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(Note: Click on a speaker’s name to view his or her bio.)

Sunday, April 22, 2012
Time Session Topic Speaker
6:30 p.m. Welcome Reception
Monday, April 23, 2012
Time Session Topic Speaker
7:00 a.m. Registration
8:00 a.m. Welcome Opening Remarks Frank L. Douglas, PhD, MD – President and CEO, ABIA
Keynote: Importance of Harnessing Big Data with Respect to Defining the Value Equation Robert E. Litan, PhD – Vice President for Research and Policy, Ewing Marion Kauffman Foundation
9:15 a.m. Session One: Defining Value-driven Engineering Value-driven Engineering History and Equation Overview Stephen Fening, PhD – Director of Orthopaedic Devices, Medical Device Development Center, ABIA
What Value-driven Engineering Means to the Medical Device Industry Mike Hess – Vice President of Corporate Technology and Innovation, Medtronic Inc.
9:45 a.m. Break
10:15 a.m. Session Two: Clinical Utility and Patient Centricity Keynote: Clinical Utility to the Clinician Marc S. Penn, MD, PhD, FACC – Director of Research, Cardiovascular Institute, Summa Health System
Why is Patient Centricity Important: A Patient Perspective Debra Lappin, JD – Senior Vice President, B&D Consulting
Patient-Centered Drug Delivery Systems R. Reade Harpham, Battelle
Driving Clinical Utility by Incentivizing Physicians to Participate A Jay Khanna, MD, MBA – Associate Professor of Orthopaedic Surgery and Biomedical Engineering, Johns Hopkins University
Short Talk One: Case Study Submissions
12:00 p.m. Lunch Keynote: The Role of Federal Funding Agencies in the Adoption of Value-driven Engineering William J. Heetderks, PhD, MD – Director, Extramural Science Program, National Institute of Biomedical Imaging and Bioengineering, NIH
1:30 p.m Session Three: Medical Device Complexity Moderator: A. Seth Greenwald, DPhil (Oxon) – Director, Orthopaedic Research Laboratories
Keynote: NASA’s Need for Less Complex Medical Devices DeVon W. Griffin, PhD – Project Manager, NASA Glenn Research Center
How Medical Device Complexity fits with Low Resource Settings Soumyadipta Acharya, MD, MSE, PhD – Assistant Professor, Biomedical Engineering, Johns Hopkins University
Using Medical Devices in a Low Resource Setting Scott D. Weiner, MD – Chairman, Department of Orthopaedics, Summa Health System
Short Talk Two: Case Study Submissions
3:00 p.m. Break and Supporter Exhibits Open
3:30 p.m. Symposium: Educating the Next Generation of Value-driven Innovators Moderator: Youseph Yazdi, PhD, MBA – Executive Director, Center for Bioengineering Innovation and Design, Johns Hopkins University
Ali Dhinojwala, PhD – Department Chair, H.A. Morton Professor in Polymer Science, The University of Akron
Martha Gray, PhD – J.W. Kieckhefer Professor of Medical and Electrical Engineering, Harvard-Massachusetts Institute of Technology, Division of Health Sciences and Technology
Lynn Stein, PhD – Founding Faculty Member, Franklin W. Olin College of Engineering
6:00 p.m. Cocktail Reception and Dinner
7:00 p.m. Moderator: Jonathan F.I. Greenwald – Business Development Director, Orthopaedic Research Laboratories
Keynote: Value Collaboration between Physicians and Engineers Thomas Fogarty, MD – Founder, Fogarty Institute for Innovation
Tuesday, April 24, 2012
7:00 a.m. Registration
8:00 a.m. Session Four: Healthcare and Device Cost Moderator: Brian L. Davis, PhD – Vice President, Medical Device Development Center, ABIA
Keynote: Cost of Treatment of Disease Ernst Berndt – Louis E. Seley Professor in Applied Economics, Sloan School of Business, Massachusetts Institute of Technology
Healthcare Cost: How is it Tracked? Martin P. Hauser – President, SummaCare Inc.
How do you Measure Cost for Value-driven Engineering? Richard Skolasky, PhD – Director, Spine Outcomes Research Center, Johns Hopkins University
Short Talk Three: Case Study Submissions
9:30 a.m. Break and Supporter Exhibits Open
10:00 a.m. Session Five: Value Moderator: Uday N. Kumar, MD – Founder, iRhythm Technologies Inc.; Fellowship Director, Global Biodesign Program, Stanford University
Increasing Value to the Supply Chain Michael Hawkins, PhD – Vice President for Corporate Research, Zimmer Inc.
Value from an Academic Perspective Luis M. Proenza, PhD – President, The University of Akron; Board of Directors, U.S. Council of Competitiveness
Regulatory Innovation Pathway Megan Moynahan – Associate Director of Technology and Innovation, FDA
DOD’s Value Engineering Initiative Stephen P. Welby – Deputy Assistant Secretary of Defense for Systems Engineering, U.S. Department of Defense
12:00 p.m. Lunch and Closing Comments


Ernst Berndt

The focus of Ernst Berndt’s recent research has been on the changing dynamics of the health care industries. He has examined how medical innovations have affected the costs of treating selected diseases over time, factors affecting the globalization of clinical trials (particularly into emerging economies), incentives to induce R&D into third world diseases, how industry funding of the U.S. Food and Drug Administration through user fees has affected review times and safety withdrawal rates, and the impact of direct-to-consumer marketing of prescription pharmaceuticals on drug utilization.

In other research, Berndt has assessed how illness and its treatment affect individuals’ ability to function at work. More generally, Berndt’s research deals with assessing the sources of productivity growth and how productivity is measured. He has implemented methods for adjusting prices for changes in quality in the pharmaceutical, health care, personal computer hardware, prepackaged software and personal digit assistant product categories. He has also published research on the structure of the advertising services industries.

In addition to carrying out his teaching duties at MIT Sloan, Professor Berndt is co-director of the Biomedical Enterprise Program, a joint program of MIT Sloan and the Harvard-MIT Division of Health Sciences and Technology. He also serves as Director of the National Bureau of Economic Research Program on Technological Progress and Productivity Measurement.

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Thomas Fogarty, MD

Dr. Thomas J. Fogarty is an internationally recognized cardiovascular surgeon, inventor, entrepreneur, and vintner.  He has been involved with a wide spectrum of innovations in business and technology. Dr. Fogarty has served as founder/co-founder, and Chairman/Board Member of over 33 various business and research companies, based on medical devices designed and developed by Fogarty Engineering, Inc.  During the past 40 years, he has acquired 135 surgical patents, including the “industry standard” Fogarty balloon catheter and the widely used Aneurx Stent Graft that replaces open surgery aortic aneurysm.   Dr. Fogarty is the recipient of countless awards and honors; most significantly, he is the recipient of the Jacobson Innovation Award of the American College of Surgeons, the 2000 Lemelson-MIT prize for Invention and Innovation and was inducted into the Inventors Hall of Fame and the National Academy of Engineering.

Recently, Dr. Fogarty and his colleagues founded the Fogarty Institute for Innovation at El Camino Hospital.  The purpose of the Institute is to create an environment where innovation in medicine is encouraged, supported, and nurtured.

Dr. Fogarty was born in Cincinnati, Ohio and received his undergraduate education at Xavier University and his medical degree from the University of Cincinnati.  He completed his residency at the University of Oregon and later served as Medical Staff President at Stanford Medical Center from 1973-1975.  After thirteen years directing the Cardiovascular Surgery Program at Sequoia Hospital, Redwood City, California, he returned to academic life at Stanford University School of Medicine in July 1993, as Professor of Surgery.  Dr. Fogarty now spends his time creating new medical devices with Fogarty Engineering and the Institute for Innovation.

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DeVon Griffin, PhD

In his current role, DeVon Griffin manages efforts aimed at using computational simulations to quantify the effects of microgravity on the human body, and to quantify the risks associated with exploration class missions.  These efforts provide cost-effective input to NASA’s investigators to understand the causes and effects of changes in microgravity anatomy and physiology, to program managers making research investment decisions, and to mission planners so they can quantify the level of risk associated with various mission operations concepts.

He previously led the IntraVenous Fluid Generation (IVGEN) project that produced USP-grade IV fluid on the International Space Station (ISS) using in situ resources.  He worked with technical experts to lay the groundwork for a compact reusable lab on a chip device capable of performing a broad range of medical diagnostics; a device currently in development continues to produce results statistically identical to gold standard laboratory devices.  He also developed the concept for advancing the state of the art in ultrasound so that these devices could quantify the changes in trabecular bone associated with spaceflight; to date early prototypes of this device class have exhibited promising behavior.  He was the microscopy specialist as NASA developed the Light Microscopy Module, which is a research grade fluorescence microscope functioning onboard ISS.

He holds a PhD in optical sciences from the University of Arizona and a BA (magna cum laude) in physics from Utah State University.

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William J. Heetderks, PhD, MD

Dr. William J. Heetderks is the Director of Extramural Science Programs at the National Institute of Biomedical Imaging and Bioengineering (NIBIB), NIH. The extramural program supports approximately 800 research and training grants at universities and research centers throughout the United States in fields of bioengineering and biomedical imaging. Dr. Heetderks received the Ph.D. degree in Bioengineering from The University of Michigan. He received the MD degree from the University of Miami and is certified in Internal Medicine. Before joining NIBIB he was at the National institute of Neurological Disorders and Stroke where he directed the neural prosthesis program.

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Stephen Fening, PhD

Dr. Stephen Fening serves as the Director of Orthopaedic Devices within the Medical Device Development Center at ABIA. In this role, Steve drives innovation in orthopaedic device development within ABIA and its partners. Dr. Fening also serves as the Director of Research and Innovation for the Department of Orthopaedics at Summa Health System and as adjunct faculty at Northeast Ohio Medical University.

Prior to joining ABIA, Dr. Fening served as the Director of Sports Health Research at Cleveland Clinic, where he had a joint appointment in the Departments of Orthopaedic Surgery and Biomedical Engineering. Dr. Fening has undergraduate and masters degrees in mechanical engineering, a doctorate in biomedical engineering, and a postdoctoral fellowship in orthopaedic biomechanics. His areas of research focus are on patient outcomes, cartilage injury modeling, and biomechanics of the knee and shoulder. Dr. Fening has been awarded the Cleveland Clinic Innovator Award and the “Basic Science Teacher of the Year” by the Department of Orthopaedic Surgery, and a Distinguished Educator by The Cleveland Clinic.

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Martha Gray, PhD

Martha Gray, PhD, has led a multifaceted career in which she has conducted research to better understand and prevent osteoarthritis, led a preeminent academic unit, and served the profession through work with organizations and institutions. Her research has centered over the past 15 years on ways to nondestructively visualize cartilage macromolecules in vivo and in vitro. Many in industry and academia are now using the MR method developed by her group, known as dGEMRIC.

Dr. Gray is the J.W. Kieckhefer Professor and former director of the Harvard-MIT Division of Health Sciences and Technology (HST). During and since her 13 year tenure as head of HST, she shepherded its vigorous growth so that now it boasts a community of over 400 students, 65 faculty and nearly 200 affiliated faculty who create a multi-disciplinary and multi-professional environment in classrooms, hospitals and laboratories and seek to advance human health. Most recently her efforts have focused on advising other institutions and governments as they pursue similar efforts.

Dr. Gray was the first woman to lead a science or engineering department at MIT. She is an elected fellow of the AAAS, the Biomedical Engineering Society (BMES) and the American Institute of Medical and Biological Engineers (AIMBE). She is associate editor of the Annual Reviews of Biomedical Engineering.

Her training includes a BS in computer sciences from Michigan State University, an MS in electrical engineering from MIT and a PhD in medical engineering from HST, and completed her postdoctoral work at Tufts University and the State University of New York Stony Brook.

She currently resides in Arlington, MA with her husband Dick and their three teenage children Andrew, Dora and George.

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Robert E. Litan, PhD

Robert E. Litan, PhD is the Vice President for Research and Policy at the Kauffman Foundation in Kansas City and a Senior Fellow in Economic Studies at the Brookings Institution. At Kauffman, Dr. Litan oversees a multi-million dollar budget for academic research relating to entrepreneurship and writes extensively about topics related to entrepreneurship, innovation, health care and economic growth (including the legal environment conductive to all of these). At Brookings, Litan pursues a wide-ranging research agenda, which includes topics in regulation, financial institutions, telecommunications, and general economic policy.

Dr. Litan has won two awards for his research. In 2011, he was awarded the inaugural Massey Prize for excellence in research on capital markets and innovation by the University of Texas Law School. In 2001, Stanford awarded him its Zale Prize for excellence in public policy research.

During his career, Dr. Litan has authored or co-authored over 25 books, edited another 14, and authored or co-authored over 200 articles in journals, magazines and newspapers on a broad range of public policy issues. His latest book is Good Capitalism, Bad Capitalism, Economic Growth and Prosperity (with William Baumol and Carl Schramm, Yale University Press, 2007), which will be followed in the fall of 2012 by Better Capitalism (co-authored with Carl Schramm), will be published by Yale University Press in the fall of 2012. Litan has also authored numerous monographs on the financial crisis for the Brookings website, and on entrepreneurship for the Kauffman Foundation’s site.

Dr. Litan was the organizer and one of the main drafters of a report, Valuing Health, just published by the Kauffman Foundation, that was drawn from a conference of health and other policy experts held during the summer of 2011.  Litan has also previously written two reports on potential for wireless technologies to reduce health care costs and increased economy-wide productivity.
Dr. Litan has been a lecturer in banking law at the Yale Law School, has taught various economics and law subjects to over 1,000 state judges (as part of the Judicial Education Program, first at the Brookings Institution and now at Northwestern Law School), and co-taught a course in economic growth in post-conflict situations at the Command General Staff College at Ft. Leavenworth in the spring of 2010.

Among his various assignments, he has written a number of influential federal reports. He co-authored two Congressionally-mandated studies for the Treasury Department on the role of the Community Reinvestment Act after the Financial Modernization Act of 1999. During 1996-97 he has served as a consultant to the Treasury Department and was the lead author of its report to Congress on the future of the financial services industry (American Finance in the 21rst Century), and in 1998-99 he was the main author of the Report of President’s Commission to Study Capital Budgeting. In 1998, he also chaired the National Academy of Sciences Committee on Assessing the Costs of Natural Disasters, which produced a report The Impacts of Natural Disasters: A Framework for Loss Estimation.

Dr. Litan also has served in several capacities in the federal government.  During 1995 and 1996, he was Associate Director of the Office of Management and Budget (where he was responsible for overseeing budgetary and other policies of six cabinet agencies).  From 1993 to 1995, he was Deputy Assistant Attorney General, in charge of civil antitrust litigation and regulatory issues.  From 1977 to 1979, he was the regulatory and legal staff specialist at the President’s Council of Economic Advisers.  In the early 1990s, Dr. Litan was a Member of the Commission on the Causes of the Savings and Loan Crisis.

Dr. Litan received his BS in Economics (summa cum laude) from the Wharton School of Finance at the University of Pennsylvania; his J.D. from Yale Law School; and both his M. Phil. and PhD in Economics from Yale University.

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Seth Greenwald, DPhil (Oxon)

Dr. A Seth Greenwald, DPhil (Oxon) is a nationally recognized bio-academician, thought leader and educator with more than 35 years of experience as a productive researcher, and is well-published in areas of joint biomechanics and artificial implants. Currently, he serves as director of Orthopaedic Research Laboratories (ORL), a medical research and education firm dedicated to improving patient outcomes through providing bench-top performance data and design optimization for orthopaedic implant systems.

Prior to joining ORL, Dr. Greenwald served as director of orthopaedic research and education at the Cleveland Clinic Health System, and as director of orthopaedic research at Mt. Sinai Medical Center. He has received numerous prestigious honors and awards, most notably the Kappa Delta for recognition of outstanding orthopaedic basic science research, and is a National Science Foundation Science Faculty Fellow.

Dr. Greenwald received his BS in physics and engineering from Mount Allison University, his MS in engineering mechanics from Columbia University, SM in aeronautics and astronautics from Massachusetts Institute of Technology and a doctorate in orthopaedic and engineering sciences from Oxford University.

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Marc Penn, MD, PhD, FACC

Dr. Marc Penn is a cardiologist and Director of Research at the Summa Cardiovascular Institute in Akron, Ohio and Professor of Medicine and Integrative Medical Sciences at Northeast Ohio Medical University where he leads the Skirball Laboratory for Cardiovascular Cellular Therapeutics.  From 2000-2011 Dr. Penn was a staff cardiologist at the Cleveland Clinic from 2000-2011 where he served as the Director of the Coronary Intensive Care Unit, Director of the Experimental Animal Laboratory, Director of the Bakken Heart-Brain Institute, and the first Director of the Center for Cardiovascular Cell Therapy.

Dr. Penn completed his undergraduate and postgraduate work at Case Western Reserve University completing a Ph.D. in Biomedical Engineering in 1989 and Doctor of Medicine in 1994. He completed his Internal Medicine training at University Hospitals of Cleveland (1994-97) and his Cardiovascular Medicine Fellowship at Cleveland Clinic (1997-2000).  He is board certified in Internal Medicine and Cardiovascular Medicine by the ABIM.  During his training he received numerous awards including the 2000 Joseph Cash Memorial Prize for Clinical Outcomes Research and the 1999 Irvine H. Page Young Investigator award for Atherosclerosis Research presented by the National American Heart Association. Dr. Penn has an adjunct appointment at Case Western Reserve University in the Department of Biomedical Engineering and the Bioengineering Center at Cleveland State University.

Dr. Penn’s research has led to several discoveries in the field of cardiovascular medicine. His education and training have helped him develop diagnostics and drug delivery systems for the treatment of cardiovascular disease, including strategies to optimize gene therapy and stem cell therapy for the regeneration of myocardial tissue.

Dr. Penn has been an invited lecturer at international symposiums and conferences and is author or co-author of numerous published articles, abstracts, book chapters and books on a wide range of topics, from diabetes and lipoprotein oxidation; the development and role of cardiovascular diagnostics in clinical medicine; and stem cell and gene based therapies for heart disease.  He is the Editor or co-Editor of 3 books including Stem Cells and Myocardial Regeneration published by Humana Press.

Dr. Penn is an active inventor and serial entrepreneur. He has generated intellectual property in the fields of diagnostics, biologics and devices that has been licensed by numerous companies.  In 2006 he was named Innovator of the Year at the Cleveland Clinic. He is the founder and CSO/CMO of Juventas Therapeutics, Inc. (Cleveland, OH) and SironRx Inc. (Cleveland, OH), privately funded clinical stage regenerative medicine companies founded on intellectual property developed in his laboratory for cardiovascular disease and wound and bone healing, respectively. He is a founder and CMO of Cleveland Heart Labs, Inc. (Cleveland, OH), a diagnostic company based on biomarkers associated with coronary artery disease, myocardial infarction and other inflammatory diseases.  He was founder and Chairman of the Board of Directors of Cour Pharma from 2007-2010 (Kalamazoo, MI).  He is an advisor and Scientific Advisory Board member of numerous companies and funds.  Of note he is the PI of the Athersys MAPC in AMI Phase I and II trials and serves on the Aastrom Biosciences Scientific Advisory Board.  In 2010 he joined the healthcare consulting group Kenwood Health Group (San Francisco, CEO David Strand, former COO of Cleveland Clinic) as CMO.  He is a Venture Partner with Oakwood Medical Investors (St. Louis, MO) and served on the Scientific Advisory Board of Frantz Medical Ventures (2004-08, New York City), and as a Clinical Partner with Foundation Medical Partners (2009-11, New Canaan, CT) representing the interests of the Cleveland Clinic.  From 2008-10 Dr. Penn served as the Senior Medical Director for Emerging Businesses at Cleveland Clinic.

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Jonathan Greenwald

Jon Greenwald joined Orthopaedic Research Laboratories in 2006 with a mandate to identify, develop and manage new pathways of growth for the organization, including expanded device design and testing services.
Prior to joining ORL, Jon worked in a variety of roles in the orthopaedic device industry, including US and international marketing positions with Joint Medical Products Corporation, Johnson & Johnson/DePuy and Waldemar Link and direct sales for WRIGHT Medical Technology in New York City.

Jon has managed several major product launches in the U.S. and Pacific Rim and directed device development initiatives for the U.S. and Japanese markets.  From 1996-1999 he was posted to Japan and Australia as an expatriate for Johnson & Johnson/DePuy and has broad experience with the orthopaedic device market in the Peoples Republic of China.

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Martin Hauser

Martin (Marty) P. Hauser currently serves as President of Akron, Ohio-based SummaCare, Inc., a provider owned health insurance company affiliated with Summa Health System.

Hauser’s career at Akron City Hospital (now Summa Health System) began over 30 years ago, where he served in both the finance and planning divisions. In 1985, Hauser developed and served as president of Akron City Health System (ACHS), a not-for-profit, Physician Hospital Organization joint venture between Akron City Hospital and members of its medical staff. Under his direction, ACHS developed many mutually beneficial relationships with insurance companies, HMOs, PPOs, employers, third party administrators and other payers on behalf of the hospital and its affiliated physicians.

In 1990, while president of ACHS, Hauser led the creation of an innovative, local managed care program named SummaCare. SummaCare was initially developed to act as the administrator of health benefits for associates of the Goodyear Tire & Rubber Company, a self-funded employer. In 1992, the success of the SummaCare program led to the creation of what is now SummaCare, Inc.

Today, under his continued direction, SummaCare has grown to include more than 225,000 members throughout Northern Ohio and several other states. It has created a network of more than 8,000 physicians and nearly 50 hospitals. SummaCare now serves not only self-funded employers, but also fully insured employers and individuals by offering products that include preferred provider organization (PPO), point of service (POS), self-funded, individual, and Medicare Advantage plans. In addition, through its subsidiary, Apex Benefits Services, SummaCare has expanded its services to clients in Vermont, Florida, and Tennessee.
An active participant in the community, Hauser is a current board member and past board chair for the American Heart Association; a graduate of the Leadership Akron program and chair of the Leadership Akron board; a board member of Valley Savings Bank; a Campaign Cabinet member on numerous United Way of Summit County campaigns; and the 2009 Honorary Red Kettle Campaign Chair for the Summit County Salvation Army.

An advocate of advancement through education, Hauser has spent more than twelve years teaching in the Baldwin Wallace College Healthcare MBA program. He also has received numerous awards and recognitions including the Western Reserve Academy Alumni Association Award; the University of Akron Alumni Honor Award; The University of Akron Athletic Department Meritorious Service Award; The University of Akron College of Business Frank L. Simonetti Distinguished Businesses Alumni Award; and the SMEI “Sales and Marketing Executive of the Year Award.”

A lifelong resident of the Akron area, Hauser attended both Western Reserve Academy and the University of Akron, where he received both his undergraduate and M.B.A. degrees. Married with three children, Hauser resides in Stow, Ohio.

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Soumyadipta Acharya, MD, MSE, PhD

Dr. Soumyadipta Acharya is an Assistant Research Professor in the Department of Biomedical Engineering at Johns Hopkins University in Baltimore, Maryland.  He also serves as the Graduate Program Director of the Center for Bioengineering Innovation and Design in the Whiting School of Engineering.

Dr. Acharya was the chief architect of a new and innovative graduate program in bioengineering innovation and design that has attracted top engineering students, outside funding and numerous awards. He also runs a program in global medical technology innovation, which focuses on developing appropriate healthcare technologies for resource restrained customers globally. Dr. Acharya’s research focuses on neural engineering. He has published over 40 peer reviewed articles and book chapters. He is the recipient of the NASA space act board award (2008) and the NASA tech briefs award (2006).

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Mike Hess

Mike Hess is the VP of Innovation Excellence at Medtronic.  Mike has been at Medtronic for 20 years, beginning as a Biomedical Engineer in the pacemaker research department.  He has also worked in product development/systems engineering, clinical trial management, program management and product planning marketing.  Mike is a Medtronic Technical Fellow, a member of the Bakken Society, and has about 25 issued patents and numerous publications.  He has a BS in biomedical engineering from Case Western Reserve University and a MS in software engineering from the University of St. Thomas.

As VP of Innovation Excellence Mike leads the Medtronic R&D council which is primarily focused on R&D productivity.  Mike also leads actives focused on improving the culture of innovation and collaboration at Medtronic, and serves as the primary sponsor of internal technical employee organizations.

Mike resides in Minneapolis, MN with his wife and five children.

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Uday Kumar, MD

Uday N. Kumar, MD is a cardiologist and cardiac electrophysiologist and the founder of iRhythm Technologies Inc., a venture- and corporate-backed medical device company focused on developing new devices and systems for cardiac rhythm monitoring. Dr. Kumar is also the Fellowship Director for the Stanford Biodesign Global Programs of India and Singapore.

Dr. Kumar has served as an Adjunct Clinical Instructor of Cardiovascular Medicine and Lecturer in Bioengineering at Stanford University, where he was a Biodesign Cardiovascular Innovation Fellow. As a Fellow, he focused on identifying and developing solutions to unmet clinical needs in the field of cardiac electrophysiology (EP) which helped form the basis for iRhythm Technologies Inc. Dr. Kumar also helped to launch Biomedical Modeling Inc., a company that created models from imaging data using rapid prototyping techniques for use in numerous medical areas.

Prior to joining Stanford University, Dr. Kumar completed fellowships in cardiac EP and cardiology at the University of California, San Francisco (UCSF). He previously completed his training in internal medicine at Columbia-Presbyterian Hospital of Columbia University. Dr. Kumar received his BA magna cum laude in biochemistry from Harvard College in 1994, and his MD from Harvard Medical School.

Dr. Kumar grew up in Rhode Island, and is originally from Bangalore, India.

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Brian Davis, PhD

Brian Davis, Vice President of the Medical Device Development Center, holds both a bachelor’s degree in mechanical engineering and a master’s degree in medicine (biomedical engineering) from the University of Cape Town (South Africa), and a PhD from Penn State University. He had a staff-level appointment at the Cleveland Clinic from 1992 to 2010. During this time he was the first Cleveland Clinic investigator to receive a peer-reviewed grant from NASA headquarters on the topic of foot biomechanics in response to impact loading (1996-1998), the first investigator to obtain funding from the Juvenile Diabetes Research Foundation, and the first to obtain a four year grant from the Howard Hughes Medical Institute. He subsequently received funding to develop and test an exercise countermeasure device for astronaut use and was part of a team that developed biomechanical sensor instrumentation that is currently on the International Space Station.

In terms of medical devices, Dr. Davis has led a number of initiatives focused on rehabilitation technology and instrumentation for assessing a patient’s risk for diabetic foot ulceration. He is currently the Principal Investigator on a State-funded project aimed at commercializing sensors for diagnosing connective tissue disorders. He is also leading an educational program named “BEST Medicine” that encourages middle and high school students to develop interests in engineering, science and technology, particularly as these relate to designing novel medical devices. Dr. Davis is a member of a number of professional societies, including the International Society of Biomechanics – a society for which he served as President from 2005 to 2007.

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A. Jay Khanna, MD, MBA

A. Jay Khanna, MD, MBA is an Associate Professor in the Departments of Orthopedic Surgery and Biomedical Engineering at the Johns Hopkins University and is Co-Director of the Division of Spine Surgery at Johns Hopkins Orthopedics Surgery at Good Samaritan Hospital.  Dr. Khanna also serves as the Clinical Director for the Johns Hopkins Center for Bioengineering, Innovation and Design (CBID).  He obtained his undergraduate and medical degrees from Georgetown University and the Georgetown University School of Medicine.  Subsequently, he pursued his orthopedic surgery residency training at the Johns Hopkins Hospital and then went on to the Cleveland Clinic Spine Institute where he completed a fellowship in spine surgery in the Departments of Orthopedic Surgery and Neurosurgery.

His clinical interests include the treatment of a wide range of spine pathologies using techniques ranging from minimally invasive spine surgery to complex spine reconstructions.  His research interests include the evaluation of clinical and functional outcomes of the spine surgery, advanced imaging of the spine including intraoperative image guidance, and the study of spine biomechanics.  Dr. Khanna is actively involved in research and has authored numerous peer-reviewed publications and multiple book chapters on topics in spine and orthopedic surgery.  He recently edited and published a textbook entitled MRI for Orthopaedic Surgeons. One of his greatest interests is that of education and he is currently the Director of the annual Johns Hopkins Orthopedic Surgery Review Course and is the Co-Director of the annual American Academy of Orthopedic Surgeons Board Review Course.

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Debra Lappin

Debra Lappin is recognized across government, academic and nonprofit sectors as a leading strategist in public health and science policy. As counsel with Faegre Baker Daniels and senior vice president with FaegreBD Consulting, she brings expertise on innovative public-private partnerships, global consortia and other strategic alliances among academic research institutions, voluntary health agencies, government and industry. Calling upon her experiences as former national chair of the Arthritis Foundation, Debra is a recognized national spokesperson on public engagement in the nation’s public health and scientific enterprise.

Debra’s practice focuses on the changing roles of academia research institutions and the increasing influence of venture philanthropic patient organizations in accelerating translational research. She is recognized for her leadership of major science policy campaigns calling for public access to scientific communications and genetic non-discrimination. Drawing upon her understanding of health agency trends, law, ethics and practical business challenges, Debra advises on the development of a broad range of emerging, complex tools to enable translation, such as disease registries, large integrated databases, bio-specimen repositories and cross-institution affiliations, to share data.

Debra serves or has served as an advisor to the leading agencies in public health, including the Centers for Disease Control and Prevention and the National Institutes of Health. She has participated on a number of committees at the National Academy of Sciences, including the Committee on the Organizational Structure of the NIH which led to a number of directions incorporated in the 2006 NIH Reform Act. Debra is President of the Council for American Medical Innovation, a member of the Board of Research!America and an adjunct professor at the University of Colorado Health Sciences Center.

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Ali Dhinojwala, PhD

Dr. Ali Dhinojwala serves as H.A. Morton Professor of Polymer Science and Department Chair of the Department of Polymer Science at The University of Akron.  Prior to joining The University of Akron in 1997, he served as Product Developer for GE Plastics.

Dr. Dhinojwala is an award-winning researcher, who focuses on spectroscopic techniques to study structure and dynamics at surfaces and interfaces, the relationship between adhesion and friction, structure and dynamics of molecules in confined geometry and developing synthetic adhesives using aligned carbon nanotubes inspired by Gecko foothairs.

Dr. Dhinojwala earned his doctorate degree in chemical engineering from Northwestern University, and his postdoctoral in materials science from the University of Illinois.

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Richard Skolasky, PhD

Richard L. Skolasky, ScD is an Assistant Professor in the Departments of Orthopedic Surgery at the Johns Hopkins University and is Director of the Johns Hopkins Spine Outcomes Research Center. Dr. Skolasky obtained his undergraduate and graduate degrees from the Johns Hopkins University and the Johns Hopkins Bloomberg School of Public Health.

Dr. Skolasky’s research interests include the evaluation of clinical and functional outcomes following spine surgery, understanding influences on health behavior, and developing metrics to evaluate the cost-effectiveness of medical interventions. Dr. Skolasky is actively involved in research and has authored numerous peer-reviewed publications on topics in spine and orthopedic surgery. He has recently published a chapter on measuring cost effectiveness in spine care.  Dr. Skolasky has mentored medical, graduate, and undergraduate students with regard to the design and conduct of clinical research. He has served on the Research Committee of the Cervical Spine Research Society (CSRS) and now serves Research Project Management and the Governance committees of the North American Spine Society and the Special Projects Committee of the CSRS.

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Frank Douglas, Ph.D., M.D.

An award-winning industry veteran with more than 24 years of experience as a leader in healthcare, pharmaceutical research and entrepreneurship, Douglas serves as day-to-day chief strategist for the Austen BioInnovation Institute in Akron, a new biomaterials institute built on a unique collaboration of five leading medical and educational institutions.

He is University Professor in the College of Polymer Science and Engineering at The University of Akron, Professor of Integrated Medical Sciences at Northeast Ohio Medical University, member of the Ewing Marion Kauffman Foundation’s Board of Trustees, and senior partner emeritus of PureTech Ventures.  Douglas currently is the national chairman of the Value-driven Engineering and U.S. Global Competitiveness initiative, a public-private coalition made up of leaders from industry, academia and the public and private sectors working to retain the United States’ lead in medical device development and innovation.

While at Massachusetts Institute of Technology (MIT), Douglas was the Professor of the Practice in the MIT Sloan School of Management and also held similar appointments in the departments of biology, biological engineering, and the Harvard-MIT Division of Health Sciences and Technology and was the founder and first executive director of the MIT Center for Biomedical Innovation.

Douglas was formerly executive vice president, chief scientific officer, and a member of the board of management of Aventis, where he headed drug innovation and approval, with global responsibilities for research, development, and regulatory and marketing support.  A leader in innovation in pharmaceutical research and development, Douglas serves on multiple boards of directors, most recently joining that of the Multiple Myeloma Research Foundation.  He has also served as Chief Scientific Advisor of Bayer Healthcare, AG.

Douglas is the recipient of the 2007 Black History Makers Award and has been honored twice as the Global Pharmaceutical R&D Director of the Year, in recognition of his leadership and success in improving innovation and productivity in pharmaceutical companies.  Other awards include: Louis B. Russell Memorial American Heart Association Award, the Chicago Heart Association’s Heart of the Year Award, the Center for Medicine in the Public Interest’s Odyssey Award, the National Organization of Chemists and Chemical Engineers–Lifetime Achievement Award, Guyanese & American Business & Professional Council’s 2010 Honoree, and was honored as one of Geoffrey Beene Gives Back® and GQ Magazine’s 2010 Rock Stars of Science™.  He was involved in the discovery, development and/or approval of more than 20 medications.  He also has received the Medal of Honor and an Honorary Professorship from the Johann Wolfgang von Goethe University, Frankfurt, Germany.

Douglas holds a PhD in physical chemistry and a MD from Cornell University.  He did his internship and residency in internal medicine at the Johns Hopkins Medical Institution and a fellowship in neuroendocrinology at the National Institute of Health.

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Megan Moynahan

As (Acting) Associate Director for Technology and Innovation, Megan directs the Center’s Entrepreneurs in Residence program, a White House sponsored program that brings thought leaders into agencies to solve challenging problems.  Targeting the Innovation Pathway, the EIR team of medical device innovators, business process innovators, and visionaries launched the End Stage Renal Disease Innovation Challenge in January, 2012, to spur medical device innovation for patients with ESRD.   In 2010, Megan led the CDRH External Defibrillator Improvement Initiative, an effort to use FDA’s regulatory oversight and public health influence to improve the performance of external defibrillators.  Megan brings insight into the unique culture and workings of FDA’s Center for Devices and Radiological Health, having nearly 16 years experience at FDA including six years as the branch chief for the premarket branch responsible for new pacemakers and defibrillators.  Her successful cross-functional working group became the model for a Center-wide reorganization in 2008.  In 2009, she was the chief architect for the Center’s Signal Escalation program, a Center-wide business process focused on product safety that was cultivated as an in-house “start-up”.  Megan has been a member of the Office of the Center Director since 2008.  Her background is in biomedical engineering with emphasis on electrical engineering and control systems.  Her current areas of focus on the innovation team include wireless telemetry, continuous physiological monitoring, biosensors, and robotics.

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Lynn Stein, PhD

Dr. Stein joined Olin College from MIT, where she was an Associate Professor of Computer Science. She has a bachelor’s degree, cum laude, in computer science from Harvard and Radcliffe Colleges and master’s and doctorate degrees in computer science from Brown University.

Dr. Stein has pioneered the development of a new and innovative approach to the teaching of computer science. Computer scientists have typically viewed computation as the step-by-step process of producing a result. Modern computational systems (such as the World Wide Web) require an alternative conceptualization of computation in terms of interactive architectures. Interactive architectures can be used to better model not only the Web, but also other complex systems such as those in robotics, information management, and software design. Dr. Stein has developed innovative robotics laboratories for students to learn and demonstrate the power of her new approach.

In robotics, her research has focused on designing, building, and understanding the architectures that underlie cognition in biological and artificial systems. The robotic systems her research group has built involve bridging the gap between the low-level behavior traditionally associated with robotics and higher levels of cognition that more closely approximate thinking.

Dr. Stein has won numerous awards and honors, including the General Electric Foundation Faculty for the Future Award and the National Science Foundation Young Investigator Award. She was named Institute Fellow, KISS Institute for Practical Robotics, and received the Ruth and Joel Spira Teaching Award. She has also served as a Mary Ingraham Bunting Fellow.

Dr. Stein has served as the invited keynote speaker at numerous international conferences on innovation in computer science and computer engineering education. She has numerous refereed journal publications, and next year is publishing a book, Introduction to Interactive Programming, which presents in detail her innovative computational metaphor and cognitive architectures.

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Stephen Welby

Mr. Stephen P. Welby was appointed the Deputy Assistant Secretary of Defense for Systems Engineering in September 2009.  He is the principal systems engineering advisor to the Secretary of Defense and is responsible for establishing and executing engineering policy and oversight across the Department.  His responsibilities include pre-acquisition development planning; engineering support to design, development and manufacturing; and independent engineering review, technical risk assessment and engineering analysis across the Department’s portfolio of major acquisition programs.  He provides functional leadership to more than 40,000 Defense acquisition professionals in the DoD systems planning, research, development, engineering (SPRDE) and production, quality and manufacturing (PQM) workforce.  Mr. Welby also serves as the Defense Standardization Executive.

Mr. Welby has over 22 years of government and industrial experience in technology and product development, including senior leadership positions at the Defense Advanced Research Projects Agency (DARPA).  His experience includes development of leading-edge aeronautical and space systems, robotics, advanced weapons, high-performance software, and military sensor systems.

Mr. Welby holds a Bachelor of Science degree in chemical engineering from The Cooper Union for the Advancement of Science and Art, a Master’s degree in business administration from the Texas A&M University, and Master’s degrees in computer science and applied mathematics from The Johns Hopkins University.

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Scott Weiner, MD

Dr. Scott D. Weiner is Chairman of the Department of Orthopaedics at Summa Health System in Akron, Ohio. In addition to his chairman duties, Dr. Weiner is Chair of the Department of Orthopaedic Surgery at Crystal Clinic Orthopaedic Center in Akron, Division Chief of Oncology Service in the Department of Orthopaedics for Summa Health System, and Director of Pediatric Orthopaedic Oncology at Akron Children’s Hospital. He also is a Professor of Orthopaedic Surgery at Northeast Ohio Medical University.

Dr. Weiner received his medical degree from the University of Cincinnati College of Medicine and served his residency at Akron City Hospital (now a part of Summa Health System). He served his fellowship in orthopaedic oncology at the University of Florida.
Dr. Weiner’s specialty is orthopaedic oncology. He treats adult and children’s bone and muscle tumors and metastatic disease.

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Youseph Yazdi, PhD, MBA

Youseph Yazdi, PhD, MBA, is executive director of the Johns Hopkins Center for Bioengineering Innovation and Design.
Prior to joining Johns Hopkins, Dr. Yazdi was corporate director in the Corporate Office of Science & Technology at Johnson & Johnson, where he was responsible for helping to build Johnson & Johnson’s open innovation network, and for using that network to nurture health care innovation.

Dr. Yazdi was the recipient of the Johnson & Johnson Standards of Leadership Award in 2007, and named a Fellow for the American Institute for Medical and Biological Engineering and recipient of four Design Contest Innovation Awards from Ethicon Endo-Surgery in 2009.

Dr. Yazdi received his BS in electrical and computer engineering from Rice University, his MS in electrical engineering and PhD in biomedical engineering from The University of Texas at Austin, and his MBA in entrepreneurial management from The University of Pennsylvania.

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