Kevin MacDonald, "How to Navigate the FDA Regulatory Process and Achieve Approval for a Novel Medical Device"

In depth knowledge along with appreciation of the FDA approval process is critical for entrepreneurs developing medical devices. If your device is so novel that you must pave a new path to approval, and you hope to see it reach the market in a reasonable time, you need to understand the Agency’s expectations and build a strategic communication plan. On April 22, Kevin MacDonald, a 25-year veteran in obtaining FDA market approvals/clearances, will explain the FDA classification system and describe a case study of a novel medical device with a complex regulatory pathway. Kevin will relate the challenges he faced and the strategy that led to FDA clearance.


5:00 – 6:00 pm       Registration + networking (drinks & refreshment will be served)
6:00 – 7:00 pm       Featured speaker: Kevin MacDonald

About the Speaker

Kevin MacDonald is currently a Regulatory, Clinical and Quality consultant working with small medical device startup companies. Kevin has more than 25 years experience and has a successful track record with achieving regulatory market clearances/approvals in the United States and abroad. Prior to his consulting role, Kevin’s recent experience includes Vice President positions at NeoTract and Concentric Medical. Earlier in his career, Kevin held various RA/CA/QA positions with Fox Hollow Technologies, Heartport, Cordis, Boston Scientific Corporation and CR Bard. Kevin graduated with a B.S. in Biology from Framingham State College.