Global Harmonization of Medical Device Regulations Symposium
Susan Alpert, PhD, MD is currently the principle of SFA Consulting LLC, focused on the strategies needed to place medical devices into the global market. Dr. Alpert joined Medtronic in July 2003 as Vice President of Regulatory Affairs and Compliance. She was Senior Vice President, Global Regulatory Affairs at her retirement in May, 2011 and in this role was responsible for all Medtronic global regulatory policy efforts. Prior to joining Medtronic, Susan served C.R. Bard, Inc., as Vice President of Regulatory Sciences. She also previously worked at the FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six 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.
Dawn Bardot, PhD brings fifteen years of experience and expertise in computational model validation and uncertainty quantification. She is passionate about the application of modeling and simulation to improve health care and lower the cost of bringing products to market. As a member of the American Society of Mechanical Engineers, she serves as vice-chair of the Verification and Validation in Computation Fluid Dynamics and Heat Transfer Committee and sub-group chair of the Committee on Verification and Validation in Computational Methods for Medical Devices.
Lisa Becker is the Senior Director of Regulatory Affairs at St. Jude Medical whose mission is to invent advanced technologies that transform the treatment of some of the world’s most expensive epidemic diseases. Lisa has previously held positions at Boston Scientific where she was the Director of Worldwide Regulatory Affairs for the Cardiac Rhythm Management Division. Becker’s early career was spent in the U.S Air Force as a Military Personnel Flight Commander. Lisa earned a Bachelor of Science degree in Organizational Behavior with a General Engineering Minor from the United States Air Force Academy and a Master of Science degree in Human Resource Management and Information Systems from Chapman University.
Bill is the Director of Business Solutions at Devicix, a contract design and product fulfillment firm focused on the medical market and headquartered in Minnesota. Bill utilizes his years of experience in the medical industry to advance device product developments into the medical and life sciences industries. Prior to joining Devicix, Bill served as vice president of business solutions at Logic PD, medical technology director at TechInsights, vice president of engineering at Nonin Medical, and in a variety of technology and product development roles elsewhere. Bill serves on the Editorial Advisory Board for the Medical Design and Diagnostic Industry, as well as Advisory Boards for the Pediatric Device Innovation Consortium, for St. Thomas University, for Minnesota State University, for Medical Alley’s R&D Advisory Group, and is a noted author and lecturer. Bill received bachelor’s degrees in electrical engineering and physics from SD School of Mines and Technology, and a masters in electrical engineering from the University of Minnesota.
LT USPHS James Coburn is a Senior Research Engineering Officer at the FDA. He is the co-Chair of the FDA Additive Manufacturing Working Group and lead for the FDA's Additive Manufacturing Core Facility – which performs research and help to direct technical strategies for 3D printing and Additive Manufacturing in medical devices and harmonization across the FDA.
LT Coburn is also principal engineer for the Functional Performance and Device Use Laboratory in the Office of Science and Engineering Laboratories. The lab specialize in experimental research, computational models, and field research into medical devices that incorporate characteristics, motions, and scenarios derived from patient usage and in vivo experience.
MATTHEW DI PRIMA
Matthew Di Prima, PhD Materials Scientist, Center for Devices and Radiological Health Dr. Di Prima’s areas of research are investigating how the additive manufacturing process can alter material properties, the interplay between corrosion and durability testing, and explant analysis. He also is the head of the Additive Manufacturing Working Group, which is spearheading efforts across the Agency to address how this technology affects medical devices and other regulated medical products. Efforts include guidance and standards development, device review harmonization, and performing regulatory science with the intent to foster innovative and high-quality products while maintaining safety and effectiveness. He received his doctorate in materials science and engineering from the Georgia Institute of Technology.
Arthur G. Erdman, PE, is the Richard C. Jordan Professor and a Morse Alumni Distinguished Teaching Professor of Mechanical Engineering at the University of Minnesota, specializing in mechanical design, bioengineering and product design. In July 2007 he was selected as the Director of the Medical Devices Center at the U of M and is also the Co-Editor of the ASME Journal of Medical Devices. Dr. Erdman has published over 370 technical papers, 3 books, holds 35 patents (plus 10 pending), and shares with his former students 9 Best Paper Awards at international conferences.
Derek Mathers is a Director of Advanced Applications Development at Worrell, and focuses on applying new technology platforms to medicine. Worrell is a design and strategic consulting firm that creates technologies for the improvement of the human condition. Derek has presented 3D printing trends and case studies to a host of leading trade shows and publications including Design of Medical Devices Conference, Interface Health, Inside3D, MEDevice, Design News, AMUG, MD&M, Young President's Organization, Medical Alley, Plastics Today, Qmed, MDDI, and more. Derek is also an Adjunct Professor at the University of Minnesota, teaching the Big 10's first dedicated course in 3D printing and additive manufacturing.
Ken Merdan is a Sr. R&D Fellow focused on global technology platforms including technological foresight and forecasting. He has contributed to the medical devices industry at Boston Scientific for over 24 years; most recently providing leadership to knowledge management strategy, business process re-engineering, and global R&D expansion. He is currently focused on business development in the area of medical imaging and visualization. Ken is a champion for applying advanced visualization and 3D printing technologies to improve business processes, product development, and patient-specific, healthcare delivery.
Ken has degrees in Mechanical Engineering (BSME) with an emphasis on design and in the Management of Technology (MSMOT) - both achieved through the University of Minnesota. Recently, Ken was inducted as a University of Minnesota (UMN) Institute for Engineering in Medicine (IEM) Fellow. He is an inventor on 17 US-issued patents.
Cristin Moran, PhD is the Front End Innovation Lead for 3M Health Care. Moran is responsible for disseminating the science of innovation and evolving the 3M Health Care Business Group Front End Innovation playbook. Leading the HCBG innovation teams in identifying new market space and R&D opportunities. She trains and coaches health care divisions in business model development and testing, customer insight methodologies, working with external experts to support innovation, R&D commercialization analytics, and collaborating on strategic planning for R&D across the HCBG. Additionally, she helps manage the HCBG portfolio prioritization efforts, commercialization activities, and strategic initiatives across the six global divisions.
Tina M. Morrison, PhD Regulatory Advisor of Computational Modeling, Center for Devices and Radiological Health leads the Regulatory Review of Computational Modeling Task Force at CDRH, which has developed guidance documents on the use of modeling and simulation in the regulatory evaluation of medical devices. She also is a scientific reviewer on medical device premarket submissions in cardiovascular devices. She is dedicated to advancing regulatory science through modeling and simulation because she believes the future of medical device design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization. Dr. Morrison received her doctoral degree in theoretical and applied mechanics from Cornell University in 2006 and studied cardiovascular biomechanics as a postdoctoral fellow at Stanford University.
Randall (Randy) Schiestl, PMP is the Vice President of R&D, Global Technology at Boston Scientific where he has responsibility for global systems and services to drive collaboration, innovation and productivity across the six divisions of the company. He leads the Boston Scientific Global Technical Community and Technical Executive Committee to introduce and leverage technology platforms supporting both new product development and operations. In addition, Randy serves on multiple industry advisory boards and innovation panels at global university, government and industry healthcare forums.
Associate Director for International Affairs, Center for Devices and Radiological Health, FDA, Since joining the FDA in 2004, Torres has held numerous positions prior to becoming the Associate Director for Internal Affairs focused on Global Harmonization, including: Biomedical Engineer/Reviewer, Branch Chief, Cardiac Rhythm and Electrophysiology Devices Branch, Quality System Specialist, Branch Chief, Interventional Cardiology Devices Branch, Deputy Director, Division of Cardiovascular Devices, and PMA/HDE Director in addition to receiving numerous FDA recognition awards, She also serves as an FDA instructor for the Association for the Advancement of Medical Instrumentation (AAMI).