FDA’s Role in the New Era of Medtech Collaboration

As the medical device industry begins to embrace a new era of healthcare collaborations and risk-sharing contracts, what role might FDA play in that trend? This was the question MD+DI posed to a senior advisor to the commissioner of FDA, and his answer might surprise you.

As we've recently noted, the shift toward a value-based care system has inspired a new era of collaboration in the medical device industry, including the emergence of risk-sharing contracts. While these agreements primarily involve manufacturers, providers, and payers, is it too much of a stretch to think FDA might, at some point, play a role in that trend?

The question seemed to catch Paul Howard a bit off guard Tuesday at the University of Minnesota's Design of Medical Devices Conference. Howard, senior advisor to FDA Commissioner Scott Gottlieb, delivered the luncheon keynote at the conference on ways modern regulation can be a catalyst for innovation and competition in U.S. healthcare.

"I think that goes beyond our regulatory reign," Howard said in response to MD+DI's question.

Then again, as FDA develops use cases based on real-world data generated by electronic health records, next-generation sequencing technologies, and other digital health tools, Howard said those are the kind of benchmarks that, if trusted by stakeholders, could be incorporated into risk-sharing or similar types of contracts.

He pointed out that payers and providers in today's healthcare environment are looking for technology that will inform clinical decisions. They want to know if a device is clinically valid for the patient currently in front of them, not necessarily one that was in a clinical trial, Howard said.

"If new sources of information that are trusted by regulators and could be used to inform regulatory decision making are also trusted by clinicians, trusted by payers, then I think you could see some synergy and hopefully see more of the community coming together to share data and develop high-quality use cases, develop ways to share structured and unstructured data, that can provide us with tools to inform decisions about safety and efficacy, but then have second- and third-order use cases that also reduce burdens on other parts of the system," he said. "When we're asking for regulatory information, obviously it would be nice if we didn't have to have one standard for [regulatory approval] and a different one used for reimbursement."

500 characters remaining