- St. Louis-based Mercy Health System is teaming up with Johnson & Johnson to assess and work to improve the safety of medical devices.
- The partnership revolves around a data platform Mercy developed to assess device performance. J&J will use the data to support regulatory decision-making and help patient outcomes.
- This is Mercy’s second collaboration on medical devices. Last fall, the Catholic health system announced a partnership with Medtronic to capture data to help improve outcomes for heart failure patients who get cardiac resynchronization therapy.
The data platform was designed and developed by Mercy Technology Services, Mercy’s technology arm.
“We began this project to make sure the devices Mercy uses work for patients,” Joseph Drozda, Mercy’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.”
The FDA has been pressing manufacturers to include more real-world data to technology assessments. Last year, it partnered with IBM Watson to identify secure and scalable ways to exchange health data using blockchain technology. The initial focus is on exchange of oncology-related data and will draw on sources such as EHRs, clinical trials and mobile devices.
The FDA is also working with data providers to speed the launch of the National Evaluation System for Health Technology, a virtual system that links data sources including registries, EHRs and payer claims. Expected to launch next year, NEST will utilize real-world data collected after a product is in the market to inform new product development and improvements in existing products.
“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 said. “That’s critical where patient outcomes are concerned.”