In the few medical device start-ups I’ve worked with, the investors keyed in on a FDA 510(k) submission as a critical milestone. On one hand I understand this. A 510(k) submission represents a culmination of product development efforts. Once the 510(k) is cleared by FDA, this is a green light to market release and hopefully revenue.
But in several of my experiences, the timeline was stressed more than the quality of the 510(k) submission. It seems as though start-ups (or maybe more correctly, start-up investors) are willing to assume more risks in order to meet due dates.
Timeline is important. But so is quality. No 510(k) submission is without risks. But many risks can be mitigated. Submit a 510(k) with significant risks to FDA, expect to get many questions back from the agency. Get questions from FDA, throw schedule out the window. Revenue delayed.