This past Tuesday, several NVCA members were invited by the Food and Drug Administration (FDA) to participate in a day-long workshop to discuss the implementation of the recently proposed Medical Device Innovation Initiative (MDII). As you may recall, this initiative is aimed at improving the regulatory review process for novel technologies. The NVCA long advocated for such a program and we were pleased to be asked to join the conversation regarding its implementation.
Representing NVCA and the venture industry were members Jack Lasersohn from the Vertical Group; Ross Jaffe from Versant Ventures; Jonathan Leff from Warburg Pincus and Lou Bock from Scale Venture Partners.
The day was a very positive step forward in terms of the level of collaboration regarding how best to implement this new initiative most effectively. In addition to the venture industry, many other stakeholders were represented including patient groups, large and small companies and the academic community. All were committed to the program’s success and shared ways in which that success could be attained. While some panelists raised concerns that the MDII would be limited to very few applications and will take precious resources away from other parts of the device center, we believe FDA is well positioned to leverage the positive lessons learned with this initiative across other areas. Having access to senior FDA officials as we explore new regulatory paths will give us a “laboratory” for testing new processes which can then be expanded beyond the novel technology initiative.
For our part, the NVCA focused on areas specific to bringing the investor risk-reward equation back into equilibrium. For example, we shared with the group the need for transparency with device sponsors, allowing companies to play a role in selecting the experts who review their products. As the devices that participate in the new program are, by definition, extremely cutting edge, there are few individual qualified to adequately assess their efficacy and safety. Often the company participating is best suited to identify these experts. We believe it is critical that the sponsor be involved in all such interactions to avoid misunderstandings or mistakes regarding the review process early on.
The program has only just begun and the FDA is committed to making the necessary adjustments to ensure that it succeeds in its intention which is to improve the approval process for groundbreaking technologies. If this program is successful, we believe it will have a positive impact on the entire FDA approval process as there is much to learn by this inaugural effort. Ultimately the success of the program will be measured by the number of companies that apply. The NVCA looks forward to working with the FDA to ensure that number is meaningful.
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