Some smartphone apps have to be cleared by the FDA

[Commentary] So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration. Our app, DANA, uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD). Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA:

1. Innovators are afraid of the FDA
2. There isn't a clear path for innovative products
3. But FDA regulators aren't always right
4. The paperwork never gets easier
5. In the end, you won't get approval and that's fine

[Dr. Corinna Lathan is the Founder and CEO of AnthroTronix]