The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that a nonprofit organization that works with the Food and Drug Administration (FDA) to advance regulatory science and support innovation in the healthcare technology industry has been tasked with a crucial role in the development of a national evaluation system for medical devices.
Specifically, the organization known as the Medical Device Innovation Consortium (MDIC), has been awarded $3 million by the FDA to create and operationalize the coordinating center for the National Evaluation System for health Technology, also referred to as NEST. According to a commentary published in the Journal of the American Medical Association, the creation of a national evaluation system for medical devices would balance a desire to speed up access to new technology and address safety issues throughout the lifetime of the device. This article was authored by FDA commissioner Robert Califf and Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren.
The initial phase of the project will involve piloting methods for tracking medical device data and patient-reported outcomes through the use of real-world evidence. The hope is that the use of real-world evidence will shift premarket data collection into the post-market by leveraging the electronic health information generated in both clinical settings and patients’ homes.
“There is great potential in using real-world data to foster innovations in medical device technology that will lead to optimized outcomes for patients and improved quality of life. In addition, real-world evidence will help measure the cost-effectiveness of these new technologies,” said MDIC board chairman Mike Minogue, who also serves as president, CEO, and chairman of the medical device implant manufacturer Abiomed. However, these benefits cannot be realized without a coordinated effort, according to Shuren. “Building a strong coordinating center for the National Evaluation System for health Technology is critical to making this system a reality,” he said in a statement. “The FDA looks forward to collaborating with the consortium in building NEST with the goal of linking and synthesizing data across the medical device landscape, including clinical registries, electronic health records, and medical billing claims.”
For Minogue, MDIC’s role as a public-private partnership focused on regulatory science makes it “uniquely suited” to take on this project and bring together a diverse group of stakeholders to lead a coordinating center that “meets the needs of patients, regulators, and industry.”
With the addition of the coordinating center to MDIC’s portfolio of projects, MDIC will be relocating its executive headquarters to the Washington, D.C. area in late 2016. As MDIC makes this move, the consortium will temporarily lease some office space from AAMI while it looks for its permanent home. “We are delighted to host MDIC as it transitions its new headquarters to Washington,” said Steve Campbell, chief operating officer for AAMI. “As we work side by side for a few months, we hope to learn more about the important work of the consortium and get a fresh perspective on the opportunities and challenges that exist for innovators in the medical device world.”