Trends

Innovating for Wearable Medical Devices

Wearable medical device adhesives

Until recently, patients could be sent home with some type of monitoring device to record anything from heart rates to sleep cycles. Such devices tend to be cumbersome because they are often strapped onto the body and may be attached to wires. This made it difficult for patients to engage in their normal activities or to sleep, limiting patient compliance and skewing data. Passage of data to the doctor was not immediate. The patient had to bring the device back to the doctor for analysis. 

Evolving Wearable Medical Device Developments

Thanks to flexible electronics, medical monitoring devices have gotten much smaller and less cumbersome. In many instances, they are now wireless 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. Wearing the device as instructed is essential to effectiveness.

Rising Demand for Wearable Medical Devices

The market for wearable medical devices is surging. The wearable technology market is expected to grow to $184.75 billion by 2033*. Patient compliance issues with increased demand for outpatient and research subject monitoring, along with more immediate test results data are driving the development of smaller, less invasive devices that can enable faster test results and treatment.

Benefits Of Wearable Devices Applied Directly to The Skin

  1. Streamlines the entire process from providing devices to patients, transferring data, to communicating treatment. Doctors receive the data electronically in real time and message the patient with treatment instructions.
  2. Devices are now 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 or longer.

The development of such devices also holds promise for the consumer market, as the technology continues to improve and the price becomes more affordable. In the meantime, health care providers can better control proper and consistent device usage because patients can wear a device for multiple days without having to remove or reapply it, thereby ensuring multiple days-worth of data.

The primary challenge lies in finding an wearable device adhesive that is aggressive enough for long-term wear while also offering pain-free removal. Breathability and the ability to withstand a brief shower or physical activity 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 tremendous potential opportunity for converters that service the medical industry. As the on-demand healthcare market grows, and as more consumer applications are developed, potentially significant converting opportunities will certainly arise.

Flexcon is ready to work with you in developing medical adhesive solutions to gain business in this market, whether it be coating materials with one of Flexcon® DermaFlex™ adhesives, which have been tested to ISO 10993-5 and -10, utilizing Flexcon® Omni-Wave™ hydrogel-free bio-sensing adhesive components, or coating your substrates with your own technologies. You shouldn’t be the only one with skin in the game. Let us help.

*Wearable Medical Devices Market Size, Future Growth and Forecast 2033