12/04/2016 | BlogPost

Dancing with the FDA

Roberto Ascione | CEO Healthware Group and President Healthware Ventures


The only way to make sense out of change is to plunge into it, move with it, and join the dance.”
Alan W. Watts

Yes we too are guilty of it! Getting involved with digital health projects that result in exciting new apps and treatment algorithms that help people manage their conditions and track their progress. Then, for some of these projects, we look at the data, and we become totally enthusiastic by the fact that it shows that our idea seems to be working and people are achieving the health results we were hoping for!!!
We want to scream to the world that we have a great solution that will change healthcare, and that everyone out there in the world should download our app (and every VC should pour money into our project) BUT… several hundred people downloading an app, using it, measuring their progress which shows significant improvements in their condition unfortunately does not meet the strict criteria of a controlled medical study, therefore we cannot legally make a marketing claim that our digital health app has proven medical benefits.

So what do we do at this point?

One common approach up to now is to launch the app and promote it as something that helps people achieve lifestyle changes by tracking their users’ health goals and progress.
Some examples of this are myFitnessPal, which at one point boasted 80 million users tracking their diets and losing weight, or more recently the app OneDrop which helps people living with diabetes track their blood glucose levels, diet, exercise, medications and allows them to share their information with other users of the platform.
In both cases these apps can help users become better educated about their lifestyle, track the factors that can contribute to their health, and this knowledge can help them make better health choices in managing things like weight loss or carbs intake.
The fast-to-market approach can definitely help build a loyal user base more quickly and the interest of investors that can help the app move to the next step of development or features.

In the case of MyFitnessPal, MFP launched in 2005, the 80 million installed user base got the attention of sports outfit maker UnderArmor, which acquired it for close to $500 million, and the main intention around the acquisition was to gain a large audience and customer base for fitness and lifestyle apparel marketing.

OneDrop has a much more ambitious and aspirational health goal which is to truly change the way that people manage living with Diabetes and help them make the type of behavior changes that can help them live and improve their condition.

When one considers the fact that MFP and OneDrop are two notable examples in a crowded field of over 165,000 health and lifestyle modification apps, then one has to start pondering about how to differentiate oneself in this very crowded field. If your digital health app has a demonstrable health benefit potential (and low risk to its users), it may truly be to your startup’s benefit to have with a go-to-market and business strategy that also includes a well defined roadmap of the steps (and finances) needed to eventually achieve an FDA registration of the health claims you will want to promote for it.

So how does the FDA look at and regulate mobile medical apps?

The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices, they might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps; more importantly, the FDA intends to exercise enforcement discretion for mobile apps that are not medical devices, and mobile medical apps.
In short any app that could be interpreted as delivering a potential health benefit or could present a potential risk to a patient can come under the scrutiny of the FDA. Luckily for us, they have now also made available a handy interactive tool that will help take a lot of the guess work out.

If your digital solution has a stated or implied medical or health benefit, then you may be required to file a pre-market application and to seek an FDA clearance for it.
A significant concern voiced by many is that this approach will ultimately require a properly designed health study which can be quite expensive implement, and can take a long time to run and in the torrid pace of digital health innovation, the time factor of a study can undermine a first-to-market advantage. Then the option to consider, if possible within the legal and regulatory framework, is to create a go-to-market strategy that does not state or imply health claims for the platform being deployed but that instead illustrates lifestyle modification, behavior change and disease awareness and education as its intended goals.

To be in the clear with the FDA, one should also file a 510k submission that clearly states that the intent of the app/platform you are releasing is to help people track their medical data (e.g. weight loss, glucose levels, blood pressure readings etc.), and to provide users relevant tips and advice on how to better manage their lifestyle.

Behind the scenes however it is important to formulate a clearly defined strategy of how your app/platform will eventually leverage an effective medical protocol or treatment paradigm so that, when the time comes, and if the data you are already collecting from your users supports your approach, you will already be well on your way to present your data (preferably supported by independent studies) and file for an FDA clearance on the medical claims your app/platform promises to achieve. This type of approach and due diligence will also show VC and other investors the long term vision and potential of your endeavor.

For more information on the current FDA guidance on Mobile Medical Devices visit the FDA’s page.

We are always looking to work with exciting new digital health startups, so contact us for partnership opportunities.

This is the first piece of Healthware's Digital Health Top 10 Trends for 2016 publication.

Roberto Ascione

Roberto is a pioneer in digital health and a recognized thought leader, people-inspiring founder, serial entrepreneur and global manager. With more than 20 years of experience he has been focusing on marketing and communications, business transformation and innovation in health and wellness.

Read more about his story.