Healthcare decision-makers have many choices when it comes to wearable medical devices. Body-worn patches present advantages for some applications.
By Deepak Prakash, global director of marketing, Vancive Medical Technologies
Healthcare clinicians and administrators alike are evaluating wearable medical devices, looking for opportunities to integrate them into their care value chain. They want to harness these new technologies to improve patient care in ways that are efficient, cost-effective, and convenient.
On the path to new paradigms, there will always be clinical, operational, and economic challenges to overcome. With wearables, devices must deliver high-quality signals, supplying information that can support meaningful analysis, encourage patient engagement, and inform treatment plans. Even when a wearable solution passes this test, there still can be many issues to resolve regarding data storage, information ownership, privacy, and system interoperability. For instance, many healthcare systems are grappling with how to integrate new Big Data streams from wearable devices into their information technology infrastructure and provider workflow.
Yet every day, leaders in clinical, IT, and executive management are making breakthroughs and finding ways to leverage wearable medical devices, including body-worn patch solutions, to transform care delivery, enhance the patient experience and, most importantly, improve outcomes.
Medical Wearables Growth: Diversity Reigns
Wearable on-body patches are one of many wearable medical device formats. Wearable applications are highly adaptable to fit diverse purposes. This is not the realm of one-size-fits-all. There are so many different applications, the research firm IDTechEx, which follows wearables closely, breaks its forecasts for medical device wearables into 12 different lines. In a July webinar, James Hayward, technology analyst, IDTechEx, explained these lines range from cardiovascular treatments/monitoring to hearing aids to continuous glucose monitoring for diabetes applications. In one webinar slide, IDTechEx stated, “In the future, the diversity of wearable medical devices will increase, with products including skin patches, apparel, and implantable devices becoming more common.”
IDTechEx estimates the medical device wearables market will reach $31.6 billion by 2026. Compared with other wearables sectors, the medical and healthcare space “is one which is a real juggernaut for the long term,” Hayward said. “The value propositions are very clear, and the product development is happening. … There is certainly a huge amount of potential, and companies are already making billions of dollars of new revenue from medical wearable technology devices.”
Medical wearables are expected to have a modest growth rate of approximately 9 percent annually, in part due to lengthy product development cycles, given regulatory complexities. “Yet this [sector] is something which could grow in the much longer term [beyond 10 years], and it could be $100 billion in market size in its own right. All the drivers are there,” he said.
Patches And Patients: Comfort And Compliance
Where do body-worn patches fit amid this wearables landscape? From a patient use perspective, body-worn patches are a discreet option that often can be worn under clothing. Device developers utilize skin-friendly adhesives and highly conformable materials to make wearable patches as comfortable as possible. Patches can be waterproof and worn for days or weeks at a time. There is a simplicity in attaching a patch and going about one’s day. All of these factors contribute to high levels of compliance among patch-wearing patients.
Like other wearables, body-worn patches present an alternative to being connected to monitoring systems with wires and leads. In both inpatient and outpatient settings, wearable patches can help improve mobility because of this wireless freedom. They also can alleviate anxiety associated with having wires attached to the body. Patches also reduce the risk of accidentally loosening a monitoring lead during activity, sleep, personal hygiene or medical care.
In a May 2015 article in the journal Frontiers in Physiology, cardiology clinicians from 11 global medical institutions explored the growing use of new wearable cardiac monitors, including adhesive patch systems, for non-invasive ambulatory electrocardiogram (AECG) monitoring and other cardiac uses. These solutions are an alternative to the use of traditional Holter monitors and similar equipment. A Holter monitor involves the use of leads, adhesive pads, and a portable recording device. “Adhesive AECG patch devices have recently been demonstrated to be superior to Holter monitors in diagnosing AF [atrial fibrillation], largely due to a longer study period and higher study completion rate owing to unobtrusive, user-friendly designs,” the article said.
“While becoming the standard for detecting arrhythmias and conduction system disorders in the outpatient setting where continuous ECG monitoring in the short to medium term (days to weeks) is indicated, these cardiac devices and related digital mobile health technologies are reshaping the clinician-patient interface with important implications for future healthcare delivery,” it stated.
Patches And Providers: Flexibility And Reliability
Beyond the benefits of patient ease of use, healthcare providers are turning to body-worn patches for reliable data and end use flexibility. Custom adhesive formulations and release chemistries can give providers the ability to tailor patches to the needs of wide-ranging patient populations. For example, patches can be designed specifically for the fragile skin of geriatric or neonatal patients. They can be engineered to alleviate pediatric patient anxiety over adhesive patch removal. Other patch designs are ideal for managing high moisture and activity levels, making them ideal for treatment and studies of athletes, soldiers or outdoor laborers.
Physicians and researchers also have been drawn to the excellent signal quality and data accuracy patches can deliver in detecting cardiac rhythms and muscle movements. Because of the intimacy of the patch’s contact with the body, very subtle signals can be detected for electrocardiography, electromyography, and other studies.
Also, patch configurations can accommodate monitoring and data collection for short- or long-term use cases, ranging from a few hours or days to weeks. They can offer on-device processing, which is helpful for recognizing certain physiologic changes and transmitting real-time alerts, such as for irregular heart beat or fall detection. Alternatively, patches also can be set up to store results for post-use analysis, which is helpful for studying sleep, activity levels and other lifestyle patterns over time.
This spring, the John Muir Medical Center, an institution based in Walnut Creek, CA, began a six-month study in which its providers are using the BeVITAL remote patient monitoring solution to follow patients who have been discharged after treatment for heart failure. The solution combines the VitalConnect HealthPatch® MD wearable biosensor with a web-based solution and app from BePATIENT. In an April announcement about the study, Vital Connect and BePATIENT said their solution “can be used to monitor and transmit eight FDA and CE cleared biometric data streams from HealthPatch MD directly to practitioners’ smartphones, tablets or computers.”
For example, doctors and nurses can be automatically alerted if a patient’s heart rate is trending too high or if the patient has not been active enough. In the study announcement, John Muir Medical Center Heart Failure Director Dr. Neal White said, “We’re looking forward to seeing how sensor technology and connected patients combine to improve heart failure outcomes for our patients, including reduced readmissions.”
Positive outcomes already are emerging from other studies involving wearable patches and associated mobile apps. In April, Proteus Digital Health presented interim results from a randomized controlled study of its Proteus Discover digital medicine solution. The solution consists of sensor-enabled medicines, a small wearable patch and mobile applications for patients and healthcare providers. “Proteus Discover directly measures medication-taking and physiology to support patient self-management and helps physicians and their care teams optimize therapy,” according to Proteus.
The interim analysis from the clinical study found that patients with uncontrolled hypertension and diabetes who used Proteus Discover achieved a statistically greater reduction in blood pressure and low-density lipoprotein-cholesterol, both of which are known risk factors for cardiovascular events. They also were more likely to achieve their blood pressure goal than patients receiving the usual care protocol. “The promising results from the pilot study demonstrate that this innovative digital approach to therapy optimization is not only patient-centered, but can lead to improved clinical outcomes,” said George Savage, chief medical officer, Proteus Digital Health.
In conclusion, body-worn patches can present compelling alternatives to traditional care protocols. They open the door to monitor and treat patients in a way that is more comfortable, private and mobile, all of which encourages patient compliance, which in turn, helps to improve outcomes. As with other wearable innovations, there can be hurdles to cross to integrate wearable patch solutions into practice. But with collaboration between device developers, clinicians, administrators and IT leaders, these challenges can be overcome, clearing the way for better outcomes and a higher level of patient care.
About The Author
Deepak Prakash is global director of marketing at Vancive Medical Technologies, an Avery Dennison business. He has 20 years of healthcare experience spanning marketing and product development. He holds a master’s degree in chemical engineering from the University of Akron and a master’s degree in business administration from Northwestern's Kellogg School of Management. He can be reached at phone 312-629-4604, email: email@example.com, vancive.averydennison.com.
Like other wearables, body-worn patches present an alternative to being connected to monitoring systems with wires and leads. (Photo courtesy of Vancive Medical Technologies)