Note to editors: The report may be downloaded from https://healthpolicy.duke.edu/publications/nest-priorities-early-effective-implementation.
WASHINGTON, D.C. – In a report released today, the National Evaluation System for health Technology planning board outlines key priorities for the new Coordinating Center as it works to implement a national system for medical device evaluation. The 25-member board, convened by the Duke-Margolis Center for Health Policy, is a broad-based group that includes patients, clinicians, the medical device industry, payers and regulatory experts, as well as five representatives from federal agencies.
The Coordinating Center is charged with implementing a national network of partners to improve evidence on the safety and effectiveness of medical devices that can help improve care for patients through better use of real-world electronic health data and developing new tools for more efficient device analyses.
“Patients have gone too long without easy access to understandable and actionable information on the safety and effectiveness of medical devices,” said Carol Walton, CEO of the Parkinson Alliance and a NEST planning board member. “This report is a clear call to action for everyone involved in medical devices, including patients themselves, to collaborate on a solution.”
“NEST now has a clear path to becoming a reality through the approach outlined in these reports and implementation guided by the Coordinating Center,” said Duke-Margolis director Mark McClellan. “Our team, first at the Brookings Institution and now at Duke-Margolis, is pleased to have supported the planning board’s path-breaking work to develop a broadly-supported, practical system to address the concerns of patients for sustainable solutions for medical device evaluation and, most importantly, better outcomes.
In two previous reports, the planning board laid the foundation for a patient-focused national system to address major gaps in the nation’s ability to reliably track medical device safety and effectiveness that affect public health and make it more difficult for patients and clinicians to make informed decisions.
The board’s second report outlined the Coordinating Center‘s function and structure. The planning board recommended that the Coordinating Center be a public-private partnership to ensure that the system meets the needs of all stakeholders including a faster, more predictable path to FDA approval for device manufacturers, more cost-effective approaches to developing real-world evidence that will benefit clinicians, insurers and patients.
“The NEST Coordinating Center has the potential to enable entrepreneurs and start-ups to access the power of advanced data collection that would have previously been cost prohibitive,” said Mark Deem, the Managing Partner of the Foundry, LLC and a Planning Board member. “Access to advanced registry tools for all organizations supports FDA’s mission to rebalance pre-and-post market evidence development and to foster innovation.”
The newest report, released today, recommends parameters for operational leadership, bylaws, and the creation of a representative governing board, as well as several demonstration projects meant to build the foundation of NEST and demonstrate how to more efficiently meet the public’s needs.
The planning board recommends that the Coordinating Center drive the development of the system through strategically chosen and innovative demonstration projects that build cooperative agreements and promote methodologies that will help NEST scale quickly. The board also emphasizes the importance of patient input and addressing long-term technical challenges such as the incorporation of Unique Device Identifiers.
The planning board recommends phase I projects that use registries to support clinical trials to allow a better balance between evidence collected prior to FDA review for marketing and evidence developed after devices are on the market and in clinical use. The board also encourages expanding and evaluating safety monitoring through methods that increase the efficiency and quality of Medical Device Reporting.
Today’s report also recommends Phase II projects focused on developing best practices for measuring the value of medical devices and evaluation of class II medical devices – a category that makes up almost half of registered medical devices including surgical mesh, imaging equipment, surgical devices, feeding pumps and ventilators. These efforts should include common data models that link unique device identifiers and electronic health information, and rapid safety evaluations techniques. Also in Phase II, the board recommends evaluating different models for patient-mediated data access that support patient engagement in clinical research and also provide ways for stakeholders to gain responsible access to the patient data necessary for post-market safety analyses.
About the Planning Board:
The NEST planning board is a diverse group of expert stakeholders convened by the Duke-Margolis Center for Health Policy to recommend strategies for the development of a national medical device evidence system. The 25-member board includes representatives from a broad range of groups including patients, clinicians, medical device industry and regulatory experts, as well as five representatives from federal agencies. For more information, go to https://healthpolicy.duke.edu/biomedical-innovation-and-evidence-development/medical-devices/.
About the Duke-Margolis Center for Health Policy
The Robert J. Margolis, MD, Center for Health Policy at Duke University is directed by Mark McClellan, MD, PhD, and brings together expertise from the Washington, DC policy community, Duke University and Duke Health to address the most pressing issues in health policy. The Center’s mission is to improve health and the value of health care by developing and implementing evidence-based policy solutions locally, nationally, and globally. For more information, visit healthpolicy.duke.edu.