The FDA’s role in the digital health monitoring space

How can pharma read the signals coming from clinical trials to predict FDA judgements on digital health products? 

At the Consumer Electronics Show in 2016, no fewer than 30 new health monitoring devices made their debut, purporting to measure and record health metrics such as heart rate, body temperature, quality of sleep and more.

These devices ranged from the pedestrian—an infrared thermometer that measures body heat from the temporal vein on the side of a child’s head—to the outré—an app-connected haptic device that guides women through kegel exercises. Although these products outwardly display flourishing innovation in the health monitoring space, this burgeoning industry is actually facing its first crisis.

Many companies are now entering the digital healthcare arena, and some of them have a minimal background in creating medical devices. Other companies have stated outright falsehoods about the efficacy of their products. Yet more organisations are now facing legal pressure from consumers who believe they’ve been cheated by devices that don’t work as intended.

Given that companies are creating devices meant to diagnose or recommend solutions for patients, the FDA is becoming increasingly involved in health monitoring innovation. The more invasive the health monitoring device, the more involvement the FDA will have in the innovation process—especially in terms of clinical trial standards.

Many pharma companies are falling behind in digital health, seeing as these clinical trials often take years to complete. The strenuous process is leaving pharma companies to question whether health monitoring innovation is worth the time and effort.

In addition, there is concern that a spate of bad publicity for health monitoring devices will result in a backlash against the industry at large, leading to a fear of innovation. For an example, look no further than Theranos, a once-hyped startup that promised to offer a revolution in medical testing.

Yet these promises came crashing down once a Wall Street Journal report revealed that the device provided inaccurate results, backed up by an FDA order to cease use of the Edison device for all but a single test.

Since October, the company has lost hundreds of millions of dollars in contracts. The company faces the removal of its federal licence, plus the potential ousting of its founder, Elizabeth Holmes. Combine this negative press with a lawsuit against FitBit, an activity tracker, for inaccurate heart rate monitors, and the entire industry could experience a chilling effect.

Whether a health-monitoring device is a consumer-grade appliance like a Fitbit, or a medical-grade testing product like an Edison, there’s a case for the FDA to intervene in order to protect patients’ health. Thus, the role of the FDA in the health monitoring space will only continue to grow.

How FDA involvement has affected the digital health industry

Both traditional pharmaceutical companies and new entrants to the digital health marketplace are now facing challenges as FDA’s policies continues to evolve. When the FDA becomes involved in a product launch, even success stories can take a winding road to completion. As an example, look at Box.

Box began as a competitor to DropBox, offering cloud-based storage, file sharing, and collaboration tools for businesses and individuals. In 2014, they began to differentiate themselves from competitors by purchasing MedXT, a startup known for medical imaging device software.

In February 2016, they announced a healthcare solution, Box for Healthcare, which will allow hospitals to use its platform in order to view and transmit images in the Digital Imaging and Communication in Medicine (DICOM) format.

Software and services that use the DICOM format are subject to heavy regulation. The FDA classified the Box DICOM Viewer as a Class II medical device, which means, according to the FDA website, that it offers higher risk than dental floss—a Class I device—but lower risk than a replacement heart valve—a Class III device. These definitions are approximate, but clearly there is a great deal of leeway for the FDA to decide which devices do and do not need to undergo a strenuous approval process.

The Box DICOM Viewer needed was categorised as Class II because the images it stores and shares are used to plan surgeries. Any loss of fidelity in the images could result in a botched operation. While FDA approval is a massive net benefit for Box—its non-medical enterprise solutions have already made strong inroads into the healthcare vertical—the other side of the issue is that approval took three years to acquire. Other companies may not be willing to invest in creating innovative devices, especially if these companies experience other challenges in the form of fines and lawsuits.

When legitimate companies get sued if their non-medical devices provide inaccurate information, this discourages innovation. When illegitimate companies pollute the marketplace with false claims of medical accuracy, this discourages innovation. If these two pressures combine and force the FDA to take a sterner look at “low risk general wellness devices,” then very few companies might find the wherewithal to navigate what amounted, at least in the case of Box, to a three-year time to market.

How other industries manage FDA involvement: the Under Armour example

Over the past few years, Under Armour has spent $710 million on acquisitions of mobile apps and tech companies including MyFitnessPal, MapMyFitness, and Endomono. Although Under Armour’s shirts measure biometric properties (heart rate, temperature) this information is useless until they develop a feedback action item. That is to say, they must tell the customer what to do with this data.

This is a step that has tripped some companies up. Some companies, such as Theranos, might fall into the trap of making false claims about their products. Others might find that, despite their best intentions, customers still believe that the advice of their wellness devices is equivalent to the advice of a doctor.

How can pharma win the digital health ecosystem?

With the growth of online information and speed of innovation today, decision makers in product development can no longer rely on traditional data gathering methods. This is why companies today are adopting data analytic platforms into their daily work routines. Executives that have access to real-time data are able to quickly identify where their competitors are innovating and what is happening outside of their organisation.

Research recently conducted by Signals shows that the market is flooded with technologies that measure biometrics such as; heart rate and ECG but market signals show us that technology applications used to measure human emotion, stress, blood pressure, and glucose level have an increasing number of clinical trials.

From the analysis above we also learn that there is nascent and accelerating interest in devices that detect emotions, body temperature, EMG, EEG, stress and glucose level. These market segments may be expected to grow rapidly in the future because of the high level of clinical trials associated with them.


If companies don’t carefully navigate the waters surrounding digital health over the next few years, they will find a future in which innovation is stifled due to an oppressive regulatory climate, and a cloud of negative publicity. A comprehensive understanding of the FDA’s involvement is key to the success of a digital health product. Through tracking new and emerging technologies, Big Pharma can track early market signals to monitor where the opportunities are, where companies are focusing, and in turn, where the FDA will be looking.

About the author

Dr. Alexandra V. Eberhard is the Executive VP of Sciences, Signals Group and General Manager, Signals Europe. Having joined 7 years ago, she is one of Signals Group’s pioneers, working with more than 30 Fortune 1000s. Dr. Eberhard earned her PhD in Immunology/Virology at BioMerieux (France) and her post-doctorate at the Weizmann Institute of Science (Israel). She co-authored more than 15 peer-reviewed international publications and received 6 academic awards.