The Challenge
An early-stage medical technology company developing an innovative AI-enabled medical device faced regulatory uncertainty associated with its novel technology, intended use, and potential pathway to US market authorization.
The company needed a proactive regulatory strategy to address FDA expectations, guide product development, and identify opportunities to accelerate regulatory progress.
FHA's Approach
Frank Healthcare Advisors (FHA) developed and supported a staged regulatory engagement strategy designed to align regulatory milestones with product development and business objectives.
FHA initially supported an FDA Pre-Submission to obtain early feedback on the proposed regulatory pathway, key safety and performance considerations, and clinical evidence expectations.
Building on this foundation, FHA identified an opportunity to pursue Breakthrough Device Designation (BDD) and supported the preparation of a successful request, emphasizing the device's potential to address an important unmet clinical need.
FHA subsequently supported the company's application to FDA's Total Product Life Cycle Advisory Program (TAP), resulting in acceptance into the program and opportunities for enhanced FDA engagement throughout development.
The Results
- Early FDA alignment through a strategic Pre-Submission.
- Successful Breakthrough Device Designation, recognizing the technology's potential to address an important clinical need.
- Invitation into FDA's TAP Program, providing opportunities for enhanced regulatory engagement.
- A clearer regulatory roadmap to guide ongoing development, evidence generation, and future market authorization activities.
The FHA Advantage
This case demonstrates the value of integrating regulatory strategy early in medical device development. By anticipating regulatory challenges, identifying strategic opportunities, and facilitating meaningful FDA engagement, FHA helped transform regulatory uncertainty into a structured development pathway supported by significant FDA program milestones.
FHA helps medical technology innovators navigate complex regulatory pathways, make informed development decisions, and advance toward market authorization with confidence.