Look around you. Doesn’t it seem like everyone is sporting a Fitbit® or other wearable technology? The fact is, consumers are quickly embracing devices that help them monitor fitness metrics. There’s a feel-good bonus in a long schlep from gate to gate in an airport, or a marathon shopping spree, when a compact wrist gadget applauds the impressive distance walked along the way. People are taking to wearable tech as they have adapted to smartphones— incorporating them as an integral piece of their everyday lives.

Fig. 1 – Wearable technology is increasingly relied upon to not only transmit vital patient data, but also be comfortable and highly secure.

Familiarity with these popular products opens a world of possibilities for developing wearable devices that can improve healthcare beyond patients’ self-monitoring. Wearable technology has the potential to revolutionize aspects of the healthcare system by doing things such as assisting doctors in operating rooms, and providing real-time access to medical records. (See Figure 1)

The newfound ability for patients to monitor their own health is a plus: informed patients are usually better equipped to partner with their physicians in following treatment plans as well as actively managing their health to achieve better outcomes.

The upshot is that wearable devices can, and will, serve more critical functions. Devices have been created that track more than activity levels, heart rate, and blood pressure. Some also measure oxygen saturation, blood sugar, and other health indicators that provide clinicians with data they can use to monitor patient conditions and treatment response. New and future development of different types of wearable sensors will become instrumental in early detection, diagnosis, and treatment of diseases. And the progression of on-the-go medical care holds great promise for contributing to the national imperative of reducing healthcare costs and supporting other measures like population health management. (See Figure 2)

The Impact on Medical Device Developers

Fig. 2 – Medical devices worn on the body are evolving from simple fitness monitoring uses to charting data trends that can serve as early-alert monitors for detection of diseases and other ailments.

However, medical device developers have their work cut out for them in designing wearable products with the level of accuracy and reliability needed for clinical applications. Practical application of this technology requires reliable connectivity and security assurances, especially in light of the 1996 Health Insurance Portability and Accountability Act  (HIPAA) regulations, presenting challenges for the exchange of healthcare data. Miniaturization, networking, intelligence, digitalization, and standardization are some of the top technology issues that developers are working to address. As data collection moves to wearables, patients will demand more aesthetic solutions, whether they’re looking to make a fashion statement (as with the Apple iWatch® and Fitbit craze), or just want their medical devices to be camouflaged or invisible.

Size matters, of course. Wearable technology must not only work well and look good but also be comfortable and unobtrusive. A search for wearable fitness trackers, the trendsetter that’s paved the way for more purpose-built medical device wearables, reveals competitive jostling among market leaders to win consumer preference with products that are both feature-rich and fashionable. Packing all the electronic circuitry, storage capacity, communications, and security capabilities into a very small device is yet another challenge for design engineers. This category of medical device design is layered with special requirements: technological, aesthetic, cyber security, miniaturization, and seamless connectivity. (See Figure 3)

However, the juice is worth the squeeze when considering the potential benefits. New and future wearable devices that can serve more sophisticated healthcare and medical functions, such as diagnostics, include:

  • Blood pressure
  • Continuous glucose
  • EKG
  • Eye tracking
  • Hydration
  • Oxygen level
  • Pain relief
  • Respiration
  • Sleep
  • Temperature

Developing sensor technology is also expanding the types of patient symptoms and responses that can be detected, driving further momentum for these devices. Sensors collect data about the physical and chemical properties of the body and local environment, and use it to feed algorithms which output insightful information. More information can be found in the IDTechEx report Wearable Sensors 2016-2026: Market Forecasts, Technologies, Players, which can be found at www.idtechex.com .

Fig. 3 – A wearable insulin pump lets patients take a more active role in managing their health.

Sensors are the most diverse component type in wearable devices, and they also enable the key functions that make them useful. They include inertial measurement units; wearable electrodes; optical sensors; stretch, pressure, and related flexible sensors; chemical sensors; and others. Digital thermopiles enable temperature measurement applications.

Photodiode/LED assemblies are playing a critical role in medical applications such as pulse oximetry, a noninvasive method allowing monitoring of the oxygenation of a patient’s hemoglobin. These are just a few examples. From Consumer-Friendly to MedTech Transformation Taking the best features that widely-available, consumer-friendly wearable devices have to offer and integrating that ingenuity into highly specialized medical devices for improved personal health monitoring is the inevitable next phase of med-tech. But developers and manufacturers will need to strike the right balance of packaging and technology to ensure sufficient adoption occurs to deliver the results the medical and insurance industries are hungry for.

Consumers’ evolving lifestyles, adoption of new technology in their everyday lives, technology development in the Internet of Things, and the urgent need for healthcare system transformation that will improve outcomes with lower costs, all help to underscore the tremendous potential for wearable medical device technologies. The tipping point is upon us—and exciting, transformative innovations are imminent. Leading the way, product developers must work their way through a web of evolving issues with the help of strategic partners who know the ropes.

This article was written by Michael Kanis, Sales Engineer, Proven Process Medical Devices, Mansfield, MA. For more information, Click Here .