Promoting AI’s Value for Patients

The number of medical devices using artificial intelligence or machine learning continues to grow. As of August 7, 2024, FDA has authorized 950 AI/ML-enabled medical devices.

“AI presents real value for patient care,” Patrick Hope, executive director of AdvaMed’s medical imaging division, tells Design News. “AI can measure and spot tumors and skin lesions, can help medical offices with back-office duties to manage the flow of patient care and address workforce shortages, and can even help patients better manage their own care.” 

The challenge, though, is a lack of reimbursement for many AI-based products. “Many of these devices really need some sort of reimbursement,” he says. “It’s really about patient access and making sure that these products get into the hands of providers for the benefit of their patients.”

To help educate US lawmakers about AI’s potential for healthcare and the need for reimbursement through the Centers for Medicare & Medicaid Services (CMS), AdvaMed hosted an Artificial Intelligence (AI) Demonstration Day on July 25. Seventeen companies ranging from startups to major medical device companies to tech companies such as Google demoed their AI-enabled medical devices and technologies. More than 100 attendees, primarily congressional staffers but also a few NIH professionals, joined the event, which was co-hosted by Senators Martin Heinrich (D-NM) and Mike Rounds (R-SD), both co-chairs of the bipartisan Senate AI Caucus. 

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Attendees “were able to get a sense that AI is an important tool for better patient care,” said Hope. “The demos helped staffers see several aspects of AI for the benefit of patients.”

The meeting also called attention to the reimbursement issues. “AI can transform the healthcare market,” but it’s use is “very piecemeal and not all patients are benefiting from these products,” he says. “That’s because there is not a universal pathway in CMS for coverage.”

Hope says it “is encouraging that we are getting good feedback from policy makers in Congress, and it’s trending in the right direction. We are getting in front of the right people.”

The demo day is part of AdvaMed’s ongoing effort to communicate with CMS. “We meet regularly with CMS to demo products,” Hope says. “Part of our effort is to impress upon CMS AI’s value to patient care and better outcomes.” 

Hopeful for the future of AI-enabled medical devices

When asked what AI innovators can do to, Hope says that “CMS is asking about patient value—that is their primary concern and addressing that will speed its adoption and use.”

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Eric Hoffman, senior counselor with Schmidt Public Affairs, tells Design News that AI innovators and investors “want the certainty that comes with a reimbursement pathway.” In the meantime, his message to AI innovators: “Keep innovating and inventing technology that improves patient care.”

AI is “the fastest growing area of membership for AdvaMed’s Imaging Division,” Hope says. “We want to be the home for AI medtech companies. Aligning AI interests with medtech is the goal. There’s a good opportunity for success if we stand together.

“We are at a historical turning point. AI technology is there—we just need to make sure we can get it into the hands of providers to benefit patients,” he says.