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Medical electronics is an exciting field to be working in right now with new ideas coming online almost daily. We last interviewed medical PCB designer Kenneth MacCallum in 2015. Recently, I asked him to give us an update on trends he sees in medical electronics, and some of the challenges in adapting the latest technology to this segment of the industry.
Andy Shaughnessy: Give us a brief background on StarFish Medical and your work there. We don’t see many physicists who are also PCB designers.
Kenneth MacCallum: StarFish is a medical device design, development, and contract manufacturing company. We help medical technology innovators throughout North America overcome challenging technology obstacles to create breakthrough products that improve health and save lives. We’re different from our competitors because we focus on enabling medical device startup companies to dial in their value proposition.
I am an engineering physicist, which means I have a strong mathematics and physics background that I apply through engineering. My deepest skillset is electronic design with a system-level first-principles approach. I believe that to design the best PCBs for a problem, the overall solution will be a balancing act across all disciplines. A tricky set of requirements is rarely optimally addressed without give and take from everyone involved—industrial designers, human factors specialists, mechanical engineers, software developers, optical designers, regulatory specialists, and project managers. This is particularly true when the primary function of a device is fundamentally reliant on some other discipline, like microfluidics or optics. In those cases, the electronics are in a supporting role.
Shaughnessy: A lot has happened with medical technology since our last interview almost three years ago. Can you give us an update on some of the trends you see in medical electronics? Are you working on any wearables, for instance?
MacCallum: There is a growing desire to bring medical devices into the patient’s home. This means that many devices no longer interact primarily with doctors, nurses, and technologists, but with the patient and without direct supervision. These devices often consist of multiple elements—those that are wearable, portable, and even implanted.
Three years ago, there was a growing buzz around connectivity—big data and the cloud. In the medical device industry, these terms collectively lumped into the phrase "digital health," which has now morphed into the concept of "connected health." Since then, it's become clearer how to successfully leverage and implement these ideas practically and economically. We're also learning how to address the associated regulatory hurdles, including the mandated attention to ensuring that identifiable patient data remains protected and secure.
Notwithstanding the trends, the fundamental focus on device safety and efficacy has not changed. If anything, this primary goal of medical device design has strengthened. No matter how cool and progressive technology gets, if we can't ensure that we can control the safety of the patient and operator—or if we cannot demonstrate that the intended use is implemented in a reliably effective manner—then we have not succeeded.
To read this entire interview, which appeared in the November 2018 issue of Design007 Magazine, click here.