4 ms·
Med device startup cofounder here. In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways): 1. Pre Mar
by ijustlovemath 2y ago
Med device startup cofounder here.
In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways):
1. Pre Market Approval: you're addressing a completely unproven technology in a novel and or dangerous space. Usually Class II and above.
2. De Novo: you're adding a new technology to a somewhat well known space. Usually Class II+
3. 510(k): There's already something in the market that addresses a similar problem and works using similar technology to your device. FDA understands these things well and have a very clear approval guideline, which usually just takes time to rubber stamp if the submission is of sufficiently high quality.
This is all ignoring Breakthrough Medical Devices, which have a ton of red tape cut (max 30 days to hear back about any submission, and if they run out of time, it's an approval). These kinds of devices are pretty rare, though.
- deleted 2y ago[deleted]
- deleted 2y ago[deleted]
- deleted 2y ago[deleted]
- dannyw 2y agoAs much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
- cruffle_duffle 2y agoWhy? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”. There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections. It’s just an SLA and holds people accountable.
- ijustlovemath 2y agoReally what happens is your application is given a higher priority level and dedicated reviewers. They're still going through the full review process, its just they're focusing on your submission.
- danudey 2y ago"Breakthrough" devices have to be devices which show a significant improvement to quality of life over existing treatments for "life threatening or irreversably debilitating" conditions, using breakthrough technology in a space where an existing device doesn't exist yet. So it's less "we made a better pacemaker that uses ChatGPT" and more "this new ventilator can keep people alive even when their lungs are filling with fluid and they're going to die otherwise".