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Why the FDA might look favorably upon such efforts.
Missouri-based Mercy has joined forces with Johnson & Johnson Medical Device Companies, in a push to use the health system’s real-world data platform to assess the performance of the manufacturer’s medical devices, according to an announcement.
At the research partnership’s core is Mercy’s real-world clinical data platform, which Johnson & Johnson intends to use to “inform and improve regulatory decision making and health outcomes” for its products, according to the announcement. The move comes after the FDA this spring issued new guidance on the use of real-world evidence in support medical devices going through the regulatory approvals process. Mercy’s data technologies could arm Johnson & Johnson with the proof it needs if it is to successfully navigate the evolving recommendations of the FDA.
“We began this project to make sure the devices Mercy uses work for patients,” Joseph Drozda, MD, the health system’s director of outcomes research, said in a statement. “With more than 8,000 new medical devices entering the market each year, it’s critical that we find better ways to evaluate their performance.”
Mercy has built a respected reputation in the health-tech world, becoming a leader in building data infrastructure and growing its stable of data scientists. The organization noted that its information technology and analytics teams have spent more than a decade working on these projects, capturing and making accessible millions of data points along the way.
“Not only does Mercy have diverse data, we have the data platform, quality, scale, and sophisticated data scientists to turn this data into meaningful information,” Drozda added. “That’s critical where patient outcomes are concerned.”
Its collaboration with Johnson & Johnson comes on the heels of a similar agreement with device manufacturer Medtronic. Drozda pointed to the FDA’s desire for real-world data as a catalyst for Mercy’s data-driven outreach.
In the FDA’s March announcement, commissioner Scott Gottlieb, MD, said real-world evidence “can help devices come to the market faster and expand the depth and reliability of the information we have to inform the safe and effective use of new products.”