Transforming Healthcare: The FDA’s Dr. Michelle Tarver on New Initiatives and the Future of Medical Devices

BioTalk with Rich Bendis

Radiological Health (CDRH) at the US Food and Drug Administration (FDA). With a distinguished background as a board-certified ophthalmologist and epidemiologist, Dr. Tarver is at the forefront of transforming the evaluation and inclusion of medical devices in underserved and underrepresented populations. In this episode, Dr. Tarver introduces the FDA and the CDRH Division, explaining the definition of a medical device by FDA standards. She discusses the creation of the Chief Transformation Officer role within the FDA, highlighting its importance and the strategic vision behind it. We explore the critical importance of diversity, equity, and inclusion (DEI) in evaluating medical devices, and how these efforts are essential for ensuring equitable healthcare for all. Dr. Tarver introduces the innovative “Home as a Health Care Hub” initiative by the FDA/CDRH, explaining its potential to revolutionize healthcare delivery. Dr. Tarver also addresses the broader transformation needed in the healthcare system to ensure no one is left behind, emphasizing the role of partnerships in achieving this goal. She delves into the role of Virtual Reality (VR) and Artificial Intelligence (AI) in making the home a central hub for healthcare, discussing this ambitious initiative’s current status, challenges, and long-term objectives. Additionally, we touch on Dr. Tarver’s impressive background, including her leadership roles within the CDRH and her academic achievements at Spelman College and Johns Hopkins University. Finally, we discuss the value of having the FDA in the BioHealth Capital Region and its impact on advancing healthcare innovation. Tune in to BioTalk for an insightful discussion with Dr. Michelle Tarver as we explore the future of medical devices, healthcare transformation, and the pivotal role of the FDA in shaping a more inclusive and innovative healthcare landscape. Dr. Michelle Tarver is a board-certified ophthalmologist and epidemiologist, serving as the Deputy Center Director for Transformation. In this role, Dr. Tarver facilitates the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH is advancing efforts to include underserved and underrepresented populations in the evaluation of medical devices. Her CDRH career has included many leadership roles, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement. Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health.