Digital Health Moves to the Center: Bakul Patel on Next Steps

Digital health is no longer some niche segment of medical technology. Increasingly, it underlies the entire sector. Just about every medical device includes some digital health component or feature nowadays, as FDA’s resident digital health expert Bakul Patel pointed out in a recent interview with Market Pathways.

That makes it even more important for the entire device and diagnostic sector to pay attention to his newly expanded gig at the agency. On September 22, FDA formally launched its new Digital Health Center of Excellence and, unsurprisingly, tapped Patel, who has led CDRH’s digital health efforts for the past decade, as its director.

A lot of the particulars of what the center will be and how it will operate are still a work in progress, Patel acknowledges. He explains that it will be a “virtual” center; his current (and growing) Division of Digital Health team will stay where they are organizationally, but take on an expanded, more cross-cutting role. The vision is for the center to serve as a connecting platform for rethinking regulatory processes, advancing best practices, and tapping technical expertise across FDA and the broader global digital health community.

There are already a lot of things cooking within CDRH’s digital health program, including the nascent Software Precertification Program, forward thinking about adaptive AI/machine learning regulation, and a vibrant guidance development program to fine-tune the boundaries of FDA’s authority in the space. All of that will fall under the new center’s umbrella, but the agency is pressing for a more comprehensive program to ensure consistency and transparent communication across the agency, the industry, and global experts. Among other things, the center will coordinate a new “Network of Digital Experts,” pre-vetted resources who can share knowledge and experience regarding digital health issues with FDA staff on an as-needed basis.

The initiative will require, among other things, targeted resources. Prior FDA budgets have reserved specific funding for the formation of the Center of Excellence and it is now hiring software engineers, AI/ML experts, and others to expand the ranks of its digital health specialists. 

But the next step to getting the center off the ground, Patel says, is to take input from the broader community. Public listening sessions have been scheduled, one in October and one in November.“We are going to understand our customers' needs, our stakeholders' needs, and start looking at where the biggest need areas are to start prioritizing,” he says.

Our recent chat with Patel, edited for length and clarity, follows. 

Market Pathways: This effort has been in the works for some time, and a lot of the pieces of what you've been doing on digital health within the device center more broadly have been moving forward in some capacity already. To start off, what does the fact that the center has formally launched mean for the regulated industry, and for other stakeholders, on a practical level, in terms of day-to-day, short term or longer term.

Bakul Patel: The launch of the center actually starts this journey on driving consistency in the application of digital health policies across different product areas. That's number one. Which we had already started, like you mentioned, but this sort of gives us the next level for coordination.

It also gives one place for CDRH and FDA to bring expertise so that when you need something, some information that is related to digital health—for example, on quality systems—you can connect with the right individuals, the right expertise. So that's taking the expertise that we have built in digital health, and now connecting across clinical trials, across quality systems, across cybersecurity, across support that will be needed for different parts of the problem sets or issues that people may be thinking about. That's how we are envisioning this. Now, is it here and established today? I think the answer is 'no.' That is the vision, the setting of this infrastructure, and we can start building that coordination. For industry, specifically, I think they can now start looking at this center as a place to look for advice, and ask questions writ large, and the Center of Excellence can provide that service.

But I just want to underscore one thing. The center is not going to review products. Those functions exist already in other parts of the agency and the center. We are serving more of an advisory capacity for both internal customers and our external customers.

For industry, I think they can now start looking at this center as a place to look for advice, and ask questions writ large, and the Center of Excellence can provide that service.

Where is the center actually going to sit organizationally, in terms of the structure of CDRH?

At the moment, I can just say that we are virtually forming the center. It doesn't mean it shifts anything organizationally. For example, there's work happening— I'm just going to pick something—in in silico modeling. That is work that's happening in other parts of CDRH. And that will stay there, because we don't want to undo the work that is going on. The virtual structure, and the virtual center is going to provide the network, and the platform. So nothing changes from an organizational reporting structure perspective.. We've been doing virtual engagement with other folks. So I think this is just the next natural level up.

So is this your existing digital health team that is expanding —I see you have hiring announcements on the website—to provide a virtual support structure for the rest of the center, correct?

Yes. My team stays as a part of the core group of the Center of Excellence. They will start providing coordination and support in addition to what we were already doing.

To briefly touch on COVID, digital health has been so central to what's happening there, as part of the pandemic response. FDA's done a lot, for instance, with enforcement discretions. How much of your time, and the center's time, do you envision is and will be taken up by COVID-driven issues? And related to that, has there been any sort of experience with this pandemic on the digital health side that may be impacting how you look at broader regulatory issues over the longer term?

You're just hitting on something that's exactly the intent and the vision of the Center of Excellence. It is about learning. It's about making sure that what we learned in this COVID situation, and what we learn in other areas [can move forward] in an aligned strategic way. We are definitely setting the Center of Excellence up to be that knowledge source, and to be the place of knowledge that we can bring together, and align our strategies, drive synergy, and make sure that next steps, either in science, in partnerships … are driving towards the goals of the Center of Excellence.

But with regards to the pandemic, are there any particular learnings that you may be taking online right now, with regards to digital health learnings in particular?

I don't have an exact list to give you. I think that's the next step. We know generally in the space of partnerships, we need to be strategic and to align our partnerships in the right direction. We know we need to advance regulatory science. We know that general direction. But I think one of the things that I do want to emphasize is, we are going to understand our customers' needs, our stakeholders' needs, and start looking at where the biggest need areas are to start prioritizing. I think the center provides that opportunity for us to start doing those things in a very concerted way.

One effort that is underway that I think will be one important plank of the new center’s focus is the Precertification Program. It envisions a new regulatory paradigm for digital health, where so-called Excellence Appraisals are conducted to assess a company’s overall operations and can qualify a firm for future streamlined premarket reviews. But it is very much in a testing stage now and I know your group has recently issued an update on how the testing of the potential paradigm is going, and what needs to be done to move the concept slowly closer to reality. What can you tell me generally about where things stand with PreSub?

I can give you a little bit of color into what we've done in addition to what we've published. I want to say that the term Excellence Appraisal means that we’ve appraised somebody, and we know what's good. I think we're in the build process for that. So we've done site visits, we've sort of understood we could do a mock appraisal, and we are asking, what would that start to look like? And what we're finding out is, this kind of information that we envisioned to get in our working model—the approach we took last year—will need to be revised and iterated. And that's kind of where we are in that process. We experimented with about nine or 10 companies last year, and we are learning, What does scaling look like? How do we take it to the next level, and get that objective data and objective information that will help us identify what is excellent and what kind of things would not be considered excellent? And that's the next phase of where we are getting to. You see in that language in the update we provided. We have learned we can’t just do this manually and then come back and hope that we recapture everything that a company is doing. It's not going to scale.

What we are trying to do next, is start to take that holistic product life cycle approach, and understand what information can be relied on at what time to develop that overall confidence in the safety and effectiveness of the products, and the people, and how they're being used.

What's your vision for the Center of Excellence overs, say, the next five years?

We want to advance science. We want to make sure that expertise is available both for internal folks, as well as external folks, and that we can be that translation bridge between the regulatory expectations and other scientific expectations. We want to develop a consistent way of applying the thinking that we have evolved toward to all product areas. Is that going to take three years, five years? I think, that is to be seen. We are still in the process of mapping it out. The very first thing we're going to do is conduct listening sessions where we want to hear from people about how well the Center of Excellence can serve them, and in what areas. And we can start mapping it out in detail.

We can be that translation bridge between the regulatory expectations and other scientific expectations.

When you say “all product areas,” what do you mean by that? Do you mean all medical devices?

So as you know, digital health is getting embedded into pretty much every medical product. Right? In every medical device, there's a component of, some portion of digital health in there. Either it's in data, it's in computational, it's AI or machine learning. And when it comes down to those methods of achieving those intended uses, so to speak, for each product that we regulate, or each medical device we regulate, we want to make sure that we apply [our policies consistently]. For example, if a mobile platform app policy applies in in one area, we want it to apply in the same kind of consistent way in other areas.

One dynamic that I feel was in play a decade ago or so is there was a very palpable distance between the way that many of the prospective new players in digital health, including some of the big Silicon Valley tech players, viewed things, and FDA's established approach and system for device regulation that might grate against those interested in iterating quickly with little government intervention. There has obviously been a lot of evolution in this area over your tenure, with companies like Apple and FitBit moving products through agency reviews. Where does that dynamic stand in your view, and does it still represent a challenge for your center—that is, working on meeting the innovators where they are, or getting the innovators to meet FDA where they are?

I don't want to single out just one group. I think that there are technologies, and then there are innovators from many walks of life that are bringing, or thinking of bringing, products into healthcare. I think the biggest role FDA can play is to create a glide path with the right expectations and transparent expectations. Those expectations should be in line with how products are made, how products should be made, what does good engineering look like, what do good clinical studies look like, what does good healthcare for patients look like. Personally, don't think about meeting where they are or that they should meet were we are. I think there's a place where we can tailor, especially for this type of technology, where the expectations should be and where the expectations need to be. I think that's where we want to meet. I would say we want to optimize our regulatory expectations to the public health community.