Medtech POV: From AI to Z | FDA’s Troy Tazbaz on the Opportunities, Challenges of AI Facing Medtech Innovators

WASHINGTON - In the first episode of the new Medtech POV series "From AI to Z", AdvaMed President and CEO Scott Whitaker sat down with Troy Tazbaz, Director of the Digital Health Center of Excellence (DCHoE) within FDA's Center for Devices and Radiological Health. The conversation delves into Troy's experience in artificial intelligence (AI) and machine-learning (ML) technologies, his role at FDA to support medtech innovators, and what he identifies as the challenges and opportunities for AI/ML-enabled medical technology.

Tazbaz, who joined FDA in 2023, previously worked at Oracle building and scaling the cloud business. The DHCoE is responsible for envisioning and enabling a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. They enable that vision through technology evaluation, clinical integration strategies, policy development, and strategic partnerships.

Arriving at FDA, Tazbaz set out to develop guiding principles for the work of the Digital Health Center of Excellence:

"When I joined, I worked with my leadership team and we spent about a month and a half coming up with three guiding principles, and we said we're going to envision what the future of healthcare is going to look like. We're going to enable it by dealing with regulatory issues - friction in the process - and then we're going to expand it through ensuring the development of these medical products [addresses] bias issues and population, and then, of course, education."

Whitaker asked Tazbaz to share the message he would give to Congress as they draft legislation related to AI/ML-enabled medical technology:

"This is an area that I spent a whole lot of time working with Congress to understand. Some of the considerations with AI, unlike traditional static medical devices, [need to be thought of] in terms of a life cycle. It's not just about how you build the product or how you train the model-it's about how you're deploying it. It's how you're monitoring it. And so, any legislation has to think through the post-market performance monitoring aspect, which is what FDA has always done: making sure the performance does not degrade once you actually deploy the model in the real world."

As part of his efforts to support medtech companies submitting their technologies for review, Tazbaz also rethought how the process worked for the smallest companies:

"I spent a lot of time talking to the industry about their pain points. And one thing in common was that it's hard to find information to help you navigate the system. We launched a program called Regulatory Accelerator that really connects a lot of the dots within the process itself so startups can also navigate the process without having multiple regulatory affairs folks on staff-because they can't afford that. The other thing we wanted to find focus on was, how do we actually speak to companies that were not large? I wanted to make sure that we were able to get some of that voice going and help companies that are highly innovative, highly agile, be successful at the process itself."

When asked about the biggest challenges and opportunities facing companies that are innovating in the AI space, Tazbaz talked about payment policy for small companies and the role of data for larger companies incorporating new technology into existing systems:

"I think the biggest challenge [for a smaller company] is probably not understanding how technology gets integrated, and because they don't understand that they end up developing 'features,' and features don't usually get coverage. Larger companies, they don't necessarily struggle with the whole payment thing, but it is actually how to continuously evolve and innovate with data that ends up becoming a big opportunity for them."

Tazbaz also shared his own thoughts on the role CMS plays in getting FDA-approved medtech to those who need it:

"I do believe that we should be trying to harmonize clinical trial requirements between the FDA process and the CMS coverage decision process. And I do think that we should be investing in education around how to ask the right set of questions that you'll most likely end up facing when you're going through that process. At FDA we have been investing in things like the Regulatory Accelerator where we're building these navigation aids. What we're trying to do is invest in those tools and make it easy for anyone to essentially be able to navigate through that process. It shouldn't be this complicated."

To hear the full conversation with Troy Tazbaz, download the Medtech POV podcast on Spotify, Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed's website for more information on the podcast and past guests.

The Medtech POV podcast is hosted by Scott Whitaker, President and CEO of AdvaMed, the world's largest medical technology association. It premiered in April 2021 and features interviews with a range of health care experts, medtech leaders, and policy experts. In each episode, guests and host Scott Whitaker cover the intersection of medtech and policy from every perspective, including current issues in business, policy, and current events.

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