Video Briefs
Regulatory Experts
 | Howard Holstein Regulatory Attorney |
 | Su-Mien Chong Regulatory Consultant |
The Stanford University Biodesign team, through funding from the Kauffman Foundation, has developed a series of video briefs that address important information about medtech regulatory processes and requirements in the U.S. The videos are intended to reinforce and expand upon the regulatory content covered in the Biodesign text. They present content on regulatory basics, fundamental regulatory strategies, and several short case studies on medtech companies and their interactions with the FDA.
Each video brief uses an interview format with Dr. Paul Yock, 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.