System Design Panel - Panelist
Bakul Patel, MBA, Associate Director for Digital Health, Center for Devices and Radiological Health, FDA
Bakul Patel is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.
Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairsthe International Medical Device Regulators Forum (IMDRF) “software as a medicaldevice” working group, a global harmonization effort.
Before joining FDA, Mr. Patel held key leadership positions working in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short‐term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fastpaced, technology‐intensive organizations. Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University.