October 13, 2017
Medtronic plc and Mercy, the fifth largest Catholic health care system in the U.S., together will establish a new data sharing and analysis network that helps gather clinical evidence for medical device innovation and patient access.
Traditional clinical trials can be complex, time-consuming and costly. To address this, Medtronic and Mercy Technology Services, the IT backbone of Mercy, seek to co-develop a new way to answer questions about medical device safety and patient outcomes through access to valuable clinical information captured during routine patient care. In the initial phase, the new data network will capture deidentified data from approximately 80,000 patients with heart failure to explore real-world factors that determine a patient’s response to Cardiac Resynchronization Therapy (CRT) – a clinically proven heart failure treatment option for some heart failure patients that is designed to help the lower chambers of the heart beat together in a more synchronized pattern.
This coordinated data network aligns with the Food and Drug Administration’s vision to establish a National Evaluation System for health Technology (NEST). 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.
“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, SVP of strategic scientific operations at Medtronic. “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.”
“This has the potential to improve patient care by using advanced data analytics,” said Dr. Joseph Drozda, Mercy’s director of outcomes research. “Heart failure is a complex, progressive condition. To more effectively treat patients, we need a better understanding of how they are responding to treatment and what leads to better health. This model will lead to evidence-based insights for our clinical teams, and better health for our patients.”