Great insights as usual Adam! The only advice I'd add and I tell fellow medical device entrepreneurs is that unless they have already successfully gone through the FDA submission process and at least one audit--is to hire an FDA consultant to do a quick review of the product/service day 1. They can help answer a lot of these questions and in some cases will tell you they don't need FDA at all. They will also let you know how to start documenting your development process--even early prototypes--so you can prove to FDA that you're following a proven product development process with risk-analysis and mitigation from the beginning. The startup can still do a lot of the heavy lifting to keep costs low--but many consultants are former FDA staff and can save you lots of time and wasted energy down the line. Thanks for your great videos--looking forward to working with you when we're ready :)
Great insights as usual Adam! The only advice I'd add and I tell fellow medical device entrepreneurs is that unless they have already successfully gone through the FDA submission process and at least one audit--is to hire an FDA consultant to do a quick review of the product/service day 1. They can help answer a lot of these questions and in some cases will tell you they don't need FDA at all. They will also let you know how to start documenting your development process--even early prototypes--so you can prove to FDA that you're following a proven product development process with risk-analysis and mitigation from the beginning. The startup can still do a lot of the heavy lifting to keep costs low--but many consultants are former FDA staff and can save you lots of time and wasted energy down the line. Thanks for your great videos--looking forward to working with you when we're ready :)
Excellent advice VF! Thanks.
Great Dose @Adam!
Great video. Thanks Adam!
Thanks for the kinds words Kevin!