FDA Direct Ep. 10: An Eye on CDRH: Regulating for a New Era on Medical Devices

Michelle Tarver, great to see you. Great to see you. CDRH head at FDA. So tell us what is CDRH and tell us about something that just came out. out of CDRH recently. So our center regulates all medical devices that are using the diagnosis, management, and treatment of medical conditions. And in fact, you probably just heard in the news that we just brought them to market.

a device that is used to diagnose our Alzheimer's disease. Oh, there it is. Yeah. Big time news. Yeah. And it moved from a device that was previously used in this. to take spinal fluid and test it for certain types of proteins to now being able to have that available by looking at people's blood, so accessible to more people. And it also helps with the population where it may vary.

very much be difficult to get samples of spinal fluid from them. So it really opens up the opportunity of diagnosing earlier and changing healthcare outcomes. And as we get earlier treatments, maybe it could help. open a window to start intervening earlier. Absolutely. So CDRH, first of all, did you come up with that acronym for your center? Because it's kind of a funny acronym. It predated me. I'll just say that. Center for... devices, and radiological health. Correct.

We may want to brainstorm. Yeah, we need a better name for that or a shorter role. Have we thought about different names for the center? You're probably like, we don't want to have this conversation now. I'll pass on that. How about I kick? a rain check and come back later. Center for Device Innovation. I'm just floating it out there. How about MedTech Innovation? Ooh, I like that. Touche. Good.

Because there's a lot of innovation you're overseeing, right? So it's not just the Alzheimer's diagnostics, but there's a range of devices, the traditional ones we think about in hospitals. But are there more consumer facing devices as well? Absolutely. I mean, I think. One of the first steps we took at the Center for Devices is the continuous glucose monitors. And you may really know about that technology. Amazing.

Because it changed how we manage diabetes in this country. I mean, it went from working with companies, having a conversation about, can we work on interoperability? Can we make it more accessible to people? And each decision that we make, it opened it to type 1 diabetics.

than to type 2 diabetics. And now it's available over the counter for many people to use. Really transforms how we look at metabolic management. I mean, it's amazing. The same food will cause a different insulin spike and sugar spike. in two different people differently. So the only way to know how you're going to respond to sushi or coconut water or whatever it is you'd like to eat in the course of a day.

is to have a continuous glucose monitor or stick yourself, which nobody's interested in. Is that what you had for lunch today? That's top of mind. It is in our beautiful cafeteria just over the window here. But I mean, it's really the ultimate in patient empowerment. I mean, there's a lot of things that empower patients with good information or people, humans. But that is really an amazing revolution in health now because for the first time ever.

People are educated on their glycemic index, can track it, and can follow it over the course of days and peg it to certain foods so they can learn. hey, this food's not really good on my pancreas. This food is softer on my insulin levels. So it's pretty amazing.

I think your point about giving people the information they need to make informed decisions is critical. I mean, it's something that has driven our center for years because we know that if people have that information, they can make some really good decisions about their health care and then help empower them to have a more fluid.

conversation with their healthcare provider, which is part of what we're supposed to help offer. So how did a renowned ophthalmologist from Johns Hopkins get involved in devices? Devices are bread and butter in ophthalmology. We're surgeons, right? And surgeons like to be able to make accurate diagnoses. So the devices that are coming on the market that allow us to get more precise into diagnosing conditions.

That's right in our wheelhouse. The tools that we're using in the operating room, right in our wheelhouse. And so all of that is what we bring to the table at the Center for Devices and Radiological Health. So it's a natural fit. You know, I come from a long line of public servants, and this was a merging of two passions, science, medicine, and public service. What kind of public service was in your family?

My dad was in the Navy. My grandfather served, both of them served in World War II. Oh, wow. And so in France. And so, you know, we've got a long history that I have siblings who've served in the military. So that is part of who we are. I was raised on the sentiment of being at a service to this nation. So I'm here for that. That's awesome. When I got to know you, when I started here, I asked you, you've seen a lot across this agency, a lot of innovation in the technology side, consumer demand.

But I know that the commissioner has been asking everyone, you know, what are things you're wanting to do or be thinking about going forward that you haven't really had the space to do before? Big ideas. Big ideas. We love big ideas. I got them. And we love Michelle Tarver. will say, you know, one of the things that you've probably heard me talk a lot about, which is ways to bring healthcare home. I mean, we have seen that people who are living with chronic diseases account for both.

$4.1 trillion of our health care expenditures, according to the CDC. It's like 70% of all health care costs. It's extraordinarily high. And a lot of that isn't just how do you manage the disease. We're mainly seeing people in clinics just to make sure something... not appearing. If we could bring that ability for people to make that decision home where they're more likely to do it.

We don't have to worry about missed clinic visits. And we can get ahead of the conditions so that we can improve health care outcomes. I mean, that's a wonderful opportunity. And that we hope medical devices will pave the way for that to become a reality for more and more Americans. And so that is one of the efforts.

that we are working on right now. How do we help foster and create a predictable pathway for that to happen so that people who live in rural South Carolina, as well as people who live in New York City, will have at their fingertips in their homes.

that can help them figure out whether or not they need to see their doctor, help them manage and control the measurements they're getting in their devices, as well as intervene at a time where we can actually make a difference without having to hospitalize them.

It is kind of cool. You're at the center of moving the hospital and the healthcare setting into a home. If you think about it, the reason that we kept... patients in the hospital for crazy amounts of time and people used to stay in the hospital after a cataract for what like two weeks or something like that after cataract procedure and what were we thinking we were thinking

Well, it's good to have eyes on them, right? But we can still do that now in the home setting in certain circumstances and reduce the risk of somebody waking up in the middle of the night and having to... step up to go to a little bathroom that they're not familiar with at a high fall risk, wearing some kind of crazy funny slippers we give them, or they get an infection at the hospital that is not.

present in the home setting. There's nosocomial infections. We're starting to realize that with good devices, sensors, cameras, other things that can monitor an individual, you can actually move some of that care to the home and you're really at the forefront of it. And we're trying to help accelerate it. I mean, as you said. There's a rich opportunity here for us to make a delible impact on cost.

as well as potentially integrating care in a way that is more holistic. And that is what we're hoping to help facilitate. We have created a virtual reality prototype for the medical device industry to say a lot of the people who are doing R&D never see a patient's home. They don't know what that experience is like. By them putting on the headset, we've had some of the industry members tell us,

That is what we're working with. We're designing for this space, for this experience. And it really does put it into context so they can provide or develop a solution that actually meets the people where they are and is more likely to be used by them.

excited about it. We're having a lot of conversations and wanting to bring all those components together. But we also talked about payment. I mean, payment is such a big part of helping to foster innovation. And when you have a predictable reimbursement and payment.

at the back end, it helps to encourage front end development. How are you thinking about that, given we have a very particular purview of what we can and cannot do as it relates to payment? Well, you know, in our last user fee negotiations, we talked about how do we help make that. pathway to commercialization more predictable? What is the evidence that the payers are going to need to

make a coverage decision? What's the evidence that a provider is going to need to say, yeah, I'm going to adopt this into my care? And then what kind of information does a patient need to say, OK, I raise my hand, I'll take that? And so we said, let's ask them. at the time when you're developing your study that you're going to collect for your pre-market device.

Talk to the patients, talk to the providers, talk to the payers. Get a sense of what kind of things they want and incorporate that in your clinical trial at the inception. So you're more likely to have the data you need by the time you get through the regulatory process so that you're prepared. for the payment, process repaired for the care, preferred practice conversations. And that is what we've been working on through our total product lifecycle advisory program called TAP.

Love the efficiencies there. So that's a better name, right? Tap, yes. Yeah, it is. And so how about kind of internally, right? You talk about a lot of external innovation, but internally, I know you're also modernizing a lot about how the team works.

And, you know, we've been talking about ELSA a lot in previous conversations. Oh, yeah, the AI-assisted tool. Yeah, I know. I've heard from some of your medical officers that they're having fun learning it and, you know, generating different prompts. How is that going within the center?

You know, we love new innovation in our centers, so they couldn't wait to get their hands wet. Oh, yes. It's really been used already. A number of folks have started looking at it. Can they identify opportunities to take notes in meetings? I mean, one of the tasks that we have.

is that we have to document a lot of our interactions can also generate the summary from the transcript of the meeting minutes. And it has been used successfully to do that. We're having folks use it to find guidance documents that can help them as they're looking at the reviews to look at standards.

that a sponsor may have been using to show that this test method works. Well, the standards documents sometimes are huge. Can we just look at it, summarize what it says in the section, give me a reference where it is, and then I can put it in my review. tools that help the reviewers move through that review process more efficiently and effectively helps to prevent burnout and can really help move the process forward. Being a reviewer is hard work. Oh, absolutely.

they're incredibly devoted folks i mean they are top-notch scientists clinicians and and statisticians and they show up work long, long hours really to make sure that these devices get to the hands of the U.S. public as quickly as possible when they're shown to be reasonably safe and effective. It's amazing. Yeah, I've been impressed with everybody that I've met. And so... The ELSA tool is going to be augmented and ELSA 2.0, I don't know if that's the official name for it.

should be released by the end of the month, and it'll have access to more information. I think PubMed is all going to be encompassed with it, so a greater body of the medical literature. And look, whatever the reviewers need to do their job well, we want to be able to... help innovate to provide better tools. But we've been tracking the number of unique users of the AI tool, ELSA, here at the FDA. And people are using it. I mean, it's optional. It's voluntary.

But we've got thousands of daily unique users within the agency staff here using it. So people must be finding value in it. Yeah, I agree. I think it's definitely a huge appetite for things that can help make their work more efficient. Right. So what are you most excited about as you think about the next few months ahead? Wow. She's always excited. I know. I work something new every time. I mean, I think the...

possibility of data and the more that data can be unleashed to help inform not only our pre-market processes, but also help us with our post-market evaluation of products. I think it's really exciting. I think there's a lot of things kind of cooking that I'm looking forward to seeing come. come to life. And that, I think, is going to be important. The one thing, though, I always come back to with data is good quality data.

probably have heard us talk about the challenges we've had with some data integrity issues for different test labs in China that we've gotten and other countries as well that have submitted to us. And those, you know, that information is hard for us to make an informed decision about the safety and effectiveness of medical device.

if we can't trust the data that's informing that decision. And so quality data is important across the board. Got to have good data. Absolutely. Or else it's unfair to people who trust our brand. And I do believe the FDA is one of the greatest brands in the world. I agree. And so when people look to that brand, we need to be able to, you know, vouch for standards as much as humanly possible, right? We're not.

Watching the researchers pull a chair up alongside their desk and watch them do their work every single day at the researchers who are submitting data. We do our best. Yeah. I think there's a lot of opportunities in data, to your point. We've talked a lot about just streamlining even how we collect and measure the data so you can see more of these relationships because it's such a clunky reporting system for the post-market monitoring. And so it'll be exciting to see how we work through that.

Yeah, looking forward to it. Definitely looking forward to that. One last question. How do you think about breakthrough designations? It seems to be an exciting sort of leap forward.

within CDRH, within your center. And I've heard a lot of enthusiasm around it. Can you just tell me how you think about breakthrough designation? you know breakthrough designations are in our law right and it came about i think during 21st century cures it came out as a provision of that where It allows for novel technologies that are going to be life-saving, life-sustaining to come to market with a little bit, well...

to come to market with a little bit more interactions, a little bit more attention and prioritization by our reviewers if they meet certain criteria. And some of those criteria include there's no other alternatives like that right there in that particular condition to treat it.

It's a new technology that we've never seen before and that it offers benefits to patients. And so that is something we can all get behind, right? How can we help accelerate those solutions should they be shown to be reasonably... safe and effective and i will say that the standards for the evidence that we need is not compromised it is still the same bar

but it allows for more frequent interactions to help expedite the questions being addressed in a more timely way so that it can get to the hands of the patients and providers that need it more quickly. Great. And that's come up a lot in the CEO listening forums, too. And so I think that that's people are really. appreciate that frequent communication. Yeah, we did a listening tour. We're in the middle of it nationally with pharmaceutical CEOs. We'd like to do one with device CEOs to complement.

the visit I did to the Avamed board where we heard from a bunch of industry CEOs. We have to be able to learn and get ideas from industry and people, you know, some people. I think there should be this firewall where we don't interact with industry. We don't believe that. We think that we've got to have a user-friendly process. We serve the American people, and that means American businesses.

developer that has a product that wants that FDA seal, we have a process, there are user fees for it, and that process is such that they send us an application and we make a determination about safety and efficacy. So keep up the great work, Michelle. It's great to have you. It's great to work with you here at FDA.

And anything else, Angela? No, I mean, I wish there was more you could share with us publicly without disclosing products. I bet you see a lot of cool technology in the pipeline. So we're excited to see what's to come. I thought you were going to say.

I wish you were a Baltimore Ravens fan, but she might be. I am. Are you? I am. There you go. Got it. Baltimore Roots. I'm a Bucks fan, so I can't relate. Okay, good. It's going to be great. Yeah. Thanks, Michelle. I really appreciate it. Well, thank you. Thank you both. Great to see you. Likewise. All right, folks. Thanks for listening to our conversation and we'll do it again.