M. Jason Brooke, M.S.E., J.D., is a director in Navigant’s Healthcare and Life Sciences Disputes, Regulatory, Compliance, and Investigations (HLS DRCI) practice. Jason brings a focused expertise in the medical device industry that combines more than 15 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance.
Jason has conducted scientific research (pre-clinical and clinical) and technology development in academic and industry environments as a biomedical engineer, worked within the FDA’s Center for Devices and Radiological Health (CDRH) as a program analyst, counseled clients as an attorney and consultant focused on the medical device and connected health space, and served as the chief executive officer and general counsel of a small medical device company.
This experience allows Jason to offer a broad perspective on the challenges that face large and small, US and international clients throughout the product life-cycle when commercializing medical devices, mobile health technology, and clinical decision support software.
Jason regularly advises clients on FDA regulatory strategies and compliance, including quality system development, pre-clinical/clinical study design, pre-submission strategy and preparation, regulatory clearance/approval strategy and submissions, post-market surveillance, regulatory investigation support, and product obsolescence. He has also counseled device manufacturers and distributors on the applicability of the US medical device excise tax, fraud and abuse risks associated with promotional activities, reimbursement strategies, and M&A due diligence concerning FDA regulatory risk.
Throughout his career, Jason has developed a reputation for thought leadership and performance excellence. He was involved in the creation and management of industry coalitions that developed and successfully advocated for FDA regulatory policy reform in the areas of connected health and clinical decision support software. He has been invited to speak and has written a number of papers, book chapters, and articles on topics that span from medical device development to intellectual property protection to FDA regulation. Jason is an inventor on dozens of US and international patents and has received numerous awards in recognition of his leadership and success as a medical device professional.