FDA-Convened Planning Board Proposes Coordinating Center For New Device Evaluation System

By Jof Enriquez,
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The national medical device evaluation system (NMDES) planning board, convened by the U.S. Food and Drug Administration (FDA), unveiled details on such a system and proposes a coordinating center that will work with multiple industry stakeholders to improve the generation and gathering of evidence on the safety and effectiveness of medical devices.

According to the planning board's report, prepared by the Duke-Margolis Center for Health Policy and titled "Enabling Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System," NMDES is envisioned as a strategically-driven, coordinated network of voluntary partnerships that include patient communities, government agencies, device manufacturers, institutional data partners, and methods partners, all working towards generating higher quality data and evidence at lower costs to inform and improve patient care.

To generate these data, NMDES will tap various resources, including:

• Data from multiple sources (including electronic health records, claims, registries, patient reported outcomes, clinical trial data, etc.) connected through re-usable, standardized data use agreements (DUAs) that optimize data standardization, expedite project-specific research agreements, and reduce the cost of evidence development through economies of scale
• A clearinghouse of expertise and advanced methods, tools, standards, and best practices (e.g., to detect safety events and to study clinical effectiveness of new technologies for regulatory and reimbursement decisions)
• A trusted and up-to-date compilation of reliable information on the benefits and risks of medical devices for patients and the broader health community (e.g., safety updates, recall management support, emerging effectiveness information)

"NMDES would be constantly identifying new sources of reliable device data and designing and implementing innovative ways of capturing and combining data from disparate sources while ensuring that federal patient-privacy laws, regulations and ethical standards are maintained," states the report.

In order for NMDES to operate, the Planning Board proposes a coordinating center, which will be charged with the development of NMDES and will act as a non-hierarchical central body, responsible for promoting the long-term sustainability of the system through both public and private funding sources. An executive director will lead the center, which will have a governing board consisting of ten to fifteen members representing various stakeholder groups (patient/consumer advocates, physicians, hospitals, health plan representatives, manufacturers, health IT, and methodologists) and government agencies (FDA, CMS, ONC, NIH, and AHRQ).

The coordinating center shall provide governance, coordination, and standardization to organizations within the medical device ecosystem. In addition, the center will build mutually beneficial shared resources and reusable pathways with standardized DUAs to drive down the time and cost of generating evidence on medical devices. 

Among other functional objectives specified in the report, the center is tasked to optimize the cost of, access to, quality of, and sharing of data related to the evaluation of medical devices, including promoting unique device identification (UDI) adoption, standardized data sharing agreements, and interoperability.

"The Planning Board believes that there is an unprecedented opportunity for a more coordinated national approach that addresses the broader needs of patients, clinicians, health care insurers, and medical device manufacturers, as well as FDA," states the report.

The board also released a timeline with key deliverables. Within the first year, the center will have initiated at least two demonstration projects based on a landscape survey of medical device evidence development methods and techniques, and an assessment of stakeholder priorities and needs. Within two years, it should have created a publically accessible information clearinghouse of medical device evaluation activities. By the third year, at least two demonstration projects, one pertaining to safety surveillance and the other focused on evidence development on device efficacy, should be completed.

"As the vision of the NMDES becomes a reality, more complete and accurate information regarding the safety and performance on medical devices will be readily available to clinicians and patients," stated Dr. Michael Mack, a planning board member and chair of the Cardiovascular Service Line at Baylor Scott & White Health, in a press release. “This allows them to make better, more informed decisions.”

In January, the Center for Devices and Radiological Health (CDRH) announced its 2016-2017 Strategic Priorities, which included the creation of a national system for evaluating medical devices with real-world evidence to support regulatory decision-making and technological innovation.

"The planning board believes that to improve high-quality, safe, effective, and timely care for patients, better information about medical devices must be a priority for the nation," said Mark McClellan, director of the Duke-Margolis Center for Health Policy, in the release.

The report from the Duke-Margolis Center for Health Policy is the first in a series of high-level papers to be released by the planning board – which first convened in 2014 – to promote and support discussion of how to address the needs and opportunities for better evidence on medical devices, according to the Regulatory Affairs Professional Society (RAPS).