Though the use of wearable sensors continue to grow, the dearth of standards for sensor algorithms has at times hindered their use in clinical trials. To resolve this issue, wearable technology company Shimmer has launched a healthcare industry open-source initiative for wearable sensor algorithms. The initiative is being co-founded by Shimmer; Dr. Vincent van Hees, author of the GGIR software and algorithms for movement sensor calibration, sensor wear detection, and signal aggregation; and Nextbridge Health, which is developing the Nextbridge Exchange, an online marketplace and discovery platform for the clinical research community.
The initiative seeks to develop a curated set of open source algorithms and software tools to analyze wearable sensor data that will be available to all medical device and pharmaceutical companies in a pre-competitive environment as a service to the industry. The initiative will allow the work conducted by thousands of researchers during the past decade to be leveraged to create commonly accepted, de facto industry standards.
Though proprietary IP in the wearable sensor arena will not disappear, Shimmer president Geoffrey Gill expects the open-source initiative to be a big step forward.
“There will always be a place for proprietary algorithms and software to run devices and capture the data,” said Gill in an e-mail interview with FierceElectronics. “However, the biggest current challenge is to develop standard, validated endpoints for use in clinical trials. Industry and regulators will not accept proprietary endpoints. Some device manufacturers may push back, but most of the players in this industry understand this already. For example, a European consortium is funding a 5-year, 50 million Euro program called Mobilise-D to develop and validate mobility endpoints for five conditions. The software developed will be open source.”
Gill noted that the scope of algorithms covered will include all biometric sensors, which requires significant infrastructure and ongoing effort. He expects Nextbridge’s support to be a great help as that company is developing an exchange for clinical research that will support open-source efforts.
The initiative is expected to give sponsors access to transparent, peer-reviewed, and validated algorithms that have been commonly accepted by the industry. This advance is expected to expedite clinical trials, reducing their cost, and improve patient access to treatments. The initiative is also expected to benefit wearable sensor developers, who will gain access to accepted, validated algorithms, thus reducing duplication of efforts, and speed acceptance of new devices by the industry and regulatory agencies.
Ultimately, Gill believes the sharing of data will speed time-to-market for new products.
“For example, we developed Verisense, a new wearable platform for clinical trials. Because we used validated open source software called GGIR, our development time and effort was less than one-third of what it could have been. Even more important, accepted wearable endpoints have the potential to significantly reduce the time and cost to develop new drugs in almost every therapeutic area.”