The company recently released its first Device Census Report in conjunction with news that it has been awarded a $225,000 Phase I Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).
“Through this grant and our own research, it’s clear that real-world data in clinical trials and the health care system more broadly is not far off,” said Dr. Sam Volchenboum, co-founder and chief medical officer of Litmus Health, which provides a real-world data (RWD) platform designed to capture and position data from wearables, smart devices, and home sensors.
"While we still have a long way to go – the maturation of the devices, the way in which we handle data in terms of both collection and management, and of course the regulatory environment, it’s clear wearables bring untapped potential to clinical trials, enabling researchers and clinicians to capture data at the point of experience.”
Volchenboum said it has always been the company’s goal to “make the whole world one clinical trial,” and now he believes the industry is officially on board.
The top wearables for RWD collection
The top 15 devices (in no particular order):
- ActiGraph, GT9X Link
- ActiGraph, wGT3X-BT
- Apple Watch Series 4 GPS
- Empatica E4
- Fitbit Ionic
- Garmin Vivomove HR
- Huawei Band 3 Pro
- Nokia Steel HR
- Polar A370
- Samsung Gear Fit2 Pro
- Spire Health Tag
- Striiv Apex HR
- Atlas Shape
- VitalConnect VitalPatch
Litmus Health’s profile of the wearables market examined more than 170 brands and manufacturers. The report recommends the top 15 devices for clinical research based on a scoring rubric, which took into consideration elements such as price, form factor, battery life, and connectivity. Though Volchenboum told us the metric of most importance was quality of the data.
The report also introduced a device transparency score indicating how open the device maker is about produced and available data.
Is the researcher given raw or derived data, or has the data been processed through an algorithm first? If so, what does that transformation comprise? Is the data’s provenance clear? Is the device identifier and serial number available in the data? The company asked these questions in its review.
Volchenboum said the answers and subsequent transparency score will help researchers understand the quality of data. “While device accuracy is important, what is more critical is how to measure and account for data quality and consistency,” he added.
The chosen top 15 devices stand out in terms of functionality, but exceed other industry competitors in data management and transparency, said Volchenboum.
“All of these devices have the potential for a future in pharma and health care – and that has everything to do with the quality of the data,” Volchenboum said.
“For researchers incorporating real-life data into studies and trials, the type, origin, and distribution of the data coming off these devices are the most important factors, and that's why these 15 have made our top list.”
As to where the medical devices of the future will be developed, among health care, life sciences, or other players, Volchenboum said there are many factors, though he expects tech companies will continue to lead for the foreseeable future, especially in the wearable market.
“Health care has been smart about their adoption, they recognize that it’s easier to meet the consumers where they are – in the wristband of Fitbit and Apple Watch’s – than try and disrupt both the medical device industry and the consumer market all at once,” he said.
“These technology companies are also doing well to do their part to make sure that these devices serve the need of the industry. There’s a long way to go, but we’re making good progress.”