Biodesign posts free video tutorials on how FDA approves medical devices
A series of video briefs recently produced by the Stanford Biodesign Program teaches innovators how to get a medical device approved for use in the United States. This free, online library of 60 videos provides detailed information on the Food and Drug Administration regulatory process, short case studies and advice on interacting with the FDA.
Tutorial content was developed by the biodesign teaching team and was designed to reinforce and expand upon the regulatory content covered in the textbook, Biodesign: The Process of Innovating Medical Technologies.
“We wanted to create a friendly, easily accessible resource with straight answers about when and how to approach the FDA with a new medical device. The experts in these videos are very practical and clear in their explanations,” said Paul Yock, MD, director of the biodesign program.
Video instruction is delivered in a question-and-answer format between Yock; Howard Holstein, JD, a medical device attorney and former deputy chief counsel at the FDA; and Su-Mien Chong, MBA, a seasoned regulatory professional. As a former vice president of clinical and regulatory affairs at Acclarent, Chong provides insights on how Acclarent was able to get its new balloon sinuplasty device, which is used to surgically open blocked nasal passages, approved by the FDA in a little over 90 days.
The biodesign program, which is in its 10th year, provides medical technology innovation training to teams of doctors, engineers and business students who — in a year — identify a medical need, develop an invention to fill it, create a business plan, then present their inventions to venture capitalists. This video series was funded by the Ewing Marion Kauffman Foundation and was produced by Chris Kurihara, Lyn Denend and Stanford Video.
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