What do you see as the big issue for 2018?
It's no surprise that the prevalence of internet connected devices has presented new challenges to product manufacturers and consumers alike, especially regarding security. When integrating wireless technology into products, it's generally understood that no system is ever 100% impervious to attacks, regardless of the magnitude of resources invested. In my line of work, the biggest recurring issue I see is medical device manufacturers being overly sensitive to security risks and hesitant to implement wireless technology to effect any real health care innovation. Certainly in many cases, this is a knee-jerk reaction to the news of a few medical devices that have been compromised in recent years. The resulting mentality of dumbing down wireless connectivity in order to lessen the probability of cyber attacks and reduce regulatory scrutiny effectively avoids addressing some of the biggest problems in health care today (e.g. cost and accessibility)
What do you see on the horizon?
Fortunately, regulatory bodies such as the United States FDA have recognized this mentality as a potential long-term threat to health care innovation. Over the past few years, the FDA has released various guidance documents for medical device manufacturers to assist in the development, testing, and post-market surveillance of wireless medical devices (
). Addressing cybersecurity risks and minimizing the drag on innovation has also become a focus of the FDA (
), and they have relaxed the regulatory scrutiny on certain digital health devices and software products where health care benefits far outweigh any safety risks. Look for regulatory bodies like the FDA to continue to become more responsive to and cooperative with device manufacturers and ultimately conducive to true health care innovation in the next few years.
Ed Palmer has a combined 16 years of electrical engineering, product development, and project management experience in medical devices and engineering services. His technical strengths include circuit design, embedded systems, wireless and IoT. Ed is the principal of Palmer Wireless Medtech (
), a consultancy firm providing wireless technology expertise to medical device companies. Ed has a BSEE degree from the University of Minnesota.
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