Mr. Brad Fox has worked for over 25 years developing and commercializing medical devices. As a serial entrepreneur leading his own firm, or as a consultant – Mr. Fox has broad based experience that includes medical device design and engineering, pre-clinical and clinical development as well as 15 years of direct engagement with the FDA and O-USA Regulatory bodies. He is a published author on using 3D Printing for solving unique manufacturing challenges including the use of 3D Printing for personalized medicine. In Regulatory, Mr. Fox has worked with clients from all over the world pilot cost effective paths through the FDA specializing in orthopedic and neurological devices, companion diagnostics and combination products. His experience includes traditional IDE’s, 510(k) and PMA’s as well as working on classification of new devices through the De Novo process. Mr. Fox holds degrees in Mechanical Engineering and Management and Leadership.
Areas of Expertise
Engineering: Leading product development goals, teams and objectives
Business: Start-up management, technology acquisition and fundraising
Regulatory: FDA and OUSA Regulatory – IDE, 510(k), PMA, De Novo