Marie Hattar

Designing Wearable Healthcare Devices We Can Trust

By Marie Hattar
Marie Hattar

As the proliferation of wearable healthcare devices expands in terms of application and availability, they’re also becoming smaller and more powerful. In turn, testing and validation in the design phase is becoming increasingly complex.

The proliferation of wearable healthcare devices is expected to transform how we prevent, diagnose, and treat illness. The latest wearable healthcare devices extend beyond measuring heart rates and oxygen levels to identify biomarkers, monitor brain states to predict strokes, leverage biometric data for early detection of infectious diseases days before symptoms appear, and much more. The healthcare industry is embracing wearable devices on a collective mission to usher in a new era for preventative health and provide more meaningful and personalized patient care.

The wearable medical device market, now valued at $27.8 billion, is expected to reach $250 billion by 2032, according to an Emergen Research report. As the proliferation of wearable healthcare devices expands in terms of application and availability, they’re also becoming smaller and more powerful. In turn, testing and validation in the design phase is becoming increasingly complex.

Many factors must be tested during the development cycle to ensure that wearable healthcare devices can operate accurately, safely, and securely in the real world. This includes everything from testing the temperatures of devices in relation to body temperature to monitoring 5G signals, Bluetooth, Wi-Fi, and radio frequency coexistence. Here’s a closer look at some of the key factors to consider when designing wearable healthcare devices that users can trust.

Reliability and Accuracy is Paramount

As wearable health devices continue to break new barriers for patient care, it’s more important than ever that the devices provide reliable performance and accurate data. This is particularly challenging considering that today’s applications for wearable devices are so diverse. Devices such as smart rings, blood pressure-monitoring bracelets, and brainwave-reading headbands leverage advances in biofeedback to track physical and emotional responses, including stress, alertness, and even drowsiness through eye movement.

The reliability of wearable medical devices begins with the ability to stand the test of time — which translates to battery testing. Advanced battery test and emulation software helps to create profiles of actual batteries, which can then be used repeatedly in tests without having to use the actual batteries. This provides snapshots of battery performance for a deeper understanding of device performance. It’s also important to measure how a connected device consumes charge over time through battery drain analysis, and then uncover new ways to optimize battery life through event-based power analysis.

Then there’s wireless connectivity to consider. This involves tests that range from analyzing 5G signals and Bluetooth to ensuring that connected medical devices, especially used in hospitals, can co-exist in noisy wireless environments. To ensure that wearable healthcare devices are trustworthy, the development cycle must involve rigorous testing and validation processes.

Interoperability for a Seamless User Experience

As wearable devices continue to churn out vast amounts of patient data, the success of this new wealth of information relies heavily on a sound, interoperable ecosystem. The ability for different devices and systems to communicate and share data, while complying with standards, is vital for earlier detection of disease and more promising treatment options. Furthermore, real-time integration between electronic health records (EHR) could be a game-changer for more personalized patient care, allowing physicians to monitor patients remotely, collect data, and reduce time and costs associated with treatments.

The healthcare industry’s push towards digitalization has led to an increasing need for software quality assurance in EHR systems. Automated software testing can improve the interconnectivity of system components while quickly and significantly surpassing the capabilities of manual testing. According to a recent survey conducted by Keysight in collaboration with HIMSS, the adoption rate for automated software in wearable medical device development is expected to triple in five years. Test automation platforms improve quality, consistency, and coverage, leading to higher satisfaction rates for early adopters when it comes to testing scalability and analytics.

Cybersecurity and Data Privacy Leaves No Room for Compromise

When it comes to connected medical devices, cyberattacks present enormous threats that could leak data, compromise device performance, and in the worst-case scenarios, lead to mistreatment or loss of life for a patient.

The Internet of Medical Things (IoMT) remains vulnerable on every exposed network interface, including Wi-Fi and Bluetooth. Implementing robust security measures help to protect sensitive data received and transmitted by the device is a must. These measures include encryption, secure data transmission, and compliance with regulatory requirements, such as the Health Insurance Portability and Accountability Act (HIPAA). To ensure that devices comply with regulatory standards, it might be necessary to obtain approval from the FDA, depending on the wearable device’s application and intended use.

Wearable healthcare devices must be trustworthy in order to achieve widespread adoption and enhance the quality of users’ healthcare and, in many cases, their lives. There are a number of ways to achieve this, from homing in on accuracy to carefully analyzing data security and implementing the necessary cybersecurity measures. Through rigorous testing and validation, wearable medical devices have the potential to dramatically change patients’ day-to-day lives and usher in an era of personalized patient care. In short, the best is yet to come.

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Marie Hattar