By Shawn M. Schmitt
Communications Specialist, Enzyme
For Jeff Shuren, parting ways with the US Food and Drug Administration is such sweet sorrow. He stepped down as the longtime Director of the FDA’s Center for Devices and Radiological Health this summer, paving the way for Michelle Tarver – CDRH’s Deputy Director for Transformation – to lead the center on an acting basis.
“I came in 15 years ago, and with the team at the time, we set a vision, and we’ve achieved that vision. And we’ve held steady. It’s time to set a new vision, a new course. I believe [CDRH] needs new leadership, needs new blood,” Shuren said. “Like from ‘A Christmas Carol,’ I am the Ghost of CDRH Past, but under the leadership of Michelle Tarver, she’s the Ghost of CDRH Yet to Come, and that’s what we need moving forward.”
Shuren made his remarks alongside Tarver at a Sept. 24 Town Hall webinar sponsored by Pathway for Patient Health. Below are six key takeaways from their joint appearance, which were lightly edited for clarity and brevity.
1. Shuren on Change
“The one constant in life is change. You can cheat death and taxes, but you can’t cheat change. And CDRH has really thrived on change. Our culture is one that embraces change and we’re a driver of change. You can see it today. For example, with COVID, there were a lot of lessons learned that have been incorporated into the center. I think the center today is much better prepared for the future, a much more agile organization. And it informed TAP, where there’s this kind of engagement in near real time. Well, that’s something that we were doing as a part of the Pre-Emergency Use Authorization approach with innovators for COVID technologies, and we kind of rolled those experiences into TAP. And there’s a whole effort underway on redesigning the pre-market review program, and a lot of innovative thoughts going into that, not to shortchange the science at all, but to actually be a much more efficient operation. No one’s asking CDRH to do it; it’s CDRH deciding on its own the importance of change.”
2. Tarver on FDA’s Role in Device Innovation
“We are charged as a public health agency to promote and protect health, and to do that, that’s not a static position. It is action-oriented. We’ve got to do things. We need to help create avenues that allow for us to actively protect and promote health. It starts with making sure that we ask the right questions, that we start to conceptualize what’s what. How are we doing it now? Do we need to rethink our premises and our assumptions, and are there ways to make sure that the devices that people need to improve their lives get to them in a timely manner?
“When you’re talking about public health, every day matters and every person matters. And if we don’t cultivate and foster technology to help address unmet needs, if we don’t cultivate and create an environment for technologies that are safe and effective to get into the hands of the providers that need to use them to help move the needle on care, or to the patients that need to operationalize them at home so they can have better healthcare outcomes, then we aren’t going to be doing a great job of protecting public health. And so it’s critical, and it’s not something that we as an agency alone can do. We have to do it as a collaborative, as a partnership. We’re just one portion of the healthcare paradigm. And information that allows us to move that needle for protecting and promoting health is really what we’re committed to do.”
3. Tarver Talks Risk
“I was trained as a surgeon, and when you’re in the operating room, you have to look at the situation before you, and you have to make pretty quick decisions. You’re looking at the risks of doing a certain approach and the benefits, and you need to make that decision with some uncertainty. I think that kind of comes into play with all that we do. We will never have all the information we need to know about how a device performs, all the outcomes that could happen in every population. It’s just an impossibility. But we have to make sure that we’re appropriately calibrating the evidence we need to understand the benefits, understand the risks, and make an informed decision.
“There’s a reason why we have multiple mechanisms in order to collect information and data and evidence, both in the pre-market and the post-market setting, because devices aren’t static. Being responsible in collecting that data in the post-market arena is also going to be important, because that is how we’re going to make informed decisions. Not only us as regulators, but clinicians and patients are going to make informed decisions. It’s going to require evidence collection beyond the limited pre-market data that may come in, because people live with devices for many, many years beyond the clinical trial and people live with devices that may need to be changed and altered. And so just understanding that is going to be important. So information, data, is going to be critical, but all of it doesn’t need to be collected at one particular point in time.”
4. Tarver on Collaboration
“Collaboration is the blood that courses through my veins. So for lack of a better phrase, I mean it really is the approach that I’ve taken in all the work that I’ve done since I’ve been at the agency. I’ve done pre-market and post-market review, I’ve done guidance and policy and regulations and all of those efforts, but I started off looking at a collaboration between the National Eye Institute, the Department of Defense and the FDA to create a patient-reported outcome measure that really captured the experience of people who had LASIK eye surgery. And so that approach didn’t just stop with those three federal agencies, but it included healthcare providers, patients who had bad outcomes, and patients who had good outcomes, who sat at the table collaboratively. I think that is kind of a reflection of the approach that I’ve taken in almost every effort that I’ve undertaken here at the at the agency.”
5. Tarver Talks Case for Quality
“Prevention is much better than treatment. If we can help encourage approaches so people can preempt challenges with their medical device so there are good design controls, quality, and continuous improvement practices inculcated throughout the organization, then people will feel comfortable raising their hands when there are challenges so they don’t have to actually impact and hurt patients before we can do something about it. And I think that’s really the power behind the Case for Quality work. The Voluntary Improvement Program has had some really impactful efforts happen as a result. People who participated in that saw a lot of benefits, including cost savings and cost avoidances. And so we are hoping that there will be an expansion there, that people will raise their hand and say, ‘You know what? This is something we want to bring in house too. We want to improve how we do business. We want to increase the trust that not only the agency has, but also that the market and the consumers and the providers and the hospital purchasers have about our products.’ It really does move that needle forward. So we’re planning to continue to work on that and obviously look at other opportunities so some version of that approach could be beneficial in other contexts for small and for larger companies.”
6. Shuren’s Parting Thoughts
“It has been a wild and wonderful ride for the past 15 years. It’s the people at CDRH that have kept me there so long, and I cannot tell you how bright I think the future is for the center and the American public we serve under Michelle’s leadership and the rest of the leadership team. I know I can ride off into the sunset feeling really good.”
