The following is a guest article by Marie Hattar, SVP at Keysight Technologies
Wearable devices are transforming healthcare through continuous monitoring, early detection, and personalized management of chronic diseases. These innovations are reinventing how health concerns are tracked and treated, with the goal of improving diagnostics, outcomes, and accessibility. However, they also introduce new technical challenges to overcome.
Factors like increasing health consciousness, aging populations, and advances in sensor technology and connectivity are helping fuel wearables’ popularity. Innovations such as sensor patches that continuously track ECG (electrocardiogram), respiratory rate, and other vital signs, to Oura rings and continuous glucose monitors are also contributing to this transformation. These devices combine sensors to monitor vital signs, utilizing Bluetooth, Wi-Fi, or other IoT connectivity for seamless data transmission. With their ubiquitous nature, the healthcare wearables sector is set to grow from $103.4 billion in 2025 to $324.73 billion by 3032. In the US, research found that 45% of adults now own a wearable.
As technology advances, the size of most wearable devices is continuing to shrink—further increasing their appeal. The smaller footprint is also making it easier to manage chronic conditions like diabetes and heart disease outside of hospital environments. However, technical issues spanning wireless connectivity, battery life, AI integration, and cybersecurity must first be addressed to ensure they perform exactly as expected. Only then can people benefit from receiving earlier warning signs.
Battery Life
As devices become smaller, there is limited space for batteries. As a result, wearables — from a continuous glucose monitor sensor patch that is replaced every couple of weeks to an ECG implant that lasts for upwards of five years — must be designed to optimize battery life and signal integrity while ensuring they perform consistently. Achieving this balance requires making trade-offs between sensor accuracy, data transmission, and power consumption. Design teams must collaborate to optimize power for medical wearables, considering battery life, form factor, and user experience.
Wireless Connectivity
With wearable devices depending on a range of wireless protocols and frequency bands, electromagnetic interference poses a risk to their performance and to patient safety. To mitigate interference and guarantee device interoperability, the U.S. FDA requires adherence to specific electromagnetic compatibility (EMC) standards such as ANSI C63.27, AAMI TIR 69, IEC 60601-1-2, and IEC 61326. This mandates that manufacturers assess coexistence to validate compliance and ensure every device functions even in complex electromagnetic environments. With wearables playing a growing role in healthcare decisions, confirming that they operate reliably in residential settings in addition to clinical environments, where there is a conflux of other connected wireless devices, is vital.
AI Integration
As wearable technology advances, AI is making devices smarter. It enhances remote monitoring with automated alerts and predictive insights, helping further personalize healthcare. This is enabling a shift from hospital-centric to remote patient care. As more vitals and biomarkers are continuously tracked in real time, devices will provide a forensic understanding of health, helping to reshape care delivery. However, with the potential risks involved, AI applications’ sophisticated algorithms require rigorous validation.
Cybersecurity
Wearables continuously collect and share health data with every device serving as another node on the network that cybercriminals can attack. To ensure compliance and safety, the FDA requires that medical devices undergo rigorous testing to identify and mitigate vulnerabilities before deployment. Manufacturers should heed the FDA guidance and take it a step further by incorporating testing as early as possible in the product design phase. This will enable them to achieve compliance and accelerate time to market as efficiently as possible. Robust security is crucial for these innovations to protect against the growing threat from ransomware, data breaches, and unauthorized access.
Healthcare Wearables: Here to Stay
These devices empower people to take a proactive approach to managing their health, and the benefits for healthcare providers and patients alike are fueling their growth. The continuous, real-time monitoring of vitals and health metrics enables earlier detection of potential issues and more data-driven care decisions.
As the healthcare industry becomes more dependent on wearables, comprehensive testing is crucial to meet compliance requirements and ensure patient safety. Rigorous evaluation is required to validate that devices are capable of continuous monitoring, clinically accurate, comply with regulations, and improve patient care. Testing is the key to unlocking patient-driven care that enhances outcomes and accessibility.
As the complexity involved grows, ensuring that every device is fit for purpose, safe, secure, and reliable will significantly increase the testing burden. However, with the adoption of wearables setting the groundwork for a smarter, more efficient, and responsive healthcare system, this is a problem worth solving.
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