> our self-funding won’t cover a class 1 FDA certification. I have no experience with VCs. Who do we talk to? What should we ask for? How long will this take?

> our self-funding won’t cover a class 1 FDA certification. I have no experience with VCs. Who do we talk to? What should we ask for? How long will this take? get involved with a startup accelerator. there will probably be one at a local university or college. There are also usually innovation/startup/buisness advisors and programmes at the local government level who can help. These guys will be able to get your foot in the door for grants programms that will start you on the way to clinical trials and approval. I'm doing a medical device in the EU right now and we are further ahead than you in our journey but still going, as always. The key is just to speak to people. There are many people that have done this before. You will find that an optimal approach becomes spending the vast majority of your time speaking to people, via phone email and yes in person. It's been a transition for me who is a product guy first and foremost but tbh it has been nessacary, I see many products that don't yet or even can't ever exist with much more funding and backing behind them because they got the right contacts and made the right pitch, and you can too.