A wearable medical device may be defined as a biosensor that monitors physiological data, usually with remote/wireless communication, as part of any wearable item that attaches to the body. Activity monitors, smart watches, smart clothing and patches are examples.

Most wearable medical devices to date have been concentrated in the arena of activity and exercise (walking, jogging, or other exercise parameters such as muscle activity) and measure distance traveled, calories burned, heart rate, etc. Some even include GPS monitoring and tracking to enhance accurate measurement of distance.

Other devices encompass a wide range of physiological measurements and, in the future, may incorporate enhanced functionality, including monitoring and/or analysis of:1

  • Blood pressure
  • Brain activity
  • Continuous glucose
  • EKG
  • Eye tracking
  • Hydration
  • Infant care
  • Ingestion
  • Oxygen level
  • Pain relief
  • Posture
  • Radiation exposure
  • Respiration
  • Skin conductance
  • Sleep
  • Temperature
  • Besides consumer and clinical/medical uses, there are also workplace and military applications.

From a business point of view, the size of the wearable medical device market is huge and fast-growing. Estimates predict that it mayreach up to $53 billion worldwide2, with 25–35 percent annual growth within the next three years. Smart watches will dominate initial sales within the wearable device category according to many sources, with the Apple Watch accounting for perhaps 40 percent of units shipped.3Google Glass and smart wristbands may also have billion dollar potential.4

From a business point of view, the size of the wearable medical device market is huge and fast-growing. Estimates predict that it may reach up to $53 billion worldwide2, with 25-35 percent annual growth within the next three years. 

What is Inhibiting Growth in the Medical Device Wearable Market?

Several factors inhibit the growth of this market, particularly in the clinical/medical category:

Many consumers see no need for consumer wearable devices or feel that the costs of these devices are unjustifiable given their lifestyle. Greater usefulness and perceived value of the devices – driven by more functionality and standalone capability like being able to operate without a smartphone or other external device – will increase consumer acceptance.

Cost may inhibit growth in the clinical sphere. It is not clear to what extent payers (e.g., insurance companies) will cover such devices.

Perceived inconvenience of the device plus complex usage instructions.

Consumer Privacy and Security Concerns

Challenges in integration of devices and information processing systems. For clinical/medical devices, the information systems must be able to handle large amounts of data in real time. Paradigms of how patients and their physicians discuss and share information will also have to be changed.

Clinical medical devices need to be highly accurate and reliable, with recording times stretching to a year or more. Better long-lasting micro batteries may need to be developed.

Low consumer adherence/compliance, especially for a device that has to be worn 24/7. Some studies have shown that, within 18 months, fewer than 50 percent continue to use the device. We suspect that the fall-off is even steeper and occurs earlier and that wearing a device on a 24/7 basis may be considered too difficult, interruptive or unreasonable for some consumers.

The difficulty of engineering a consumer device that works for a large- scale population. For example, advanced health features such as EKG, stress monitors, or blood pressure monitors have been cut from the Apple Watch. Although Apple is said to have had meetings with the FDA about these advanced features, engineering challenges are the chief cause of their elimination. The applications supposedly did not perform well on individuals with dry skin and hairy arms. Furthermore, performance varied substantially depending on the fit of the watch on the arm.5

Some Interesting Consumer Devices

Smart watches and advanced versions of these devices will dominate sales. Several devices now available are innovative and worth mentioning.6

Lumbo Lift measures your posture. When you slouch, it vibrates and thus indicates the need to change your body position. The small sensor cube can be worn as a fashion accessory or hidden under clothes. The retail price is around $100.

Jabra’s Heartrate Tracking Earbuds. The originality of this device lies in the form factor being earbuds rather than a smart watch. According to the manufacturer, they are the only device of this nature to deliver clinical grade data. It integrates training management and has three fitness tests. The average retail price is under $200.

Mimo Baby Monitor measures respiration, skin temperature, body position, sleeping and activity of infants. It is washable and you can check on your baby from anywhere in the world. The retail price of the starter kit is around $200.

Withings Aura Sleep Tracking Device tracks REM and light sleep, wakeups and total sleep duration and makes suggestions regarding how to improve the quality of your sleep. It also serves as a daytime activity monitor. The retail price is around $125, depending on the model.

More innovative devices will undoubtedly be introduced in the near future.

What Does the FDA Have to Say About Wearable Devices?

The Food and Drug Administration (FDA), which has regulatory control over medical devices, categorizes wearables into three classes:7

Class I are simple in design and have no potential risk. Examples are tongue depressors, band aids, etc. Such devices must be registered, exhibit proper branding and labeling, and be produced using proper manufacturing techniques.

Class II are more complicated in design and have minimal risk. Examples are x-ray machines, powered wheelchairs and surgical and acupuncture needles.

Class III are intricate in design and have the strictest guidelines because they pose the greatest risk. Examples are implanted pacemakers, heart valves, etc.

Without intending to provide regulatory guidance to anyone, it appears that most of the currently-marketed consumer wearable devices would not fall under the regulations set by the FDA and are not marketed as such. For guidance, one is encouraged to consult the FDA database and other appropriate sources of information.

Consumer wearable products that do not need to register with the FDA are in effect considered to be general wellness products; that is, they have an intended use that is related to maintaining or encouraging a general state of health or a healthy activity and are not intended to cure or treat specific illnesses or conditions. They are not presently seen by the FDA as posing any risk to the consumer.

As wearable medical devices become more sophisticated and complex, consumer health and wellness devices may end up in a grey area or beyond and may need to shift to fall under FDA purview.

The FDA has recently issued guidance about general wellness claims for low risk devices.8

Market Research Implications

Device screens, such as those available on smartphones, are currently too small and lack sufficient clarity to serve as vehicles to respond to market research surveys conducted via mobile interviewing platforms. This may change in the future. The iPad and other tablet-style devices have already revolutionized the manner in which online research studies are undertaken. Interactive Voice Response (IVR) surveys can currently be conducted via wearable devices with voice capabilities, but such interviews are inherently limited in what they cover.

Despite these current limitations, the health and wellness information provided by wearable medical devices can be quite usable in clinical and market research applications.

One of the greatest challenges in healthcare is patient adherence/compliance.9 Lack of patient adherence can potentially lead to increased emergency room visits, hospitalizations and other inefficient uses of the healthcare system. Pharmaceutical companies lose out on sales when patients fail to renew medications on time, follow prescribed dosage or use prescribed medications at all. Estimates of yearly lost revenue for the pharmaceutical industry are $564 billion worldwide and $186 billion in the U.S. alone.10

Much research attention has been paid to addressing lack of patient adherence. Wearable devices can serve as vehicles for measuring adherence in terms of such things as monitoring patient activity, calorie intake, or health-related regimens. Furthermore, reminder messages to help increase adherence can be sent out via wearable medical devices. Using wearable medical devices to identify the more effective adherence programs is a vital healthcare need. It is also possible that, in the future, wearable medical devices will be able to enhance patient adherence. For example, if a device could communicate patients’ physiological data directly to their physician, patients may not need to take measurements or keep a log of these levels or track progress over time.

In Summary

Wearable medical devices are a fast-expanding and here-to-stay phenomenon that should be carefully watched for new developments. Although pundits’ estimates of market expansion may be over- or under-stated, wearable medical devices are sure to impact consumer healthcare and medical delivery systems in the very near future. As wearable devices expand in the medical arena (see for example, Apple Researchkit11), increased FDA scrutiny will undoubtedly follow. 

References

  1. The Future of Biosensing Wearables, Rock Health Slide Presentation, June, 2014 and Wearable Technology and Digital Healthcare Strategies Should Shift Focus to Chronic Medical Illness, Forbes.com, November 20, 2014.
  2. Launch of the iWatch Expected to Galvanize the Fledging New Sector, Juniper Research, September 9,, 2014.
  3. Davona, Tony, The Wearables Report: Growth Trends, Consumer Attitudes and Why Smart Watches Will Dominate, Business Insider, February 12, 2015.
  4. Wearable Technology 2014–2014, Technologies, Markets & Forecasts, idtechex.com. (See also their 2015–2025 forecasts.)
  5. The Apple Watch Won’t Keep the Doctor Away: Advanced Health Features Get Cut Prior to Launch, FierceLife Sci Weekly Digest, February 20, 2015.
  6. 14 Health and Fitness Wearables and Gadgets Worth Giving, Mashable.com, December 2, 2014.
  7. About FDA: What Does It Mean for FDA to “Classify” a Medical Device? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm.
  8. General Wellness: Policy for Industry and Food and Drug Administration Staff: Draft Guidance, FDA, Center for Devices and Radiological Health, January 20, 2015.
  9. Whitcup, Morris, and Garcia-Lopez, Joaquim, Patient Adherence Update: New Approaches for Success, Guideline Trend Report, October, 2008. (In conjunction with MedAd News.)
  10. Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence, Capgemini Consulting, November 20, 2012.
  11. Apple announces ResearchKit, a New Service for Medical Studies, CNET, March 9, 2015.