Because of their mobility and their flexibility, wearable medical devices can make life easier, Bill Betten, president of Betten Systems Solutions LLC, told MD+DI. Adoption of wearable health technology has been on a slow path, but changes in healthcare because of COVID-19 are driving interest for a number of reasons. Betten hopes that progress will continue long after the pandemic ends, and he points to a number of opportunities for innovators.

When it comes to wearables, most people think of Fitbit and Apple Watch, Betten explained, but there is a market for wearable medical devices that could be used in a clinical environment. "If you've ever been in a hospital, there's certainly an appreciation for portable wearable medical devices," he said, recounting his own experience as a patient last year. "I woke up wired up in the ICU after surgery for a brain tumor. I called myself the ultimate connected patient."

Wearable medical devices also provide the opportunity for real-time monitoring of conditions outside the hospital, he said, pointing to devices that would be needed for episodic care (for treatment and rehabilitation for a specific condition) and to those for chronic disease care of ongoing conditions.    

IoT-Enabled Wearable Medical Devices

Can wearables benefit the healthcare industry? Betten thinks so, as IoT-enabled or what he prefers to call IoMT (Internet of Medical Things)-enabled wearable technology can accomplish several things. "It could provide data on a continuous basis, allow monitoring outside the clinic, allow physicians to look at data on a routine basis (such as from a Holter monitor or pacemaker, the ultimate wearable), and potentially make real-time patient information available," he told MD+DI. "While patient-reported information is of value, objective data [collected by a wearable] is very helpful." Data could include heart rate, blood pressure, oxygen saturation, blood glucose, even activity.

Connectivity not only enables data collection capability but also storage and transmission, he says. "Such capability opens up the field to data analysis that I'm convinced will help change healthcare in the future and provide an opportunity for new players," Betten said. For instance, data no longer needs to sit in a file room waiting for someone to retrieve it. It could be remotely retrieved and shared, he added. A key question for wearable manufacturers to answer is whether such data would need to be shared in real-time, such as with an emergency alert from a cardiac monitor or an accelerometer, or if it could be collected and retrieved as needed for trend analysis.

Medical wearables include more than data collection and transmission devices. Connectivity in wearable technology is expanding the capabilities of traditional devices to ease treatment. For instance, IoT-enabled hearing aids now enable "telefitting" or remote programming, which has eased patient access to audiologists during the COVID-19 pandemic, Betten said. Such capability may also enable hearing aid manufacturers to compete with OTC hearing aid manufacturers that could emerge thanks to pending regulations. (The FDA Reauthorization Act of 2017 set forth a process for establishing an OTC category for hearing aids and applicable requirements. FDA was expected to publish proposed regulations by August 18, 2020.) 

Betten encourages companies developing any sort of medical device to consider the possibility of connectivity. "In general, what is your connectivity strategy? Because if you don't prepare one, it could be really expensive to do so later on."

But Betten says that such connectivity must have utility. "If it doesn't provide people with something useful, they won't use it," he said.

COVID-19's Influence on Wearables

COVID-19 could indirectly increase the popularity of wearable medical devices. In March 2020 the Centers for Medicare & Medicaid Services (CMS) announced that Medicare will temporarily pay clinicians to provide telehealth services for beneficiaries throughout the country. (Prior to this announcement, such Medicare reimbursement for telehealth services was limited to certain circumstances, but generally not in the home.) The expanded telehealth benefits are authorized under the Coronavirus Preparedness and Response Supplemental Appropriations Act.

"The Trump Administration is taking swift and bold action to give patients greater access to care through telehealth during the COVID-19 outbreak," said Administrator Seema Verma in a news release. "These changes allow seniors to communicate with their doctors without having to travel to a healthcare facility so that they can limit risk of exposure and spread of this virus. Clinicians on the frontlines will now have greater flexibility to safely treat our beneficiaries." 

On August 3, President Donald Trump signed a new Executive Order further expanding access to telehealth services. According to a White House fact sheet, the order extends "the availability of certain telehealth services after the current public health emergency ends."

Betten told MD+DI that "the recent regulatory change providing reimbursement for telehealth services during the COVID-19 pandemic has encouraged the use of wearable technology." He hopes and believes "it will continue, but there is still an infrastructure issue rather than a technology issue," he said. (Coincidentally, during Betten's conversation via cell phone with MD+DI, the call dropped, demonstrating the vulnerabilities of cell-to-cell communications.)

What About Cybersecurity Risks to Wearable Health Technology? 

"Wearable medical devices face the same set of risks that computers and cell phones face," Betten said. "We need to take cybersecurity into account just as we do need to consider HIPPA, GDPR, and other data privacy concerns."

The good news is that hacking into individual devices hasn't been as lucrative as other targets such as financial systems, he said. "There may be a few thousand patients using a particular device, which may not be as appealing compared with the gains from hacking financial systems."

Still, "there are potential risks that could present life and death situations," he said. "There is a lot of energy going into managing cybersecurity for financial systems, and the medical device industry will piggyback on that work." 

Data from Wearable Medical Devices Could Drive Innovation

Data from wearable tech may provide insights that could encourage innovation. "Data can provide real-world evidence on how the wearable device is performing as well as how the patient is using it," Betten explained. "Incremental improvements can be made from understanding how the device is being used in the field."

Connectivity could be a significant step in innovation. "What happens when I pull out info that today exists in silos?" Betten asked. Data can be collected from pulse oximeters, blood glucose levels monitors, and accelerometers, but it often stays in these "silos," he told MD+DI. "But there are very few medical conditions that exist in silos."

He encourages innovators to consider what he calls "sensor fusion."

"I believe in the value of information from different sources," he said. "If you have sensors in all the right places, you can look at [the patient] holistically." There is a sensor for almost anything—the trick is to integrate them in an easy-to-use format, he said.

As examples of IoT- and sensor-enabled medical devices, Betten points to an early medical-grade wearable from Nonin, a Bluetooth-connected pulse oximeter dating back to 2009. Fast-forward to today, and multiple sensors can be integrated into watches or patches. 

Betten also called cardiac wearables "hot." He pointed to innovations such as AliveCor's portable device for on-demand patient monitoring for atrial fibrillation. 

Whether accelerometers are medical devices, however, is "debatable," he said. "They are popular consumer wearables that have value in getting patients moving, but it is important these manufacturers are clear about what patients can do and how the products have been tested." 

Risks of Wearable Health Technology 

It is important for wearable device manufacturers—and therefore patients—to be able to distinguish between consumer-grade and medical-grade wearables as well as between wellness devices and FDA-approved or -cleared medical devices, Betten said. "It is important that people understand the differences," he said, adding that it should also be clear if a wellness device is being recommended for use in conjunction with a medical device.

"In a well-designed system, hopefully, there are no risks," he told MD+DI. However, "it should be made sure that the wearer understands the conditions for which a wearable should be used. The risk comes from a patient not understanding the appropriate manner and environment for which a wearable product was designed." 

Designing a product so that it does no harm may also involve building in safety. "If I counted on a cell phone to communicate with an implanted device and then lost cell service, that could harm me," Betten explained. "Or if a sensor is designed to detect falls and communicate alerts through a cell phone, what if the wearer doesn't charge their phone?"

Some may wonder whether wearables could harm the healthcare industry, as the increasing popularity of wearables is introducing new competitors to traditional medical device companies. 

Betten told MD+DI it comes down to how medical device value is being provided. In the past, "it used to involve both a medical device and a doctor," he said. "But now there is a shift in the clinician's role with a medical device. The value chain is now undergoing a transformation."

As information is more available and silos are broken down, there will be new opportunities for competitors in the wearable medical devices market. "Disruption can be painful for entrenched medical device companies." However, "disruption is the promise for healthcare," he added.

Opportunities for Wearable Medical Device Innovators

"I am hopeful in the power of 'me'—that my information can make healthcare better for me," Betten said. 

For instance, "what would healthcare look like if a patient could see the impact of every cigarette or every added pound," he asked.

Betten offered a few concluding thoughts on future opportunities for connected wearable medical devices:

"Healthcare is ripe for disruption and change," Betten said. There are new opportunities, especially now that "reimbursement has changed because of COVID-19," he added. 

And there are opportunities for wearables that have been tested for their medical claims. "Ensuring claims are correct is important," he said. "If you have too many wellness products and a flood of unapproved devices, that's a concern. For medical applications, the veracity or truth of the data is critical. Each wearable has its place and its intended use and it is important to understand each."