Talk to the Regulator Early!

Most new medical devices are typically developed by small (less than 10 people) venture-backed startup companies; their survival is dependent on reaching milestones efficiently  and to raise the required funding to support the development activity.  Having confidence in the predictability in delivering these elements is imperative, particularly for clinical investigation planning.  Funding is not a bottomless source if testing fails (requires repeat development, retest) or is rejected for inadequacy (e.g., inadequate clinical study endpoints, population size/type, study structure).  From the medical device developer’s perspective, underestimating and/or getting the clinical strategy wrong is almost guaranteed company failure.  

FDA’S (USA) Q-Submission process allows medical device developers to request feedback in writing and/or during a meeting about device approval pathways including device classification and potential/planned clinical study applications.  In contrast with Europe, getting access to the relevant device panel is a straightforward, well-defined process.  With each submission, the medical device developer may ask specific questions to which FDA will provide a detailed response – the response (given in writing), in my experience, is extensive, far exceeding the responses to the specific questions posed.  Following the written feedback, if a meeting has been requested, there is the opportunity to further clarify the medical device developer position in the context of the regulator’s response.  

There is no cost for or limit to the number of Q-submission meetings, allowing for ongoing interaction with FDA as the device development proceeds throughout the stages.  While FDA does not provide “instruction”, they do provide plenty of information about their expectations to address risks and provide context on required testing, clinical study structure and approach.  While the Q-submission process does not guarantee product clearance/approval – access to the US regulator is a powerful tool in ensuring that the regulator understands the intended use of the device, the mechanism of action and provides an opportunity for insight into their thinking on unmet clinical need and benefit-risk balance.  This can bring clarity to device classification, regulatory strategy and related deliverables, which are key in having confidence when establishing product development milestones and associated funding.  It is the difference in “might be”-based planning versus informed planning with written evidence of those areas of agreement established with regulator input.   

Interaction with FDA, via the Q-Submission process, is predictable in terms of timing, with straightforward electronic access and leaves a sense that the regulator has a desire to harness new technology to get it into the hands of clinicians to treat patients, whilst ensuring patient safety and protection.  It is not “easy” to achieve product clearance/approval of a novel device/technology for the US market – and nor should it be.  Safety and the protection of patients from untested/inadequately tested devices remains paramount.

Remember - running out of funds before reaching a market-ready product is a common pitfall for medical device companies1; typically the time for first product approval/clearance for higher risk devices was reported as between 3-7 years2 (2004 data) however currently is realistically 10 years or more, which translates to 10 years of zero revenue for a single product startup company.  

1. A.V. Kaplan, D.S. Baim , J.J. Smith, D.A. Feigal, M.S. Simons, D.J. Jefferys, T.J. Fogarty, R. E. Kuntz, M. B. Leon, (2004), “Medical Device Development. From prototype to regulator approval”, Circulation, Volume 109, Issue 25, 29 June 2004; Pages 3068-3072, doi.org/10.1161/01.CIR.0000134695.65733.64

2. Nocturnal (2023), Medical Device Design Considerations for the Cash Strapped Startup, June, Online Article available at: https://nocturnalpd.com/2023/06/12/medical-device-design-considerations-for-the-cash-strapped-startup/.  Accessed 5-May-2024.