Digital Health Devices in Clinical Trials: Opportunities, Challenges and Considerations

Medical device companies are running more and more trials where they are using digital health devices to collect data from patients. By doing so, they hope to demonstrate efficacy, accelerate timelines, reduce costs and enhance clinical trial outcomes. To bridge the gap between reality and potential, these companies will need to be prepared for the challenges and opportunities that lie ahead of them in utilizing digital health devices.

The Potential

The digital health ecosystem, consisting of web-based programs, digital biosensors, wearables, and other digital devices, is growing rapidly. In 2015, the global digital health market recorded sales of $80 billion, and by 2020, the market is expected to grow 260 percent. Among all digital health tools, more than 318,000 health apps and 340,000 consumer wearable devices alone are available worldwide, with over 200 health apps being released each day.

Sponsors are starting to leverage this boom by incorporating health devices with digital elements into their clinical trials. In a clinical trial, the patient wears or interacts with one of these devices, which collects data in digital form and transmits it to a site where it can be turned into an endpoint. The data can also be used as “digital biomarkers” to explain, predict or influence health-related outcomes. For medical device companies, the best use for this collected data would be to zero in on the best-suited patient populations for particular trials. Trials, as a result, would be more streamlined, with faster timelines and smaller, yet more specific, sample sizes. These devices also improve a patient’s experience in a trial. All of this adds up to lower site burden, improved recruitment and retention and improved adherence (to both trial protocols and prescribed medications).


Wearable devices, sensors, processors, batteries, and telecommunications systems are getting better every year, creating increasing opportunities for sponsors. New, powerful digital algorithms convert measurements into novel endpoints, potentially providing new insights into the safety and efficacy of medical devices both before and after approval during post-market surveillance. These devices can also record patient responses to study protocols, test their comprehension of informed consent documents and provide direct insight into a patient’s experience living with a disease. This can help a sponsor enhance the study experience and design and reduce attrition. Finally, devices can collect data that helps sponsors pre-screen patients for their eligibility in a trial to make recruitment more efficient.


While the digitization of health devices is aimed at improving data accuracy and patient adherence in clinical trials, it can also introduce new challenges toward achieving those goals. One often overlooked, but critical, consideration for the use of digital health devices is data validation. Since these devices are new and exciting, it’s easy to focus on their capabilities. Some stakeholders tend to accept the data they generate without accounting for potential error and interpreting their significance.

Another significant challenge is the need to navigate increasingly complex regulations surrounding the use of digital health devices in clinical trials. FDA Commissioner Scott Gottlieb recently announced the FDA will enhance its focus on digital health devices next year, describing five key areas of regulation they plan to address. Sponsors must formulate and shape tailored solutions to address the FDA’s current and future regulatory expectations on digital health technology.


A sponsor can ensure the device’s design is appropriate from a research and a patient perspective by abiding by the following five considerations:

  • Usability: The device must provide the desired metric, whether heart rate, steps per day, or sleep time, in a clear, accurate, and usable format.
  • Convenience: Sponsors must consider how the patient interacts with the device. It must be of an appropriate size and weight, or reside in a convenient place, to enable natural movement, behavior, and accessibility.
  • Reliability: The device should have a battery life that allows it to function long enough to collect data with minimal glitches to maintain data continuity.
  • Reproducibility: The manufacturer or the service provider must be able to support logistics, as well as provide full documentation on how the device was built and coded.
  • Fidelity: The manufacturer must provide secure and reliable methods for transmitting data from the device to the analysis site.

Relying on an Experienced Partner

The digital component of a medical device brings value to patients, payers, and providers, increasing the return on a sponsor’s investment in a clinical trial. Novella Clinical’s MD&D division is active in the digital, mobile health and technology space, working with clinical technologies from leaders throughout the industry. Through partnerships with leading technology companies, Novella is constantly growing its knowledge base to stay abreast of innovative devices and applications to ensure our capabilities support our customers’ strategies and therapeutic needs.





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