ASU professor, planning board outline priorities for national medical device evaluation center

Monday, September 26, 2016

In a report released on Sept. 19, the National Evaluation System for health Technology (NEST) 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 consists of patients, clinicians including Natalia Wilson, clinical associate professor for the School for the Science of Health Care Delivery at Arizona State University, 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.

“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 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.