According to Deepak Prakash, Vancive Medical Technologies, wearable medical technology is opening new healthcare frontiers. Skin-worn patches present one path to remotely and accurately capture and monitor vital signs and other health information.
Wearable technology plays a prominent role in today’s healthcare transformation. Wearables are closely intertwined with an evolving healthcare delivery model. With this new model, care is being brought to the patient, wherever he or she is, rather than the patient having to visit a medical facility.
At the same time, many medical devices are undergoing an exciting design refresh to enhance the patient experience. They are becoming smaller and more mobile, opening new alternatives to traditional ways providers have interacted with patients, performed tests, collected data and delivered treatments.
Wearables come in many forms. There are smart wristbands, watches, shirts, shoes, shorts, caps, headbands, eyeglasses, belts and necklaces etc. Most contain sensors that gather raw data which is then fed to a database or software application for analysis. This analysis typically triggers a response. For example, it might alert a physician to contact a patient who is experiencing abnormal symptoms or it might send a congratulatory text message when an individual achieves a fitness or diet goal.
This article focuses on skin-worn wearable patches. This type of wearable does not require straps, buckles or bands. Instead, it is secured directly to the skin. Body-worn patches take a variety of formats, ranging from tattoo-like transparent films to coin-sized pods that adhere to various parts of the body.
Medical wearables – a burgeoning opportunity
In a 2014 report, Soreon Research linked the emergence of wearables to the beginning of a “deep transformation of the healthcare sector,” driven by four factors:
- A shift from disease treatment to prevention,
- Greater personalisation of medical care vs. a one-size-fits-all approach,
- Growing importance of medical standards based on “intelligent interpretation of continuously measured physiological data of a large number of individuals,”
- New players such as software and hardware companies who are changing healthcare industry dynamics. (Source: Soreon Research.)
Projections for the future of wearables vary but there is consensus that the category has high-growth potential:
- Wearable technology market: $20 billion (£13.8 billion) in 2015 to $70 billion (£48.4 billion) in 2025. Source: IDTechEx.
- Wearable medical device market: $41 billion (£28.3 billion) by 2020, 65% CAGR. Source: Soreon Research.
- Clinical and non-clinical wearable patch market: $3.3 billion (£2.3 billion) or 12.3 million units, by 2020 up from 67,000 units in 2014. Source: Tractica.
Wearable healthcare applications abound. In its study, Soreon Research focused on the following nine segments. It identified the first four listed (and underlined) below as the biggest growth segments:
- Diabetes
- Sleep disorders
- Obesity
- Cardiovascular diseases
- In-hospital monitoring
- Geriatry/personal emergency response system (PERS)
- Asthma
- Alzheimer’s disease
- Epilepsy
Wearables also are being used to monitor participants and gather data for clinical research trials and academic research studies. In addition, fitness/wellness wearables are being used as clinical tools. This complements a trend toward counting physical activity as a vital sign category. For example, Exercise is Medicine is a global initiative that has started to make steady inroads in advancing the implementation of comprehensive strategies for the inclusion of physical activity in healthcare.
As reported in MobiHealthNews, at the 2016 HIMSS Patient Engagement Symposium, Carolinas Healthcare System discussed how it is collecting data from 70 consumer health and fitness devices. The system analyses it along with clinical data and uses the findings as part of its care management programs for chronic heart failure. For example, through this patient-generated data, the healthcare system can see if a patient isn’t getting enough activity or sleep, and its care team can reach out to identify and treat the root cause of the problem.
Is a patch a good fit?
For medical device developers who are exploring wearable options, when could a body-worn patch be a good solution? There is no single answer, but here are some important considerations:
Image courtesy of Vanice Medical Technologies
Wearable patches can monitor physical activity-healthcare professionals are putting more emphasis on measuring physical activity as part of chronic disease management.
Comfort and compliance: Patient comfort, both physically and psychologically, is one of the most essential variables in designing a wearable medical device. When a patient is comfortable with a wearable solution, he or she is much more likely to use it as prescribed. Skin-worn patches usually can be worn under clothing, making them an extremely discreet wearable option and preserving the patient’s privacy. No one has to know the individual is undergoing a medical treatment or being monitored by healthcare professionals.
Likewise, because many patches are designed to be worn around-the-clock for several days to a week, they require little to no attention from patients. They can go about their daily activities without having to remember to recharge a battery or take their wearable device on and off to do the dishes or shower. The patient can all but forget about the device. All of these factors can be important for healthcare applications that require uninterrupted monitoring for multiple days.
Data quantity and quality: The type and amount of data to be gathered play major roles in determining the wearable form factor. With advances in sensor miniaturisation and battery solutions, a lot can be packed into a patch. As with any wearable solution, there may need to be trade-offs in the number of data points collected, the use period and processing power. Generally speaking, the greater the intimacy between the wearable device and the signal it is collecting, the stronger the data accuracy. Because patches provide such direct contact with the skin, they can detect very subtle changes in the patient’s physiologic condition. For example, a patch worn on the chest can sense heart signals with high accuracy. For this reason, patches can be a compelling solution for cardiovascular monitoring and disease management. For some physiological monitoring, such as that involving cardiac and muscle signals, a patch form factor may give the most viable signal from skin contact.
There are other reasons to consider skin-worn wearables. Do you need to deliver a therapy through the skin? Can you utilise signals related to perspiration? Do you want to sense changes in the blood just below the skin’s surface? For example, research continues toward a non-invasive way to measure a diabetic patient’s glucose levels through the skin without having to draw blood. Someday, there could be a wearable patch that not only detects blood glucose but administers insulin as needed.
Wearable patch material selection
Wearable patch material selection has to be a high priority because no matter what is inside the patch, if it does not adhere properly or comfortably, the healthcare application is unlikely to be successful. Not all adhesives are created equally. Here are some key characteristics to seek in next-generation adhesive formulations for wearable patches.
Skin-friendly qualities: The patch material will need to be gentle and conformable to the body’s contours. The latest generations of adhesive medical materials are very thin and breathable. They also feature just the right release chemistry, so that the patch adheres reliably yet also releases from the patient’s skin with minimal discomfort when it’s time to take off the wearable device.
Extended wear: Leading materials’ suppliers can deliver different types of adhesive systems depending on how long the patch must be worn. They can address a variety of use cases, such as whether the patient will be showering or exercising repeatedly during the monitoring period. The adhesive formulation also can take into account variables such as whether the patch will be exposed to soiling or other stressors. Extended wear requires efficient moisture management. Modern medical-grade adhesive materials offer a carefully controlled moisture-vapor transmission rate. This ensures the right balance of adhesion and absorbency.
Partnerships are important
In wearables device development, there is a need to forge alliances with partners with expertise in diverse areas. This is especially important in wearable patch development. Rarely does a single company have enough talent and specialisation in-house to master all of the core competencies. Wearable patch technology can benefit from knowledge in many areas (see Table 1).
Table 1
Wearable Patch Development: Diverse Expertise Counts
Clinical healthcare and physiology
Advanced materials science
Skin science
Adhesive chemistries
Material performance characteristics and production technologies
Contract manufacturing, such as slitting, finishing, converting and packaging
Consumer electronics (mobile devices)
Sensors and processors
Battery science
Data analytics and algorithms
Cloud computing
Wireless technology
Medical device regulatory requirements
Pharmacology (for drug delivery)
Clinical trial protocols
Software development and EMR
Social media/app development
In its report, “The Wearable Health Revolution: How Smart Wearables Disrupt the Healthcare Sector,” Soreon Research stated: “New technologies are being developed by innovative medtech companies, pharma, mobile phone manufacturers, software companies, start-ups and research organizations around the world.”
Who will be among the next wearable innovators? Is a patch the answer? With the right partners, device developers can see how their solutions could be integrated into a skin-worn patch and from there, work toward turning vision into reality.
Sources:
Dolan, B. (2016, March 1). Carolinas HealthCare monitors Fitbit data to intervene with CHF patients. Retrieved from MobiHealthNews: http://mobihealthnews.com/content/carolinas-healthcare-monitors-fitbit-data-intervene-chf-patients
Exercise is Medicine. (n.d.). Retrieved from http://exerciseismedicine.org/
IDTechEx. (February 2015). Wearable Technology 2015-2025: Technologies, Markets, Forecasts. Retrieved from http://www.idtechex.com/research/reports/wearable-technology-2015-2025-technologies-markets-forecasts-000427.asp?viewopt=showall
Soreon Research. (2014). The Wearable Health Revolution: How Smart Wearables Disrupt the Healthcare Sector. Zurich: Soreon Research. Retrieved from http://www.soreonresearch.com/wearable-healthcare-report-2014/
Tractica. (2015, May 18). Connected Wearable Patch Shipments Will Reach 12.3 Million Units Annually by 2020. Retrieved from https://www.tractica.com/newsroom/press-releases/connected-wearable-patch-shipments-will-reach-12-3-million-units-annually-by-2020/