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Some of the coolest new electronic products have come courtesy of the medical market. I wanted to find out more about this fast-growing segment, so I contacted Kenneth MacCallum, an engineering physicist with StarFish Medical. StarFish is a medical device design company that’s created some major electronic medical innovations, and they’re about as cutting-edge as you can get.
I asked Kenneth to talk about the medical electronics industry, medical PCB design, and some of the unique challenges that technologists face in this fascinating market. Plus, what does digital health mean for electronics designers?
Andy Shaughnessy: Why don’t you start off by giving us a quick background on StarFish Medical?
Kenneth MacCallum: StarFish is a consulting design engineering firm that specializes in the development of medical devices. Unique for a boutique design firm, we have a full complement of manufacturing services. We work for all sorts of companies, big, little, all across North America and Europe. Many are serial entrepreneurs that have launched and sold medical device start-ups to industry leaders. We work on products as varied as ultrasound systems, lab on a chip, orthopedic surgery assist devices. Digital health is a rapidly growing segment.
Shaughnessy: You’re a principal engineering physicist at StarFish, and you’re involved in PCB design. Tell us about your work there.
MacCallum: I do two things. I’m an engineering physicist and a project manager. That means I’m a technical guy, but I also make sure projects stay on the rails. From a technical standpoint I behave like an engineer. I design PCBs and circuits. The engineering physicist part of me adds basic principles analysis of all sorts of fun stuff including optics, algorithmic processing for ultrasound, or image processing. Like most electrical engineers, I also work on firmware and logic design.
Shaughnessy: How is designing a medical PCB different than designing any other high-reliability board?
MacCallum: Although the medical industry is fairly heavily regulated, designing a medical PCB is not that different than designing for lab equipment or a consumer device. There are still safety standards to meet. The medical standards are more stringent and they span a bit more.
I’ve worked in metrology, general engineering (remotely operated vehicles), and consulting engineering for consumer and dental devices. I’ve seen a bit about what is required for various product sectors, developed products and gone through regulatory hurdles for each. They all have regulatory requirements—especially Europe—but the requirements are generally harmonized around the world. We meet ISO 60601 for medical and ISO 61010 for laboratory equipment. These are standards we must comply to or we can’t sell in the various markets.
To read this entire article, which appeared in the January 2016 issue of The PCB Design Magazine, click here.