Another Year, Another Report on National Medical Device Evaluation System but Still Few Details

By Allyson B. Mullen –

For the past several years, a public-private stakeholder Planning Board has been evaluating the possibility of a new National Medical Device Evaluation System (NMDES). See our earlier posts on this initiative here and here. As discussed in our earlier posts, the NMDES is intended to aggregate significant amounts of both pre-and postmarket information into a single system, including information from claims and administrative systems, patient-generated data, EHRs, and device-specific and clinical care registries.  This information is intended to be useful to a wide variety of stakeholders, including CDRH.

In late 2015, FDA requested that the Duke-Margolis Center for Health Policy (Duke) convene the Planning Board to lead the next phase in development of the NMDES. This phase of development focused specifically on the NMDES governing body, the Coordinating Center and its Governing Board. On April 5, Duke issued the latest National Medical Device Evaluation System Planning Board Report. 

The report provides a framework for the Coordinating Center and its Governing Board. The Coordinating Center is intended to “provide governance, coordination, and standardization to drive down time and cost of generating evidence on medical devices, while increasing the accessibility and usability of real-world data.” The Planning Board recommends that the Coordinating Center be organized as a non-profit entity with both public and private representatives sitting on the Governing Board. The report outlines the principles, goals, capabilities, and objectives of the Coordinating Center.

The report gives the sense that creation and implementation of a NMDES may happen sooner rather than later, which was generally lacking in other reports on this same topic. For example, the report highlights that it is a goal of CDRH to establish the Coordinating Center in the near-term as part of its 2016-2017 Strategic Priorities. As a practical matter, the report indicates that it would not be possible to create a de novo entity to act as the Coordinating Center in a short timeframe. Therefore, the report recommends that the Coordinating Center be incubated at “an established hosting organization.” The report acknowledges that there could be inherently competing interests in structuring the Coordinating Center this way and suggests that there be a plan to ultimately spin off the Coordinating Center from the hosting organization into its own independent entity.

Like the earlier reports on NMDES, however, there are many still unanswered questions in this report. The Planning Board continues to state that the NMDES will not be adequately funded by FDA seed money alone and will need to be a financially stable and independent entity. The report suggests that the hosting entity obtain matching funds to support the Coordinating Center. The report states that manufacturers, health insurance organizations, and research organizations could provide funding for NMDES development. It is unclear why such private entities would voluntarily provide funding for NMDES development without some incentive. Longer-term, the report indicates that funding could come from a variety of sources including patient groups (it is unclear why patient groups would use their scarce resources to provide funding), and funding for research studies from clinicians, hospital systems, manufacturers, health insurance organizations, and research organizations. It is possible that funding could come from philanthropic donations, but there is no mention of this potential funding source in the report.

Perhaps the most curiously unanswered question, however, relates to next steps, including who will appoint the hosting center for the Coordinating Center. The organization and compensation (if any) of the hosting entity and Coordinating Center could significantly affect the role and impact of NMDES. The report concludes with an optimistic timeline: 

• Within 6 months after selection of the host entity for the Coordinating Center, appoint an interim executive director to provide day-to-day leadership.

• Within 1 year – public appointment of the Governing Board for the Coordinating Entity; propose and initiate two demonstration projects (projects that demonstrate the value of NMDES); create initial governing policies for the Coordinating Center and NMDES; and charter and convene expert committees to advise the Coordinating Center.

• Within 2 years – create a publicly accessible clearing house of medical device evaluation activities; create publicly accessible expert guidelines for evaluating patient signals and patient-focused processes for information dissemination; and initiate two additional demonstration projects.

• Within 3 years – complete two demonstration projects.

• Within 5 years – have a financially stable, independent Coordinating Entity.

There are no details about the immediate next step to get the NMDES program started: appointing the host entity for the Coordinating Center and who is responsible for this appointment. In addition, the plan does not appear to address creation of the actual data systems necessary for NMDES, unless these systems are what the plan describes as the “publicly accessible information clearing house of medical device evaluation activities.” The report indicates that this is the first in a series of papers that will be issued by the Planning Board; perhaps additional details will follow. We will certainly keep you posted.