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38 The PCB Design Magazine • December 2014 Introduction PCBs are an increasingly important part of modern medical devices—especially electrome- chanical devices. The opportunities are large, but PCB designers and manufacturers must be aware of and work within the regulations and limitations in the medical device design pro- cess. This article will provide an overview of the medical device design process, the role of PCBs in that process and in modern medical devices, and include design considerations and tips for incorporating PCBs into medical devices. Medical Device Design Process The medical device development industry is heavily regulated. Not only are the charac- teristics and performance of the devices regu- lated, the design and development processes are as well. The focus is on well-defined and understood requirements, quantification of risk of harm to patient and operator, verifica- tion that the design meets the specifications and finally validation that the design is effec- tive and safe. Many medical devices are manufactured in lower volume than consumer electronics and have higher margins; and most have longer de- sign cycles. Notwithstanding these differences, the technologies used in medical devices are of- ten heavily leveraged from consumer electron- ics. This means the same creep towards higher density circuits and component packaging ap- plies in the medical field. The same techniques of replacing wiring harnesses with PCBs and flex circuits that are found in consumer elec- tronics are found in medical devices, although the drive towards these technologies may be increased reliability and reduced labour cost in- stead of decreased size and reduced parts cost. PCBs for Medical Applications–A Designer's Perspective article by kenneth MacCallum sTarFIsH MeDICal This article originally ran in the November 2014 issue of The PCB Magazine.