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Both the FDA’s Human Factors Engineering (HFE) guidance and the global HFE standard IEC-62366 list “inherent safety by design” as the most effective method of managing use-related risks associated with medical devices. In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design...

Overview of Threshold Analyses for Combination ProductsThreshold analyses help determine if differences related to external critical design attributes lead to additional use-related risks to the end user when comparing a proposed generic product to a reference product. The methodology for threshold analyses is described by the U.S. Food and Drug Administration (FDA) draft guidance document relea..

A medical device company may have multiple business divisions and device types all working in silos, creating the potential for multiple, seemingly disconnected graphical user interface (GUI) designs and user experiences. Aligning these with a single source of design plans, behaviors and guidelines (i.e., a design system), while taking accessibility and inclusivity into consideration, will aid i..