DUBLIN and ST. LOUIS – Medical technology provider Medtronic has joined forces with Mercy Health System on a data sharing and analysis network that will help gather clinical evidence for medical device innovation and patient access.
The partners will develop a resource for information about medical device safety and patient outcomes based on clinical information captured during routine patient care.
“Having the ability to study patient care pathways and conditions before and after exposure to a medical device is crucial to understanding how those devices perform outside of the controlled clinical trial setting,” said Dr. Rick Kuntz, senior vice president of strategic scientific operations at Medtronic, in a statement. “By partnering together, Mercy and Medtronic have set out to create a comprehensive and economical evidence generation model that ultimately allows patients to benefit from the latest therapies and technologies as early as possible.”
In the initial phase, the new data network will capture de-identified data from about 80,000 patients with heart failure to explore real-world factors that determine a patient’s response to cardiac resynchronization therapy.
“Heart failure is a complex, progressive condition,” said Dr. Joseph Drozda, director of outcomes research at Mercy, in a statement. “To more effectively treat patients, we need a better understanding of how they are responding to treatment and what leads to better health.”
The coordinated data network aligns with the U.S. Food and Drug Administration’s vision to establish a National Evaluation System for Health Technology. With a national system, the FDA aims to quickly generate meaningful insights from routine clinical care data. The partnership was recently selected by the Medical Device Innovation Consortium as a demonstration project for its use of scalable methods that generate real-world evidence. This project will ultimately help shape the model for NEST to provide faster, more cost-effective regulatory decisions and accelerated therapy innovation that keeps patients safer and healthier.
“This has the potential to improve patient care by using advanced data analytics,” said Drozda.
Mercy includes 44 acute care and specialty hospitals, more than 700 physician practices and outpatient facilities, 40,000 co-workers and more than 2,000 Mercy Clinic physicians in Arkansas, Kansas, Missouri and Oklahoma. Mercy also has outreach ministries in Arkansas, Louisiana, Mississippi and Texas.