On Jan. 12, the Stanford biodesign program and the Stanford School of Medicine signed a memorandum of understanding (MOU) with the Food and Drug Administration (FDA). This memorandum gives both organizations a foundation that allows future collaboration on projects, such as working to improve the regulatory process for innovations in medical technology.
Paul Yock, a medical professor and director of the biodesign program, said that the partnership was inspired by a mutual consensus that the FDA regulatory process is too “burdensome.” Yock noted that Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), has been spearheading an outreach effort to speak with universities about possible collaborations and new projects for “regulatory science.”
Yock said that he believes Stanford was chosen as a partner “because we are in a hotbed of tech innovation out here” and because of Stanford’s national reputation.
When asked if he thought the FDA was pursing similar agreements elsewhere, Yock said that “their intention is absolutely to work with other universities,” but that he did not know which universities these might include.
While the MOU promises more collaboration in the future, its concrete provisions are yet to be developed. Describing the memorandum as “a first level of agreement,” Yock said that it allows Stanford and the FDA “to jointly pursue projects … as a formal partnership, so that we can fundraise together, for example.”
“It gives us the legal clearance,” he added.
The memorandum goes into effect immediately and was signed by a panel of medical device and technology experts, including Shuren and Yock. Although the FDA has interacted most closely with the biodesign program so far, Yock said the program is “a kind of the conduit” and that members of the FDA “are absolutely interested in reaching into the medical school.”
Harry Greenberg, professor in the School of Medicine and director of Spectrum, an independent research group funded in part by an award from the National Institutes of Health, was also present at the signing of the memorandum. Greenberg noted that the Stanford biodesign program — which he said focuses on “medical devices and how best to sharpen the skills and train young people who are interested in being innovators in that field” — has garnered “a great reputation around the country and around the world.”
“The memorandum of understanding provides a sort of agreement to say, ‘What should we do?’” Greenberg said. “The federal government … like[s] to have memorandums of understanding as sort of a baseline thing, [certifying that] ‘we agree to work together.’ Now, specifics need to be added to the MOU if it’s going to do anything.”
According to Greenberg, the MOU does suggest the foundation of what Yock calls a “bilateral education” program. Yock and the biodesign program expect to expand their joint fellowship program with the FDA, which has hosted around 16 Stanford students since its inception in 2004. Yock anticipates both “expand[ing] the educational impact for Stanford students beyond just this fellowship,” as well as “creat[ing] a mechanism for the reviewers at the FDA [to come to Stanford] to understand a little bit what it’s like to develop a new technology.”
Although Stanford has worked with the FDA before, both on investigating regulatory processes and bringing new devices through it, this will be the first time that the biodesign program has established an educational partnership with them.
“It’s complicated; but at its heart, I think, I would say that the FDA realizes that to best do its job in the 21st century, it has to have a deeper understanding of some of the scientific breakthroughs and new types of science that are going to … [be] brought to them,” Greenberg said of the new partnership. “The FDA, I think, reached out to us and said, ‘We [want] … an agreement with Stanford to really take advantage of the innovative stuff you’re doing there … and our people at the FDA can get a better feel of what’s actually happening now in the real world that they’ll have to deal with.’”
Yock said he also looks forward to “developing some case studies of local companies … and what their experience was in going to the FDA.”
“This will be just the start of what we hope will be a series of teaching models that are available nationally and internationally that talk about the regulatory process, that look at aspects of regulatory science and how it can be improved,” he added.
Other plans, Greenberg said, have “just started” and are no more than “a gleam in the dean, and my and several other people’s eye.”