Artificial Intelligence | April 8–10, 2019 | Boston, MA USA

Michelle McMurry-Heath, MD, PhD

  • VP, Global Regulatory Affairs and International Clinical Evidence, Johnson & Johnson Medical Devices,

Michelle McMurry-Heath joined Johnson & Johnson in 2014.  Under her leadership, multiple medical devices regulatory teams were unified into one global organization; a new global approach to regulatory policy was implemented; and a single digital regulatory information management system was designed and deployed.  In July 2017, Dr. McMurry-Heath’s role was expanded to include regional clinical, preclinical, and medical affairs and to lead the global evidence generation council for Johnson & Johnson Medical Devices Companies.  The purpose of her work is to continue to drive synergies, improve quality, and to facilitate the timely access of device innovation to patients.

Earlier in her career, Dr. McMurry-Heath was the senior health policy advisor for Senator Joseph Lieberman’s presidential campaign. She was the founding director of The Aspen Institute Health Biomedical Science and Society Initiative, which brought together leaders representing pharmaceuticals and diagnostics, patient advocacy, and health care to address issues ranging from regulation to health insurance reform for chronic diseases. Her health diplomacy work included projects in 11 countries, including Cambodia and Rwanda. From 2010-14, Dr. McMurry-Heath was the Associate Center Director for Science at the U.S. FDA Center for Devices and Radiological Health (CDRH). Dr. McMurry-Heath led the FDA team tasked with defining a new role for patients in the regulation of medical devices and diagnostics. She drew on this experience as the primary architect of the Medical Device Innovation Consortium (MDIC), a novel public-private partnership between the FDA and almost 50 members of the medical technology industry and patient advocacy community. MDIC members have pooled resources and talent to take on some of the most intractable topics in medical device innovation: optimizing clinical trials, applying computer modeling to device design and regulation, compliance science, pathways for insuring the clinical validity of new diagnostics, and the science behind measuring patient preferences.  In September 2018, Dr. McMurry-Heath was appointed to chair The National Evaluation System for Health Technology Coordinating Center (NESTcc) governing committee.  NESTcc is a FDA-funded, volunteer network of data partners whose aim is to efficiently consolidate real-world evidence (RWE), inform medical device evaluation and support regulatory decision-making throughout the total product life cycle and improve patient outcomes.

After studying biochemistry at Harvard University, Dr. McMurry-Heath became the first African-American to receive both M.D. and PhD degrees from Duke University. Trained in pediatrics and immunology, Dr. McMurry-Heath has committed her life’s work to providing patients with better health information and greater clinical options through science and innovation policy.

 

 

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