IEM Keynote Luncheon

Director
Center for Devices and Radiological Health
US Food and Drug Administration

"CDRH: Regulating and Fostering Medical Device Innovation"
The US Food and Drug Administration’s Center for Devices and Radiological Health ensures that medical devices are safe, effective and of high quality for patients in the United States. Medical devices are becoming increasingly complex with the integration of software and hardware. Dr. Michelle Tarver will discuss innovation in medical devices, current device initiatives, and other important topics relevant for the medtech ecosystem.

Bio: Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture. Dr. Tarver has held various leadership positions while at the US Food and Drug Administration, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement. Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways. Dr. Tarver received a BS in Biochemistry from Spelman College in Atlanta, GA and completed the MD/PhD program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health. As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.

Director, Earl E. Bakken Medical Devices Center; Bakken Professorship for Engineering in Medicine; Endowed Lions Professorship in Otolaryngology; Institute for Translational Neuroscience Scholar; Co-Director, Center for Neural Engineering; Professor of Biomedical Engineering and Otolaryngology

University of Minnesota

Director, Institute for Engineering in Medicine
Director, Advanced Technologies for the Preservation of Biological Systems (ATP-Bio)
Director, Clinical and Translational Science Institute, Office of Discovery and Translation
Medtronic-Bakken Endowed Chair for Engineering in Medicine
Distinguished McKnight University Professor, Department of Mechanical Engineering 

Bio: Bischof works in the area of thermal bioengineering with a focus on biopreservation. He has been a faculty in Mechanical and Biomedical Engineering at the University of Minnesota since 1993. Bischof is a Distinguished McKnight University Professor in the Departments of Mechanical and Biomedical Engineering, and the Medtronic-Bakken Endowed Chair and Director of the Institute for Engineering in Medicine, and Director of the NSF Engineering Research Center ATP-Bio.