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Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers

Susan Alpert, PhD, MD, joined Medtronic in July 2003 as vice president of regulatory affairs and compliance. She is now senior vice president and chief regulatory officer and is responsible for all Medtronic global regulatory efforts. Before joining Medtronic, she served C.R. Bard Inc., as vice president of regulatory sciences. She also previously worked at the Food and Drug Administration (FDA), where she held a variety of positions in the centers dealing with drugs, devices and radiologic health, and foods, including 6 years as the director of the Office of Device Evaluation. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Dr. Alpert has served on the board of the Food and Drug Law Institute. She serves on the board of advisers for the Medical Technology Leadership Forum, an educational organization focused on policy-makers, the general public, and the mass media regarding critical issues affecting the development and adoption of advanced medical technology. She also serves on the board of Women Business Leaders, an organization of women leaders in the health-care sector, and on the board of the Minnesota International Center. She is a past chair of the Regulatory Affairs Professional Society and a Fellow in that society. She serves on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public–private partnerships working with FDA to streamline the development of medical products. Dr. Alpert received her undergraduate degree at Barnard College and holds a master’s degree and a PhD in biomedical sciences from New York University. She received her medical degree from the University of Miami (Florida) and completed her



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B Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers Susan Alpert, PhD, MD, joined Medtronic in July 2003 as vice president of regulatory affairs and compliance. She is now senior vice president and chief regulatory officer and is responsible for all Medtronic global regulatory ef- forts. Before joining Medtronic, she served C.R. Bard Inc., as vice president of regulatory sciences. She also previously worked at the Food and Drug Administration (FDA), where she held a variety of positions in the centers dealing with drugs, devices and radiologic health, and foods, including 6 years as the director of the Office of Device Evaluation. She is a microbiolo- gist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Dr. Alpert has served on the board of the Food and Drug Law Institute. She serves on the board of advisers for the Medical Technology Leadership Forum, an educational organization focused on policy-makers, the general public, and the mass media regarding critical issues affecting the development and adoption of advanced medical technology. She also serves on the board of Women Busi- ness Leaders, an organization of women leaders in the health-care sector, and on the board of the Minnesota International Center. She is a past chair of the Regulatory Affairs Professional Society and a Fellow in that society. She serves on the Executive Committee of the Clinical Trials Transforma- tion Initiative, one of the public–private partnerships working with FDA to streamline the development of medical products. Dr. Alpert received her undergraduate degree at Barnard College and holds a master’s degree and a PhD in biomedical sciences from New York University. She received her medical degree from the University of Miami (Florida) and completed her 65

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66 THE FDA 510(k) CLEARANCE PROCESS clinical training at Montefiore Medical Center in the Bronx, New York, and at Children’s National Medical Center in Washington, DC. Robert E. Fischell, ScD, was employed at the Johns Hopkins University Applied Physics Laboratory full-time for 25 years and part-time for an ad- ditional 13 years. At Johns Hopkins, Dr. Fischell was the chief engineer of the Space Department, where he worked on more than 50 spacecraft. His interests at Johns Hopkins then turned to the invention of new medical devices, such as pacemakers and implantable heart defibrillators. Starting in 1969, Dr. Fischell began the formation of 14 private companies that licensed his patents on medical devices. The companies included Pacesetter Systems Inc. (now called St. Jude Medical), IsoStent Inc., NeuroPace Inc., Neuralieve Inc., Angel Medical Systems Inc., and Svelte Medical Systems Inc. Dr. Fischell has over 150 issued US and foreign patents for medical devices. Dr. Fischell is a trustee of the University of Maryland College Park Foundation and a member of the Board of Visitors for the College of Engineering and the College of Computer, Mathematical, and Physical Sci- ences and the University of Maryland School of Medicine. Dr. Fischell’s was elected to the National Academy of Engineering in 1989. He has received numerous awards for his contributions including the Inventor of the Year for the USA in 1984; Distinguished Physics Alumnus Award of the Univer- sity of Maryland; the 2004 Discover magazine award for Technology for Humanity; the 2005 TED award; the 2007 Master Inventor award from the Applied Physics Laboratory, and the Woodrow Wilson Prize for Public Ser- vice from the Woodrow Wilson Society for Scholars, as well as several other medals for his accomplishments in science, engineering, and innovation. In 2005, he gave $30 million to create and fund the Fischell Department of Bioengineering in the Clark School of Engineering. In that same year, the University of Maryland created the Robert E. Fischell Institute for Medical Devices to further the pioneering work that Dr. Fischell has created. Dr. Fischell received his BSME from Duke University and MS and ScD degrees from the University of Maryland. Kevin Fu, PhD, is an assistant professor in the Department of Computer Science of the University of Massachusetts Amherst. Prof. Fu investigates how to achieve trustworthy computing for embedded devices that must withstand both unintentional interference and determined, malicious intent. Prof. Fu’s research contributions range from the design and implementation of cryptographic systems to the security-risk analysis of computer systems, such as implantable cardiac defibrillators, automated software updates, con- tactless no-swipe credit cards, and Web site log-in systems. He is an Alfred P. Sloan Research Fellow, MIT Technology Review TR35 Innovator of the Year, and recipient of the National Science Foundation CAREER award.

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67 APPENDIX B His research appears in computer-science conferences and medical journals and has been featured in the mass media, such as the New York Times, the Wall Street Journal, and various news programs. He served on numerous program committees of leading conferences in secure systems and has given dozens of invited talks worldwide to industry, government, and academe. He is a member of the Institute of Electrical and Electronic Engineers, the Association for Computing Machinery, and USENIX. Prof. Fu leads the University of Massachusetts Amherst Security and Privacy Research (SPQR) Laboratory. He serves as codirector of the Medical Device Security Center and director of the RFID Consortium on Security and Privacy. Prof. Fu is a frequent visiting faculty member at Microsoft Research and Beth Israel Deaconess Medical Center. He received three degrees from the Massachu- setts Institute of Technology, including a PhD in electrical engineering and computer science. Susan Gardner, PhD, is the director of the Office of Surveillance and Bio- metrics (OSB) in the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). She joined FDA in 1995 as deputy director of OSB and became director in 2002. The responsibilities of OSB include providing statistical support to CDRH, development of in- novative statistical and epidemiologic techniques, design and oversight of postmarket studies, postmarket problem signal detection through monitor- ing of adverse events databases and other data sources, interpretation of the Medical Device Reporting (MDR) regulation, and CDRH coordination of data-management standards. Before joining FDA, Dr. Gardner was the associate director of health studies at Westat, a social-science research firm. After graduating from the Johns Hopkins School of Nursing, Dr. Gardner attended Boston University, where she received a BA in sociology. She re- ceived her PhD in medical sociology from Catholic University of America. Ralph F. Hall, JD, serves as Distinguished Visiting Professor of Law at the University of Minnesota Law School. He is also counsel to the Indianapolis, Indiana, law firm of Baker & Daniels, where he counsels clients in drug and medical-device regulation. He serves as CEO of MR3 Medical LLC, a startup medical-device company. Before his association with the university, Prof. Hall served in various capacities with Guidant Corporation, including senior vice president and deputy general counsel for litigation and compli- ance, general counsel of the Cardiac Rhythm Management group, special counsel to the Guidant Board of Directors Compliance Committee, and counsel to the Guidant chief compliance officer. Before joining Guidant, he was with Eli Lilly, including serving as the head of Lilly’s worldwide environmental law group. Prof. Hall received his BA from Indiana Univer- sity in 1974 and his JD from the University of Michigan, where he was a

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68 THE FDA 510(k) CLEARANCE PROCESS Weymouth Kirkland Scholar. Prof. Hall’s interests include Food and Drug Administration regulation, negotiations and alternative dispute resolution, intellectual-asset management, and the interface between corporate practice and the academic world. Larry Kessler, ScD, was appointed professor and chair of the Department of Health Services at the University of Washington (UW) School of Public Health in January 2009. The department also contains four centers; three are concerned with different aspects of public-health research, and the fourth is the Northwest Center for Public Health Practice. Before joining the faculty at UW, he spent 30 years working for the federal government, first at the National Institute of Mental Health, then at the National Cancer Insti- tute, and most recently at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). In September 2002, Dr. Kessler was appointed director of the Office of Science and Technology of CDRH. In that position, he directed the efforts of the laboratories of CDRH and the Standards Coordination Program. The office became the Office of Science and Engineering Laboratories (OSEL) in a reorganization effort designed to improve integration into the function and mission of CDRH. In June 1995, he first joined CDRH as the director of the Office of Surveil- lance and Biometrics. From 1996 through 2001, he served as chair of Study Group 2 of the Global Harmonization Task Force (GHTF), concentrating on postmarket vigilance and surveillance. In 2007, Dr. Kessler became chair of the GHTF for 1-1/2 years. In the period September 2001–August 2002, Dr. Kessler took a position as a visiting scientist at the Fred Hutchinson Cancer Research Center. From 1984 to June 1995, Dr. Kessler served as chief of the Applied Research Branch at the National Cancer Institute (NCI). Dr. Kessler has published over 100 peer-reviewed journal articles and numer- ous book chapters and government reports. His research has concentrated on applications of quantitative methods and health-services research to problems in surveillance and public health. Dr. Kessler obtained his degree in operations research from the Johns Hopkins School of Public Health in 1978 and received his ScD in the same year. William H. Maisel, MD, MPH, is director of the Medical Device Safety Institute, a nonprofit, industry-independent organization dedicated to im- proving the safety of medical devices. He is also a practicing cardiologist at Beth Israel Deaconess Medical Center and associate professor of medicine at Harvard Medical School, both in Boston, MA. He has served as a con- sultant to the Food and Drug Administration (FDA) Center for Devices and Radiological Health since 2003 and previously chaired FDA’s Post Market and Heart Device Advisory Panels. Dr. Maisel’s research interests involve the

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69 APPENDIX B safe and effective use of medical devices, and he has published extensively on medical-device safety and innovation and on consumer protection. Frederick A. Masoudi, MD, MSPH, is a practicing cardiologist and director of echocardiography at the Denver Health Medical Center. He received his medical degree from the Johns Hopkins University School of Medicine and served as a resident and chief resident in medicine at the University of Cali- fornia, San Francisco. After completing his fellowship in cardiology and re- ceiving a master of science in public health from the University of Colorado Denver (UCD), Dr. Masoudi joined the UCD faculty; he is now an associate professor. Dr. Masoudi is an expert in clinical registries and quality measure- ment. He served for 2 years on the Research and Publications Committee of the National Cardiovascular Data Registry (NCDR) Implantable Car- dioverter Defibrillator (ICD) Registry. He is the senior medical officer and chair of the NCDR Science Oversight Committee. He served as the clinical coordinator of the National Heart Care Projects sponsored by the Centers for Medicare and Medicaid Services (CMS) from 1999 to 2005 and is the clinical coordinator of the CMS Hospital Measures Special Study for acute myocardial infarction and heart failure. Dr. Masoudi has published more than 100 peer-reviewed papers. His most recent research has focused pri- marily on patterns of care and effectiveness of ICDs in community practice in the multicenter Cardiovascular Research Network. Dr. Masoudi holds positions in national organizations focused on quality of care and outcomes research. He is the chair of the American College of Cardiology–American Heart Association Task Force on Performance Measures, a member of the American Society of Echocardiography Quality Task Force, and an associate editor of Circulation: Cardiovascular Quality and Outcomes. Eric D. Peterson, MD, MPH, FAHA, FACC, is a professor of medicine in the Division of Cardiology of Duke University Medical Center. He is also an associate director and director of cardiovascular research at the Duke Clinical Research Institute. His formal research training includes an MPH from Harvard University with emphasis in biostatistics, health economics, and decision analysis. Dr. Peterson is a leader in quality research, with 480 peer-reviewed publications in the field. He is also the principal investiga- tor for the National Institutes of Health–Agency for Healthcare Research and Quality Duke Centers for Education and Research on Therapeutics, the Society of Thoracic Surgeons National Cardiac Surgery Database, and the Data Coordinating Center for the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and the American Heart Association (AHA) Get With the Guidelines (GWTG) database. He is also principal investigator and center director for one of the four AHA Pharmaceutical Roundtable Outcomes Centers nationwide. Dr. Peterson

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70 THE FDA 510(k) CLEARANCE PROCESS participates on multiple national committees, including the AHA Quality of Care and Outcomes Research Interdisciplinary Working Group and the AHA Strategic Planning Committee and the National Quality Forum Out- patient Imaging Efficiency Project Steering Committee and the ACC–AHA Performance Measures Task Force; the American College of Cardiology Foundation Appropriateness Criteria Implementation Working Group; the Department of Veterans Affairs Quality Enhancement Research Initia- tive Executive Committee; the oversight board of the Massachusetts Data Analysis Center; the National Quality Forum Technical Advisory Panel for Priorities, Goals and a Measurement Framework: Efficiency and Episodes of Care; the Institute of Medicine (IOM) Committee on Redesigning Insur- ance Benefits, Provider Payments, and Accountability Programs to Promote Quality of Health Care Delivery; and the IOM Committee on Secondhand Smoke Exposure and Acute Coronary Events. Dr. Peterson is a member of the American Society for Clinical Investigation Council. He received the DukeMed Scholar Award in 2007. In April 2010, he became the Fred Cobb, MD Distinguished Professor. He is also a contributing editor of the Journal of the American Medical Association. Rita F. Redberg, FACC, MD, MSc, graduated from Cornell University and the University of Pennsylvania Medical School and received a master’s of science and health policy and administration from the London School of Economics. She is a professor of medicine in the Division of Cardiology of the University of California, San Francisco School of Medicine. She is the ed- itor of Archives of Internal Medicine. Dr. Redberg has had long experience and training in health-policy and technology assessment. She served on the Medicare Evidence, Development and Coverage Advisory Commission from 2003 to 2006. She is a member of the California Technology Assessment Forum, the Medical Policy Technology and Advisory Committee, and the Food and Drug Administration (FDA) Cardiovascular Devices Expert Panel and is a consultant to the Center for Medical Technology for medical tech- nology policy. She has recently completed an extensive review of the FDA cardiovascular-device premarket approval process, which was published in the Journal of the American Medical Association. In addition, Dr. Redberg has gained extensive knowledge of health-care and health-care–financing legislation through her experience in working with the Senate Judiciary Committee as a Robert Wood Johnson Health Policy Fellow in 2003–2006. In 2008, she was invited to speak at the Institute of Medicine (IOM) Evi- dence Based Medicine Roundtable on Engineering a Learning Healthcare System: A Look at the Future. Dr. Redberg is a member of the American College of Cardiology (ACC) Clinical Quality Committee and serves on the Quality in Technology Work Group. She does comparative-effectiveness research and serves on the ACC Comparative Effectiveness Work Group and several other ACC committees, including several on appropriate use of

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71 APPENDIX B cardiac imaging. She is the ACC representative to the Institute of Clinical and Economic Review Advisory Board. Frederic S. Resnic, MD, received his undergraduate degree in electrical engineering from Duke University and his MD from Mount Sinai School of Medicine and completed his residency, cardiovascular fellowship, and inter- ventional cardiology fellowship at Brigham and Women’s Hospital (BWH) and Harvard Medical School. In addition, he has a master of science degree in medical informatics from the Massachusetts Institute of Technology and has completed a fellowship in medical informatics at BWH. In 2006, Dr. Resnic was appointed the director of the BWH Cardiac Catheterization Laboratory. His research interests have focused on the development of informatics tools to monitor medical device and procedural safety, and he leads a research program funded by the National Institutes of Health and the Food and Drug Administration (FDA) to explore the automated sur- veillance of medical-device safety in a network of Massachusetts hospitals. In addition to his clinical and research work at BWH, Dr. Resnic serves as a senior medical adviser for the Massachusetts Data Analysis Center and the Massachusetts Department of Public Health. In 2007, Dr. Resnic was appointed to the medical advisory panel for circulatory devices for FDA; in 2008, he became the chairperson of the Quality Oversight Committee for Massachusetts of the Massachusetts chapter of the American College of Cardiology (ACC). Dr. Resnic was elected president of the Massachusetts chapter of ACC in 2009. Paul D. Varosy, MD, is the director of cardiac electrophysiology in the De- partment of Veterans Affairs (VA) Eastern Colorado Health Care System and assistant professor of medicine at the University of Colorado Denver. He is a recipient of a research career development award from the VA Office of Health Services Research and Development (HSR&D), evaluating real- world outcomes in veterans who have implantable cardioverter defibrillators (ICDs) and are enrolled in the VA National ICD Surveillance Center. He also serves in national roles as a member of the Science and Publications Com- mittee for the National Cardiovascular Data Registry ICD Registry and as a member of the development team for the Safety of Atrial Fibrillation Abla- tion Registry Initiative. As a member of VA’s Denver-based Cardiovascular Assessment, Reporting, and Tracking (CART) program (the VA national program under the leadership of John Rumsfeld, MD, PhD, by which all car- diology procedures are documented in the VA system), Dr. Varosy is leading the development of CART-EP, a new comprehensive VA-wide implantable arrhythmia-device monitoring system spanning preimplantation evaluation, documentation of the implantation procedure, in-clinic followup, and re- mote monitoring followup for veterans who have pacemakers, implantable defibrillators, and cardiac resynchronization therapy devices.

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