Innovation Workshop

Edward Black, MBA

Edward Black has been active in medical technology consulting for over 15 years advising companies around the world on reimbursement, market access and health economics in the highly complex U.S. market. Prior to consulting, Mr. Black worked for 25 years in medical management and hospital and physician relations within the Blue Cross Blue Shield system and served on two national advisory boards. During this time, he served as the executive director of three managed care business partnerships with large multispecialty clinics for which he was awarded the 1995 Outstanding Contribution to the Healthcare Industry citation by the Medical Alley Association.

Mr. Black has been involved in several global medical technology initiatives and has been a frequent international lecturer in eleven countries including Canada, Ireland, the UK, Denmark, Norway, Sweden, Germany, Australia, and Japan. His newest company, Edward Black and Associates, LLC, works with reimbursement and health economics professionals around the world to offer these services in the major markets of the US, Europe, and Asia. He is a co-author on three health economics analyses in major international journals. Mr. Black is a member of the University of Minnesota Business Advisory Group, the U of M Encore Group, and the National University of Ireland-Galway medical technology accelerator.

William Durfee is Professor and Director of Design Education in the Department of Mechanical Engineering at the University of Minnesota, and Director, Bakken Medical Devices Center. His research and professional interests include the design of medical devices, rehabilitation engineering, muscle physiology, wearable robots, product design and design education. Dr. Durfee is a Fellow of the American Institute for Medical and Biological Engineering, the Editor-in-Chief of the ASME Journal of Medical Devices and a member of the Academy of Distinguished Teachers at the University of Minnesota.

Danny Gelfman is Distinguished Designer - Innovation Lab at Medtronic where he directs innovation activities corporate wide, working with teams to create clear product, system and service solutions that address identified user needs. Before Medtronic he was an industrial designer with redgroup. He received his BSID in Industrial Design from the University of Cincinnati.

Paul A. Iaizzo, PhD FHRS ([email protected]) is a Professor is the Departments of Surgery, Integrative Biology & Physiology and the Carlson School of Management, at the University of Minnesota. He also serves on the graduate faculties in Biomedical Engineering, Neuroscience, Integrative Biology & Physiology, Biological Science, Bioinformatics and Computational Biology and Mechanical Engineering. He is the Director of the Malignant Hyperthermia Diagnostic Center and Medtronic Professor of Visible Heart® Research. Additionally, he is the Associate Director and Medtronic Chair of the Institute for Engineering in Medicine, also at the University of Minnesota. He earned both MS and PhD degrees (Focus: Physiology/Neurophysiology) from the University of Minnesota. His main research focus is translational systems physiology, where his research group does a broad range of studies. The Visible Heart® Laboratories are well known for their multimodal imaging techniques of functional cardiac anatomies and device testing within large mammalian hearts, including human: see the Atlas of Human Cardiac Anatomy (http://www.vhlab.umn.edu/atlas/). Other research areas include: cardiac pacing and ablation, muscle pathophysiology and biophysical properties, thermoregulation, black bear hibernation, 3D computational modeling and printing and educational uses of virtual reality. In 2002, he was acknowledged as a “Distinguished University Teaching Professor”. Since 1990, he has trained over 200 graduate students, postdoctoral fellows, and medical students in his laboratories. Dr. Iaizzo, has authored more than 280 original articles, over 100 book chapters, edited 5 books, and is on numerous patents related to medical devices. In 2012, he was named to College of Fellows of the American Institute for Medical and Biological Engineering (AIMBE) for "outstanding contributions to research and education in translational systems physiology and cardiovascular engineering". In 2015 he was named a Fellow of the Heart Rhythm Society and in 2016 was made a Senior Fellow of IEEE.

Vice President, Research & Development
Medtronic

Adjunct Assistant Professor
University of Minnesota

Dr. Tim Laske is currently the Vice President of Research & Development for the Cardiac Ablation Solutions Business at Medtronic.  He is a Medtronic Bakken Fellow and Technical Fellow and a Fellow of the American Institute for Medical and Biological Engineering.  His previous roles at Medtronic include VP of Research and Business Development for AF Solutions, Senior Product Development Director for Heart Valves, Senior Program Director for Transcatheter Heart Valves, Technology Director for Cardiac Rhythm Therapy Delivery, and various technology management and design engineering positions.  Prior to his 31-year tenure at Medtronic, he worked as a Design Engineer at Ford Motor Company in Crash Safety and Advanced Vehicle Systems Engineering.  He has a B.S. degree in both Biological Sciences and Mechanical Engineering from Michigan Technological University.  He received his M.S. in Mechanical Engineering from the University of Michigan, Ann Arbor, and his Ph.D. in Biomedical Engineering from the University of Minnesota where he serves as an Adjunct Assistant Professor in the Department of Surgery.  His doctoral research was centered on the use of isolated working hearts in the design of medical devices and in parallel co-founded the Visible Heart® Laboratories.  In addition to medical device design and cardiac physiology, his research interests include the study of hibernation physiology in wild black bear and brown bear populations and conservation of endangered species.  He has more than 95 U.S. patents and numerous publications in the fields of Biomedical Engineering and Wildlife Biology/Ecology.

Regulatory Scientist
Adjunct Professor
University of Minnesota

Recently retired from Industry Mac continues to teach the MDI5008 Quality Regulatory course at TLI and is active on various Boards and committees.

Mac McKeen has over 30 years of experience in the medical device industry in regulatory and quality roles focused on the Total Product Life Cycle related to the product development, quality compliance, clinical study, and the regulatory submission and approval of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. Recently, Mac provides Regulatory guidance and leadership to Global Sterilization Operations and product supply chain programs and manages the FDA Master File Program for BSC. For the last 14 years Mac has served as an Adjunct Professor at the University of Minnesota instructing undergraduate and graduate level courses in the Technology Leadership Institute on medical device development. Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and elected as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S).