On September 25th of this year, after approximately 2 years of soliciting comments from Industry, the FDA released a guidance document entitled “Mobile Medical Applications.” The document defines under what circumstances smartphone apps, and the like, are considered medical devices. The reason that this is important is because if you or I create an app that performs some medical function, (e.g. it turns a phone into an electrocardiogram that records and sends irregular heartbeats to the doc,) it becomes a medical device and as such, regulations require that you register yourself with the FDA as a medical device manufacturer and become compliant to the regulations. You may even have to submit a pre-market notification to the FDA for the app you choose to commercialize. Ignore these regulations and you could be fined and even thrown in jail.
By issuing this document, the FDA acknowledged that it’s in the 21st century and that medicine is becoming more and more mobile. It’s also acknowledged that the mobile medical industry is only in its infancy, so rather than anticipate what types of apps should be classified as medical devices, it created a framework for determining when an app is a medical device. (The ECG app I mentioned is but one example.) All in all, whereas most new regulations often can stifle innovation, this document isn’t like that. It actually can further innovation.
This is because one particular group of developers (who also happen to be the app users) are in a privileged place – they are not considered medical device manufacturers and hence not required to register with the FDA. Who are these folks?
Licensed medical practitioners (physicians, dentists, optometrists, etc.).
These professionals are able to innovate in a way that other app developers are not…with one caveat. These doctors can only use their apps in the context of their own practices (or keep them within their group.) If a doctor chooses to commercialize the app, she then becomes a medical device manufacturer and all the regulations kick in.
Still, even with this caveat, physicians are in a very good place, entrepreneurially speaking.
Think about it.
By exempting physicians who create and use mobile medical apps, physicians can:
- Receive real-time feedback on the suitability of the app for its purpose and modify/optimize it as needed.
- As a result of number 1, they can ascertain what the potential market for the app may be.
- Buzz can be created about the app (both amongst patients and doctors) and results can be published if desired.
The above benefits are things that are very hard to come by in the medical device world (for that matter, they’re often difficult to obtain for non-medical products and services!) In addition, they enable physician entrepreneurs to see if a business case can be built around the app. If it can, time and money can be spent on registering with the FDA and becoming regulatorily compliant - in short, a medical device company can be started and the product commercialized. (It’s important to note here that not all mobile medical apps are the same, even if they are regulated. Some are under more stringent regulations than others and require different types of manufacturing systems.)
Again, this is an enviable position for physicians to be in. Not too many entrepreneurs in regulated industries are allowed to do what physician entrepreneurs are able to do. It will be interesting to see how many physicians answer the call to create apps that help others, and then build businesses from those apps.
If you’re a physician entrepreneur, or a non-physician entrepreneur, with a mobile medical app, I’d love to hear your story. If you’re confused by the regulations, I’m here to help.