File before you publish, demo, or pitch a stranger
In the US, you have a 12-month grace period after public disclosure to file - most other markets do not. Treat any pitch deck, conference poster, or non-NDA conversation as a disclosure event. File a provisional first, then build the full prosecution strategy around your FDA pathway.
Investors will not lead a Series A on an asset that competitors can clone. Strategic acquirers value the IP estate more than the revenue. And every founder eventually gives an unguarded demo at a conference - the question is whether a provisional was on file beforehand.
Most medtech roadmaps include a layered IP estate, not a single patent.
Method-of-use claims should align to your indication for use statement in the 510(k). If your patent claims a use the FDA hasn't cleared, the claim is unenforceable in commercial settings. Coordinate patent counsel and regulatory counsel from week one.