Could This Device Bring Us One Step Closer to Predicting Illness?

HHS funds further research of a wearable device that could warn of early illness.

It's a device the size of a key fob that measures breathing, heart rate, sleep, and movement. It can be attached to clothing such as undergarments, requires no recharging, and will survive cycles through the washer and dryer.

The U.S. Department of Health and Human Services (HHS) is hoping that one day this easy-to-use monitor will issue early warnings that the individual wearing it is about to become sick. The implications for health systems managing population and chronic health initiatives is obvious: early detection and treatment of illnesses such as the flu could prevent hospitalizations, improve outcomes, and lower costs.

San Francisco-based Spire received a $62,200 grant from HHS to further gather data from these devices and discover, through artificial intelligence, if patterns exist that can predict the onset of illness. The total cost of the project is $88,860, with Spire providing the retaining funds.

The product, Health Tag, is already commercially available for consumer health and wellness use to monitor sleep, stress, and activity. Currently available in a variety of package sizes, with a heavy adhesive for each unit that does not loosen during laundering, individuals using the sytem can attach the monitors to frequently worn clothing and never have to check them again to download information or change batteries. Collectively, an 8-pack lasts about 18 months, says Jonathan Palley, CEO and co-founder of Spire.

The device can send messages to the user’s cell phone to report findings and alert the wearer to real-time bio-signals, like heart-rate and breathing variability, stress levels, and other changes in the user's unique health signature.

One reason Palley believes Health Tag offers advantages over other such devices on the market is that it requires minimal interaction to operate.

"It really solves the adherence problem," Palley says. Ideally, data from such monitors needs to be collected continuously, but If constant interaction is required, compliance drops, he explains.

The grant to Spire was awarded through the Division of Research, Innovation and Ventures (DRIVe), a division of the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response. One expected outcome from this venture, says Palley, is that BARDA will be able to accelerate development toward Food and Drug Administration 510K clearance.

Palley says he was not aware of opportunities to work with BARDA before the agency approached his company. DRIVe is spurring innovation in the way the government prevents, detects, and responds to major health security threats. The grant was awarded as part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio to develop products that will let people know they are sick before the first symptom appears.

A news release from DRIVe further explains the organization's interest, "Innovative technologies like wearable ENACT products hold the potential to also strengthen the nation’s ability to protect Americans from health security threats and to save lives."

In July, BARDA granted funding to two California-based biotech companies for development of at-home flu tests. In September it announced an award to EnLiSense to accelerate development of a wearable device that detects infections in a person’s sweat. The division also has an initiative related to prevention and early detection of sepsis.

Editor's note: This story has been updated to note that the product is available in a variety of package sizes and does not track body heat, as indicated in a DRIVe news release.