I guess you could say that the Stanford Biodesign Program “wrote the book” on how to teach medical technology innovation to multidisciplinary teams. The U.S. Food and Drug Administration recently acknowledged the effectiveness of this training program by signing a “memorandum of understanding" with Stanford, which I discuss in today's Inside Stanford Medicine.
The agreement lays the groundwork for the FDA and Stanford to collaborate on a number of initiatives, including educational outreach, cross-training of scientific personnel, and the development of new biostatistical methods for more accurately evaluating the safety of emerging medical technologies.
The biodesign program, which is in its 11th year, trains teams of doctors, engineers and business students — in an intensive one-year program — to identify a medical need, develop an invention to fill it, create a business plan, navigate the regulatory process, then present their inventions to venture capitalists. Since its inception, the program has led to more than 200 patents and 24 start-up companies.
Previously: Stanford Biodesign Program releases video series on the FDA system, FDA walks line between innovation and safety, Stanford physician-entrepreneur discusses need to change FDA approval process, and New biomedical device textbook gets early praise