Bakul Patel, MSEE, MBA
Director, Digital Health Center of Excellence Director, Digital Health Division Center for Devices and Radiological Health Food and Drug Administration
Mr. Patel, in 2013, created the term “software as a medical device” (SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD. The concepts, principles and vocabulary created in harmonized regulatory framework has been used as a foundation and adopted by medical device regulatory bodies in the European union, Japan, Canada, Brazil, Australia and in the USA by US-FDA. Mr. Patel is currently leading the effort for the agency in developing an innovative software precertification program to reimagine a pragmatic regulatory approach for Digital health that that aims for patients and providers to have timely access to safe and effective digital health products.
Prior to joining FDA, Mr. Patel held key leadership positions in several sectors including 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 fast-paced, 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.