A medical device startup approached Faros with a clear goal: bring its novel implantable neurostimulator for chronic pain to market.
Because the device used a new mechanism and was invasive, the team had planned to pursue a Class III PMA pathway. On the surface, this appeared to be a logical regulatory route based on the product’s risk profile and novelty.
However, that pathway would require significant clinical evidence, millions of dollars in spend, and a multi-year timeline before approval.
Faros reviewed the technology and identified that the core device concept closely mirrored an existing product already on the market.
Rather than treating the entire device as Class-III, we identified an opportunity to integrate the innovative solution to be an adjunctive class-II device, thus dramatically reducing the commercialization time and cost.
To validate this approach before committing the company’s resources, Faros, with guidance of the Company, composed and submitted a Pre-Submission (Q-Sub) to the FDA. The agency agreed with the proposed pathway.
By separating the predicate-based elements from the novel add-on, the client was able to obtain a Class-II approval instead of a PMA, significantly reducing its clinical burden, cost, and time to market.
