MDIC Head Andy Fish On Driving Positive Change In The Medtech Ecosystem

One of its biggest wins has been the development and the establishment of this platform. This is a proposition for collaboration among such a wide range of stakeholders, and the creation of the organization itself is a significant accomplishment. MDIC is unique. There's really nothing else like it in terms of the topics that we take on and the way that we take them on by finding this common ground, this pre-competitive space, this transparent collaboration among all stakeholders.

If I call out a few of the significant initiatives that have yielded significant results, the top one is our work on patient engagement, which goes back to near the beginning of MDIC, and early work with FDA in developing the first patient-centered benefit-risk framework. And as is the case with much of MDIC’s work, that framework is not policy per se, but it informs policy and helps all stakeholders understand how to better convert patient information into credible evidence that regulators and others can use to actually inform decision-making. Our work has continued since the development of that framework, as we continue to advance the science of patient engagement. FDA has built on that framework to develop new policy.

Another area in which I would call out is our work in early feasibility studies, where we collaborated with many other entities to identify that early feasibility studies were often being conducted outside the United States. We realized that there were significant benefits if you initiate more early feasibility studies here in the United States instead, so we worked to identify the barriers and developed a whole series of materials and guides and how-tos to help clinical sites and manufacturers expedite the process of getting early feasibility studies off the ground. The work that we've done, according to those who've used the materials, has accelerated the initiation and the enrollment completion of early feasibility studies by months, which saves time and money and ultimately gets devices to patients faster.

We have what we would call toolkits. We have frameworks, we have case studies – which are particularly useful because we show people how someone else has done something successfully. So much of our work manifests in a document of some kind or another, and it is all critical information for companies, for example how to improve a process such as quality manufacturing, or how to better approach the Food and Drug Administration or CMS with the right evidence that meets their expectations.

What I say all the time is that MDIC’s business is putting up things that are useful. Everything that we produce has to have utility. Ultimately, we want to see that if people use the work, it has a measurable impact and makes a positive change in the ecosystem.

One of our critical priorities is continuing to develop our work, primarily in the [National Evaluation System for health Technology] and in other places, around real-world evidence. That's not a new topic, but the work to really mature that field is very much ongoing, and our work through NEST is a critical initiative to advance the field of real-world evidence, both in terms of the science itself and a common understanding of how to find and structure data in a way that produces credible real-world evidence, and also to work with individual manufacturers to help them develop real-world evidence for individual submissions.

Another major initiative for us is expanding the work that we're doing to support companies of all sizes, but particularly companies that are participating in FDA’s total product lifecycle advisory program (TAP). We have been working closely with the agency to figure out what more we can do in terms of both materials and hands-on workshop advisory approaches with companies in the TAP program to help them better understand their whole path to market. As FDA said about the TAP program, if companies can't ultimately be commercially successful, those technologies will never be in the hands of doctors and patients. We're looking forward to doing a lot more to help support the overall ecosystem, starting with TAP companies and then beyond, with a particular focus on those early innovators. (Also see "Stakeholders: Get Ready To Submit TAP Program Feedback In FY 2025" - Medtech Insight, 10 Nov, 2023.)

Finally, one of our other initiatives at an earlier stage is developing more educational programming around our work. One of the things I realized when I came into this role a couple of years ago is that we have a tremendous library of resources that has great value but that wasn't really being fully utilized, and we were moving on too quickly from project to project without actually making sure that we were driving that work out into the ecosystem, so we'll be doing a lot more through educational professional development programming to really make sure that our entire library is being used.

We have internal processes around portfolio management so that no project gets initiated without full internal review, and it comes through me under board-designated criteria. But we also have such a wide array of stakeholders working together that we have a high confidence level that we're kind of identifying the right work, and then we're choosing the right priorities.

Just to make a finer point around that, the way we do our work is we convene stakeholder groups that consist of the right folks from the relevant agencies, from manufacturers, from patient advocacy organizations, clinicians, researchers and other experts. We will go out and seek out the right subject matter experts to be in our work groups. They identify the challenges they see in an area, and they develop what they believe would be the right kind of solution for MDIC to bring forward. So that's how we make sure that we're working on the right things. We only take on the projects that we know we can support.

Part of it is the inherent understanding that MDIC exists to achieve that balance. If there's a topic that comes up in which there's some significant divide among various stakeholders, it wouldn't be something we'd be taking on. But because we have this process of identifying and bringing forward various topics, there's almost an organic process that makes sure that those things that come forward are the things that everyone's already agreeing on and they want to work on together.

At this point, I don't expect our work will change in any fundamental way. We're really fortunate that over the years, we've developed a lot of credibility and a working relationship across CDRH at a number of levels with a lot of different staff people. While we're as eager as anyone to see what comes next and who fills some critical roles, we see a lot of continuity underlying those leadership changes.

We have about 10 to 12 program areas across MDIC, so the best way for folks to understand that a little better, of course, is going to our website. But I would call out maybe a couple of areas. For example, in digital software and AI, we have worked across several different areas that are very much science-based. We're doing work on computational modeling and simulation, and we do that very collaboratively with FDA and other agencies and industry to help drive an understanding of how to use that kind of technology. Then we also have work in medical imaging and medical imaging software, and that's another area where we see cutting-edge technology and some challenges and uncertainties about how that will be deployed, and thinking through that from a regulatory perspective. We also do work in cybersecurity, and particularly around producing a regular benchmarking report that helps companies really understand where they are against industry in terms of best practices to adopt and implement. (Also see "MDIC Benchmark Survey Finds Cybersecurity Maturity Still Lacking Among Device Manufacturers" - Medtech Insight, 23 May, 2024.)

I was a science and tech guy from way, way back, even before going to college. I went to college thinking I was going to be a hard sciences major. But along the way, I became also very interested in government and policy, so I found my way to DC right out of college. I’ve been working in various fields, in and out of Congress, and then ultimately in health care for the last 20-plus years, always with that health and technology focus. I've just gravitated towards these areas where technology is being developed and innovations happening to better people's lives.

I'm invested in the work of MDIC because there's so much going on here that's making a big difference, and it's not well understood by a lot of people. It's fun and energizing to make sure that more and more people understand the work we're doing and come participate in it.

More broadly, I would say medical technology is a fascinating field because it's so complex and diverse. Pharmaceuticals are extremely powerful, but in comparison to medical technology, relatively simple. A pharmaceutical compound has an effect in the body. Medical technologies cover this incredible span of different technologies. They're innovating and changing so quickly. There's also this fascinating convergence of technologies coming in from microelectronics and sensors and various kinds of materials technology, so the field is benefiting from all these advances across the other areas of science and technology. What we've seen to date is fascinating but what we're going to see over the next 10 plus years is just going to be truly mind-blowing.