Two projects conducted by Yale School of Medicine faculty have been selected as Demonstration Projects by NEST, the National Evaluation System for Health Technology, which was established by the Medical Device Innovation Consortium and funded by FDA.
The projects will evaluate the quality and use of data obtained from mobile health applications to inform post-market surveillance and support NEST’s mission of timely, reliable, and cost-effective development of real-world evidence associated with medical devices, intended to satisfy both for pre- and post-market requirements.
Dr. Joseph Ross and Dr. Rachel Lampert will each lead a group at Yale selected for this initiative. The projects will test approaches to collecting and using “real-world” data and evidence in the post-market setting. The first project focuses on comparing the quality and reliability of data acquired via an mobile health application to data acquired in an industry- owned, post-market surveillance registry. The second project tests the feasibility of using a mobile health application to aggregate multiple sources of health data to support medical device surveillance initiatives.
The researchers hope their findings will provide knowledge that not only informs post-market assessment of medical devices, but can be used to enhance pre-market device development and evaluation.
“This is a terrific honor,” said Ross, associate professor of medicine and public health at Yale. “NEST is a forward-thinking enterprise funded by the FDA to advance and enhance the methods being used to collect evidence for medical device appraisal. We look forward to working collaboratively with NEST, FDA, as well as other experts and stakeholders, to improve healthcare experiences and outcomes for patients.”
The projects are also designed to have wider impact: to develop methods of evidence; to scale across health systems and device types; to potentially demonstrate impact on patient health; and to identify gaps in strategy.
The Yale-led projects partner with Me2Health, founded by Dr. Harlan Krumholz, the Harold H. Hines, Jr. Professor of Medicine and Public Health at Yale; Medtronic, Inc.; Johnson & Johnson; Yale-New Haven Health System; the Mayo Clinic; and the FDA. Ross’ project is also supported by the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation.