# How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation

**December 11, 2025**

With 420 million downloads and a user base that represents one in five women aged 18-35 in markets like the UK and US, [Flo Health](https://flo.health/) faced a critical challenge: How to evolve from a wellness app to a regulated medical device without sacrificing speed.

Their answer? Build regulatory compliance into the fabric of development rather than bolting it on top.

### Interview transcript