MedTech Cardio Conference Speakers
Conference Chair
Brian Buntz, Editor-at-large — UBM Canon Medical Device Group
Brian works as the San Francisco-based editor-at-large for MD+DI. He covers on topics ranging from outsourcing to cutting-edge medical technologies. He has worked for UBM Canon since 2005, Most recently, he worked as the managing editor of MD+DI, and before that of EMDT, a European publication also published by UBM Canon.
Keynote Speaker
Francis G. Duhay, M.D., Vice President, Medical Affairs and Chief Medical Director — Edwards Lifesciences
Francis G. Duhay, M.D. is vice president, medical affairs and chief medical director of Edwards Lifesciences, and is a board certified general and cardiothoracic surgeon having completed residency training at UC San Francisco and Duke University. Since joining the company in 2008, Duhay also served as the vice president and general manager of Ascendra, a division of the transcatheter heart valve therapies business unit. Prior to joining Edwards, he was a clinical professor of cardiothoracic surgery at the University of California, Irvine Medical Center and the chief of cardiac surgery at St. Luke’s Hospital & Health Network in Bethlehem, PA. Duhay holds 24 worldwide patents, has published 32 articles in international journals with particular contributions in cardiothoracic surgery and has written chapters in six books. He is the past-president of the American Heart Association Six-State Southwest Affiliate (AR, CO, NM, OK, TX, and WY) and is currently on the board of the Orange County chapter of the American Heart Association. He is also a member of Le Club Mitralé, International Society for Minimally Invasive Cardiac Surgery, David C. Sabiston Surgical Society, University of California, Davis Surgical Society and Alpha Omega Alpha. Duhay received his bachelor’s degree from Washington University, his doctor of medicine degree from Meharry Medical College and his master’s degree in business administration from the University of Hawaii.
Kenneth Cavanaugh, Ph.D, Chief of Peripheral Vascular Devices Branch — Division of Cardiovascular Devices, CDRH, FDA
Dr. Kenneth J. Cavanaugh Jr. is a biomedical engineer working as a scientific reviewer with the U.S. Food and Drug Administration's Center for Devices and Radiological Health. His appointment is within the Division of Cardiovascular Devices of the Office of Device Evaluation, and his primary responsibilities include the review and administration of marketing applications and IDEs (clinical studies) for implant and non-implant devices used in the peripheral vasculature. He serves as the team leader for carotid and renal stent applications within the Center. Prior to joining FDA, Dr. Cavanaugh earned a baccalaureate degree in chemical engineering from Villanova University and a doctorate in bioengineering from the University of Pennsylvania.
Victoria Hampshire, VMD, Veterinary Medical Officer and Director of Device Review — Division of Cardiovascular Devices, CDRH, FDA
Currently serve as preclinical review expert, FDA/CDRH/DCD.
Graduated from UPenn with VMD 1988, Ten years as clinical and scientific support veterinarian at National Institutes of Health, Bethesda, MD. Captain USPHS Veterinary Category
Ten years now at FDA; first at the Center for Veterinary Medicine Division of Postmarket Surveillance and Compliance and then since 2005 here at CDRH. Author of the preclinical cardiovascular device guidance “General Considerations for Animal Studies of Cardiovascular Devices (July, 2010)”.
Author of 23 peer-reviewed publications in veterinary science, laboratory animal medicine, and research bioethics. Recipient of nine PHS service awards. Currently credentialed as a licensed veterinarian in Maryland, Virginia, and Maine working under a professional agreement monthly in busy metropolitan animal hospitals.
Dr. Peter Fitzgerald, Director of the Center for Cardiovascular Technology and the Cardiovascular Core Analysis Laboratory, and Associate Professor of Medicine (Cardiology) — Stanford University Medical School
Peter Fitzgerald, M.D., is an Associate Professor of Medicine (Cardiology), an Associate Professor of Electrical Engineering (by courtesy), and Co-Director of the Center for Research in Cardiovascular Interventions at Stanford University School of Medicine. Additionally, he serves as Director of Core Cardiovascular Analysis Lab at Stanford. He is Professor in both the Departments of Medicine and Engineering at Stanford. He has led or participated in over 95 clinical trials, published over 300 manuscripts/chapters, and lectures worldwide. Dr. Fitzgerlald has been principle/founder of eleven medical device companies in the San Francisco Bay Area. He has transitioned eight of these start-ups to large medical device companies. He serves on several boards of directors, advised dozens of medical device startups as well as multinational healthcare companies in the design and development of new diagnostic and therapeutic devices in the cardiovascular arena. In 2001, he co-founded Latterell Venture Partners, a venture firm, focused on medical device and biotechnology start-ups in San Francisco. Currently, he is a consultant, contributing his more than 20 years of expertise in the medical device and healthcare industry. Additionally, he serves on the FDA Medical Device Advisory Panel. Dr. Fitzgerald received his Ph.D. and M.D. from Dartmouth, his R.A from Stanford, and M.S. from Rensselaer, and his B.S. degree from Santa Clara.
Josiah N. Wilcox, Chief Scientific Officer, Cardiac and Vascular Group — Medtronic
Dr. Josiah N. Wilcox (Cy) is currently Chief Scientific Officer for Coronary and Renal Denervation at Medtronic CardioVascular in Santa Rosa, California. Dr. Wilcox has been with Medtronic since July 2003 joining first as a full time consultant and Visiting Scholar while on sabbatical from his position at Emory University (2003-2004). After taking a full time position at Medtronic he held the positions of Senior Director Cell & Molecular Biology (2004-2005) and then Vice President of Science and Technology (2005-2011). As Vice President of Science and Technology he directed an interdisciplinary R&D team focused on early innovation and new product development for the Coronary and Peripheral Business. While at Medtronic Dr. Wilcox worked closely on the development of both the Endeavor and Resolute drug eluting stents, a polymer free drug filled stent as well as renal denervation for the control of hypertension.
Dr. Wilcox received his Ph.D. from Rutgers University in 1982 followed by postdoctoral training at Columbia Physicians & Surgeons (1982-1985). Dr. Wilcox was previously employed by Genentech (1985-1990) before joining the faculty at Emory University School of Medicine (1990-2004) where he was a tenured Professor of Internal Medicine with appointments in Cardiology, Hematology/Oncology and Pathology. While at Emory Dr. Wilcox did research in the area of vascular biology, cardiovascular disease, angioplasty restenosis and vascular brachytherapy. He has served on a number of peer review panels at the National Institutes of Health and American Heart Association and is the author of over 100 original research manuscripts.
Dave E. Albert, Founder and Chief Medical Officer (Former Chief Clinical Scientist of Cardiology at GE Healthcare) — AliveCor
David E. Albert, MD is a physician, inventor, and serial entrepreneur who has developed medical and other life-saving technologies and products over the last 30 years, turning a number of those innovations into tech startups. Today, he is a founder of three tech companies, InnovAlarm, Lifetone Technology and AliveCor. His previous startups include Corazonix Corp (sold to Arrhythmia Research Technology) and Data Critical (sold to GE). Dr. Albert left GE in 2004 as Chief Scientist of GE Cardiology to disrupt several new markets. His latest invention, the iPhone ECG, became a global sensation via a 4-minute YouTube Video in January around the Consumer Electronics Show and was featured on local media, ABC, CBS, CNN, and Fox News among many other media outlets. Dr Albert has 32 issued US patents, a large number pending, and several new "secret inventions" in development. He has authored or co-authored over 50 scientific abstracts and publications. Dr. Albert graduated with Honors from Harvard College and from Duke University Medical School.
Bridget Hurley, R&D Director — Abbott Vascular Structural Heart
Bridget Hurley is currently the R&D Director for Abbott Vascular Structural Heart based in Menlo Park. Bridget has over 14 years of medical device experience, both in product development and clinical trial management. Bridget joined the Vascular Intervention division of Guidant Corporation in 1998 and played an integral role in the design and development of the XIENCE V drug-eluting stent program. In 2006, Bridget transferred to Brussels, Belgium with Abbott Vascular, and as the Director for EMEA Clinical Operations supported the international clinical trials for coronary and endovascular applications. Bridget holds a B.S. in Mechanical Engineering from The University of Texas at Austin, and a M.S. in Mechanical Engineering from Georgia Institute of Technology.
James Feng, Principal R&D Engineer, Interventional Cardiology — Boston Scientific
Dr. James Feng is a Principal R&D Engineer working on devices for interventional cardiology at Boston Scientific, which led to 25 patent filings. His main responsibilities have been in the areas of developing new product design concepts and reducing such to practice with prototype design, production, and testing. His research interests include precision material-deposition processes for minimally invasive medical devices, electromechanics, fluid mechanics, transport phenomena, and applied physics. Prior to Boston Scientific, Dr. Feng worked for University of Minnesota, Oak Ridge National Laboratory, Xerox Corporation and Clear Science Corp. He graduated from Tsinghua University in Beijing with a BS in Chemical Engineering and an MS in Physics, and from the University of Illinois at Urbana-Champaign with a PhD in Atmospheric Sciences.
Syed Hossainy, R&D Fellow and Director of Innovation Incubator — Abbott Vascular
Syed F. Hossainy, Ph.D., is the Director of the Innovation Incubator at Abbott Laboratories, a division of Abbott Laboratories. At Abbott Dr. Hossainy works to create pipeline options by fast prototyping. Additionally, he is a professor of bioengineering at the Massachusetts Institute of Technology. From 1995 to 1999, Dr. Hossainy was a senior scientist at Johnson and Johnson where he worked on drug delivery technology development for cardiovascular application. He went on to work as a research fellow at Guidant from 1999 to 2003 working in the same field. Dr. Hossainy holds a M.Sc and a Ph.D. in Chemical Engineering from the University of Austin, Texas in addition to a B.Sc in Chemical Engineering from BUET, Bangladesh.
Julia C. Fox, PhD, R&D Manager — Abbott Vascular
As Manager of Research and Development at Abbott Vascular, Julia is responsible for Finite Element Analysis, Fatigue, and Test Methods in the Absorb Bioresorbable Vascular Scaffold (BVS) program. Julia also holds leadership roles in national and international standards development organizations, including the Association for the Advancement of Medical Instrumentation (AAMI), the American Society for Testing and Materials (ASTM) and the International Organization for Standardization (ISO).
Prior to joining Abbott Vascular, Julia was the Bio-X External Affairs Manager at Stanford University, a Managing Engineer at Piziali and Associates (now Exponent, Inc.) and a Fulbright Fellow at Aarhus University Hospital, Denmark. Julia has a B.S. in Biomedical Engineering from The Johns Hopkins University and a Ph.D. in Mechanical Engineering from University of California, Berkeley.
Lisa Jennings, Founder and Chief Scientific Officer (currently Professor of Medicine at University of Tennessee Health Science Center) — Ariste Medical
Dr. Jennings is a tenured Professor of Medicine at the University of Tennessee Health Science Center (UTCHS) in Memphis, Tennessee, USA. She has secondary appointments at the rank of Professor in the Departments of Molecular Sciences and Surgery as well as in the Joint Program of Biomedical Engineering at UTHSC and the University of Memphis.
Dr. Jennings founded Cirquest Labs, a life science company that serves the specialty needs of pharmaceutical, biotech, and device industries from the discovery/preclinical stage through Phase IV clinical trials. CirQuest Labs represents the culmination of Dr. Jennings' expertise in academic research as well as industry consultation assisting pharmaceutical and device companies globally in research and product development, regulatory, and strategic marketing. She also founded Ariste Medical, a drug delivery company with a proprietary novel technology that coats and elutes drugs by a controlled release mechanism from implantable medical devices made of Teflon® (PTFE*).
Kishore Udipi, President — BioPolymer Designs
Dr. Udipi has had a successful industrial career spanning over 30 years. During this period, he has worked in and had led projects in such wide ranging areas as biomaterials, drug delivery, polymeric coatings, implantable polymers, polymer syntheses, polymer blends and alloys among others. Dr. Udipi received his Ph.D. in Polymer Chemistry from the University of Akron and subsequently worked at Princeton University as a NASA postdoctoral fellow. He began his career in industry working as a Senior Research Chemist at Phillips Petroleum Research Center before joining Monsanto. Dr. Udipi had a very successful career at Monsanto where he attained the position of Senior Science Fellow in recognition of his excellence in science, his contributions to their businesses and his international reputation, a position that less than 1% of the scientists at Monsanto attain.
Dr. Udipi joined Medtronic in 2002 as a Senior Principal Scientist and was quickly promoted to Research Director in 2003. He built a world class polymer program at Medtronic CardioVascular focused on the development of biostable and bioabsorbable polymers for drug eluting stent and other similar applications. He is the co-inventor of the BioLinx Polymer System employed in Endeavor Resolute, Medtronic’s second generation drug eluting stent. In recognition of his leadership and technical contributions, Dr. Udipi was also appointed to the position of Distinguished Scientist in 2007. He has 27 awarded US patents; scores of awarded foreign patents, as well as 17 pending US applications. He has authored and co-authored >30 papers in peer reviewed journals. He has also made presentations and chaired sessions at national and international polymer and biomedical conferences.
Robert Tranquillo, Distinguished McKnight University Professor, Biomedical Engineering Department Head — University of Minnesota
Prof. Tranquillo received his Ph.D. in Chemical Engineering in 1986 from the University of Pennsylvania. He was a NATO Postdoctoral Fellow at the Center for Mathematical Biology at Oxford for one year before beginning his appointment in the Department of Chemical Engineering & Materials Science at the University of Minnesota in 1987. He has served as the head of the new Department of Biomedical Engineering since its inception in 2000. Prof. Tranquillo has used a combined modeling and experimental approach to understand cell behavior, in particular, directed cell migration and cell-matrix mechanical interactions. More recently, his research program has focused on the role of cell behavior in cardiovascular and neural tissue engineering applications. His research has resulted in over 90 peer-reviewed publications. Prof. Tranquillo is a Fellow of the American Institute of Medical and Biological Engineering and the Biomedical Engineering Society, and a Distinguished McKnight University Professor.
David Dausch, Ph.D., Senior Research Engineer, RTI International
Dr. David Dausch is a Senior Research Engineer at RTI International with over 18 years of R&D experience in MEMS sensor and actuator devices and electronic materials development. Dr. Dausch is Inventor and Principal Investigator of piezoelectric micromachined ultrasound transducers (pMUT) and is the project leader of a commercialization effort at RTI for the development of the Live Volumetric Imaging (LVI) intracardiac ultrasound catheter based on pMUT transducer technology. Before joining RTI, Dr. Dausch served as a Research Associate from the National Research Council at NASA Langley Research Center, and received a Ph.D. in Ceramic Engineering from Clemson University.
Peter Herman, VP R&D and US Operations — Lake Region Medical
Pete Herman has been active in product development and operational management of medical devices since 1995 and is currently VP of R&D and US Operations for Lake Region Medical. He has engineering and management experience in a wide range of technology driven industries including data storage, optical communications, automotive, computer, and medical. His background includes executive management roles in successful start-ups, small, mid-sized, and large companies developing and manufacturing Class II and Class III devices in the cardiovascular, urology, diabetes, and neurology sectors. His international experience includes past management responsibilities in The Netherlands, Mexico, Singapore, Japan, Thailand, and China.
Pete serves as an advisor to a number of small technology companies and has past experience serving as a member of the Pine Island school board, University of Minnesota MOT advisory board, Minnesota High Tech advisory board, and other non-profit organizations. He graduated with a degree in Mechanical Engineering in 1984 from the South Dakota School of Mines and Technology and holds 10 United States patents. He is currently completing his Healthcare MBA at the University of St. Thomas.
Arun Kumar, Principal Scientist — Medtronic
Arun Kumar, Ph.D. is a Research Scientist in the Bradycardia Research group at Medtronic, leading pacemaker R&D for emerging markets. His interests include clinical research, sensor technology for patient diagnostics and wellness monitoring, and solutions to improve healthcare access in developing countries.
Arun served as Chairman of the IEEE Twin-Cities Section in 2008 and 2009. Arun enjoys volunteering for education of underprivileged children in India. He served on the leadership committee of Asha-Cleveland from 2000-05, and is a current volunteer with Vibha-Minnesota.
Arun received his B.E. in Electronics and Communications Engineering from the University of Madras, India, and his M.S. and Ph.D. in Biomedical Engineering from Case Western Reserve University. He is currently pursuing an Executive MBA at The Wharton School.
Amra Racic, Senior Regulatory Affairs Specialist — Bayer Healthcare
Amra Racic, MBA is a Senior Regulatory Affairs Specialist at Bayer HealthCare Interventional group in Coon Rapids, Minnesota. Her primary focus encompasses working with a variety of Thrombectomy, Atherectomy and Fluid Delivery devices and bringing those to the US market via 510(k) clearances and PMA and Supplement approvals.
Prior to joining Bayer, Amra retained a Regulatory role at Medtronic Inc. for five years. Her primary responsibilities were in the areas of Cardiovascular and In Vitro Diagnostic Devices. She was also an active member of the Medtronic Corporate 510(k) Subcommittee and Working Group discussing the FDA recommendations to the 510(k) Device Modification: Deciding When to Submit a 510(k) for a Change to an Existing Device, draft guidance.
She holds a Master's Degree in Business Administration and in addition to English, speaks several other languages including German, Bosnian, Croatian and Serbian.
Current areas of focus include Regulatory, Clinical and Compliance matters in the U.S and International regions.
Chuck McGinley, Director of Worldwide Applications — Omnify Software
Chuck McGinley is the Director of Worldwide Applications for Omnify Software. Chuck has a background in electrical engineering with over 13 years of experience designing FPGAs, board level designs, system level designs and system level integrations. Over the past several years Chuck has been deeply involved in implementing the Empower PLM system for medical device clients throughout the United States and Europe and has been instrumental in setting up processes for enterprise collaboration and compliance.
Susan Silavin Ph.D., Director of Regulatory Affairs — Abbott Vascular
Sue Silavin, Ph.D. is Director of Regulatory Affairs at Abbott Vascular in Santa Clara, CA. Sue has more than 17 years of Regulatory Affairs experience in medical devices. Her current regulatory focus is in the area of permanent implantable combination products and she is primarily responsible for strategy development and approval of these products in the US. She is a member of RAPS.
Sue received her Ph.D. from Colorado State University in Physiology and completed post-doctoral fellowships at the University of Kansas Health Sciences Center and the Hospital of the University of Pennsylvania. Prior to joining industry, Sue was an Assistant Professor in Obstetrics and Gynecology at the University of Oklahoma Health Sciences Center where she taught and conducted research.
Sanjeev Kulkarni, R&D Fellow — Boston Scientific
Sanjeev Kulkarni is an industry recognized technical leader at Boston Scientific. He applies computational modeling to the design and development of innovative cardio-vascular medical devices from conception to product commercialization. As an expert, Sanjeev participates in activities that include developing new methodologies, directing regulatory submissions, pursuing international strategy with a focus on due diligence of companies in emerging markets, identifying new technologies, significantly contributing to relevant industry standards and research consortia, championing technology infrastructure (hardware and software), nurturing relationships with external research and engineering Entities. Prior to Boston Scientific, he worked as a Senior Consultant for Exponent and cofounded KB Engineering. Sanjeev graduated from Pune College of Engineering with a BE in Mechanical Engineering and from Vanderbilt University with an M.S. and a Ph.D in Mechanical Engineering.
Bryan E. Lynch, Vice President, Research & Development — MicroMed Cardiovascular
Mr. Lynch joined MicroMed Cardiovascular in July 1997 where he has held numerous positions including Director of Operations, Vice President of Operations, Vice President of International Sales and Chief Operating Officer. He is co-Inventor of several key patents including pulsatile loop and implantable pump patents at MicroMed which resulted in the commercialization of the world's first and smallest, full support axial flow ventricular assist device. Previously, he served as Director of Marketing and Product Development with Komet Medical, Inc., a German Manufacturer and Distributor of surgical instruments and hard tissue cutting systems. From 1990 to 1994, Mr. Lynch served as Manager of Engineering, Research and Development for Surgimedics, Inc., a Texas-based Medical Device Company, developing products for minimally invasive surgery, laser surgery and autologous blood transfusion. Mr. Lynch holds a B.S. in Mechanical Engineering from Texas Tech University and an M.B.A. from Texas Christian University.
Peter D. Gabriele, Director Emerging Technology — Secant Medical
Peter Gabriele joined Secant Medical in January 2012, as director, emerging technology to lead the advancement of corporate emerging technologies, with responsibilities in managing strategic relationships with academia, research institutions and surgeon groups.
Prior to Secant Medical, Gabriele was technical director at ARmark Authentication Technologies, LLC, where he was a co-founder of the corporate division and medical fiber platform technology. Before his time at ARmark, Gabriele was Technical Director and R&D Fellow at Adhesives Research, Inc. He was the division research manager & director of analytical services at BIC Corporation and previously held management positions at MacDermid Incorporated, and Biopolymers, Inc (Ensign-Bickford Industries). Gabriele started his career at CIBA-Geigy as a technical marketing representative and a polymer additives research group manager. Gabriele was formerly project director of conservation of the NIH National Library of Medicine.
Gabriele has a bachelor degree in Biology/Chemistry and a master’s of science degree in Biochemistry from University of Hartford. He holds master of science degrees from the University of Pennsylvania (Engineering in Technical Management M.S.E) and from John-Hopkins University
Siobhan O’Bara, Vice President — GS1 Healthcare US
Siobhan O’Bara, vice president, Healthcare for GS1 US, is an accomplished leader with over 20 years’ experience in supply chain, logistics and operations management. Over the course of her career she has become known in the industry as a thought leader in supply chain re-engineering. Her record of successful change management, a deep industry understanding of the complexity of the healthcare supply chain, and work with data standards has added tremendous value to the GS1 Healthcare US initiatives.
Prior to joining GS1 US, O’Bara was vice president, Customer Operations and Supply Chain Systems and Solutions for Covidien, a leading global provider of healthcare products. Over the course of 15 years at Covidien, O’Bara managed supply chain functions at multiple Covidien divisions, including medical supplies, retail, imaging, pharmaceutical, and respiratory technologies. Prior to Covidien, O’Bara was part of the James W Daly Division of Cardinal Health.
Throughout her career, O’Bara has spearheaded successful programs in customer care, shared services, transportation, planning, procurement, global replenishment, distribution operations and supply chain systems, and has expertise in acquisitions, integrations and business process development. Additionally, her background includes public relations and professional writing.
O’Bara is a graduate of Johnson & Wales University, the University of Connecticut and Babson College with degrees in culinary arts, communications and business. She is often invited to speak as a subject matter expertat healthcare supply chain and operations events. She resides in Wickford, Rhode Island and is an avid gardener and chef.
Guido Gaggini, R&D Manager — Sorin Group, CRM
Guido Gaggini has been working in CRM R&D since 1980. He is currently the Implantable Devices System Manager for the Cardiac Rhythm Management Business Unit of SORIN GROUP - Italy, responsible of the research activities at system level for implantable pacemakers, defibrillators and leads. In his career Guido covered different management and engineering roles in many CRM relevant fields, from sensor and integrated circuit development to pre-clinical experiments and leads development. He has been a key contributor in the development of an implantable contractility sensor used for different clinical application in the CRM domain and more specifically in CRT optimization.
Guido graduated in Physics from the Studies University of Milan in 1975, holds 15 United States patents and authored or co-authored more than 30 papers presented to major CRM congresses or published in peer-reviewed journals.
Karen Conway, Executive Director, Industry Relations — GHX
As the executive lead for industry relations at GHX, Karen Conway works with industry associations, standards bodies, government agencies, analyst firms, academic institutions and the media to identify opportunities for hospitals and suppliers to optimize supply chain operations and improve business and clinical performance.
Prior to joining GHX, Conway served as principal of Conway Associates, a strategic communications firm built on the principles of continuous quality improvement and based on the work led by her business partner between Procter & Gamble and Wal-Mart. She has also worked on the state and national levels as both a journalist and a lobbyist.
Conway was recently elected to the board of directors of AHRMM, the supply chain organization for the American Hospital Association. She serves on the leadership council of the Arizona State University Health Sector Supply Chain Research Consortium and as co-chair of the HIMSS Supply Chain Special Interest Group. In addition, she is active in the Strategic Marketplace Initiative (SMI) and the Medical Device Supply Chain Council and serves on the editorial board of Healthcare Purchasing News. Conway's work has been published in numerous trade publications as well as USA Today, Redbook and Parent magazines. She was also a contributing writer to the book "e-Business in Healthcare" published by Springer in 2007.
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