Meeting New Challenges in Connected Medical Devices

2023-08-29
●New Opportunities and New Challenges
■As the need for less expensive and more accessible health care continues to increase, many practitioners and medical are relying on connected medical devices to monitor vital signs, perform electrical or chemical analyses, diagnose medical conditions, and even treat patients by administering things treatments such as electrical pulses or insulin. These technologies are improving the length and quality of countless lives, and they bring healthcare to patients outside of medical facilities. This extends the benefits of sophisticated technologies to persons who could otherwise not obtain or afford these treatments in a hospital setting.
■This increased reach and growth, however, also means that the expectations, requirements, and challenges associated with these devices are increasing. Here are a few of the more significant issues that connected medical device designers and manufacturers face:
▲The increasing number of wireless devices makes wireless coexistence both more important and more difficult.
▲ The cybersecurity threat landscape becomes greater.
▲ The demand by consumers, insurance companies, and governments for reduced healthcare costs puts additional pressure on device vendors, which makes hitting the highly profitable early adopter phase more critical than ever.
▲ The increasing use of devices by non-specialists on a variety of hardware and software platforms drives greater testing challenges for device firmware and associated apps.
■Solving these problems drives a virtuous cycle, in which successful devices drive high adoption, which provides additional revenue for device vendors who can then produce additional devices. When connected medical devices work properly, everybody benefits: patients receive safe, low-risk and efficacious care, practitioners are able to help more patients, costs decrease, and the device manufacturers are rewarded with profit and growth.
●Conclusion
■Engineers who design and test connected medical devices are providing innovative solutions that improve both the duration and the quality of patient lives. As these devices proliferate away from hospitals and medical facilities, several types of challenges become greater. The challenge of wireless coexistence becomes greater as devices experience more prevalent overlaps in space, time, and frequency. The challenge of cybersecurity becomes greater as the attack surface increases and the move into more mission-critical applications make ransomware more potentially lucrative.
■The need to get to market quickly makes it more important than ever to turn regulatory compliance testing from a check-the-box item into a competitive advantage. Finally, as the number of users, hardware platforms, and software platforms increase, the software testing challenge becomes exponentially greater.
■By using high-quality test solutions and guidance from organizations such as the IEC and the FDA, test engineers can overcome these challenges and provide users with safe and efficacious devices.

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August 25, 2022

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