“There are some key challenges when introducing devices into clinical studies, notably usability, adherence, and accuracy,” Golz explains. “If the wearable device you are using in your study is too difficult for patients to use, you can significantly increase the workload for your clinical research coordinators. As the majority of patients with chronic diseases tend to be older, there can be problems associated with the adoption and adherence to newer forms of technology.”
He adds: “A lot of people find them uncomfortable and don’t like wearing them at night. There is also a visual stigma associated with wearing these devices – most seniors don’t want flashy or high-tech devices on their wrist.
“While studies generally run for six to twelve months, most of the best-in-class devices only last for a few days. This means you have to rely on patients to remember to charge them, contributing to low adherence or a need for replacement devices. This results in potential data gaps or additional costs and complexity.”
Golz says there are two ways to drive engagement and reduce the daily burden of these devices on patients.
Spire Health has chosen to focus on the other path – reducing the burden to patients – when developing the Spire Health Tag.
“Our first thought was to emulate the one thing that people do everyday – put on their clothes,” says Golz. “Linking our device to clothing was a very natural step to ensure that we fit into everyone’s daily routine and they don’t need do anything different.”
This then informed every aspect of the design. Health Tags are small devices that can easily be attached to clothing – typically bras and underwear. They come in packs of multiple devices, so that each one can be placed on a different garment. They have up to 1 year battery life and never need to be charged. Devices are washer and dryer safe, so patients can just wear their clothes as they normally do.
In addition, Golz says “We typically use a smartphone as the gateway device, but it’s also possible for us to use devices like a home hub. We use bluetooth to transmit data from a Health Tag to the gateway device, which then relays it to the cloud, where it is accessed by researchers.”
These factors make Health Tags better suited for research studies than other wearables because it is frictionless and has almost no burden for patients or researchers – and so far adherence data suggests that this approach paying off.
“We’re running a long term clinical study right now in COPD in which 86% of all hours have been monitored,” says Golz. “I don’t think any other wearable device would be able to do that.”
He adds that data accuracy is a common concern among wearables, especially for smaller devices. To address this, Spire Health has run validation studies to prove the Health Tag’s accuracy, benchmarking them against gold standard technologies. “We can capture respiration data at a level no one has been able to see before, with the full morphology of the breath curve visible including inspiration and expiration breadth, depth and ratios between. In addition, we can also monitor heart rate, activity, sleep and stress.”
Dr Richard Murray, a prominent pulmonologist and big pharma veteran, was so impressed by Spire Health’s technology that he has since joined the company as CMO. He stated that in a world of incremental innovation and me-too drugs, quality of life measures like these can be a vital differentiator: “The ability to distinguish different members of the class based on more patient-centric endpoints is very important. While respiratory rate is an important endpoint for several diseases, that data has been notoriously unreliable because it is often an afterthought annotated by staff. We now have a way to continually monitor it with high accuracy and see trends or responses to interventions.”
He adds: “Increasingly there’s also a desire to have studies not be tethered to physician or nursing visits. Wearables can keep the costs of visits down and provide real data instead of self-reported physiological assessments that are one step removed from reality.”
To aid researchers in handling the large amount of raw data being collected from the Health Tags, the company has just launched its Spire Health Research Platform.
Golz adds: “Having full control and visibility of your study is really important, but clinical operations staff and clinical researchers should not be expected to be experts in specific technology. We’ve created a solution to address those needs by including a compliance and real time monitoring service, which helps patients get setup and accustomed to using the devices and then ensures that they are wearing the devices at all times. We have the ability to prompt them with text messages or phone calls if they stop wearing them; this reduces gaps in data, which could compromise a study.
“Another unique feature is that we give researchers full access to the data. While most companies only provide processed data, Spire Health provides access to every metric we capture at a granular level, which can easily be accessed via a portal or integrated directly into existing study data capture systems via an API.”
With Spire Health having found several ways to address what it sees as the biggest challenges associated with wearable devices, Golz is confident that Health Tags and the Spire Health Research Platform will be successful. He adds: “In healthcare there is sometimes a hesitation to adopt wearables because some people think it makes trials more complicated. Right now we’re seeing the innovative, vanguard companies having a go at it, but in five or ten years’ time you’ll see that most studies run will have some form of wearable or data capture device in them.”
Dr Richard Murray is currently chief medical officer at Spire Health. He joined Spire Health in December 2018 after spending a year at Harvard University as a fellow at the Advanced Leadership Initiative. He was previously at Merck & Co. in a variety of senior positions in medical affairs, scientific affairs, chief medical office and chief patient office.
Phil Golz is an entrepreneur and healthcare innovation specialist who has worked in healthcare roles for almost 20 years in the United States, Europe and Latin America. Prior to joining Spire Health as the VP of healthcare, Phil held a number of roles within the Pharmaceutical industry (Johnson and Johnson, GlaxoSmithKline and ViiV Healthcare) and more recently led the commercial development and US office of HealthUnlocked, a prominent social network for health.
Spire Health is the leading digital healthcare company for continuous respiratory monitoring and actionable feedback. The Spire Health Tag enables remote patient monitoring with unparalleled adherence and clinical-grade accuracy. Spire Health’s remote patient monitoring approach has the potential to identify and predict health events, enable early interventions, and prevent hospital admissions. Spire is backed by leading medical health investors and has received a grant from the US Department of Health and Human Services. For more information visit: www.spirehealth.com