Describing the rise of medical “wearables” in the U.S. and global marketplace as meteoric seems fitting given the rapid growth of the industry over the past decade. Wearable technology has been around for decades (check out an amusing history of some medical and not-so-medical wearables here), but mainstream adoption of the technology occurred more recently. Fitbit entered the scene in 2009 followed by several offshoots. Pebble kicked off the smartwatch craze just five years ago, in 2012. Now, one in six consumers in the United States currently use wearable tech such as the aforementioned fitness bands and smartwatches1. This trend will not slow any time soon, as the industry could see more than 3x growth in the next few years, expanding from $5.1 billion in 2015 to $18.9 billion in 20202. How will the expansion of medical wearables impact the life sciences industry?
An article on Insights, a division of Samsung focused on researching how their devices are used by everyday people in everyday life, reports on the adoption of digital health tech in clinical trials and pharmaceuticals. The article cites a survey by digital health technology vendor, Validic, on how digital health devices and data impact clinical trials:
- “Sixty percent of respondents said they have used digital health technology to conduct clinical trials.
- Ninety-seven percent of respondents said they will increase their use of digital technologies in clinical trials in the next five years.
- Mobile apps and in-home clinical-grade devices are currently the most commonly used devices in clinical drug trials, but wearable activity trackers and sensors will be the focus of future use.
- Seventy percent of respondents said patient-generated health data (PGHD) could have the greatest impact on improving treatments for chronically ill populations.”3
Current consumer-grade wearables are accessible and powerful, but a number of companies see the need to advance the use of clinical-grade devices as well. For example, the Insights article notes a collaboration between Validic and Sutter Health with the Office of National Coordinator for Health Information Technology. Their pilot project aims to determine how to best deliver patient generated health data (PGHD) to healthcare clinicians and researchers. The project “monitors and collects data from Sutter Health patients with Type2 diabetes through the SutterMpower app, which connects to devices measuring patient blood glucose, blood pressure, weight, and activity level.”3.
Medical wearables make remote monitoring of patients a powerful option for clinicians. The Insights article describes another pilot study that explores if patient hospitalization can be avoided through the combination of clinician visits to patient homes and advanced continuous electronic digital patient monitoring. In addition to improving an individual’s health, digital health tech could also reduce healthcare costs. Insights references a study published in The American Journal of Managed Care that analyzed anonymized medical and pharmacy claims data from over 1.2m patients with diabetes, high blood pressure, or high cholesterol. It was found that “payers could save approximately $38 million to $63 million per 100,000 members by deploying resources for improving medication adherence in specific patient populations.”3.
Digital health technology’s transformation of the health care and life science industries has just begun. Medical wearables bring opportunities for individual consumers to track and assess personal vital health information. Health care and life science professionals face the challenge of managing and analyzing this data while continuing to find innovative and safe ways to improve patient health while maintaining the confidentiality of private health data. Our team of experts at Pearl IRB can promptly review your study to prepare for human subject trials or support your company’s efforts to develop new digital health devices by navigate the changing regulatory landscape impacting these products.
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737495/#pmed.1001953.ref002