At a town hall featuring FDA leadership at the AdvaMed MedTech Conference in Toronto, Michelle Tarver, M.D., Ph.D., took the time to introduce—or reintroduce—herself to members of the industry, this time as the acting director of the agency’s Center for Devices and Radiological Health (CDRH).
Tarver took the position in late July after the announcement that CDRH’s director of the past 15 years, Jeff Shuren, M.D., would be retiring. Currently, Shuren carries the title of center director emeritus, and he continued to represent the FDA at the AdvaMed annual meeting.
In addition to speaking about her background, Tarver—a practicing ophthalmologist, who graduated with a bachelor’s degree in biochemistry from Spelman College in Atlanta and received her M.D. and Ph.D. in epidemiology from the Johns Hopkins University School of Medicine and the Bloomberg School of Public Health—also spoke about her years at the FDA.
That time has included leadership roles such as helping to run the agency’s Office of Strategic Partnerships and Technology Innovation as well as its Patient Science and Engagement program. Most recently, Tarver was named deputy center director for transformation, with a hand in directing CDRH’s future-looking strategy.
“I've been at CDRH for 15 years—I've done premarket and post-market reviews, I've done policy and guidances and workshops, and all kinds of initiatives,” Tarver said. “And the important part of all of that work is that I didn't do it by myself, I did it as part of a team. And I believe bringing that collective brain power to a problem and working together to tackle it is instrumental to how you move the needle.”
She described her leadership approach as mission-driven and backed by curiosity, with the goal of helping patients “not merely to survive, but to thrive, and to do so with some compassion, some passion, some humor and some style.”
Tarver also named advancing health equity as a priority and discussed how the agency aims to address patient preferences in how they interact with health systems as well as disparities in access to care.
“Over the past few years, we have been increasingly aware of the changes in life expectancy across this country—but we don't often talk about how some communities live 25 years less than other communities,” she said.
“Chronic disease rates are rising at an astronomical rate, and, in that same context, we have a shrinking provider network. In fact, over 100 million people do not have a primary care physician, and 25% of them are children.”
“We also have a contracting amount of specialists, with many doctors who provide clinical care retiring from clinical practice,” Tarver added. “And, in parallel, we have a healthcare system where care is not necessarily coordinated, where there's duplication of tests being ordered, and there is a waste of healthcare resources in some situations.”
“It is really the perfect crucible where we can cook up a new solution.”
One option the FDA is looking at is making the home a central hub for healthcare. Tarver and Shuren helped launch an agency initiative earlier this year that, in part, aims to increase access among people who live in rural communities or lower-income neighborhoods, as well as to capitalize on the public’s adoption of remotely administered products and services during the COVID-19 pandemic.
It also wants to create an “idea lab,” Tarver said, to aid both members of the medtech industry and agency staff in being cognizant of how medical devices may fit into different housing situations—including both physically and within peoples’ day-to-day lives.
“We're looking at some of the homes with the least resources, such as those that may only have one bedroom, one bathroom and a kitchen, with a small footprint,” she said. With informed designs, it will be easier for patients to engage and ultimately adhere to their therapies even in constrained settings.
The effort includes contracting an architectural firm to build housing layouts in virtual reality—expected for release by the end of this year—where certain medical device designs can be tested out digitally, in addition to talking to patients where they live. The program will start with a focus on people with Type 1 or Type 2 diabetes.
“We chose that because it’s a condition that affects children and adults; certain populations have more disparities in terms of outcomes; and it impacts every single organ system,” she said. “The other important thing about diabetes is that it translates to $312 billion in healthcare expenditures every year. It is a huge market, and it's a place where we can see significant cost savings and we can make a dent.”