Published on March 26, 2013
This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more.
RockHealth recently published a great guide on how to navigate the FDA for the emerging wave of digital healthcare innovations including mHealth apps. It is especially useful for any team member of an early stage startup that may not be familiar with the FDA regulatory environment. I liked the simple and succinct examples provided from classification to 510(k) premarket submission to post-market recommendations.
If you are in a healthcare startup keep on eye on this blog (there are a bunch of posts related to FDA) and or visit our SlideShare presentations here.
Orthogonal also runs the Chicago Lean Startup Circle whose mission is to teach lean startup methods and provide support and mentoring to Chicago’s startup community. There are over 3,000 members and it’s our third year of running the Chicago Lean Startup Challenge. This year we’re adding a healthcare track.