John Doucet is a neuroscientist and biomedical engineer with 10+ years of FDA experience in medical device regulation, and 13+ years of Johns Hopkins experience in discovery science, and 6+ years of management experience at FDA and Johns Hopkins School of Medicine. He has extensive knowledge of medical device regulatory pathways to drive technologies from conception to market.
John received a B.S. in Bioengineering from Syracuse University in 1987, a Ph.D. in Neuroscience from Syracuse University in 1994, and a Postdoctoral Fellow in Neuroscience from Johns Hopkins University in 1997.
Prior to joining MCRA, John was the Former US Food and Drug Administration (FDA) Policy Lead, for the Breakthrough Device Program. In this position, John managed the Breakthrough Device Program, where he oversaw all aspects of the program, was involved in the granting or denial of all Breakthrough designation requests, and served as CDRH’s expert for internal and external stakeholders regarding the regulatory standard for obtaining the Breakthrough designation for a medical device.
In addition to John’s leadership role with the FDA Breakthrough Designation Device Program, John also served in additional roles at FDA including Acting Director of IDE Program, Lead Reviewer of Neurology and Physical Medicine Devices, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch, and Policy Analyst of Office of Device Evaluation.
John joined MCRA on August 31st, 2020 as Senior Director, Neurology Regulatory Affairs. At MCRA, John provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies.