Stanford’s decade old biodesign program is partnering up with FDA Center for Devices and Radiological Health to help the agency adapt the way it screens new medical technologies.
The parties have reached a “memorandum of understanding,” rather than a formal agreement to specific projects, but the framework creates a method by which cooperation can now take place.
From the announcement:
“This agreement is the first step in a new collaboration between the FDA and Stanford University to promote better scientific understanding and education concerning the development of new technologies in the life sciences and the issues that affect their safety and effectiveness” said Shuren. “We look forward to working together on collaborative research initiatives and the education of students and fellows.”
Although specific projects have yet to be defined, this agreement paves the way for both institutions to jointly apply for grants and extramural funds to support their mutual objectives. Stanford’s contributions primarily will focus on two areas — education on med-tech “best design practices” and the development of new methods for more accurately evaluating the safety of emerging medical technologies.
Paul Yock, MD, director of the biodesign program, will lead the effort to promote better design practices, which includes improving understanding of regulatory practices. The biodesign program, which is in its 11th 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.
More from SCOPE: Stanford and FDA to collaborate on med-tech education
Announcement: FDA and Stanford to work together on med-tech education