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.
510K submission vs. PMA/IDE is becoming more of a factor of what product and indication you are trying to get approval on. If you are involved with implantables, it is almost becoming impossible to go for a 510K nowadays. 510K’s in the past for implantables was done to save money and get to the market asap but today the FDA is not allowing many companies to file 510K and are at least trying to get them to do a special 510K with clinical data or small pilot study per say. This is especially the case within the vascular (cardio or peripheral) area but I suspect such with other segments too. This makes it very difficult for start-ups in today’s economic environment and getting seed money required to stay afloat.
510k VS PMA/IDE discussion is of course relative to off label use, e.g., vascular vs. non-vascular indication and use
Michael,
Thanks for the comments. I think the 510(k) path will be challenging for many of the issues you mentioned. It’s especially challenging for a start-up that believes they have an innovative solution and where there are not clear predicate devices.
Take care,
j