Ready to Wear -- Wearable Medical Devices Are Becoming Fixtures in Everyday Life

Much more than just accessories, wearable medical devices are being used by an increasing number of patients to diagnose, treat, and monitor their diseases. The wearable medical devices market, valued at USD $27.91 billion in 2019, is expected to reach USD $74.03 billion by 2025, while exhibiting a CAGR of 17.65% over the forecast period of 2020 to 2025, according to a report by Mordor Intelligence. MD+DI spoke with industry experts to determine what companies are the top manufacturers of wearable medical devices, what tech companies are developing new wearable devices, and what startup companies are creating wearable medical devices.

The trend toward the development and use of wearable medical devices has exploded in the past few years, and all sources indicate that the demand for wearable technology will only increase over time. There are a lot of trends that have lead to the increased popularity of wearable medical devices, but one of the most important is that wearable technology could help improve a patient's quality of life by enabling continuous monitoring of various conditions. Both users and physicians are driving the growing trend toward wearable devices.

"On the patient side," Tina Deng, medical devices analyst at GlobalData, told MD+DI: "There is a growing population of those who are comfortable with technology, a growing popularity of health and wellness, and an increased demand for patient-centered care.

"From the physician side," she continued, "the trends include big data as well as treating patients using personalized, preventative, and remote care during the COVID-19 pandemic. Macroeconomically, the aging population and emerging markets are the main market drivers," she said.

New technologies and the rapid adoption of them are also enabling the boom in the wearable medical devices market. "Apps as a whole are the engagement accelerators on wearable devices that users communicate with," said Deng. She stated that advancements in wireless communications technology have driven the highest growth in the market.

"Last, but not least," Deng said, "are computation tools and machine learning software to analyze data that are collected or transmitted to the wearable medical devices. The development of AI tools for data analysis and cloud-based service also accelerates the development."

Danielle Bradnan, analyst at Lux Research, credits computer vision for allowing new wearable device development. "Through computer vision and also, increasingly, natural language processing, it's becoming possible to integrate things like electronic health data records with your wearables data, and so it's allowing for this more complete picture of the individual, which in turn drives more personalization in care," she said.

She added that that there is an element to crowdsourcing with wearables that traditional medical devices don't have. "People tend to be just a little more relaxed than about their traditional medical data," she explained.

Who Are the Top Manufacturers of Wearable Medical Devices?

According to Deng, the top manufacturers of medical device wearables are Medtronic, Abbott, Omron, Dexcom, Philips Healthcare, and Masimo.

Three of the top manufacturers are in the wearable diabetes care market. Medtronic is currently developing its Personalized Closed Loop (PCL) insulin pump system. In December 2019, the company announced that it had completed the acquisition of Klue, a software company focused on behavior tracking that can provide real-time insights into when a person is consuming food. Medtronic says this technology is expected to be incorporated into the PCL to automate insulin delivery in a way that is real-time, personalized, and adapts to the user, with a goal of dramatically simplifying diabetes management for the patient.

Abbott's FreeStyle Libre 2 system was recently cleared by FDA as an integrated continuous glucose monitoring (iCGM) system for adults and children, ages 4 and older, with diabetes. The company says that it is the only iCGM system with optional real-time alarms that measures glucose levels every minute. The sensor is worn on the back of the upper arm for up to 14 days and with a one-second scan using a handheld reader, users can see their glucose reading, trend arrow, and eight-hour history.

Rounding out the diabetes management companies, Dexcom offers the G6, a continuous glucose monitor that is FDA-permitted to make diabetes treatment decisions without confirmatory fingersticks or calibration. The device is a small, wearable sensor and transmitter that sends glucose numbers to a smart device or receiver every five minutes.

HeartGuide, from Omron, is a wearable blood pressure monitor in the form of a wristwatch. With its companion app, HeartAdvisor, the device tracks and manages a patient's blood pressure fluctuations with clinical accuracy. Users can collect, review, and store information as detailed, usable data to enable patients to develop a more thorough understanding of how their lifestyles directly impact heart health.

Philips Healthcare makes a wearable sensor that provides a convenient and comfortable way to keep watch of patients in need of frequent monitoring. The self-adhesive biosensor automatically and continuously measures vital signs, body posture and step count, and detects falls.

Masimo offers the MightySat, which it says is the only fingertip pulse oximeter to measure five key vital signs: oxygen saturation, pulse rate, breathing rate, perfusion index, and pleth variability index. It uses its proprietary Signal Extraction Technology that uses advanced signal processing techniques to separate the arterial signal from sources of noise. This enables the device to deliver accurate measurements even in conditions such as movement and cold extremities.

When asked what makes these top wearable medical device companies stand out from the rest of their competitors, Deng noted that they are constantly investing in technology innovation and targeting a large patient pool.

A timely illustration of this innovation and adaptation to current needs is the response of wearable medical device companies to the COVID-19 pandemic.

For example, Masimo has developed the SafetyNet-Open COVID-19 remote patient monitoring solution, which is already being used by hospitals to help keep safe not just their patients, but also their frontline workers. Masimo SafetyNet-Open helps coordinate the continuous monitoring of people through a variety of sensors and an app. Using a centralized dashboard, the system can help organizations better understand patterns that may support contact tracing. The system components work together to provide integrated and secure monitoring that organizations can use to identify when additional actions may be needed.

Dexcom has recently partnered with Current Health to add continuous glucose monitoring capabilities to Current Health's AI-powered remote patient monitoring platform. Using this platform, healthcare providerscan determine whether a patient needs in-person attention or if their symptoms can be treated at home. This is especially important for diabetic patients, who are at a higher risk of becoming infected during the COVID-19 pandemic.

Which Tech Companies Have Branched Out to Create Wearable Medical Devices?

Big technology companies are taking note of the growing demand for wearable medical companies, and some are edging into the medical device market, whether with partnerships, or supplying data, or even providing hardware, such as the sensors.

"I'm going to start with the major players—Fitbit, Apple smart watch," Bradnan said. "I'd also include Oura, which makes a smart ring, and WHOOP, which is a more sports-focused wearable that has an emphasis on recovery. I would also include Google because they have a lot of partnerships with wearables and, in the event that Google is actually allowed to purchase Fitbit, that will really help Google in that space."

Deng named Apple, Google, Samsung, Fitbit, Sony, Microsoft, Huawei, and Xiaomi as her top tech companies in the wearable space, noting that some of these players have received FDA approval for medical use for some of their products.

Bradnan said these tech companies have long provided the kind of consumer health information for what has historically been known as the "worried well." "But then companies started to realize that they were collecting an enormous amount of healthcare data, and they could actually do something with it," she said. "And that's when you start to see the real advances like Apple's EKG trial, which Fitbit also has now, too."

Fitbit is currently conducting a heart study with Plushcare and has also recently launched a COVID-19 feature with them that allows the user to connect with a doctor virtually and access information about exercising indoors.

Bradnan said that the tech companies are great at collecting digital biomarkers in a continuous, noninvasive manner with their devices. "Wearables are perfect for that," she said, noting that AI can then be used to derive insights from that data.

"Fitbit and Oura and WHOOP have been on the market for a while, and they have been able to collect huge data sets that are increasingly being shown to predict disease, not only [for conditions] like diabetes, but back in January, the Scripps Institute showed that you could identify individuals who are going to get the flu before they actually had it, based entirely on Fitbit data, which is really cool."

There is a huge need in the medical community to get a lot of this continuous data, Bradnan said. "Volumes of data are needed, and wearables companies are also sliding in with partnerships that way."

There are many potential ways in which the tech companies can interact with medical device companies to create wearables. "There are the classic wearables, there's partnerships with apps going into them," she said. "There are also the companies that are just building the hardware for a start-up company that just wants to have their focus on the software and their own secret sauce."

"So there's two big flavors [the tech companies are doing], there's actually working with medical professionals to help build out diagnostics and pharmaceutical solutions. And then there's the consumer-focused, which is just sort of edging constantly toward more and more medical applications," Bradnan concluded.

What Startups are Developing Wearable Medical Devices?

Many startups are focusing on developing algorithms to detect or monitor specific digital biomarkers and forging partnerships or just flat-out purchasing the sensor component to their devices. Sensors are not hard to get, Bradnan said. "You can use them off the shelf. The problem for a lot of startups is that requires a lot of capital, and so there has been this emerging trend that companies are manufacturing what I call a blank wearable," she explained. "In February, Sony did their hard launch of what you think of as a blank wearable. There's no software associated with it, just sensors and the band."

She said that Sony's approach there is to try and target companies whose "special sauce" is their algorithm. "It's making it cheaper so that you don't have to build your own. You can just leverage someone else's off-the-shelf wearable and it's your own product. And so that is an emerging trend that we're seeing."

Sensor capability was a big factor for Overwatch in choosing the hardware for its Overwatch Seizure Detection app. The company makes a monitoring application that pairs with the Apple Watch to detect seizure-like movement and sends alerts to caregivers in real time for people living with epilepsy.

Although Overwatch does have plans to expand to an Android platform in the 12 months, company co-founder and Director of Patient Advocacy Stephanie Fokas said that they chose the Apple Watch as the first platform because there were so many complementary features on it.

"We knew that it would be helpful to utilize all of the features available on an Apple Watch for the epilepsy community. As an example many people experience heart-rate changes when they are going to have a seizure," Fokas said. "So if their body feels it is going to have a seizure, their heart rate starts to go up. In addition, the worry about a huge drop in the heart rate would be very important, too, because of a condition called SUDEP [Sudden Unexpected Death in Epilepsy]," she explained.

"Walking our customers through how to use heart rate functionality on the Apple Watch is actually part of our user manual. We want to make sure our customers are taking full advantage of the Apple Watch features, in addition to our seizure monitoring, to receive the value of what both Apple and Overwatch together bring to the table."

Nanowear takes a different approach and embeds its sensors into its products. The company has developed a cloth-based diagnostic monitoring nanosensor technology. Its first product, an FDA-approved device called SimplECG, is a remote cardiac monitoring undergarment that collects continuous multichannel ECG, heart rate, and respiratory rate data from the garment and transfers it to a web-based portal for review by a physician, by way of a mobile application. The initial version of the product is iPhone-based.

Recently, Nanowear has applied for FDA approval for its SimpleSENSE, a monitoring undergarment and closed-loop machine learning platform, which captures and algorithmically scores phonocardiography, impedance cardiography measuring stroke volume and cardiac output, multichannel ECG assessing heart rate and heart rate variability, respiratory rate, thoracic impedance, activity, and posture.

"Nanowear's core of cloth-nanotechnology sensors is a differentiator from smartwatches, adhesive patches, and other medical or consumer wearables," said Suraj Kapa, MD, of Mayo Clinic, in Nanowear's press release. "With billions of touchpoints per centimeter and large vectors across the heart and lungs, Nanowear's skin-to-impedance barrier is lower than other wearable sensors, resulting in location-agnostic, high signal-to-noise raw data from basic skin contact. The breadth of metrics, quality and quantity of data, and comfortable user experience are key for machine learning algorithms in various diagnostic verticals, even beyond healthcare."

Startups are also exploring therapeutic wearable devices. Innovators from Purdue University have created a wearable patch to provide an improved treatment experience for people with melanoma. The patch has fully miniaturized needles, which enables drug-delivery through the skin for the management of skin cancers. The patch is fully dissolvable by body fluids in a programmable manner so that the patch substrate is dissolved within one minute after the introduction of needles into the skin, followed by a gradual dissolution of the silicon needles inside the tissues within several months.

"The uniqueness of our technology arises from the fact that we used extremely small, but long-lasting silicon nanoneedles with sharpened angular tips that are easy for their penetration into the skin in a painless and minimally invasive manner," Chi Hwan Lee, a Purdue assistant professor said in a company statement.

Where Is the Wearable Medical Devices Market Expected to Perform Best in the Coming Years?

North America was the largest segment of the wearable medical devices market in 2019, owing to the growing prevalence of cardiovascular disorders, diabetes, and cancer within this region. In addition, the rise in chronic diseases that need routine monitoring and presence of sophisticated healthcare infrastructure are further likely to drive market growth over the forecast period.

Asia Pacific is expected to witness exponential growth over the forecast period. Major factors boosting market growth are favorable government initiatives for use of such medical devices, an increasing geriatric population base, and increasing healthcare expenditure in this region.

What Factors are Expected to Have an Impact on the Wearable Device Market?

Although the wearable device market will undoubtedly grow, there are still some pitfalls companies should be aware of. "A number of factors are inhibiting the market," Deng cautioned. "From the patient side, the high cost of wearables, difficulty in getting them reimbursed, and concerns over privacy are all barriers to wearable use. Physicians are less likely to suggest use of wearables due to a perception of poor quality of data, as well as a lack of clinical evidence supporting them. Finally, regulation slows down the pace of innovation in the wearables market," Deng concluded.

Despite these concerns, all signs point to the wearable device market continuing to expand. Both established and startup medical device companies and increasingly, tech giants, are responding to demand for these products and ever-developing new technologies in wireless communication, AI and machine learning tools, and growing acceptance by patients are paving the way forward.