedom, which does not compensate for scaling and mirroring.

Fig. 2. Mechanical minimally invasive manipulator (MIM) developed at the Academic Medical Center, Amsterdam. The manipulator and the surgeon console are connected by a mechanical linkage system.

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Fig. 4. Close-up of the steerable tip of the Endo-Periscope III designed at the Delft University of Technology. The arrow visualizes the camera’s line-of-sight. The tip can be steered in all directions between –110◦ and +110◦ .

MAY/JUNE 2007

49

world. The actuation of the PADyC comes exclusively from a human operator. This choice of a passive device also was aimed at providing intrinsic safety. Different types of constraints (region, trajectory, position, etc.) are implemented with the system depending on the task to be executed. At the AMC a force-controlled robotic device has been developed in the frame of a European project (ROBOSCOPE) intended for the control of a neuroscope (neuroendoscope) in brain surgery [37]. The instrument is designed to let the surgeon feel mechanical boundaries in his working space (active constraints). The mechanism is a motorized parallelogram manipulating a neuroscope in four degrees of freedom. It is a master–slave system with the master (sensor ring) located on the slave (motorized arm). By manipulating a four-degree-offreedom force sensor ring (master) at the tip of the robotic arm, the force exerted is translated into a velocity of the instrument (slave). This gives the surgeon the impression that he manipulates the instrument himself. At Karlsruhe, the ROBITOM, (Robot for Biopsy and Therapy of the Mama carcinoma) which is a manipulator system, was developed intended for breast cancer diagnosis and therapy directly in the iso-center of closed MRI systems. The system should be suitable for use in strong magnetic fields; therefore, the system relies on technical plastics. The system should enable the radiologist to remotely take a precise biopsy of a localized lesion in the MRI [38]. Instruments to Move Through the Colon

Colonoscopy is a standard medical procedure in which a long and flexible endoscope is inserted into the rectum for inspection of the large intestine and for simple interventions. Pushing the endoscope tip from the backside via a long and flexible tube leads easily to buckling when the tip meets with sharp curves in the intestinal wall. Buckling is accompanied by painful cramps and makes it difficult to complete the procedure. Inchworm devices specialized for locomotion in the colon have been developed at the Scuola Superiore Saint’Anna, in Pisa, Italy [39]. These devices have two types of actuators: a clamper and an extensor. The clamper is used to adhere or clamp the device onto the substrate while the extensor generates a positive displacement. A new way of locomotion developed at Delft [40] is based on a rolling donut that is positioned around the endoscope tip. The donut functions like a circular caterpillar and is constructed from three flexible stents that have high friction with the intestinal wall. The resulting rolling-stent endoscope contains

a new steerable mechanism by which the tip can be bent in all directions over a very large angle. Training and Simulation

Traditionally, surgical training is obtained in the operating room under supervision of an experienced surgeon. The minimally invasive surgical technique is difficult to learn, and learning curves of more than 30 procedures [41] are reported. So, more efficient and effective training facilities are a real medical necessity. Several training methods are becoming available to train minimally invasive surgical skills outside the operating room; e.g., Pelvitrainers (a box in which instruments can be inserted), and virtual reality trainers, with and without a haptic feedback, have been developed. In Dundee an advanced computer-controlled system (ADEPT) has been developed for the objective evaluation of endoscopic task performance. The target object consists of a sprung base plate incorporating various tasks. It is covered by a sprung perforated transparent top plate that has to be moved and held in the correct position by the operator to gain access to the various tasks [42], [43]. Imperial College is focusing on assessment of training. They have developed a computer-based device that tracks the movements of a surgeon when operating and which computes scores of how dexterous he or she is on the basis of time taken, distance traveled, and the number of movements [44]. A new sensor system for the tracking of any laparoscopic surgical instrument has been developed at Delft. The TrEndo system consists of a two-axis gimbal mechanism incorporating three optical sensors (Figure 5). The gimbal mechanism is to guide the laparoscopic instrument, mimicking the degrees of freedom of a trocar, whereas the optical sensors are used for recording the movements of the instrument. Optical computer mouse sensors are applied to reduce costs and to simplify interfacing [45]. In Oslo, in cooperation with SimSurgery, a virtual reality simulator was developed to train minimally invasive surgical skills. The system includes a suturing and knot tying module [46]. At Delft a new virtual simulator was developed, called the Simendo (DelltaTech, Delft) (Figure 6). The simulator is developed for hand–eye coordination training. The system is designed as a plug-and-play feature on a PC and is therefore affordable and mobile and can be used even at home [47]. At IRCAD-EITS, virtual reality is applied to assist surgical strategy and for surgical simulation in liver surgery. A computer interface was developed to manipulate the organ and to define surgical resection planes according to internal anatomy [48]. Furthermore, a realistic radiofrequency ablation simulation tool was developed, coupled with a 3D reconstruction and visualization project. It helps radiologists to have a better visualization of patient’s anatomic structures and pathologies and allows them to easily find an adequate treatment [49]. At Trondheim, a 3D navigation technology is proposed based on preoperatively acquired magnetic resonance or computed tomography data used in combination with a laparoscopic navigation pointer [50]. The laparoscopic navigation pointer has an attached position tracker that allows the surgeon to control the display of images interactively before and during surgery. The technology helped the surgeons to understand the anatomy and to locate blood vessels. Clinically Driven Instrument Design

Fig. 5. The TrEndo tracking system for laparoscopic instruments (Delft University of Technology and AMC).

50 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Many research groups in Europe are working on new technology supporting surgical techniques. In the past it has been shown that many of the developed systems never enter the operating MAY/JUNE 2007

room, or only in specialized academic centers. During the instrumentation development process, it is therefore very important that the engineers and surgeons are cooperating closely together. There are two principally different approaches to clinical problems: technologically driven approaches and clinically driven approaches [51], [52]. In the technologically driven approach, a new instrument is developed at the request of a medical professional or based on a new technique or a bright idea of an engineer. In this case, engineers are showing their medical counterparts what is technologically possible and how pinventive they are. This results in hi-tech instruments/systems, such as robotic systems, that are often not affordable by the practicing medical doctor. In the clinically driven approach, as developed and used at Delft, the surgeon is observed by the engineer in his work environment using, e.g., task-analysis methods. These analyses are then used for problem assessment, instruments design, and evaluation of new technologies [53]. The surgeon’s activities during and after the actual surgical procedure are discussed by the engineer and surgeon together in order to detect fundamental problems and limitations occurring during the surgical process. In this way, as a joint enterprise, the functional specifications for an instrument can be defined. This is a complex process, since the medical professionals and the engineers speak different languages, have different cultures, and do not know each other’s field. The engineer is not able to understand the medical needs and problems if the medical process has not actually been observed. So, engineers have to spend quite some time in one of the operating theaters in order to define a realistic clinical problem that is considered to be important by the surgeons involved. In this way, the integration of technology and medicine can be guaranteed. Conclusions

Although this overview does not cover all the research on the development of instruments and systems that support surgical procedures, it shows that many institutes are working in this challenging field. The research involves technology that enhances surgical skills such as master–slave systems as well as more automatic systems to enhance precision. To limit training on patients and to support surgical decision making, the development of (virtual reality) surgical trainers will become a field where the contribution of engineers is essential. Jenny Dankelman obtained her degree in mathematics, with specialization in system and control engineering in 1984 at the University of Groningen. Her Ph.D. was obtained in 1989 at the Man-Machine Systems Group, Mechanical Engineering Department, Delft University of Technology (DUT) based on her research of the dynamics of coronary circulation. This work was performed in close cooperation with the Department of Medical Physics of the Academic Medical Center at the University of Amsterdam. She continued her postdoctoral research on coronary circulation for three years at both universities. Since 1992 she has been a researcher at the DUT Man-Machine Systems Group and since 2001 she has been a professor of biomedical engineering. She is cooperating with surgeons of several (academic) hospitals. Her interests and research projects are in the fields of medical instruments, training and simulation tools, and patient safety, with a focus on minimally invasive techniques. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Fig. 6. The Simendo for training basic minimally invasive surgical skills (DelltaTech and Delft University of Technology).

Cornelis (Kees) A. Grimbergen received his Ir. degree in electrical engineering at the Delft University of Technology and a Ph.D. in 1977 from the State University of Groningen based on research in solid-state physics and semiconductor technology. Since 1977 he has been with the Laboratory of Medical Physics of the Faculty of Medicine of the University of Amsterdam working as an assistant professor. Since 1991 he has been a part-time professor at the Measurement and Control Department of the Faculty of Mechanics of the Delft University of Technology. Since 1995 he has also been a professor of medical technology at the Academic Medical Center of the University of Amsterdam and heads the Medical-Technological Development Department. His interests and research projects are in the fields of medical instrumentation, medical image processing, minimally invasive techniques, and safety and training in medicine. Henk G. Stassen graduated in 1964 with a degree in mechanical engineering and in 1967 obtained a doctorate in control engineering, both from the Delft University of Technology. His academic career has been at Delft, first in control engineering and since 1977 as a professor of man–machine systems. He is a member of the Royal Dutch Academy of Science, the Dutch Academy of Technology, and the Dutch Investigation Safety Board. His research interests are man–machine systems and biomedical engineering (coronary circulation, endoprosthesis, and minimally invasive surgery). Address for Correspondence: Jenny Dankelman, Department of BioMechanical Engineering, Faculty of MAY/JUNE 2007

51

Mechanical, Maritime and Materials Engineering, Delft University of Technology, Mekelweg 2, 2628 CD Delft, The Netherlands. Phone: +0 15 278 5565. Fax: +0 15-278 4717. E-mail: [email protected]. References [1] R.H. Taylor and D. Stoianovici, “Medical robotics in computer-integrated surgery,” IEEE Trans. Robot. Automat., vol. 19, pp. 765–781, Oct. 2003. [2] K. Cleary and C. Nguyen, “State of the art in surgical robotics: Clinical applications and technology challenges,” Comput. Aided Surg., vol. 6, pp. 312–328, 2001. [3] P. Dario, B. Hannaford, and A. Menciassi, “Smart surgical tools and augmenting devices,” IEEE Trans. Robot. Automat., vol. 19, pp. 782–792, Oct. 2003. [4] P. Breedveld, H.G. Stassen, D.W Meijer, and J.J. Jakimowicz, “Manipulation in laparoscopic surgery: Overview of impeding effects and supporting aids,” J. Laparoendos. Adv. Surg. Tech., vol. 9, no. 6, pp.469–480, 1999. [5] P. Breedveld, H.G. Stassen, D.W Meijer, and J.J. Jakimowicz, “Observation in laparoscopic surgery: Overview of impeding effects and supporting aids," J. Laparoendos. Adv. Surg. Tech., vol. 10, no. 5, pp. 231–241, 2000. [6] P. Breedveld and M. Wentink, “Eye-hand coordination in laparoscopy— Overview of experiments and supporting aids,” Min. Inv. Ther. Allied Technol., vol. 10, pp. 155–162, 2001. [7] M.O. Schurr, G. Buess, B. Neisius, and U. Voges, “Robotics and telemanipulation technologies for endoscopic surgery—A review of the ARTEMIS project,” Surgical Endoscop. Intervent. Techn., vol. 14, no. 4, pp. 375–381, Apr 2000. [8] J.P. Ruurda, I.A.M.J. Broeders, R.K.J. Simmermacher, I.H.M. Rinkes, and T.J.M.V. Van Vroonhoven, “Feasibility of robot-assisted laparoscopic surgery,” Surg. Laparosc. Endoscop. Percutan. Techn. vol. 12, no. 1, pp. 41–45, 2002. [9] T. Ortmaier, H. Weiss, and V. Falk, “Design requirements for a new robot for minimally invasive surgery,” Industrial Robot, vol. 31, no. 6, pp. 493–498, 2004. [10] J.E.N. Jaspers, M. Bentala, J.L. Herder, B.A. de Mol, and C.A. Grimbergen, “Mechanical manipulator for intuitive control of endoscopic instruments with seven degrees of freedom,” Min. Inv. Ther. Allied Technol., vol. 13, no. 3, 191–198, 2004. [11] M.O. Schurr, G. Buess, and K. Schwarz, “Robotics in endoscopic surgery: Can mechanical manipulators provide a more simple solution for the problem of limited degrees of freedom?” Min. Invas. Ther. Allied Technol., vol. 10, no. 6, pp. 289–293, 2001. [12] D. Gossot and G. Lange, “Deflectable and rotatable endoscopic instrument with intuitive control,” Min. Invas. Ther. Allied Technol., vol. 10, no. 6, pp. 295–299, Nov. 2001. [13] P. Breedveld, J.S. Scheltes, E.M. Blom, and J.E.I. Verheij, “Miniature steerable mechanism inspired by tentacles of squid for use in endoscopes, instruments and catheters,” IEEE Eng. Med. Biology Mag., vol. 24, no. 6, pp. 40–47, 2005. [14] T.G. Frank and A. Cuschieri, “A prehensile atraumatic grasper with intuitive ergonomics,” Surgical Endoscopy, vol. 11, no. 10, pp. 1036–1039, Oct. 1997. [15] A. Cuschieri, T.G. Frank, S. Brown, D. Martin, and J.L. Gove, “A new multitool for hand-assisted advanced laparoscopic surgery (HALS),” Surgical Endoscopy, vol. 17, no. 9, pp. 1368–1371, Sept. 2003. [16] E.A.M. Heijnsdijk, A. Padeloup, A.J. van der Pijl, J. Dankelman, and D.J. Gouma, “The influence of force feedback and visual feedback in grasping tissue laparoscopically,” Surgical Endoscopy, vol. 18, no. 6, pp. 980–985, June 2004. [17] E.A.M. Heijnsdijk, A. Pasdeloup, J. Dankelman, and D.J. Gouma, “The optimal mechanical efficiency of laparoscopic forceps,” Surgical Endoscopy, vol. 18, no. 12, pp. 1766–1770, Dec. 2004. [18] J.E.N. Jaspers, K.T. den Boer, B.A.J.M. de Mol, and C.A. Grimbergen, “Design and evaluation of endoscope positioners,” in Engineering for Patient Safety, Issues in Minimally Invasive Procedures, J. Dankelman, C.A. Grimbergen, and H.G. Stassen, Eds. Mahwah, NJ: Lawrence Erlbaum Assoc., pp. 162–179, 2005. [19] M.O. Schurr, A. Arezzo, B. Neisius, H. Rininsland, H.U. Hilzinger, J. Dorn, K. Roth, and G.F. Buess, “Trocar and instrument positioning system TISKA—An assist device for endoscopic solo surgery,” Surgical Endoscopy, vol. 13, no. 4, pp. 528–531, May 1999. [20] J.E.N. Jaspers, K.T. den Boer, W. Sjoerdsma, M. Bruijn, and C.A. Grimbergen, “Design and feasibility of Passist, passive instrument positioner,” Laparoendscopic Adv. Surg. Techn., vol. 10, pp. 631–636, 2000. [21] K.T. Den Boer, M. Bruijn, J.E. Jaspers, L.P.S. Stassen, W.F.M. van Erp, A. Jansen, P.M.N.Y.H. Go, J. Dankelman, and D.J. Gouma, “Time-action analysis of instrument positioners in laparoscopic cholecystectomy. A multicenter prospective randomized trial,” Surgical Endoscopy, vol. 16, pp. 142–147, 2002. [22] A. Schäf, R. Mikut, L. Gumb, M.O. Schurr, R. Oberle, U. Ullrich, G. Buess, W. Eppler, A. Grünhagen, V. Falk, P. Schlossmacher, U. Voges, W. Pfleging, U. Kühnapfel, W.A. Kaiser, H. Çakmak, S. Schüler, H. Maass, R. Cichon, H. Becker, M. Cornelius, H. Breitwieser, U. Kappert, H. Fischer, M. Selig, J. Vagner, B. Vogel, E. Hempel, M. Kaiser, K. Brhel, A. Hinz, and A. Felden “The medical engineering program of Forschungszentrum Karlsruhe,” Min. Invas. Ther. Allied Technol., vol. 9, pp. 255–267, 2000. [23] P. Berkelman, P. Cinquin, J. Troccaz, J.M. Ayoubi, C. Letoublon, and F.A Bouchard, “Compact, compliant laparoscopic endoscope manipulator,” in Proc. IEEE Int. Conf. Robotics Automation, 2002, pp. 1870–1875. [24] S. D’Attanasio, O. Tonet, G. Megali, M.C. Carozza, and P. Dario, “A semiautomatic handheld mechatronic endoscope with collision-avoidance capabilities,” in Proc. IEEE Int. Conf. Robotics Automation, 2000, pp. 1586–1591. [25] P. Dario, M.C. Carrozza, M. Marcacci, S. D’Attanasio, B. Magnani, O. Tonet,

52 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

and G. Megali, “A novel mechatronic tool for computer-assisted arthroscopy,” IEEE Trans. Inform. Technol. Biomed., vol. 4, pp. 15–29, 2000. [26] B. Deml, T. Ortmaier, and H. Weiss, “Minimally invasive surgery: Empirical comparison of manual and robot assisted force feedback surgery,” in Proc. EuroHaptics, Munich, 2004, pp. 403–406. [27] G. Marti, P. Rouiller, S. Grange, and C. Baur, “Biopsy navigator: A smart haptic interface for interventional radiological gestures,” in Proc. Int. Congr. Computer Assisted Radiology and Surgery, London, vol. 1256, June 2003, pp. 788-793. [28] I. Nagy, H. Mayer, and A Knoll, “Application of force feedback in robot assisted minimally invasive surgery,” in Proc. EuroHaptics, Munich, 2004, pp. 240–246. [29] J. Peirs, J. Clijnen, D. Reynaerts, H. Van Brussel, P. Herijgers, B. Corteville, and S. Boone, “A micro optical force sensor for force feedback during minimally invasive robotic surgery,” Sens. Actuators A, Phys., vol. 115, pp. 447–455, 2004. [30] J.L. Herder, M.J. Horward, and W. Sjoerdsma, “A laparoscopic grasper with force perception,” Min. Invas. Ther. Allied Technol., vol. 6, pp. 279–286, 1997. [31] P. Breedveld and S. Hirose, “Development of steerable endoscopes to improve depth perception during laparoscopic surgery,” in Proc. ASME Design Engineering Technical Conf. Computers Information Engineering Conf., Montreal, Canada, paper DETC2002/MECH-34283, Sept. 2002. [32] B.L. Davies, R.D. Hibberd, A.G. Timoney, and J.E.A. Wickham, “A clinically applied robot for protatectomies,” in Computer-Integrated Surgery: Technology and Clinical Applications, R.H. Taylor, S. Lavallee, G.C. Burdea, R. Mosges, Eds. Cambridge, MA: MIT Press, pp. 593–601, 1996. [33] M. Jakopec, S. Harris, F.R.. Baena, P. Goves, J. Cobb, and B. Davies, “The first clinical application of a ‘hands-on robotic knee surgery system’,” Comp. Aid. Surg. vol. 6, pp. 329–339, 2001. [34] G. Duchemin, E. Dombre, F. Pierrot, P. Poignet, and E. Degoulange, “SCALPP: A safe methodology to robotize skin harvesting,” in Proc. 4th Int. Conf. Medical Image Computing and Computer-Assisted Intervention, 2001, pp. 309–316. [35] A. Vilchis, K. Masuda, J. Troccaz, and P. Cinquin, “Robot-based tele-echography: The TER system,” Stud. Health. Technol. Inform. vol. 95, pp. 212–217, 2003. [36] O. Schneider and J. Troccaz, “A six degree of freedom Passive Arm with Dynamic Constraints (PADyC) for cardiac surgery application: Preliminary experiments,” Comput. Aided Surg., vol. 6, no. 6, pp. 340–351, 2001. [37] C.A. Grimbergen, J.E.N. Jaspers, J.L. Herder, and H.G. Stassen, “Development of laparoscopic instruments,” Min. Inv. Ther. Allied Technol., vol. 10, no. 3, pp. 145–154, 2001. [38] H. Fischer, S. Kutter, J. Vagner, A. Felden, S.O.R. Pfleiderer, and W.A. Kaiser, “ROBITOM II, Robot for biopsy and therapy of the Mamma,” in Proc. IEEE Int. Conf. Systems, Man & Cybernetics, 2004, pp. 2530–2555. [39] L. Phee, D. Accotto, A. Menciassi, C. Stefanini, M.C. Carrozza, and P. Dario. “Analysis and development of locomotion devices for the gastroinestinal tract," IEEE Trans. Biomed. Eng., vol. 49, pp. 613–616, June 2002. [40] P. Breedveld, D.E. van der Kouwe, and. J. van Gorp, “Locomotion through the intestine by means of rolling stents,” in Proc. ASME 2004 Design Engineering Technical Conf. Computers Information Engineering Conf., Salt Lake City, UT, 2004, pp. 1–7. [41] M.J. Moore and C.L. Bennett, “The learning curve for laparoscopic cholecystectomy. The Southern Surgeons Club,” Am. J. Surg., vol. 170, no. 1, pp. 55–59, July 1995. [42] G.B. Hanna, T. Drew, P. Clinch, B. Hunter, and A. Cuschieri, “Computercontrolled endoscopic performance assessment system,” Surgical Endoscopy, vol. 12, no. 7, pp. 997–1000, July 1998. [43] N.K. Francis, G.B. Hanna, and A. Cuschieri, “The performance of master surgeons on the Advanced Dundee Endoscopic Psychomotor Tester—Contrast validity study,” Arch. Surgery, vol. 137, no. 7, pp. 841–844, July 2002. [44] K. Moorthy, Y. Munz, A. Dosis, F. Bello, A. Chang, and A. Darzi, “Bimodal assessment of laparoscopic suturing skills—Construct and concurrent validity,” Surgical Endoscopy, vol. 18, no. 11, pp. 1608–1612, Nov. 2004. [45] M.K. Chmarra, N.H. Bakker, C.A. Grimbergen, and J. Dankelman, “TrEndo, a device for tracking minimally invasive surgical instruments in training setups,” Sens. Actuators A. Phys., vol. 126, pp. 328–334, 2006. [46] V. Sorhus, E.M. Eriksen, N. Gronningsaeter, Y. Halbwachs, P.O. Hvidsten, J. Kaasa, K. Strom, G. Westgaard, and J.S. Rotnes, “A comprehensive platform for laparoscopic education,” Min. Invas. Ther. Allied Technol., vol. 13, no. 5/6, p. 372, Dec. 2004. [47] E.G.G. Verdaasdonk, L.P.S. Stassen, and J. Dankelman, “Evaluation of the simendo, a new virtual reality simulator for training of minimally invasive surgical skills,” Min. Invas. Ther. Allied Technol., vol. 13, no. 5/6, pp. 370–371, Dec. 2004. [48] J. Marescaux, J.M. Clement, V. Tassetti, C. Koehl, S. Cotin, Y. Russier, D. Mutter, H. Delingette, and N. Ayache, “Virtual reality applied to hepatic surgery simulation: The next revolution,” Ann. Surg., vol. 228, no. 5, pp. 627–634, Nov. 1998. [49] C. Villard, L. Soler, N. Papier, V. Agnus, S. Thery, A. Gangi, D. Mutter, and J. Marescaux, “Virtual radiofrequency ablation of liver tumors. Surgical simulation and soft tissue modeling,” in Proc. Lecture Notes Computer Science, vol. 2673, 2003, pp. 366–374. [50] R. Marvik, T. Lango, G.A. Tangen, J.O. Andersen, J.H. Kaspersen, B. Ystgaard, E. Sjolie, R. Fougner, H.E. Fjosne, and T.A.N. Hernes, “Laparoscopic navigation pointer for three-dimensional image-guided surgery,” Surgical Endoscopy, vol. 18, no. 8, pp. 1242–1248, Aug. 2004. [51] J. Dankelman, C.A. Grimbergen, and H.G. Stassen, “Engineering for patient safety: The clinically driven approach,” Biomed. Instrument. Technol., vol. 39, pp. 60–63, 2005. [52] J. Dankelman, C.A. Grimbergen, and H.G. Stassen, Eds. Engineering for Patient Safety, Issues in Minimally Invasive procedures. Mahwah, NJ: Lawrence Erlbaum Assoc., 2005. [53] K.T. Den Boer, J. Dankelman, D.J. Gouma, and H.G. Stassen, “Peroperative analysis of the surgical procedure,” Surgical Endoscopy, vol. 16, pp. 142–499, 2002.

MAY/JUNE 2007

EXPLORING EXCITING FRONTIERS IN EUROPE

Engineering for Health A Partner in Building the Knowledge Economy of Europe © ARTVILLE, IMAGE SOURCE

BY MARIA SIEBES, MARCO VICECONTI, NICOS MAGLAVERAS, AND C. JAMES KIRKPATRICK

n a reflection paper underlying the European Commission Consultation for a new European Union (EU) health strategy, Commissioner David Byrne stated “Health generates wealth” [1]. The health sector is driven by scientific and technological progress, and health is a productive economic factor in terms of employment, innovation, and sustainable development and growth. The continuity of healthcare represents a major challenge especially for the enlarged EU of 25 countries, given the rise of an aging population, and considering the growing innovation imbalance between the EU and Japan and the United States in this sector. Innovation and development in biomedical engineering and technology are therefore of increasing socioeconomic importance in today’s knowledge-based EU society. The EU committed itself to achieve an ambitious objective by 2010: to become the most competitive and dynamic knowledge-based society and economy in the world (Lisbon 2000), and to increase investment in research and development on average to 3% of GDP of member states (Barcelona 2002), two-thirds of which should come from private investment, with the bulk of the remaining 1% coming from the public sector. Current research spending (EU25 average in 2003) is only 1.92%, compared to 2.59% for the United States and 3.15% for Japan [2]. The gap between the United States and the EU is about €64 billion a year, 80% of which can be attributed to the difference in private-sector spending for R&D, which stands at 54% for the EU against 63% in the United States and 75% in Japan. An overall policy of growth is therefore necessary not only to improve competitiveness and ensure economic stability but also to meet the needs of a knowledge-based economy, and especially to respond to challenges of a diminishing and aging population. The EU currently holds the highest “human development index” worldwide. This index combines three basic indicators of human well-being: living a long life in good health, being well-educated, and having access to the resources necessary to enjoy a decent standard of living. On the other hand, Europe has the fastest growing percentage of elderly in the world. The proportion of people over 65 in Europe’s population will have doubled to reach 51% in 2050, reaching 40% in some member states by 2020 [3]. The recent enlargement of the EU poses an

I

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

additional challenge for the health sector if new member states are to receive equal access to benefits [4]. The availability of well-educated human capital is crucial in achieving the transition to a knowledge-based society [5]. The latest composite indicators, based on R&D expenditure per capita, human research capital, and overall investment per capita, show that Europe is lagging behind the United States and Japan. Although Europe produces more science and technology Ph.D.s per capita, the number of full-time researchers is significantly lower in Europe compared to the United States and Japan, since a large number of European Ph.D.s are not employed in research or leave the European research system to work abroad [3]. To be a genuinely competitive, knowledge-based economy, Europe must become better at producing knowledge through research, at diffusing it through education, and at applying it through innovation. This “knowledge triangle” makes up the core of the recently revised Lisbon strategy (Brussels 2005), focusing on the contribution of national economic policy actions to higher growth and more employment [6]. MBES: Engineering for Health

Medical and biological engineering and science (MBES) is an interdisciplinary field of science representing an integrative platform for all medical technology-related applications. It is recognized by the International Council for Science (ICSU), representing a global membership that includes both national scientific bodies (104 members) and international scientific unions (29 members). Through cross-disciplinary activities that integrate the engineering sciences with the biomedical sciences and clinical practice, MBES pursues ➤ the advancement of fundamental concepts in engineering, biology, and medicine ➤ the improvement of human health and quality of life. MBES is a rapidly developing field whose roots can be traced back for centuries. Current research areas in MBES cover an ever-expanding array of new fields and technologies, whose scope ranges from bio-nanomedicine and cellular engineering to advanced diagnostic and therapeutic devices and ICT-inspired e-health applications [7]. Closely linked with advances in computer and information technology, biology, and sensor miniaturization, it undergoes a transition from 0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

53

The objective of Engineering for Health is to help Europe exploit, in this postgenomic era, the unprecedented opportunities for generating new knowledge and translating it into applications that enhance human health. medical-based engineering toward biology-based engineering. It is estimated that 25 to 50 years from now there will be as many applications outside of the medical field as within it. This will require the expansion of research activities into biology-based areas and the establishment of innovative educational programs in all engineering disciplines.

EU

Year

Electrophysiology

1850s

Ionizing Radiation

1895

1st Biophysics Institute

1921

1st Ph.D. Progr. (Germany) Biophysical Society

1940 1943

IFMBE

US

1948

1st EMB Conference

1950s

1st Acad. Programs

1959

IFMBE

1960s

NIH Study Section

1968

BMES

1975

Whitaker Foundation

> 20 Natl. Societies

1980

ESEM

1992

AIMBE

2000 2003

NIBIB

EAMBES

Fig. 1. MBES developments in Europe and the United States.

54 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MBES in Europe Brief History

Academic activities of biomedical engineering reach back to early developments in electrophysiology nearly 200 years ago and to research originating with the discovery of ionizing radiation in the late 19th century, which together formed the basis for establishment of a formal Ph.D. training program in Frankfurt in 1921 (Figure 1). By the 1950s, there were societies or groups of researchers identifying their area as biophysics, bioengineering, or medical electronics in several countries in Europe, North America, and Asia. The initially loose communications between them eventually led to the establishment of the International Federation of Medical and Biological Engineering (IFMBE) in 1959. Private and public support rapidly advanced the success of MBES in the United States: In the early 1960s, the National Institutes of Health (NIH) established special study sections and training grants, followed by the creation of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) in 2000. The Bioengineering consortium BECON coordinates US$900 million worth of research and training opportunities throughout the NIH. The Whitaker Foundation has contributed more than US$800 million to the field of biomedical engineering since 1975, with the focus over the last 10 years on establishing biomedical engineering departments. As a result, the number of biomedical engineering departments and programs in the United States has risen to more than 90. In 1992, the American Institute for Medical and Biological Engineering (AIMBE) was created to address issues of public policy and public and professional education in biomedical engineering. In Europe, more than 20 national societies existed in the 1980s. Academic training has since undergone a fundamental change from a postgraduate specialty to fully established undergraduate and graduate education, and European universities have developed innovative training programs at all levels [8]. The number of academic programs and research institutions in Europe has risen to almost 70. There are several transnational societies, and most EU countries now have a national MBES society as well as societies in subfields of MBES. Optimal exploitation of ongoing and future research opportunities requires a concerted effort on a European level. In 2003, the European Alliance for Medical and Biological Engineering and Science (EAMBES) was founded as an umbrella organization to act as “one voice” in promoting medical and biological engineering at European and national levels. Its mission is to improve the health, wealth, and wellbeing of the people with the following major objectives: ➤ address issues of MBES education, research, and training activities ➤ promote research and development MAY/JUNE 2007

Engineering for Health provides an essential link bridging the “bio-nano-info” themes and will play a crucial role in fostering future frontier research for improving innovation and production of new knowledge. ➤ establish and maintain liaisons with national and European

governments and agencies ➤ promote public awareness of MBES as “Engineering for Health.” EAMBES is member of Health First Europe (HFE), an alliance of patient groups, healthcare workers, academics, experts, and the medical technology industry established in 2004 with the mission to ensure that equitable access to modern, innovative, and reliable medical technology and healthcare is regarded as a vital investment in the future of Europe.

operations to the U.S. headquarters, leaving the EU out of the next innovation loops. Similar stories can be found for other sectors of the medical technology industry. The United States has a strong world dominance (over 70%) both as originator and as developer of licensing agreements. Most medical technology innovations (more than 70%) are also patented in the United States [13]. Underlying reasons contributing to this imbalance are differences in healthcare technology assessment and in funding and reimbursement systems across the EU, which greatly affect

Socioeconomic Impact and Competitiveness

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

World Market Total = €184 Billion

Rest of World 27%

US 43%

EU 30%

Fig. 2. Distribution of the medical technology market. Data from 2003 [11].

16

Medical Industry R&D (% of Sales)

Innovation in medical technology and pharmaceuticals is a major factor in modern health systems and in nations’ ability to compete. Health science globally is a US$2.5 trillion business that is growing about 3% per annum, with patient care accounting for approximately 65% of health sciences expenditure, while medical technology and life sciences dominate the remaining turnover [3]. The health sector employs 10% of the EU active population with 386,000 jobs in the medical device industry, and it generated over 2 million jobs from 1995 to 2001 in the EU [1]. In Europe, an average of 8.6% of GDP is spent on health. Of this figure, 6.4% goes to medical technology. In the United States expenditure on healthcare is about 13.9% of the GDP with 5.1% spent on medical technology [9]. Healthcare expenditures in the Organisation for Economic Co-operation and Development (OECD) countries are projected to increase by 3.5% to 6% of GDP over the period 2005–2050 [10]. Health-related industries play a major role in the EU economy. With a 30% share of the world market (Figure 2), the value of the EU medical technology market, at US$55.2 billion, is the second largest market after the Unites States (43%). However, the EU medical technology industry spends almost 50% less than its U.S. competitors on R&D investments (Figure 3) [11]. For example, in orthopedics, most innovation in joint prostheses was accomplished in the United Kingdom (Charnley Group) and Switzerland (Muller Group) in the 60s, with important contributions also coming from Germany, France, and Italy. Europe had the first outcome register (Sweden); Europe developed the first method to monitor implants (Sweden); Europe collected the most accurate information on the forces acting on total hip replacements (Germany). However, in the past decades, Europe has been losing ground against its major competitors due to mergers, takeovers, and buyouts. Zimmer, the largest U.S. producer, recently bought the Swiss company Sulzer, the largest EU orthopedic manufacturer. The United States saw US$83 billion worth in health sciences merger and acquisition activity in 2002, compared to US$14 billion in Europe [12]. These buyouts are usually followed by a progressive move of all R&D

12.9 12

8 6.35

5.8

4

0 EU

US

Japan

Fig. 3. R&D investment in the medical technology industry. Data from 2003 [11].

MAY/JUNE 2007

55

acceptance of new technologies [14]. Moreover, medical device directives contain areas of regulatory uncertainty, which tend to result in a cautious approach to investment by venture capital organizations in Europe. A slower ICT diffusion can contribute to less productivity growth [13]. Although general practitioners’ use of IT has grown rapidly and widely, with 78% of GPs in the EU working with a PC in 2002, the actual role of IT in the healthcare sector remains significantly lower in Europe when compared to that in the United States. The average spent on IT per hospital in Europe is 1.2% of the overall budget, compared to 2.0 to 2.5% in the United States. Innovations in healthcare technologies are needed to facilitate access to information and communication, and to simplify diagnostic and therapeutic processes. Clinical information systems and electronic health records that operate under international information standards are becoming essential. Assessment, evaluation, benchmarking, and accreditation also represent major challenges. An ambitious vision has been put forth outlining plans for the implementation of an infrastructure that provides userfriendly, validated, and interoperable systems for medical care, disease prevention, and health education through national and regional networks that connect citizens, practitioners, and authorities online [4], [15]. These efforts involve significant engineering activity in design, development, and production. Implementation of the plans for a knowledge-based approach to healthcare requires human resource development in terms of both research and in-depth understanding of the functional capabilities of new technologies and applications through appropriate education and training [16]. These efforts are supported through specific actions in the EU Framework Programme (FP) for Research and Technological Development. While FP4 (1995–1998) included a specific action for MBES (BIOMEDII), it was replaced in FP5 (1999–2002) by specific programs with

several technology-based key actions that contained a role for MBES applications. The recent FP6 (2003–2006) was centered on realizing the European Research Area (ERA) by promoting better cooperation and integration of research efforts and capacities at universities, research centers, and industry across national borders. Funding for MBES was primarily provided within further differentiated thematic priorities such as nanotechnologies and nanosciences (“nano”), genomics and biotechnology for health (“bio”), and information society technologies (“info”). The cooperation and coordination of national activities was enhanced by the ERA-NET action along areas such as health and biotechnology. Support for these activities continues to be a focus of the current FP7 (2007-2013), which has been organized into four categories: Cooperation, Ideas, People, and Capacities (for more information see CORDIS Web site). The “Cooperation” program is the core of FP7 and fosters collaborative research along key research themes, such as health, biotechnology, ICT, or nanosciences. Increased funding opportunities for MBES exist in FP7, which also supports multidisciplinary and cross-theme research. Within the objective of the “Health” theme, emphasis has, for the first time, also been put on medical technology. Enhancements of human resources and mobility of researchers are pursued through the “People” program, by building on the successful Marie Curie Actions in FP6 (see link in sidebar) which provide (international) fellowships and grants for training, conferences, and excellence teams. Researcher mobility will also be improved by the realization of a European Higher Education Area (EHEA) aimed at harmonization of education. However, in contrast to the developments in the United States, no umbrella agency exists at the European government level to guide MBES policy issues or to coordinate funding, leading to fragmentation of research funding in the MBES domain within a number of selected priorities that are further-

RELATED LINKS • CORDIS, Community Research and Development Information Service, www.cordis.europa.eu • EAMBES, European Alliance for Medical and Biological Engineering and Science, www.eambes.org • EUCOMED, European Medical Device Trade Organization, www.eucomed.be • European Medical Device Trade Organization, www. eucomed.be

• Europe’s Information Society, eEurope 2005 Action Plan, ec.europa.eu/information_society/eeurope/2005 • European Trendchart on Innovation, EU benchmarking, trendchart.cordis.lu • Eurostat, European Statistics, epp.eurostat.ec.europa.eu • ESEM, European Society for Engineering and Medicine, www.esem.org • ESF, European Science Foundation, www.esf.org

• ELSF, European Life Sciences Forum, www.elsf.org

• ERC, European Research Council, erc.europa.eu

• ERA, European Research Area, www.cordis.europa.eu/era/

• HFE, Health First Europe, www.healthfirsteurope.org

• EURAB, European Research Advisory Board, europa.

• ICSU, International Council of Scientific Unions,

eu.int/comm/research/eurab • European Commission Research, ec.europa.eu/research • European Commission Human Resources and Mobility,

www. icsu.org • IFMBE, International Federation for Medical and Biological Engineering, www.ifmbe.org

Marie Curie Actions, http://ec.europa.eu/research/

• MTG, The Medical Technology Group, www.mtg.org.uk

fp6/mariecurie-actions

• TMA, Telemedicine Alliance, www.esa-int/SPECIALS/

• European Researcher’s Mobility Portal, ec.europa.eu/

Telemedicine_Alliance

eracareers

56 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

Both fundamental and applied research, with an emphasis on integrated, multidisciplinary, and coordinated efforts, will help to increase the competitiveness of the European healthcare system.

more shared with nonbiomedical fields. Cross-disciplinary research activity is firmly embedded in MBES activities, but although interdisciplinarity is considered a “sign of methodological openness and moreover a driving force for a European vision of a modern knowledge society supported by EU policies,” [5] it suffers from administrative barriers with respect to proposal evaluation, training, and funding opportunities [17]. For example, the European Science Foundation (ESF), while promoting multidisciplinarity as one of their governing values, is structured along traditional disciplines such as physical and engineering sciences or medical sciences. A recent development is the creation of a European Research Council (ERC) in 2005 as a pan-European funding agency with significant spending power to provide competitive funding for basic research, infrastructures, and human resources [5], [18]-[20].The ERC is part of the “Ideas” Program in FP7 and accepts basic research applications from individuals, independently of thematic priorities. Peer review will be carried out by 18 panels to cover all areas of science. It is currently offering its first round of funding where priority is given to support starting independent researchers. A second funding stream will be established later for projects led by advanced investigators. For more informayion, see the ERC Web site link provided in the sidebar. Engineering for Health: A Value Proposal

Engineering for Health is one of the fastest growing fields of technology [21]. Its objective is to help Europe exploit, in this postgenomic era, the unprecedented opportunities for generating new knowledge and translating it into applications that enhance human health. Health and Quality of Life

The past decades have seen tremendous improvements in the provision of healthcare, and as a result, people are living longer and healthier lives. This success is the result of a combination of factors: better informed patients, skilled clinicians, scientific discoveries, and technological innovation. Central to all of these improvements have been the technological advancements realized through MBES. Already, the use of diagnostic and therapeutic modalities of medical technology brings about improved patient outcomes. Although an overall cost-effectiveness analysis is hampered by the lack of harmonization and coordination in the use of evidence-based medicine and health technology assessment of member states and the lack of a coherent European Database on Medical Devices (EUDAMED), studies on specific healthcare areas have concluded that enormous net cost savings can been achieved [22]. In cardiac care, prominent examples include the use of coronary artery stents, implantable defibrillators and pacemakers, and intelligent ambulatory heart monitoring systems. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Advances in orthopedics, minimally invasive surgery, and biomaterials have resulted in safer operations, faster recoveries, and improved end results. These and other advancements have significantly reduced mortality rates, improved patient quality of life, and reduced both frequency and length of hospitalization, leading to reduced social costs associated with sick leave, reduced mobility, and early retirement [23]. Substantial steps ahead, particularly in areas such as regenerative medicine, cell therapies, nanomedicine, minimally invasive sensors and surgical technologies, advanced biomaterials, medical imaging, and telemedicine will revolutionize diagnosis, treatment, and rehabilitation. Technological advancements realized through MBES innovation and research will positively and widely affect the quality of life of EU citizens not only in relation to disease but will extend to tangible outcomes regarding the efficacy, safety, ergonomics, and comfort in all aspects of empowering, reenabling, or assisting the human body in normal activities (i.e., children, disabled, and elderly) as well as in exceptional activities (i.e., work, sports, security, and the exploration of hostile environments). Competitiveness in Research and Innovation

Both fundamental and applied research, with an emphasis on integrated, multidisciplinary, and coordinated efforts, will help to increase the competitiveness of the European healthcare system. Areas where MBES R&D contributes significantly to enhanced competitiveness in research and innovation include tissue and organ engineering for regenerative therapies, biological and physiological systems analysis, biomolecular imaging, diagnostic technologies, computer-integrated surgery systems, human-environmental interfaces, and all aspects of telecare and independent living devices in healthcare. Through modernizing modalities for prevention, diagnosis, and treatments, MBES creates greater efficiency and savings in the health system. Overall productivity is improved by better prevention, fewer complications, and faster recovery to health. MBES plays a significant role in healthcare technology assessment, thereby supporting the implementation of innovative technology. These are vital elements with a huge potential for positive economic and employment benefits in an economy facing a predominant demographic shift toward an aging society. Job opportunities for biomedical engineers are bright, with more than double the average predicted rate of increase in other fields [24], and bodies such as EAMBES are expected to help create many new jobs in the future [25]. Necessary steps in achieving global competitiveness will include harmonization of the EU patent systems to facilitate intellectual knowledge transfer, and preventing the access to the European market of counterfeited innovative technology MAY/JUNE 2007

57

Excellence in MBES research and education has the capacity to be a dynamic and effective engine for the development of the EU knowledge society and economy, and a magnet for international top-quality talents. products. Furthermore, EU-wide initiatives are needed to establish more balanced and harmonized reimbursement schemes and an appropriate common regulatory environment in order to ensure a more equitable level of patient and clinician access to innovative treatments across the EU and to create favorable conditions to make the EU more attractive for R&D activities in MBES. Knowledge-Based Healthcare

The European “eHealth Action Plan” adopted in 2004 aims at delivering better quality healthcare for European citizens while reducing costs, with one of its major targets to create by the end of the decade a borderless European health information space. The Telemedicine Alliance, comprised of the European Space Agency, the World Health Organization, and the International Telecommunication Union, was established with support by the EC DG Information Society to formulate an overlying policy for the application of telemedicine in support of the European citizen by the year 2010. MBES is intimately engaged in developing the required technological backbone for this ambitious knowledge-based approach to healthcare, which ranges from the development of electronic health records to creating an “intelligent environment” that allows ubiquitous management of each person’s health status and high-quality access to telecare, independent living services, and online health services. Related key research and technology areas encompass telematic biomedical implants (bioinformatics, DNA/protein sensors, self-powered micro- and nanosystems), standards and interoperability, human–environment interfaces (personalized ambient intelligence for augmented and virtual reality), secure communications and networking (including personal and body area networks), health information management (data mining, decision support systems, applications of GRID technologies, etc.), the modeling and simulation of complex systems (such as those needed for the Virtual Patient in computer-based training and surgery simulation, and the Virtual Physiological Human (VPH) initiative of the European Physiome project), and methodologies for the effective and efficient assessment of complex technologybased systems prototypes. Human resource development is an important prerequisite for the development and widespread introduction of new technologies in the health sector [16]. Central to its support is the need for public awareness and recognition of the importance of science, and to improve the image of researchers within society [5]. In this aspect, MBES holds an advantageous position through the tangible personal benefits experienced by European citizens as a result of MBES research. Investment in necessary human resources must be geared toward maintaining promising human capital in Europe and 58 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

attracting world-class researchers from abroad. In an era where many exact sciences have faced declining student numbers because of loss of appeal, the many-facetted aspects of biomedical engineering and science attract increasing numbers of the best and brightest students and make it well suited to keeping this creative intellectual potential firmly linked to an important core science for Europe’s transition to a knowledge society. In particular, it has been demonstrated that MBES is an attractive field for women, with female students outnumbering male students in many educational programs with a biomedical engineering component. Conclusions: The Road Ahead

Medical and biological engineering and science in Europe has come a long way from the initial steps taken more than a century ago. Today, MBES is organized in national and transEuropean societies and alliances and has established firm synergistic relationships with other stakeholders. The contributions of Engineering for Health to economic growth and competitiveness in Europe are a vital ingredient for achieving the Lisbon goals. Excellence in MBES research and education has the capacity to be a dynamic and effective engine for the development of the knowledge society and economy, and a magnet for international top-quality talents. Through its activities and opportunities, Engineering for Health represents a major thrust in policy-oriented research and development and provides European added value in important areas identified as key EU policy targets in the four main programs of FP7 (2007–2013). Engineering for Health provides an essential link bridging the “bio-nano-info” themes and will play a crucial role in fostering future frontier research for improving innovation and production of new knowledge. If Europe is to address the problem of sustainable development of the healthcare sector, then it must establish the necessary policy and investment structures to support and catalyze these endeavors with the development of an overall joint strategy of R&D in Engineering for Health that extends across all relevant departments and includes a joint definition of strategic goals. These actions would provide an essential pillar that strengthens the European science base by supporting interdisciplinary research endeavors in an area that intrinsically benefits European citizens. Maria Siebes received her undergraduate degree (1981) in biomedical engineering from the University of Applied Sciences in Giessen, Germany, and her M.S. (1984) and Ph.D. (1989) in biomedical engineering from the University of Southern California, Los Angeles. She joined the faculty of the Department of Biomedical MAY/JUNE 2007

Engineering at the University of Iowa, Iowa City, and transferred in 1997 to the Academic Medical Center, University of Amsterdam, The Netherlands, where she currently holds a tenured faculty member in the Department of Medical Physics. Her research projects center on diseased coronary circulation and its assessment from physiological measurements in man. She is a Fulbright Scholar and member of Tau Beta Pi, Sigma Xi, IEEE EMBS, ASME, and the AHA. She currently serves on the Council of the European Alliance for Medical and Biological Engineering and Science (EAMBES) and chairs the committee of Women in MBE of the International Federation of Medical and Biological Engineering (IFMBE). Marco Viceconti has an M.S. in mechanical engineering from the University of Bologna and a Ph.D. from the University of Florence. He is currently the technical director of the Laboratorio di Tecnologia Medica of the Istituti Ortopedici Rizzoli, Bologna, Italy, and the president of the BioComputing Competence Centre (B3C). His main research interests are related to the development and validation of medical technology for orthopedics and traumatology. In his career he has published over 120 papers, 80 of which are indexed in Medline. He is currently the president of the European Society of Biomechanics and member of the Council of the European Alliance for Medical and Biological Engineering and Science (EAMBES). He is the promoter and animator of community initiatives such as the ISB Mesh Repository and the Biomechanics European Laboratory virtual laboratory, and the scientific coordinator of the Europhysiome action. Nicos Maglaveras received the Diploma in electrical engineering from the Aristotelian University of Thessaloniki, Greece, in 1982, and the M.Sc. (1985) and Ph.D. (1988) from Northwestern University, Evanston, Illinois, both in electrical engineering with emphasis in biomedical engineering. In 1990 he joined the faculty of the medical school in the Lab of Medical Informatics at Aristotelian University, where he is currently an associate professor of medical informatics. His research interests are in nonlinear biological systems simulation, cardiac electrophysiology, medical expert systems, medical imaging, medical telematics, and neural networks. He has contributed to more than 140 publications in refereed international journals and conferences. He has participated in several Greek national research projects and in CEC programs dealing mainly with medical informatics, computer patient records, and medical information processing, and served as the scientific coordinator of CEC-funded IST projects. He has been a member of IEEE, EAMBES, the Greek Technical Chamber, the New York Academy of Sciences, CEN/TC251-WG5, and Eta Kappa Nu. C. James Kirkpatrick is a graduate in science (B.Sc. 1972, Ph.D. 1977, D.Sc. 1992) and medicine (M.B. 1978, M.D. 1982) from the Queen’s University of Belfast in Ireland and was a lecturer in pathology at the University of Ulm, IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Germany, and Manchester, United Kingdom, in the 1980s, before taking up a professorship at the Technical University of Aachen, Germany, in 1987. Since 1992 he has been a professor of pathology and chairman of the Institute of Pathology at the Johannes Gutenberg University of Mainz, Germany. His principal research interests are in the fields of biomaterials and regenerative medicine, with special emphasis on developing relevant in vitro methods to reduce animal experimentation. He (co)authored more than 240 publications in peer-reviewed journals. He is a Fellow of the Royal College of Pathologists, London (FRCPath), and the International Union of Societies for Biomaterials Science and Engineering (FBSE), and is honorary professor at the Peking Union Medical College, Beijing, and at the Sichuan University, Chengdu, China. He is former president of the German Society for Biomaterials and current president of the European Society for Biomaterials. Address for Correspondence: Maria Siebes, Department of Medical Physics, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Phone: +31 20 566-7240. Fax: +31 20 6917233. E-mail: [email protected]. References [1] D. Byrne, “Enabling good health for all. A reflection process for a new EU health strategy,” EU DG Health and Consumer Protection, 15 July 2004 [Online]. Available: http://europa.eu.int/comm/health/ph_overview/strategy/health_strategy_en.htm [2] S. Frank, “R&D expenditure in Europe,” Statistics in Focus (Science and Technology) Eurostat, no. KS-NS-06-006-EN-N, 6/2006. [3] European Commission (2003), Third European Report on Science and Technology Indicators 2003: Towards a Knowledge-Based Economy [Online]. Available: http://ec.europa.eu/research/press/2003/pdf/indicators2003/ reist_2003.pdf [4] A. Braun, A. Constantelou, V. Karonou, A. Ligtvoet, J.-C. Burgelman, and M. Cabrera, “eHealth in the context of a European ageing society: A prospective study,” European Commission DG JRC, ITPS Tech. Rep. EUR 21377 EN, 2004 [Online]. Available: ftp://ftp.jrc.es/pub/EURdoc/eur21377en.pdf [5] Proc. The Europe of Knowledge 2020. A Vision for University-Based Research and Innovation, Liege, Belgium, Apr. 2004. [6] Council of the European Union (26 May 2005), “Integrated guidelines for growth and jobs (2005–2008)” [Online]. Available: http://www.international.lga. gov.uk/IGP_June_05.pdf [7] F. Nebeker, “Golden accomplishments in biomedical engineering,” IEEE Eng. Med. Biol. Mag., vol. 21, no. 3, pp. 17–47, 2002. [8] R. Jox, “Europe chips in for training,” Nature, vol. 425, p. 326, 2003. [9] “Medical technology brief,” Eucomed 2004 [Online]. Available: http://www.eucomed.be/publications.aspx [10] Organisation for Economic Co-operation and Development, “Projecting OECD health and long-term care expenditures: What are the main drivers?” OECD Economics Dept., Working Paper 477, 2006. [11] The Medical Technology Market Place 2003. EUCOMED Industry Profile, 2004 [Online]. Available: http://www.eucomed.be. [12] Earnst & Young Corporate Finance (2003), Health Sciences Global M&A Survey 2002 [Online]. Available: http://www.ey.com [13] PricewaterhouseCoopers’ Health Research Institute (2005), Healthcast 2020: Creating a Sustainable Future [Online]. Available: http://www.pwc.com/us/eng/ about/ind/healthcare/pubhc2020en.html [14] L. Ryden, G. Stokoe, G. Breithardt, F. Lindemans, and A. Potgieter, “Patient access to medical technology across Europe,” Eur. Heart J., vol. 25, pp. 611–616, 2004. [15] M. Cabrera, J.C. Burgelman, M. Boden, O. Da Costa, and C. Rodriguez, “eHealth in 2010: Realising a knowledge-based approach to healthcare in the EU. Challenges for the ambient care system,” European Commission DG JRC, Tech. Rep. EUR 21486 EN, Apr. 2004. [16] A. Constantelou and V. Karounou (Feb. 2004), “Skills and competencies for the future of eHealth” [Online]. ITPS Tech. Rep., no. 81. Available: http://www. jrc.es/home/report/english/articles/vol81/ICT4E816.htm [17] “Interdisciplinarity in research,” European Union Research Advisory Board, EURAB 04.009-Final, Apr. 2004. [18] L. Spinney, “European research council gets thumbs up,” The Scientist, vol. 4, no. 1, Feb. 10, 2003.

MAY/JUNE 2007

59

Improving Corrective Maintenance Efficiency in Clinical Engineering Departments

BY ANTONIO MIGUEL CRUZ, CAMERON BARR, AND ELSA P. POZO PUÑALES

ultiple linear regression and clustering techniques are tools that have been extensively applied in several financial, technical, and biomedical arenas, where vast quantities of data are produced and stored [1]. These techniques show promise in analyzing the performance of departments responsible for and related to hospital equipment maintenance and, thereafter, identifying and improving areas of concern. As a contributory measure, this research is focused on the analysis of quality and effectiveness of corrective (nonscheduled) maintenance tasks in the healthcare environment and the improvement of those processes. The two main objectives of this research are to build a predictor for a TAT indicator to estimate its values and to use a numeric clustering technique to find possible causes of undesirable values of TAT. To build the predictor for TAT the sequential minimal optimization algorithm (SMO) was selected [2]. The SVM algorithm is a nonlinear generalization of the Generalized Portrait algorithm developed in Russia in the 1960s [3]. The remarkable feature of the SMO algorithms is that they are fast (it has been reported to be several orders of magnitude faster up to a factor of 1,000) and exhibit better scaling properties as well as being very easy to implement [2]. The SMO algorithms have also been demonstrated to be valuable for several real-world applications. For example, they have been applied in many areas including cost-benefit models for regression test selection, test suite reduction, test case prioritization, time series prediction applications, scheduling of jobs and maintenance tasks in equipment, and power supply and stock management problems. In stock management, an interesting study compared various learning algorithms (lazy Bayesian rules classifier (LBR), weighted regression (WR), K-nearest neighbors classifier (Ibk), Kstar, and least median square linear regression [4]-[6]) with the SMO algorithm in different scenarios (six experiments). It showed that the SMO algorithm was the best in four cases and the second best in the two remaining cases. The data sample for this study was taken from a hospital inventory with 749 medical devices located in 25 cost centers. These devices

M Multiple Linear Regression and Clustering Techniques for Analyzing Quality and Effectiveness of Technical Services

60 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

0739-5175/07/$25.00©2007IEEE

MAY/JUNE 2007

were distributed into 400 different models inside the inventory and were acquired from 180 different vendors and/or OEMs. In the period from 2002 to 2006 a total of 980 corrective work orders were analyzed, and all of this data are maintained by means of a computerized maintenance management system (CMMS) called SMACOR. In performing the preliminary reduction on this data, a problematic overall value was readily identified and required attention. The average TAT for corrective maintenance was 5.42 days over the analyzed period (2002–2006) over all equipment type groups. The TAT affects the availability [7] of medical devices and, consequently, the wait times of patients in the healthcare system. With a TAT of more than one work week, the value was deemed unacceptable. So from this initial observation, a specific focus for the present endeavor has been identified, because the TAT is a principle measure of a clinical engineering department’s (CED) performance. Not all equipment has the same impact on the TAT value and, so, the primary objective is to identify which medical devices groups are producing an effect in this indicator. To accomplish this, the segmentation of work-order count and TAT per device type group for corrective maintenance tasks were all carried out. Table 1 shows the total number of medical devices and work orders generated by equipment type. Figure 1 shows the average of TAT and acquisition cost penetration according to the respective equipment type

40

Table 1. Total number of equipment and work orders per equipment type (No. WO and No. equipment type means the total number of work orders and equipment type respectively). Equipment Type

No. WO

No. Equipment Type

C

300

221

B

141

110

E

131

26

A

89

59

H

83

71

D

79

32

L

45

84

F

39

27

I

35

42

K

19

15

G

15

44

J

4

18

Where equipment type categories are A(Imaging), B(Medical Electronics), C(Electro-mechanics), D(Oxygen devices), E(Sterilization), F(Laboratory devices), G(Optical Fiber), H(Dentistry), I(Optics), J(Electro-optics), K(Vacuum devices), and L(Measurement devices) respectively.

37.2599

35

Penetration

30 25 20 15.2394 15 10.1029

10

8.6536 6.1608

5.6207

5 0

A

B

C

D

E

F

4.3631

G

4.3481

3.7049

2.7263

2.137

1.1407

H

I

J

K

L

2.17

1.8

1.07

0.79

0.88

0.53

H

F

I

G

L

J

Equipment Type

20

TAT

15

14.32

13.39 11.49

10

8.11

7.39 3.38

5 0

A

C

K

D

E

B

Equipment Type

Fig. 1. Acquisition cost penetration and average turn-around time (TAT) per equipment type.

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

MAY/JUNE 2007

61

(acquisition cost penetration represents the % of acquisition cost of a category in comparison with the total acquisition cost for all categories). Now that the gross statistical properties of the data have been retrieved, some interesting “insights” emerge and are summarized as follows: 1) Equipment types C, B, E, and A represent 55.54% of the hospital inventory (by number) and cause 67.45% of the total work orders (see Table 1). 2) The type E device is a mere 3.6% of medical devices (26) in the inventory but cause 13.37% (131) of the total work orders (see Table 1, row 3). 3) Equipment types A, B, E, and D account for 71.26% of acquisition cost penetration (see Figure 1). 4) Equipment types A, C, K, and D have the higher values of TAT, ranging from 14.32 to 8.11 days (see Figure 1). The process continues with an analysis of all the “insights” to discard those that do not contribute or make a redundant contribution to the resolution of the TAT problem. It is important to examine the specifics and implications of these insights more closely and be explicit in their interpretation. Initial considerations of the work-order count (insights 1) do not readily reveal its impact on equipment TAT. However, it is of interest to note that if a simple calculation is performed to yield the total TAT for each device type given the number of work orders it received, it is clear that equipment type C has 50.67% pro-

portion of the total TAT, whereas it accounts for only 30.61% of the work orders. Although this result has little bearing on the individual TAT, it is a definite indicator of its likely prevalence in the CED’s maintenance management issues. Looking specifically at the average service times of those groups from the first insight, the averages for C, B, E, and A were 1.2, 1.21, 1.5, and 2.9 hours, respectively. Notably, type A has a rank 4 in insight 1 but has the highest average service time of those included here. In fact, the ranks are reversed, running A, E, B, and C. Regarding the third insight, device type group A is the major acquisition cost penetration, with a value near 38%, and its closest competitor, B, is at approximately 15%. This fact could be indicative of the relative complexity of composite devices of type A. A final consideration of the average TAT insights is that equipment types A and C have the highest individual values of 14.32 and 13.39 days, respectively. Doing the same simple calculation of total TAT contribution for type A yields a 16% proportion. With these latest developments it becomes clear that service time does not seem to have a likely significant impact on TAT (i.e., in type A: 2.9 hours