Dr. Michelle McMurry-Heath is Worldwide Vice President for Global Regulatory Affairs, International Clinical Evidence, and Strategic Operations for the Medical Device Companies of Johnson & Johnson, where she leads a team that generates clinical and preclinical studies and executes approval strategies for a wide range of medical devices in countries around the world. She also serves as the Chair of the National Evaluation System for Health Technology (NEST) Governing Committee, a public-private partnership between the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services, patients, private payers, leading epidemiologists, and device companies. NEST seeks to strengthen the real world evidence infrastructure for medical device studies. Dr. McMurry-Heath formerly served as Associate Center Director for Science in the Center for Devices and Radiological Health at the FDA, where her team drove regulatory science innovation. This included the refinement and use of formal patient preference studies in regulatory decisions and the founding of the Medical Device Innovation Consortium, a partnership between FDA, medical technology companies, and the patient advocacy community to address common challenges in regulatory science. After completing her undergraduate studies at Harvard University, she received an MD and PhD in immunology from Duke University.
Conflict of Interest Disclosures
As of December 10, 2018
- Johnson & Johnson, Employer; stock
- National Evaluation System and Health Technology (NEST), Governing Committee Chair