Google’s quest to expand its positioning of smart wearable devices beyond a contact lens for glucose monitoring has led the company to develop a new health-tracking wristband that can monitor pulse, heart rhythm, skin temperature, light exposure and noise levels for use in clinical trials and provide physicians with real-time data about their patients’ activity and vital signs between checkups.

The proposed prescription-only Google wristband, announced last week, is still in the prototyping phase with first human testing for accuracy set for later this summer. If those tests are successful, Google will start identifying and selecting potential manufacturers to scale up production.

The research and development of these special wristbands comes from the life sciences group operating inside Google’s X research division. The wristbands are not intended to be consumer devices, which represents a major difference between the Google wristband and the Apple Watch. Apple chose not to launch additional health monitoring sensors as those capabilities would require FDA evaluation and approval.

Google, which will seek FDA approval, said it is working with academic researchers and biopharmaceutical companies to make sure the device and its sensors are accurate, credible and helpful to medical professionals and the clinical research enterprise.

“Our hope is that this technology could unlock a new class of continuous, medical-grade information that makes it easier to understand these patterns and manage serious health conditions,” Andy Conrad, head of Google’s life sciences team said in a statement, adding that the company plans for the new sensor-packed wristband “to become a medical device prescribed to patients and used for clinical trials.”

Last summer Google launched a new project—the Baseline Study—to learn about the human body and to detect fac­tors associated with the early onset of fatal illnesses such as cancer and heart disease. Google said the new wristband would be used in the Baseline Study.

Google has been involved in other clinical research activity recently including a partnership with Biogen on a multiple sclerosis project tracking patients’ disease progression and another with Novartis to develop a contact lens that can monitor glucose levels from tears.

Initial industry reaction to the new an­nouncement is positive. The market views this strategic move as a major signal that Google is extending its portfolio beyond consumer technology products to new and potentially large markets.

“For Google, the wristband could be a big win,” said Matt Winslow, co-founder at Conversant Health, a company focused on delivering critical research outcomes through a patient-centric and modular tech­nology platform. “The challenge for Google is how they normalize the data and present it in a way that is digestible and actionable. Some researchers will also be interested in using these sorts of devices to improve healthy living,” he said.

Other insiders and observers believe the Google device may be suitable for some—but not all—disease conditions such as insomnia and outpatient cardiovascular safety that affect the quality of life as it relates to activity.

“If the Google wristband can improve or at least maintain the resolution and/or make the miniaturization of technology more seamless and less obtrusive to patients, then that will see a success,” said Nicholas Rich­ards, Parexel International’s vice president, product management. “Some of today’s wearable devices are clunky and will affect the patient’s experience due to their design leaving much to be desired.”

“Google’s ability to develop a device that can detect motion—for nocturnal scratch­ing, for example, where a patient has a skin inflammation from eczema, or movement associated with an epileptic seizure—could be a major improvement in the use of wear­able devices in clinical research,” Richards said.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 26, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »