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 (FDA).
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).
For something so important, a serious investment of time and money for clearance may not sound extravagant, but few small companies can afford a two-year go-to-market delay, not to mention the significant investment and heartache that goes with it. And although the FDA has tried to facilitate regulation by providing guides like the Mobile Medical Applications Guidance Document and the Mobile Medical Applications website, the regulatory process remains confusing.
Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA: