Regulatory strategy, 510(k) pathways, and SBIR guidance for founders building medical products.
A plain-language guide to the three main FDA device pathways and how to tell which one applies to your product before you write a grant.
Jun 26, 2026You validated the problem. You have customer interviews. Now you have to actually build a regulated company — and that's where most medtech founders stall.
Jun 20, 2026What NIH and NSF reviewers actually look for in the regulatory portion of an SBIR application — and the phrases that cost you points.