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  • Writer's pictureShannon Lantzy

"The Golden Age of Medical Device Innovation" and Free Consulting from FDA

FDA used to be the choke point to get to market. FDA accelerated, and now payment is the primary problem. FDA is offering TAP, a free consulting program to speed breakthrough devices to clinical adoption.

The Medical Device Innovation Consortium (MDIC) annual public forum just ended. It was a fantastic event for a regulatory innovation nerd like myself, filled with regulators and medtech leaders who are changing the world for the better. They were gathered with a common purpose: how to make the medtech ecosystem work better. The session topics ranged from policy to science. All presentations centered around the theme of making innovations available to the people and patients who need them.

During an "Inside Washington" panel, I heard "FDA used to be the choke point." I was surprised to hear so much about payment, reimbursement, and adoption at an event that is so focused on FDA. It was almost as if the panelists were saying "We've done our job to speed up FDA, now we need to speed up CMS." Perhaps that is because we're in the first year of MDUFA V, so policy innovators can take a respite from FDA-focused change.

(Aside: FDA is no longer the choke point precisely because of the work of organizations like MDIC and the individuals who decided to fix the ecosystem problems. I'd love to learn the stories of all of the people who were there, having made medtech what it is today. One of those individuals is Dr. Jijo James, CMO of J&J Medtech and outgoing chair of the MDIC board. He called the audience to action, "set aside time to promote evidence-based science." He is asking the next generation of leaders to follow in his footsteps. I can only imagine the burden of his day job, and yet he had the vision and commitment to participate. As an organization, J&J demonstrated its organizational commitment in its NESTcc participation; J&J's Biosense achieved the first FDA clearance based on real-world evidence. Dr. James is an inspiring medtech innovator, and he's only one of many in that room this week.)

In a later panel, the incoming MDIC board chair Chip Hance said "We may have reached the golden age of medical device innovation." Indeed, FDA has gone from the choke point to the accelerator. During this panel, FDA laid out details of its Total Product Life Cycle Advisory Program (TAP) program, which was funded as part of MDUFA V. Not only is FDA no longer the choke point, FDA is offering FREE CONSULTING on how to not only get through FDA with a breakthrough product but also how to get all the way to clinical adoption.

MDIC Panel: A Lifecycle Lens on Innovation

TAP will bring groups together for early, pre-approval collaborative conversations: "Better evidence for faster commercialization."

Why would FDA concern itself when its separation from pricing and payment is by regulatory design? It comes down to evidence. Some companies can't survive two evidence generation phases, one for FDA review, and one for reimbursement. The TAP program is designed to help early-stage companies generate the evidence they will need to carry all the way through clinical adoption, reducing rework. The catch: you have to have a breakthrough designation.

I look forward to hearing how TAP goes. It will be great to hear about the new devices that get all the way to clinical adoption and breakneck speed as a result of the program. I'm sure it'll be a big topic at next year's MDIC and later in the MDUFA VI negotiations. I'll bet it is wildly successful, the industry will want more, and the program will expand. And/or, the industry will take the baton and emulate it outside of FDA.

~Shannon Lantzy, the Optimistic Optimizer


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