Estimates vary, but one thing is certain: Wearable medical devices sector will be huge

Analysts predict market size anywhere between $7.8 and $41 billion by turn of the decade
By: 
April 15, 2016

While it is undeniable that the healthcare wearables market is growing by leaps and bounds, projections of the size of that market going into the next decade are all over the map. In March, PlasticsToday reported that one market research firm, Mordor Intelligence, estimated that the global medical wearables market will surpass $7.8 billion by 2020. Now, a new report from Tractica, a technology-focused market intelligence firm headquartered in Boulder, CO, predicts that worldwide shipments of healthcare wearables will increase from 2.5 million in 2016 to 97.6 million units annually by 2021. By that time, Tractica forecasts that the global healthcare wearables market will account for $17.8 billion in annual revenue. Yet another market consultancy, Soreon Research, estimates that the smart wearable healthcare market will be worth more than $41 billion in 2020.

Biostamp MC10
The BioStamp from MC10.

Even in the black art of business forecasts, those are some huge variances, but they can be partially explained by nomenclature. There is a difference between medical wearables, which one can assume are regulated, and the more nebulous category of healthcare wearables, which may include fitness trackers that do not fall under the purview of FDA. In draft guidance titled, "General Wellness: Policy for Low Risk Devices," published by FDA in January 2015, the agency’s Center for Devices and Radiological Health (CDRH), which is responsible for medical devices, noted that it did not intend to insert itself into the marketing of “general wellness products” that track exercise activity, for example. “CDRH defines general wellness products as products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a very low risk to users’ safety,” notes the agency in the document. Products that claim to diagnose or treat a medical condition do not fall under this category.

Interestingly, however, many manufacturers of wearable devices that used to shy away from developing products that would fall under FDA oversight are changing course. The lure is added value, and the prospect of being covered by health insurance providers. The straightest path to that is FDA approval. As noted in an article by Reuters, published in Fortune on December 18, 2015, “Consumers, doctors, payers all want to know if a product provides a clinical benefit,” said Julie Papanek of the venture capital firm Canaan Partners, who invests in wearables startups. “Working with the FDA is the one way to get the ability to market that benefit.”

FDA, for its part, is investing in resources to “prepare for the coming onslaught” of wearable devices that “detect and monitor serious diseases,” adds Reuters. “Bakul Patel, FDA’s associate director for digital health, told Reuters the agency is reviewing applications for three new senior health scientist positions focused on digital health.”

The report from Tractica notes that the healthcare wearables market is very much in its infancy, although there is a considerable amount of activity across the healthcare value chain, according to Research Director Aditya Kaul. “Wearables are being seen as an extension of the digital transformation of healthcare, helping pharmaceutical companies to expand clinical trials, enabling insurance companies to engage with customers by incentivizing healthier living, helping healthcare providers to improve the delivery of healthcare, and empowering patients by providing them access to their own health data,” writes Kaul.

Kaul adds that the market faces a number of remaining challenges related to sensor accuracy, consumer confidence, user experience optimization, customer education and regulatory hurdles.

That said, the sector is surging and medical wearable devices will increasingly become a fixture of our daily lives. Will it be a $7.8, $17.8 or $41 billion market in just a few years? Your guess is as good as mine, but it will be transformative economically and socially.

Advances in medical wearables technology

Since the beginning of the year, we have reported on a number of remarkable technological developments in the medical wearables space. In case you missed these pieces, here are summaries and links to the full articles:

A blog post published by Worrell, a design bureau in Minneapolis, MN, provides a vivid description of the far-reaching potential of wearable technology not only to monitor patients but to actively help them to heal.

The MC10 BioStamp RC has been called a “giant leap forward in the wonderful world of wearables” by USA Today, and for good reason. Weighing just under six grams, the flexible, soft and waterproof band-aid like device is unobtrusive to the wearer while providing unprecedented visibility into physiological data in real time.

A wearable device developed by NeuroMetrix Inc. (Waltham, MA) to treat a range of chronic pain conditions took first place at the 19th annual SXSW Interactive Innovation Awards in Austin, TX, last month. Quell was recognized for its breakthrough technology by going beyond traditional wearables that only offer tracking to truly improving the quality of life for its users.

A wearable medical device designed by Cambridge Design Partnership (Cambridge, UK) will help medics and first responders to provide triage on the battlefield and during natural disasters, allowing them to focus on delivering care where it is most needed and will be the most effective. The connected device clips onto the nose and delivers at-a-glance readings of respiration and heart rate of multiple casualties via a smartphone app. The readings can also be viewed individually through a tiny display on the device itself.