Mercy Hospital Systems has partnered with Johnson & Johnson to investigate the device-maker's products in the real world. This is the second such partnership announced by Mercy; last year it entered into an identical agreement with Medtronic PLC to evaluate how their products hold up in Mercy hospitals.
Both device-makers will be using Mercy'sEpic electronic health records system to gather and analyze product data that the hospital notes was adopted a decade ago. That, along with the provider's IT backbone and analytics tool Mercy Technology Services, will allow the hospital to provide real-time information on how devices from the two firms are performing.
"We began this project to make sure the devices Mercy uses work for patients," said Joseph Drozda, Mercy’s director of outcomes research. "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."
"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," Mercy Hospital Systems' Joseph Drozda says.
In recent years, US FDA has pushed for more real-world data-gathering as it has promoted a new regulatory paradigm that could allow some devices onto market based on less pre-market evidence, but dependent on gathering more post-market data. The objective is to show that a product stands up to the agency's safety and efficacy standards in the real world. (Also see "'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover" - Medtech Insight, 29 Sep, 2017.)
FDA has also pushed for a National Evaluation System for health Technology (NEST), which received its initial funding from the agency and the most recent user-fee deal. (Also see "NEST Coordinating Center At Year One: Device Data-Sharing Network In Its Sights" - Medtech Insight, 26 Jan, 2018.)
This move toward more real-world evidence now seems to be inspiring device-makers to jump on the bandwagon. The original partnership between Mercy and Medtronic was selected by theMedical Device Innovation Consortium as a Demonstration Project to help the organization develop the NEST program. MDIC was contracted by FDA to run a coordinating center to develop NEST. (Also see "Pilot Of New US Evaluation System Will Include At Least Two Devices" - Medtech Insight, 31 Oct, 2016.)
Identical to the partnership with Medtronic, J&J will now also be able to use Mercy's data infrastructure to help make regulatory decisions about its products while also trying to figure out how to attain better health outcomes, according to the hospital system.
"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," said Drozda. "That’s critical where patient outcomes are concerned." From the editors of The Gray Sheet