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Molex 2022 5 Learn More Learn More Molex ISM Standalone Antennas SlimStack Battery 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 biofunctions, such as blood oxygen levels and heart rhythms, and they do so with impressive accuracy. However, these devices are not regulated by 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 for 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 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. In response to these challenges, Molex engineers have developed cutting-edge solutions. Moving beyond the confines of past medical device strategies, we leverage innovations from other markets and push beyond theoretical boundaries to create real-world solutions that help to ensure optimal health monitoring. 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, Molex also offers a broad antenna portfolio to provide real-time communication of health data between users and their healthcare providers. Connected devices 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 engineering, better healthcare and a healthier population are within reach. n