Appendix B
Speakers’ Biographical Sketches

Susan Alpert, M.D., Ph.D., is Vice President, Regulatory Sciences at C.R. Bard, a mid-sized medical device company in Murray Hill, New Jersey, where she is responsible for the oversight of quality assurance and regulatory and medical affairs. Prior to this she was the Director of the Food Safety Initiative at the FDA’s Center for Food Safety and Applied Nutrition. She previously served as Director of the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health, FDA, which is responsible for the pre-market evaluation of the safety and effectiveness of medical devices. Dr. Alpert joined the FDA in 1987 as a Medical Officer in the Division of Anti-Infective Drug Products in the Center for Drug Evaluation and Research, where she also served as a supervisor for anti-infective and dermatological drug products. Dr. Alpert received her A.B. in biology from Barnard College, Columbia University, and her Ph.D. in medical microbiology from New York University School of Medicine. She earned her M.D. at the University of Miami School of Medicine, trained in Pediatrics at Montefiore Hospital, Albert Einstein College of Medicine in New York, and completed her training in Pediatric Infectious Diseases at Children’s Hospital in Washington, D.C. as part of a joint program with the FDA.

Robert W.Anderson, M.D., is the Chief of Staff of the Duke University Medical Center. In addition, he is Professor and Chairman of Surgery and Professor of Biomedical Engineering at Duke. Dr. Anderson earned a bachelor’s degree in engineering from Duke University and an M.D. from Northwestern University. After serving in the U.S. Army and holding several positions at the Duke University Medical Center, he served as Professor of Surgery at the University of



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Innovation and Invention in Medical Devices: Workshop Summary Appendix B Speakers’ Biographical Sketches Susan Alpert, M.D., Ph.D., is Vice President, Regulatory Sciences at C.R. Bard, a mid-sized medical device company in Murray Hill, New Jersey, where she is responsible for the oversight of quality assurance and regulatory and medical affairs. Prior to this she was the Director of the Food Safety Initiative at the FDA’s Center for Food Safety and Applied Nutrition. She previously served as Director of the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health, FDA, which is responsible for the pre-market evaluation of the safety and effectiveness of medical devices. Dr. Alpert joined the FDA in 1987 as a Medical Officer in the Division of Anti-Infective Drug Products in the Center for Drug Evaluation and Research, where she also served as a supervisor for anti-infective and dermatological drug products. Dr. Alpert received her A.B. in biology from Barnard College, Columbia University, and her Ph.D. in medical microbiology from New York University School of Medicine. She earned her M.D. at the University of Miami School of Medicine, trained in Pediatrics at Montefiore Hospital, Albert Einstein College of Medicine in New York, and completed her training in Pediatric Infectious Diseases at Children’s Hospital in Washington, D.C. as part of a joint program with the FDA. Robert W.Anderson, M.D., is the Chief of Staff of the Duke University Medical Center. In addition, he is Professor and Chairman of Surgery and Professor of Biomedical Engineering at Duke. Dr. Anderson earned a bachelor’s degree in engineering from Duke University and an M.D. from Northwestern University. After serving in the U.S. Army and holding several positions at the Duke University Medical Center, he served as Professor of Surgery at the University of

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Innovation and Invention in Medical Devices: Workshop Summary Minnesota Medical School for five years. He then served as Professor of Surgery and Professor of Biomedical Engineering at Northwestern University Medical School for 10 years, before returning to Duke in 1994. Dr. Anderson is a member of several professional societies and the recipient of several NIH honors and awards. Pamela G.Bailey is President of the Advanced Medical Technology Association (AdvaMed), a Washington, D.C.-based national trade association and the largest medical technology association in the world. AdvaMed represents more than 800 innovators and manufacturers of medical devices, diagnostic products, and medical information systems. As president, Bailey is responsible for developing and implementing legislative and grassroots policy and communication strategies in the health policy arena in order to ensure patients receive timely access to life-saving, life-enhancing medical technologies throughout the world. Bailey has been involved in health care public policy, government relations, and communications for over 30 years. She has worked in the public and private sectors in support of market-based health care reforms. Prior to joining AdvaMed, Bailey served from 1988 to 1999 as president of the Healthcare Leadership Council (HLC), a group of over 50 health care industry chief executives— leaders from the hospital, health plan, pharmaceutical, technology, and physician/nurse sectors. Initiated in 1988, HLC is the exclusive forum for the leadership of the health care industry to jointly develop policies, plans, and programs to accomplish their goals on public policy issues. During the early 1970s, Bailey was a member of the White House staff, rising from a research assistant to the President to Assistant Director of the Domestic Council. From 1975 to 1981, she was director of government relations for the American Hospital Supply Corporation, and from 1981 to 1983, she was Assistant Secretary for Public Affairs for the Department of Health and Human Services (HHS). She joined the White House staff again in 1983 as Special Assistant to the President and Deputy Director of the White House Office of Public Affairs. In 1987, she was named President of the National Committee for Quality Health Care (NCQHC). James S.Benson is the Executive Vice President, Technology and Regulatory Affairs, at the Health Industry Manufacturers Association. Prior to joining HIMA in 1993, Mr. Benson held various positions at the Food and Drug Administration, most recently as the Director for the Center for Devices and Radiological Health. In 1988, Mr. Benson was enlisted as Deputy Commissioner, with his appointment as Acting FDA Commissioner following in 1989. He held this position for one year, when he resumed the role of Deputy Commissioner. He received a B.S. degree in civil engineering from the University of Maryland and an M.S. degree in nuclear engineering from the Georgia Institute of Technology. Mr. Benson is a member of the Board of Trustees of the American Society for Artificial and Internal Organs. He also serves on the Institute of Medicine Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, as well as on the National Cancer Institute’s Technology Evaluation

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Innovation and Invention in Medical Devices: Workshop Summary Committee. In 1997, Mr. Benson was elected to the Food and Drug Law Institute Board of Advisors. During his time at HIMA, Mr. Benson led the Association’s efforts to develop and advocate the Biomaterials Access Assurance Act of 1998 and the FDA Modernization Act of 1997. Robert M.Califf, M.D., is Associate Vice Chancellor for Clinical Research, Director of the Duke Clinical Research Institute, and Professor of Medicine, Division of Cardiology, at the Duke University Medical Center, Durham, North Carolina. He is also editor of the American Heart Journal. Dr. Califf has led a coordinating effort for many of the best-known cardiology trials of recent years, including CAVEAT (Coronary Angioplasty versus Excisional Atherectomy Trial), GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries, EPIC (Evaluation of c7E3 Fab in Preventing Ischemic Complications of High-Risk Angioplasty, and TAMI (Thrombolysis and Angioplasty in Myocardial Infarction). He graduated from Duke University summa cum laude and Phi Beta Kappa in 1973 and from Duke University Medical School in 1978, where he was selected for Alpha Omega Alpha. He is a certified specialist in internal medicine (1984) and in cardiovascular disease (1986) and a Fellow of the American College of Cardiology (1988). He did his internship and residency at the University of California, San Francisco, and a fellowship in cardiology at Duke University. In conjunction with colleagues at the Duke Databank for Cardiovascular Disease, he has written extensively about clinical and economic outcomes in chronic ischemic heart disease. With Drs. Mark and Wagner he is an editor of Acute Coronary Care, 2nd edition. He is a section editor in the Textbook of Cardiovascular Medicine and is the author of over 500 peer-reviewed articles. Robert B.Chess is Chairman of Inhale Therapeutic Systems. Mr. Chess joined Inhale in 1991 as its first non-founder employee, and served as its CEO and then co-CEO until 2000. Mr. Chess was previously the co-founder and President of Penederm, Inc., a dermatological pharmaceutical company focused on improved topical delivery. He has held management positions at Intel Corporation and Metaphor Computer Systems (now part of IBM), and served as a member of President Bush’s White House staff. Mr. Chess serves on the Board of Directors and Executive Committee of the Biotechnology Industry Organization, is a member of the Board of Pharsight Corp., and is a trustee of the Committee for Economic Development. Mr. Chess received his B.S. degree in Engineering from the California Institute of Technology and an M.B.A. from Harvard. Ronald W.Estabrook, Ph.D., received his B.S. degree from Rensselaer Polytechnic Institute and his Ph.D. in biochemistry from the University of Rochester. He has held appointments as Professor of Physical Biochemistry at the University of Pennsylvania and as Virginia Lazenby O’Hara Professor of Biochemistry and Chairman of the Department of Biochemistry at the University of Texas Southwestern Medical School. He has also served as Dean of the Graduate School of Biomedical Sciences at the Dallas campus of the University of Texas.

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Innovation and Invention in Medical Devices: Workshop Summary Dr. Estabrook has co-authored over 260 publications, including the editing of 14 books. He has an honorary Doctor of Medicine from the Karolinska Institut in Stockholm, Sweden, and a Doctor of Science from the University of Rochester. David W.Feigal, Jr., M.D., M.P.H., is Director, Center for Devices and Radiological Health, Food and Drug Administration. He received his B.S. from the University of Minnesota, his M.D. from Stanford University, and his M.P.H. from the University of California at Davis. He held a joint appointment at the School of Medicine and the School of Dentistry at the University of California, San Francisco, as a member of the Department of Medicine and the Department of Epidemiology and Biostatistics. Dr. Feigal joined the FDA in 1992 and has served in a variety of positions in both CDER and CBER, before assuming his current position. He has served on a number of committees sponsored by the World Health Organization, the National Institutes of Health, the Institute of Medicine, and the Centers for Disease Control and Prevention. Stephen P.A.Fodor, Ph.D., is currently Chairman and Chief Executive Officer of Affymetrix, Inc. He received his B.S. in Biology and M.S. in Biochemistry from Washington State University, and his Ph.D. in Chemistry from Princeton University. From 1986 to 1989, he was a National Institutes of Health postdoctoral fellow at the University of California, Berkeley, working with Professor Richard Mathies. He joined the Affymax Research Institute in Palo Alto in 1989, where he and colleagues were the first to develop and describe combinatorial chemistry synthesis strategies which they then applied to construct the high- density arrays of peptides and oligonucleotides on small glass substrates (chips). These chips now offer the opportunity for tens of thousands of assays to be carried out and detected in a rapid parallel format. Seminal manuscripts describing this work have been published in Science (1991, 1996), Nature (1993), and PNAS (1993). In 1993, Dr. Fodor co-founded Affymetrix, where the chip technology has been used to synthesize many varieties of high-density oligonucleotide arrays containing tens to hundreds of thousands of DNA probes. In 1992, Dr. Fodor and colleagues received the AAAS Newcomb-Cleveland Award for an outstanding paper published in Science. He has received various prizes including the Washington State University Distinguished Alumni Award, the Intellectual Property Owner’s Distinguished Inventor of the Year Award, the Chiron Corporation Biotechnology Research Award, the Association for Laboratory Automation Achievement Award, and the Jacob Heskel Gabbay Award in Biotechnology and Medicine. He serves on the Keystone Symposium Board of Directors, as well as on the board of directors of several scientific advisory companies. Thomas J.Fogarty, M.D., is Professor of Surgery at Stanford University. He received his undergraduate degree in biology from Xavier University in Cincinnati and his M.D. from the University of Cincinnati College of Medicine. Previous positions include President of the Medical Staff, Stanford University, and Director of Cardiovascular Surgery at Sequoia Hospital in Redwood City, California. He has acquired over 70 surgical instrumentation patents, including the

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Innovation and Invention in Medical Devices: Workshop Summary Fogarty balloon embolectomy catheter. He has also founded or co-founded over 20 companies in the medical device or services field and serves as a scientific advisor on the boards of numerous other companies. Dr. Fogarty is a member of the American Board of Surgery and the American Board of Thoracic Surgery, and has published over 200 scientific articles and textbook chapters in the fields of general and cardiovascular surgery. He is past president of the Society for Vascular Surgery (1995) and is president-elect of the International Society for Vascular Specialists. Dr. Fogarty was recently honored to receive The Lemelson Prize for Invention and Innovation (2000) and is a 2001 inductee to the National Inventor’s Hall of Fame. Annetine Gelijns is Director of the International Center for Health Outcomes and Innovation Research, and an Associate Professor of Surgical Sciences in the Department of Surgery, College of Physicians and Surgeons, and the School of Public Health (Health Policy and Management), Columbia University, New York City. Her current research focuses on the factors driving the rate and direction of innovative activity in medicine, academic medical centers, and the diffusion of medical technology, and measuring the clinical and economic outcomes of clinical interventions. She directs the Data Coordinating Center for the NIH-supported REMATCH trial, comparing mechanical assist devices to medical management in end-stage heart failure. Before coming to Columbia in 1993, she directed the Program on Technological Innovation in Medicine at the Institute of Medicine, National Academy of Sciences. From 1983 to 1987, she worked for the Steering Committee on Future Health Scenarios and for the Health Council, The Netherlands. Dr. Gelijns has been a consultant to various national and international organizations, including WHO and OECD. She holds a Ph.D. from the medical faculty, University of Amsterdam, and a bachelor’s and master’s degree in law from the University of Leyden, The Netherlands. Clifford Goodman, Ph.D., is a Senior Scientist at The Lewin Group, a health care policy and management consulting firm based in Falls Church, Virginia. Dr. Goodman’s methodological expertise involves technology assessment, outcomes research, health economics, decision analytic modeling, and studies pertaining to technological innovation, diffusion, and payment. His experience includes managing projects for an international range of government organizations, pharmaceutical and medical device companies, and professional and industry associations. As a National Research Council Fellow and later as director of the Council on Health Care Technology, he managed a series of technology assessment projects at the Institute of Medicine of the National Academy of Sciences (1982–90). He is a board member of the International Society of Technology Assessment in Health Care and is a Fellow of the American Institute for Medical and Biological Engineering. He did his undergraduate work at Cornell University, received a master’s degree from the Georgia Institute of Technology, and earned his doctorate from the Wharton School of the University of Pennsylvania.

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Innovation and Invention in Medical Devices: Workshop Summary John Hines is Technology Development Manager for the NASA Space Life Sciences Fundamental Biology Research Program, which operates within the Office of the Director, Ames Research Center (ARC). He also manages the Advanced Technology Development Project in Biosensor and Biotelemetry development (ATD-B) for the NASA Headquarters Life Sciences Division (HQ Code UL), and coordinates sensor technology issues for the Human Space Life Sciences Program (BioAstronautics), managed at the Johnson Space Center. He also originated and presently serves as Program Executive/Advisor for the Sensors 2000! (S2K!) Program, an Advanced Sensor Systems Technology Development Team operating from within the Life Sciences Division of the Astrobiology and Space Research Directorate at ARC. In 1996, Mr. Hines received the NASA exceptional service medal, highlighting his accomplishments in biosensor, biotelemetry, and space flight hardware development and applications. Prior to his NASA activities, he was a Major in the U.S. Air Force assigned as Deputy Chief of the Information Processing Technology Branch in the Avionics Laboratory at Wright-Patterson AFB, Ohio. From 1977–1986, he managed the ARC Cardiovascular Research Laboratory. Mr. Hines has a B.S. in Electrical Engineering from Tuskegee University and an M.S. in EE/Biomedical Engineering from Stanford University. Dean Kamen is president and owner of DEKA Research & Development Corporation, a Manchester, New Hampshire-based company specializing in advanced technologies in medical equipment. A physicist, engineer, and inventor, Mr. Kamen holds more than 100 U.S. and foreign patents. His inventions include a wearable infusion pump, a portable home dialysis machine, the cardiovascular Crown stent, a high-performance arthroscopic and laproscopic irriga-tion pump, and a device that is an integral part of a photopheresis machine for the treatment of cancer. Dean’s latest invention, unveiled in 1999, is the Independence 3000 IBOT™ Transporter, which was developed for the disabled community. It allows a seated user to move about at eye-level, climb stairs, and traverse uneven and hilly terrain. Mr. Kamen has received numerous awards in the field of medical devices, including: Design News Magazine’s Engineer of the Year (1994); Fellow of the American Institute of Medical and Biological Engineering (1994); Kilby Award (1994); Hoover Medal (1995); SPE International John W.Hyatt Service to Mankind Award (1996); and the Heinz Award in Technology, the Economy, and Employment (1998). He was elected to the National Academy of Engineering in 1997. Harry M.Jansen Kraemer, Jr., is chairman and chief executive officer of Baxter International Inc. Mr. Kraemer joined Baxter in 1982 as director of corporate development. He has held senior positions in both domestic and international operations, including senior vice president and chief financial officer. He was named President of Baxter International in 1997. Before joining Baxter, Mr. Kraemer worked for Bank of America and for Northwest Industries. He currently

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Innovation and Invention in Medical Devices: Workshop Summary serves on numerous boards, including Northwestern University, Comdisco, Inc., Science Applications International Corporation, Lawrence University, and the Advisory Board for the J.L.Kellogg Graduate School of Management at Northwestern University. Mr. Kraemer received bachelor’s degrees in mathematics and economics from Lawrence University and a master’s degree in finance and accounting from the J.L.Kellogg Graduate School of Management. Jeffrey Charles Lerner, Ph.D., for the past 18 years has served as Vice President for Strategic Planning for ECRI, a nonprofit agency and Collaborating Center of the World Health Organization. ECRI’s technology assessment information programs are now used worldwide by ministries of health, U.S. federal agencies (such as the Social Security Administration, the Center for Medicare and Medicaid Services, FDA, and AHRQ), state governments, private health plans (such as Kaiser Permanente), clinical specialty societies (such as the American Academy of Pediatrics), hospitals, and other professional constituencies and by consumers directly. Dr. Lerner is Center Director of an Evidence-based Practice Center funded by the Agency for Healthcare Research and Quality and the Coordinator of the Technical Expert Panel of the National Guideline Clearinghouse (a project sponsored by AHRQ in cooperation with the American Medical Association and the American Association of Health Plans). He is also a member of the Medicare Coverage Advisory Committee (MCAC). Dr. Lerner is former president and current member of the Board of the Health Strategy Network, a society of healthcare planners and managers. He is an associate editor of the Journal of Ambulatory Care Management and an Adjunct Senior Fellow of the Leonard Davis Institute of Health Economics of the University of Pennsylvania. Dr. Lerner received his B.A. from Antioch College and his M.A., M.Phil., and Ph.D. from Columbia University. He also studied abroad at St. Andrew’s University, Scotland. Thomas M.Loarie served as chairman and chief executive officer of Kera Vision, Inc., which pioneered a non-laser approach to treat common vision problems that reshapes the cornea by surgically adding materials. Mr. Loarie has 30 years of experience in the medical device industry with direct responsibility for bringing numerous innovative medical technologies to the fields of neurosurgery, interventional neuroradiology, oncology, thoracic and cardiovascular surgery, plastic surgery, general surgery, and ophthalmology. Mr. Loarie previously held senior management positions at American Hospital Supply Corporation (now Baxter Healthcare Inc.) in both the medical specialties and international business sectors, including president of Heyer-Schulte. He also served as an Assistant Professor of Surgery at Creighton University Medical School, lecturing on medical technology and public policy. He was a board member, and Executive Committee member of the Health Industry Manufacturers Association, the founder and chairman of the Medical Device CEO Roundtable, a board member of the California Healthcare Institute, and a member of the Medical Technology Leadership Forum. He also served on the Editorial Advisory Board

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Innovation and Invention in Medical Devices: Workshop Summary of the Medical Device Executive Portfolio, a professional journal, and on the Medical Industry Advisory Board of Ophthalmology Times. Mr. Loarie holds a B.S. degree in engineering from Notre Dame University. In addition, he participated in graduate business studies at the University of Minnesota, University of Chicago, and Columbia University. He has lectured and written extensively on medical technology innovation and its implications for health care public policy, including articles in the Wall Street Journal, Royal Academy of Engineering World Technology Update, the Journal of Applied Manufacturing Systems, and the Journal of Refractive Surgery. Robert W.Mann, Sc.D., since 1974 Whitaker Professor of Biomedical Engineering and now emeritus, has been engaged in biomedical and rehabilitation engineering research at the Massachusetts Institute of Technology since the late 1950s. His contributions have been recognized by his election to the Institute of Medicine in 1971, the National Academy of Engineering in 1973, and the National Academy of Sciences in 1982. In 1977 he was the recipient of the Gold Medal Award of the American Society of Mechanical Engineers and concurrently was awarded their inaugural H.R.Lissner Award for Outstanding Bioengineering. Other related recognitions include: in 1969 a Citation for Sensory Aids for the Blind from the Associated Blind of Massachusetts, in 1972 an IR-100 Award for the M.I.T.Braillemboss, in 1976 the Goldenson Award for Outstanding Scientific Research in Technology for Cerebral Palsy and the Physically Handicapped, and in 1979 the Engineering Society of New England Award. In 1979–1981 he was Sigma Xi National Lecturer, and in 1980 he was the ALZA Distinguished Lecturer of the Biomedical Engineering Society. He is a fellow of the American Society of Mechanical Engineers, the Institute of Electrical and Electronic Engineers, the American Association for the Advancement of Science, the American Academy of Arts and Sciences, and a founding fellow of the American Institute of Medical and Biological Engineers. Tobias Massa, Ph.D., is Executive Director, Global Regulatory Affairs, Eli Lilly and Company, responsible for all regulatory aspects of chemistry, manufacturing, and controls for all Eli Lilly products, as well as submission coordination, labeling, and medical information. He is a member of numerous research and corporate executive steering committees in the areas of regulatory affairs, pharmaceutical development and manufacturing, preclinical and clinical research, and labeling. He received his B.A. (cum laude) in chemistry from SUNY at Buffalo and his doctorate in biomedical sciences from the Mt. Sinai School of Medicine (CUNY). He has been a Diplomat of the American Board of Toxicology since 1981. Dr. Massa was a toxicologist at the Schering Plough Research Institute from 1978 to 1986 and was Associate Director/Group Leader in Toxicology for Pfizer from 1986 to 1990. He rejoined Schering Plough as Associate Director of Regulatory Affairs in 1990 and was most recently Senior Director of Worldwide Regulatory Affairs (Chemistry/Manufacturing/Controls) prior to joining Lilly in 1998. Dr. Massa is past chair of the Biology and Biotechnology Committee, and

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Innovation and Invention in Medical Devices: Workshop Summary member of the PDUFA III implementation team of the Pharmaceutical Research and Manufacturers of America. He currently chairs PhRMA working groups on site-specific stability, Phase 2/3 CMC IND requirements and manufacturing changes. He is chair of the Product Quality Research Institute Scientific Steering Committee and is a member of the PQRI Board of Directors. He is also past chair of the FDA Committee of the Biotechnology Industry Organization. J.Casey McGlynn is a partner at Wilson, Sonsini, Goodrich, and Rosati. His practice focuses on the organization, funding, and corporate representation of companies in the information technology and life sciences industries, providing assistance to hundreds of companies in the life sciences, semiconductor, software, and telecommunications sectors. As a strategic business partner, Mr. McGlynn and his group offer focused resources and capabilities to meet the most critical needs of startup and emerging growth companies, including private and venture capital financings, public offerings, university licensing, and strategic collaborations. Mr. McGlynn joined the firm in 1978 and has been a member of the firm’s executive, nominating, and compensation committees. He is a frequent contributor to magazines and newsletters focused on angel and venture investing. He is also a frequent speaker on issues relating to the organization and funding of new ventures. Mr. McGlynn received his B.S. and J.D. degrees, with highest honors, from Santa Clara University. Kshitij Mohan, Ph.D., is Corporate Vice President for Baxter International, Inc. He is responsible for corporate research and technical services, including research centers in the United States and Europe, and for emerging technology ventures and technology strategy development. He is also the founder and leader of the Baxter Technical Council and serves on the Baxter Operating Management Team. Before joining Baxter in 1988, Dr. Mohan was a researcher at the National Bureau of Standards, served in various capacities in the U.S. Food and Drug Administration, and served in the Office of Management and Budget. He also served on two White House task forces and led an inter-agency study of the U.S. Antarctic program. Dr. Mohan has published widely in the fields of health policies, regulations, R&D policies and applied physics, and has lectured and consulted worldwide. He has also served on numerous boards and editorial boards. Dr. Mohan received his Ph.D. in physics from Georgetown University and has extensive training in Management. James E.Muller, M.D. is a senior member of Center for Integration of Medicine and Innovative Technology, with responsibilities for general CIMIT development and cardiovascular medicine. From 1972 to 1989, Dr. Muller conducted clinical research at the Brigham and Women’s Hospital on the triggering of the onset of cardiovascular disease. Prior to joining CIMIT in 1999, he served as Chief of the Cardiovascular Division of the Deaconess Hospital in Boston and subsequently as Director of the Gill Heart Institute in Lexington, Kentucky. He is currently the Director of Clinical Research in the Cardiology Division of the

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Innovation and Invention in Medical Devices: Workshop Summary MGH, Harvard Medical School, and Principal Investigator of a multicenter NIH grant on the triggers of sudden death. Dr. Muller was one of three United States founders of the International Physicians for Prevention of Nuclear War, the organization awarded the 1985 Nobel Peace Prize. He has experience with application of high technology to medicine, through his work as a founder of InfraReDx, a start-up company dedicated to improving health care through photonics. Richard Nadeau, Ph.D., is the co-founder, chairman, and CEO of Cytometrics, Inc., a medical device company commercializing point-of-care clinical and diagnostic instrument systems that use its patented orthogonal polarization spectral imaging (OPS Imaging) technology, which he co-invented. As recently published in Nature Medicine., OPS Imaging provides, for the first time in humans, the ability to easily observe and measure the microcirculatory system and its surrounding tissue. Dr. Nadeau was co-inventor of Dupont’s Automatic Clinical Analyzer (aca®) and was responsible for its commercial launch. He has patented seven inventions, including the reference method of determining blood-urea-nitrogen (BUN). Prior to founding Cytometrics, Dr. Nadeau served as president of several medical diagnostics companies. He received his Ph.D. in biochemistry from West Virginia University. He has served in leadership roles for several professional organizations, including as president of the National Committee for Clinical Laboratory Standards, as a member of the Expert Panel on Instrumentation for the International Federation of Clinical Chemistry, and as an advisor to the FDA. Dr. Nadeau also served as a Visiting Research Associate at the University of Pennsylvania’s School of Engineering. Glen D.Nelson, M.D., is Vice Chairman of the Board of Medtronic, Inc. and has been a director since 1980. He joined Medtronic in 1986 as executive vice president and was elected vice chairman in 1988. Prior to joining Medtronic, Dr. Nelson practiced surgery for 17 years and also served as chairman and chief executive officer of American MedCenters, Inc. and chairman, president, and chief executive officer of Park Nicollet Medical Center. He received his A.B. from Harvard College and his M.D. from the University of Minnesota. Dr. Nelson serves on the boards of several organizations, including St. Paul Companies; Carlson Holdings, Inc.; ABS, INC.; the Medical Technology Leadership Forum; and the Johns Hopkins Medicine Board of Visitors. John A.Parrish, M.D., is the Chairman of the Department of Dermatology at Harvard Medical School (HMS), Chief of the Dermatology Service at Massachusetts General Hospital (MGH), Professor of Dermatology at HMS, and Professor of Health Science and Technology at Massachusetts Institute of Technology (MIT). Although his original training was in internal medicine, dermatology, and clinical research, he has spent the last 20 years conducting and directing basic research in photobiology, biological effects of lasers, and cutaneous biology. Dr. Parrish, in collaboration with Thomas B.Fitzpatrick, M.D., developed a novel treatment of psoriasis (oral psoralen photochemotherapy, or

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Innovation and Invention in Medical Devices: Workshop Summary PUVA) which is now used worldwide. His research group at MGH introduced laser lithorripsy of kidney stones, selective laser therapy of vascular birthmarks and lesions, and novel laser-based diagnosis and treatments of selective cardiovascular disorders and malignancies. Dr. Parrish organized the first, and now the world’s largest, multidisciplinary research group to systematically study the basic nature of laser effects on tissues, the Wellman Laboratories of Photomedicine at MGH, of which he is director. Dr. Parrish is also director of the MGH-Harvard Cutaneous Biology Research Center (CBRC), a research center committed to fundamental research in cutaneous biology as broadly defined. Dr. Parrish is also Director of the Partners-MIT-Draper Center for Innovative Minimally Invasive Therapy (CIMIT), a multidisciplinary research and clinical effort to introduce new therapeutic and diagnostic procedures to improve health care. Dr. Parrish has over 300 publications, many of which describe new treatments and diagnostics. He has written eight books, most of which are textbooks, but include a book on baseball, a book on the Vietnam War, and a book for the lay-person on skin. Kenneth I.Shine, M.D., is President of the Institute of Medicine, the National Academies, and Professor of Medicine Emeritus at the University of California, Los Angeles School of Medicine. He is the immediate past Dean and Provost for Medical Sciences at UCLA. He is also currently Clinical Professor of Medicine at the Georgetown University School of Medicine. Dr. Shine received his A.B from Harvard College and his M.D. from Harvard Medical School. A cardiologist and physiologist, Dr. Shine has held appointments as Assistant Professor of Medicine at the Harvard Medical School and Chair of the Department of Medicine at UCLA. He served as Chair of the Council of Deans of the Association of American Medical Colleges in 1991–92 and President of the American Heart Association in 1985–86. John P.Wareham is chairman, president and chief executive officer of Beckman Coulter, Inc. Wareham became CEO in September 1998 and was named chairman in February 1999. Prior to these changes, he had served as president and chief operating officer) since 1993. During his tenure as president and COO, Wareham successfully managed a corporate restructuring plan that resulted in significantly improved margins for the corporation. He also led an aggressive acquisition strategy that ultimately resulted in the union of Beckman and Coulter as a new industry leader in diagnostics. Wareham joined Beckman Instruments, Inc. in 1984 as Vice President-Diagnostics Systems Group, a position he held through October 1993. In this capacity, he propelled the company’s diagnostic business to a leadership position in the clinical laboratory market, making it one of the most profitable entities in the industry. Wareham’s move to the company was preceded by a 15-year career with SmithKline. He began there as an operations research analyst and held positions of increasing responsibility, ultimately serving as Director of Business Planning at SmithKline & French Laboratories-Worldwide, and finally, President of Norden Laboratories. Wareham, who holds

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Innovation and Invention in Medical Devices: Workshop Summary a bachelor of science degree in pharmacy from Creighton University in Omaha, Nebraska, began his career as a pharmacist in his family’s business. He has a master’s degree in Business Administration from Washington University in St. Louis. In addition to being a member and chairman of the Beckman Coulter Board of Directors, he is chairman of the Board of Directors of the Advanced Medical Technology Association (AdvaMed), formerly known as the Health Industry Manufacturers Association (HIMA) in Washington, D.C., is a member of the STERIS Corporation Board of Directors, and is also on the Advisory Board for the John Henry Foundation. Additionally, Wareham is a member of the Center for Corporate Innovation in Los Angeles and the University of California, Irvine (UCI) Executive Roundtable. John T.Watson, Ph.D., is the Director, Clinical and Molecular Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health. Dr. Watson came to NIH in 1976 from the University of Texas Health Science Center where he was chairman of the Graduate Study Program in Biomedical Engineering and Assistant Professor of Surgery and Physiology. He has bachelor’s (University of Cincinnati) and master’s (Southern Methodist University) degrees in mechanical engineering, and earned a doctorate in physiology from the University of Texas at the Southwestern Medical School. Dr. Watson’s experience includes 10 years in industry, 10 years in academia, and 25 years in the public sector. His research interests include medical implant design and science, biomaterials, imaging, and heart failure. He is a Founding Fellow of the American Institute of Medical and Biological Engineering and a member of the National Academy of Engineering.