Wearable medical glasses

Beyond the Fitbit: The Changing Landscape of Medical Wearables

Yearly growth of the wearable tech market is predicted to increase 23% to over $100B by 2023 and over $150B by 2026, according to IDTechEX. The Apple Watch stands at the front of the pack with 20 million new watches shipped in 2018. Yet, it was just a year ago that analysts suggested that the wearables market was on the decline, fading quickly after bursting onto the scene with great fanfare. Why this pessimistic view? A large presence by wearables firms was noticeably absent from the Consumer Electronics Show (CES) in 2018, spurring analysts to wonder whether the trendy tech had lost some of its panache. Even Fitbit, the granddaddy of consumer wearables, was largely silent at the show.

But reports of the demise of wearable tech seem premature, at best. Wearables, in particular medtech wearables, are actually rising in popularity. According to Report Linker, the global market for wearable medical and health-related devices is expected to reach nearly $19.5 billion in 2021. Innovative medtech devices were showcased prominently at this year's CES, and a growing number of firms are actively developing wearable products.

Wearables for a Healthy Lifestyle

Since smartphone technology first appeared, innovators have been figuring out uses for body-mounted sensors connected to a smartphone-based interface. Perhaps the most visible product (though certainly not the first) in what's now referred to as the medtech wearables category, the wrist-worn Fitbit rolled out in 2013. (Non-wrist Fitbit versions first hit the market in 2009.) It tracks health-related metrics like heart rate and sleep quality using sensors to provide users with information to help them make better wellness choices.

While Fitbit was early to market, these days the shelves are crowded with consumer-targeted "entertainment and informative" wearables. There are smart watches, rings, necklaces, jackets and even shoes, to name but a few, that all integrate with cloud-based systems. These clever bundles of sensors and connectivity collect a wide range of biometric data and make it accessible to users typically via smartphone app. Heart rate, blood pressure, daily caloric intake and a host of other metrics can now be collected, analyzed and visualized.

Some of these devices offer groundbreaking tech, while others simply adapt existing tech for a new purpose. For instance, the Owlet smart sock uses pulse oximetry, technology already used in devices targeted at adults, to track an infant's heart rate, oxygen levels and sleep. The device pairs with a base station that lets parents know if heart rate or oxygen levels exit preset zones. Existing tech, new use.

Though the market for fitness trackers and similar products has matured, there is still much excitement in the wearables space revolving around "diagnostic and assistive" wearables — devices that go beyond mere entertainment. These devices quantify vital data for people with serious conditions from asthma to heart disease, and some devices even help people actually address specific conditions, not just capture data.

At the CES 2019, one of the novel and highly lauded devices making its debut was the Dfree from Triple W. Dfree, which stands for "diaper free," consists of a small sensor that is taped to the user's torso to monitor his or her bladder fullness. When a preset level is reached, the device sends a notification to the user's tethered smartphone. Targeted at the elderly and the disabled, this device could be life-changing for some users. That's one of the reasons it won the 2019 Best of CES award in the Digital Health and Fitness Category.

Also making its CES debut this year was Samsung's consumer exoskeleton called the Gait Enhancing Mobility System (GEMS), which provides the wearer with walking assistance and posture correction.

Additionally, there was buzz about the emerging category of "hearables." These small, wearable audio devices offer much of the same functionality as other types of wearables, such as the ability to measure activity and vital signs like heart rate, body temperature, blood pressure, ECG and pulse oximetry. And like most wearables, sync to mobile phones or smart home devices.

But hearables aren't simply headphones for listening to the latest beats. They're typically designed for more serious uses. Some offer sound amplification for users with hearing loss, similar to traditional hearing aids, but at a fraction of the cost. Plus, these new Bluetooth-enabled hearables integrate with the user's iPhone for maximum convenience. Some hearable devices incorporate biometric personal identification using sound waves to acoustically recognize a user based on ear size and shape, while others incorporate layered-listening technology that allows users to filter out or enhance specific sounds.

The FDA Takes Notice

Perhaps the most exciting thing about the medical portion of the wearables market involves the changes impacting the industry courtesy of the Food and Drug Administration's (FDA) 21st Century Cures Act of 2016. Though the agency is concerned about the implications of self-diagnosis and has slowed approval for certain devices designed to actually treat diseases, the FDA has established processes to fast track new wearable medical devices the agency classifies as Class 1 or "low risk."

The FDA guidance contained in Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act aims to help companies that develop wearable medtech navigate this shifting landscape. Their Digital Health Innovation Action Plan document further describes the agency's shift in thinking about digital devices and outlines a plan that allows select companies to become pre-certified to market their low-risk devices with minimal FDA review. This pilot pre-certification program, launched in July 2017, is intended to regulate standards for companies and software, not individual wearable devices.

Pilot participants span medical product manufacturers and software developers building high- and low-risk medical device software products. Companies include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Samsung, Roache and Phosphorus.

The Challenge for Designers

Learning how to design appealing, useful and compliant wearables, both entertainment-level and more hospital-grade devices, is an exciting challenge for user experience (UX) practitioners. Designers need to consider use cases that span both the digital and physical worlds, and figure out how best to meld the two. Information is today's building material, as pliable as clay in the hands of talented designers and developers.

Designing for the wearable experience covers several areas: the physical device; the service that the device enables or accesses; and the digital aspect of the service, such as a mobile app or a web portal. Designing the physical device is a multidisciplinary endeavor encompassing branding, ergonomics and industrial design.

Designers already have a pretty good handle on the digital aspects of wearables. If the device has a small screen, they can apply many of the same techniques and heuristics that are used to create digital experiences on mobile phones. However, an increasing number of wearable devices do not have that screen so their users have to get information from the device in other ways. LEDs, haptics, even sound, can play a part in letting the user know what the device is up to.

Since many devices forego any kind of screen, developers move complex inputs and output to the companion device, say smart phone or voice assistant. The companion mobile app allows users to configure the device, and it provides more-involved access to the functions of the physical device. Since the device is pushing data at the smartphone, it's a short step to getting that data over the internet and making it accessible over the web.

As the IoT becomes ingrained in modern life, wearables of all sorts — but particularly the more clinical, assistive and diagnostic-type devices — offer clever and convenient ways to improve people's lives. As designers, it is our job is to make wearable (and hearable) tech not only helpful but as safe as possible. By applying UX best practices to interface design, we can shrink the potential for human error and thus deliver better, safer products.

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