Design Challenges in Consumer and Medical Wearables

Article #1 of Improving Lives with Digital Healthcare Series: Developing wearable devices for consumer and medical applications can come with different sets of challenges.

author avatar

21 Jul, 2022

This is the first article in an 8-part series featuring articles on Improving Lives with Digital Healthcare. The series focuses on electronic systems that enable innovation in the healthcare industry. This series is sponsored by Mouser Electronics. Through the sponsorship, Mouser Electronics shares its passion for technologies that enable smarter and connected applications.

The health monitoring technologies that were once available only in hospitals for the medical diagnosis and monitoring of critical diseases are now readily available in consumer wearables, allowing a vast majority of people to purchase them for monitoring their personal health. The present generation of wearables can directly measure multiple bio functions, such as temperature, heart rate, blood pressure, oxygen levels, and more.

Though the working principles of consumer wearables and medical wearables (used by doctors) are similar, consumer wearables are not subjected to stringent performance tests and complicated approval procedures, making them available to users who wish to monitor their health. Regardless of the usage,  each device comes with a unique set of design challenges for product makers to overcome.

This article discusses consumer and medical wearables to explain how products with similar technologies undergo different design and testing procedures before reaching the market. It also lists the common design challenges engineers face when working on such products.

Wearables Enable Early Diagnosis to Reduce Hospitalizations

With advancing sensor capabilities and wireless connectivity, there’s real potential for improving public health by giving consumers, patients, and healthcare providers a complete picture of a person’s health in real-time. In the world of medicine, remote patient monitoring devices, including wearables, hold the promise of better clinical outcomes by detecting problems early, facilitating earlier diagnosis, and as a result, enabling earlier intervention and potentially reducing hospital admissions. 

For example, in-home monitoring for conditions such as heart disease, chronic obstructive pulmonary disease (COPD), and diabetes has been shown to reduce hospitalizations, according to a 2018 KLAS Research Report. Additionally, in the consumer world, the biodata gathered by wearable devices can help users make more informed decisions regarding their health and give them real-time data to manage their physical activity and lifestyle actively.

Similar Technology, Different Path to Market

While consumer and medical wearable devices share much of the same technology, some differences impact their design and marketing. Consumer wearables offer real-time measurements of bio functions, such as blood oxygen levels and heart rhythms, and they do so with impressive accuracy. However, these devices are not regulated by public healthcare regulatory organizations such as the U.S. Federal Drug Administration (FDA) and do not undergo the agency’s approval process. Therefore, consumer wearables do not support claims of a clinical diagnostic or therapeutic role.

The benefits of designing a consumer product include a faster time to market compared to a regulated medical device because it may not undergo FDA scrutiny and require regulatory approvals. However, despite their potential technical sophistication and accuracy, consumer wearables cannot make specific claims that medical devices can. The result is that consumer wearable manufacturers have to communicate a more general promise to potential customers, relaying factual statements or data about what their products measure without making claims beyond that. 

On the other hand, many wearables that are FDA-approved and classified as regulated medical devices have proven clinical data supporting diagnostic claims. For example, while a consumer wearable can identify an abnormal heart rhythm in a generalized way, it doesn’t have the diagnostic capacity of a medical device that helps a doctor determine the particular type of abnormality.

Furthermore, because of the immense variety of human anatomy and physiology, medical device designs require a broad range of options. To meet the needs of diverse populations, engineers must design and test for performance and accuracy across different patient types.

Overcoming Design Challenges in Wearables

Despite the differences in the regulatory hurdles they face (or avoid), both medical and consumer wearables have common design challenges inherent in creating a comfortable and easy device to use while also being reliable and accurate. For instance, wearable devices and their circuitry must fit, flex, and stretch to accommodate different body types to deliver unencumbered use. Wearables must also handle the stresses of everyday life and have circuitry that performs while the body moves.  

Additionally, this same circuitry must withstand moisture due to sweating and bathing and occasional shocks and bumps—and do all of this over days, weeks, or even months. Both consumer and medical wearables must also be lightweight and low profile, so users feel unencumbered by their presence. But as devices shrink and function increases, space constraints become more daunting. 

Solving for size/dimensional challenges, microminiature and hybrid connectivity can reliably communicate between and power subsystems and functions without sacrificing compactness. Furthermore, flexible circuitry that bends in multiple directions can help engineers mitigate space constraints while being lightweight, contributing to user mobility and comfort. To meet the expectations of wireless connectivity and data transmission, electronic solutions manufacturers are also offering a broad range of antennas to provide real-time communication of health data between users and their healthcare providers.

Connectivity Solutions for Next-Gen Wearables by Molex

Molex is a specialized manufacturer of electronic connectivity systems that fulfill the interconnection needs of electronic devices. With an experience of over 75 years, the company offers innovative connectivity solutions for a wide range of industries, including automotive, consumer electronics, Information Technology (IT), manufacturing, retail, military, and healthcare.

In response to challenges in circuit design for wearables, Molex engineers have developed cutting-edge solutions for product development. Moving beyond the confines of past medical device strategies, they leveraged innovations from other markets and push beyond theoretical boundaries to create real-world solutions that help ensure optimal health monitoring.

Here are some connectivity modules by Molex for wearable product development:

Molex SlimStack Hybrid Power SMT Board-to-Board Connectors provide up to 15 A of power and electrical reliability in an ultra-compact design. The dual-contact designed SlimStack line offers a wide selection of low-profile, narrow width options in various stack heights and circuit sizes. Molex SlimStack Hybrid Connectors are designed for battery and other power applications for mobile devices such as cellphones, tablet PCs, and portable medical equipment.

Fig. 1: Molex SlimStack Hybrid Power SMT Connectors

Molex Premo-Flex Flat Flexible Cable (FFC) Jumpers offer an extensive range of standard products that deliver flexibility and performance with various pitch sizes, cable lengths, and thicknesses. This range of options makes these cables ideal for use in virtually any industry. In combination with Molex Easy-on Connectors, these Premo-Flex FFC cables provide a completed flat flexible connectivity solution.

Fig. 2: Molex Premo-Flex FFC Jumpers

Molex Standalone Antennas offer high performance and easy integration for demanding wireless applications spanning the industrial, consumer, medical, and automotive markets. Molex uses state-of-the-art technology to deliver high-quality, reliable, and high-performance antennas. These Standalone Antennas include Bluetooth®, WiFi,, cellular, Ultra Wide Band (UWB), Near Field Communication (NFC), industrial/scientific/medical (ISM) antennas, or a combination of many of them.

Fig. 3: Molex Standalone Antennas

Conclusion

As is the case with several industrial and consumer products, the applications and intended use cases of medical and consumer wearables are quite different. While the former is used in hospitals as a basis for a diagnosis of medical conditions and deciding the course of treatment, the latter is used mostly by individuals who wish to be aware of their personal health.

Regardless of the product type, connected technologies and the data they transmit are at the heart of medical innovation. These products help to create immediate, and possibly even lifesaving connections. With innovative design and the latest electronic systems, better healthcare and a healthier population are within reach.

This article was initially published by Mouser and Molex in an e-magazine. It has been substantially edited by the Wevolver team and Electrical Engineer Ravi Y Rao. It's the first article from the Improving Lives with Digital Healthcare Series. Future articles will introduce readers to some more interesting applications of electronics in healthcare.


Introductory article covered the fundamentals of biomedical instruments and the ways in which digitizing them is transforming healthcare. 

Article 1 explored the design challenges in Consumer and Medical wearables. It showcased how technologies once limited to hospitals are now made available to everyone for monitoring personal health.

Article 2 was focused on the present state of robotic surgery. It explained how advancements in robotics and communication, combined with the expertise of surgeons, enable customized treatments for patients. 

Article 3 presents an overview of how new sensing, communication, and energy systems, engineered for the healthcare sector can be used to transform cardiovascular disease treatment procedures.

Article 4 examined Brain-Computer Interfaces and how they help in enhancing human vision, motor recovery for disabled limbs, and more.

Article 5 featured an informative webchat between Mike Depp, and Glen Capek from Molex, as they discussed trends in flexible electronics driving new solutions for medical wearables applications. 

Article 6 discussed how immersive digital technologies like Augmented Reality (AR) and Virtual Reality (VR) make medical learning more engaging through lifelike experiences.


About the sponsor: Mouser Electronics

Mouser Electronics is a worldwide leading authorized distributor of semiconductors and electronic components for over 1,100 manufacturer brands. They specialize in the rapid introduction of new products and technologies for design engineers and buyers. Their extensive product offering includes semiconductors, interconnects, passives, and electromechanical components.

21 Jul, 2022

Mouser Electronics is a worldwide leading authorized distributor of semiconductors and electronic components.

Wevolver 2022