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Will Self-Adhesive Wearable Devices Become a Real Thing?

Our bodies are constantly sending signals—chemicals and electronic impulses—to other areas of the body. A variety of medical monitoring devices have been developed to turn these previously imperceptible signals into something doctors can understand and use to diagnose disease and develop effective treatments. Quite often, however, the provider needs a longer-term reading than can be obtained in a single office visit or short hospital stay. This is where home monitoring enters the picture. Patients are routinely sent home with some type of monitoring device to record anything from heart rates to sleep cycles. Unfortunately, such devices tend to be cumbersome because they are often strapped on and may be attached to wires. This can make it difficult for patients to engage in their normal activities or to sleep. Furthermore, if the device is something the patient must take on and off, the doctor must rely on the patient to remember to put the device back on, such as after bathing. Finally, passage of data to the doctor is not immediate. The patient must bring the device back to the doctor for analysis.

Skin Contact Skin Patch Clear

RECENT DEVELOPMENTS

Thanks to flexible electronics, medical monitoring devices have gotten much smaller and less cumbersome. In many instances, they are now wireless as well and can communicate directly to a smart phone app. In fact, medical researchers are using streamed data to remotely track a variety of vital signs in their subjects through the use of wireless monitoring devices. This shrinking in size has also led to the development of personal monitoring devices, such as step-counters and tracking bracelets, which allow consumers to self-monitor activity, heart rate and sleep cycles with an eye toward meeting their own wellness goals. Here again, remembering to wear the device every day is essential to effectiveness and, according to a survey conducted by Endeavor Partners, about a third of consumers abandon such devices within six months.

RISING DEMAND

Notwithstanding the sometimes unreliability of patients and consumers to use monitoring devices as prescribed, increased demand for outpatient and remote research subject monitoring, and more immediate test results/data and treatment, are driving the development of ever-smaller, less invasive devices that can enable faster test results and treatment. Consequently, doctors want and need the technology to provide them. The hope is to eventually get to the point where devices can be worn on the body as a barely noticeable second skin similar to a pharmaceutical patch. This would be achieved by applying the device directly onto a substrate that has an adhesive approved for skin contact.

BENEFITS OF DEVICES APPLIED DIRECTLY TO THE SKIN

  1. They would streamline the entire process as we know it, from providing devices to patients, to potentially transferring data, to communicating treatment. In an ideal scenario, doctors would receive the data electronically in real time and could message the patient with treatment instructions.
  2. Devices would be innocuous — no more uncomfortable straps or wires that can limit range of motion.
  3. Set it and forget it. The devices could be applied in the hospital or doctor’s office and stay in place for several days. No more need for patients to remember to put them on.

The development of such tiny devices also holds promise for the consumer market, so long as the technology continues to improve, and the price becomes more affordable. Time will tell. In the meantime, the value proposition for health care providers is that patients don’t have to remember every day to apply a device. Rather, they can wear a device for multiple days, thereby ensuring multiple days-worth of data.

The primary challenge lies in finding an adhesive that is aggressive enough for long-term wear while also offering pain-free removal. Successful application to damp skin and breathability are also important factors.

SAFETY REGULATIONS

While the safety regulations typically fall upon the medical device manufacturer or the end manufacturer, the FDA recommends certain portions of ISO 10993 for medical device manufacturers depending on contact with the skin. Of particular importance are ISO 10993-5 and -10, which include testing for irritation, sensitization, and cytotoxicity. Once these three tests are performed, the adhesive supplier can furnish a bio-compatibility letter to their customer ensuring that the adhesive meets the necessary criteria for skin contact.

MARKET OPPORTUNITY

This all means huge potential opportunity for converters that service the medical industry. In fact, the journal Sleep Review predicted in 2015 that the wearable healthcare devices and services market will increase at a compound annual growth rate (CAGR) of 30.42% through 2019, and ABI Research estimates that five million disposable, wearable, medical sensors will ship by 2018. Furthermore, the market size for wearable devices is estimated to reach $12 billion by 2018. As the on-demand healthcare market grows, and as more consumer applications are developed, potentially significant converting opportunities will certainly arise.

SKIN IN THE GAME

If you already service the health care industry, or if you’ve been thinking about it, now may be a good time to learn more about these new technologies and potential applications. Keep in mind that FLEXcon stands ready to work with you in developing solutions to gain business in this market, whether it be coating materials with one of our dermaFLEX™ adhesives, which have been tested to ISO 10993-5 and -10 (irritation, sensitization, and cytotoxicity), or coating your substrates with your own adhesives. You shouldn’t be the only one with skin in the game. Let us help.

Want to start a conversation?

Contact Jim Joyce for more information or to uncover what's possible for your company.