A series of video briefs recently launched by the Stanford Biodesign Program offers insights into the regulatory processes and requirements that face U.S. medical device companies. The online resource is comprised of 60 videos that provide detailed information on the Food and Drug Administration and its regulatory process, short case studies, and advice for innovators as they interact with the FDA. As explained on the program's website:
Each video brief uses an interview format with Paul Yock, MD, Director of the Biodesign Program, asking questions of two different regulatory experts. Su-Mien Chong is a seasoned regulatory professional who has worked with multiple companies on obtaining the regulatory approval/clearance of their devices. Most recently, she assisted Acclarent with the regulatory strategy for its Balloon Sinuplasty system. Howard Holstein is a regulatory attorney with over 30 years of experience representing medtech companies, industry associations, and the FDA. Howard is a long-time supporter of the Biodesign program and a contributor to the Biodesign textbook.