Andrew Fish Presents Medical Device Innovation Consortium at LSI USA '24

Andrew Fish  0:48  
Morning again, I'm Andy fish. I'm president, CEO of the medical device Innovation Consortium or MD, AIC, I want to thank LSI, for having us here today. Looking forward to a great morning of present presentations. I'm going to get right through just a couple more minutes on FDIC. And we'll get into our get into our presentation. So at FDIC, we're a public private consortium, formed initially in 2012. It's a collaborative initiative among between the FDA and the medical device industry. And I'll just take a couple minutes to explain more who we are, what we're doing, how we how we get there, how you can participate, I can learn from our work, we share a vision with all of you to lead innovation, improve health outcomes, support wellness for all people, but how do we do that? So our mission is to break down barriers in the medical technology lifecycle to accelerate the path to patient for critical medical technologies. And we do that by bringing together trusted collaborators to identify the big problems, the big complex challenges, and then come up with solutions to all the disciplines is going to drive the scientific disciplines and, and evidence generation and all the aspects of medical technology development that propel medical technology development and access for patients. We are a consortium as I said, among government agencies, Jeff Shuren, with FDA sits on our board of directors cameras, Eric Jensen, who leads the coverage and analysis group at CMS sits on our board of directors and numerous other agencies sit around the consortium table, we bring together the entire device community, ranging all technologies, all sizes of companies from early stage startups to the some of the biggest companies on the on the planet. And we bring together all of these entities along with nonprofit stakeholders, everyone from patient advocates, to researchers, clinicians, academia, we develop resources, toolkits, points to consider all sorts of documents and tools that are useful, particularly for medical device manufacturers and navigating all stages of the medical device lifecycle. We do that with input from hundreds of trusted expert advisors, subject matter experts across a number of companies and across the whole communities that I just that I just mentioned before, we have 75 or so participating member organizations, membership for small and emerging growth companies is 5000. A year access to all our workgroups participate in our work, rub shoulders with FDA get to know your peers across the medical device community. And we have at any given time, probably about 50 working groups and committees that are driving the various products that I'm that I'm referencing here. So we have four core areas, all of our work across eight major programs. Dr. Sue kind of this matrix of four major areas of activity, quality design and manufacturing, we are driving the adoption of advanced technologies and processes in manufacturing, to drive down recall in its in its improved quality of devices, improve internal processes and efficiencies drive down costs while driving up quality, and enhancing device quality and patient safety as a result. In evidence generation. We're advancing the science of real world evidence across multiple disciplines, including specifically driving more real world evidence into decision making for payers and regulators. I call your attention and particularly to our national evaluation system for health technology, which is working directly with individual medical device manufacturers on specific technologies to develop real world evidence that goes into FDA submissions. We're doing that in collaboration with the agency to develop new approaches to road evidence and the review process. And that's a dynamic, fast moving program that we've got running in digital health technologies. Similarly, we're leveraging advanced tools and really educating the entire device community about how to adopt new technologies at the cutting edge of digital digital tools and technologies to drive the drive those tools into healthcare and into medical devices. Next month, for example, we're having a two day symposium on computational modeling and simulation and medical extended reality during that two day program in conjunction with FDA. So if that's of interest to you check it out on our website. Finally, patient engagement. We're driving the science of patient input across multiple domains, specifically with regulators. But this is really about the whole discipline of how do you gather input from patients patient preference information, and develop it into evidence that can be considered valid and trusted by decision makers, both payers and regulators? In summary, we're taking the risk, a lot of the risk out of device innovation with all these tools, we're working with entities just like you to identify the big problems and come up with the solutions to what's at the leading edge of the science and the technical disciplines behind metal technology. I'd invite you to come to our website. All of our work is publicly available, it's publicly funded, it's there to use. But if you want to get more involved, consider membership. As I said before, come sit down with your peers across the medical device community, get to know agency leaders across all of our workgroups participate in contribute to and drive our work. I really appreciate the opportunity to be here. Let's get on with our presentations.