Compremium Quantis CVP enables noninvasive measurement of the central venous pressure (CVP). [Image courtesy of Compremium]
The FDA designed TAP to “help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health” and expedite patient access to medical devices by providing frequent communication with the agency.
In a Medical Design & Outsourcing interview, Compremium Chief Technology Officer Robin Demesmaeker offered advice on the FDA regulatory process and his company’s experience with FDA’s TAP program so far.
For more from Compremium, you can read our first interview with Demesmaeker. We’ve also interviewed former Compremium Chief Strategy and Innovation Officer Kolaleh Eskandanian in our MDO Min-Vasive Medtech Special Report.
The following has been lightly edited for length and clarity.
MDO: What advice do you have to help companies get into the FDA’s TAP Program?
Compremium Chief Technology Officer Robin Demesmaeker [Photo courtesy of Compremium]
“Applying does not require much more than submitting a letter together with the accepted BDD/STeP application. However, the time window for applying is short, as the application needs to be filed before any formal FDA pre-submission related to the same device. Product development must be in the pre-pivotal stage and, with few limitations in mind, acceptance is given according to FDA’s quota for the ongoing fiscal year. Therefore, I would encourage all companies to immediately lodge an application for TAP upon BDD or STeP acceptance.
“Indeed, the value of being part of the TAP Program can be major. Inclusion in the TAP Program not only provides the fastest possible interactions with the regulatory review teams, but also gives the benefit of FDA supporting efficient de-risking and timely in-depth work on product market fit and market access by facilitating discussions with all relevant stakeholders across the product pathway, including patients, healthcare professionals, hospitals, buyers, payers, etc. These are critical aspects to address in order to successfully enter the market and ensure highest possible benefits for the patients.
“While our journey within TAP has kicked off only recently, we already do experience its value and look forward to the next steps.”
Where is your noninvasive medtech headed next and what technologies do you need to get there?
Compremium’s Quantis CVP combines imaging and pressure sensing into one device. [Image courtesy of Compremium]
“From a hardware perspective, improved sensor technology, low-power electronics and miniaturization could be key enablers, whereas from a software perspective, AI is a multifaceted ally that will simplify and enhance the measurement workflows and that will enable to (semi-) automatically assess each new data point within the context of all other clinical parameters to inform a medical decision. The key will be to stay pragmatic and solution-oriented to let the real medical needs define the required technology rather than the opposite.”
Any final words of advice?
Demesmaeker: “It may seem obvious, but it cannot be repeated enough: Bringing medtech innovation to meaningful market impact requires streamlined teamwork across multiple different disciplines. It is key to not only consider clinical, technology and regulatory aspects, which may give you the fastest regulatory clearance, but to also weave in elements such as product positioning, pathway integration, market access and reimbursement from the very beginning to enable smooth market entry and penetration. It’s definitely not easy, but we all like a challenge, don’t we?”
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