For the last 30 years, medical device regulators have shone an increasingly bright light on human factors and medical device usability. It is now commonly recognised that human error is a leading cause of patient harm. In fact, an independent nonprofit organisation, ECRI (who are tasked with improving the safety, quality and cost-effectiveness of healthcare worldwide), listed usability of home-use devices among the top 10 hazards associated with health technology for 2024.
Regulatory guidance, such as those from the FDA or IEC 62366, now demands a robust and thorough approach to ensuring new devices are safe to use. This includes assessing use-related risks, designing mitigations to potential hazardous situations, and providing evidence, through testing, of inherent device safety.
Download our handbook by completing the form below. It is intended to be a useful introductory guide to the discipline of human factors, specifically in medical device and combination product development. Human factors is a broad and nuanced topic and cannot be fully described in a booklet like this; it is therefore our intention that this is simply a helpful starting place or aide-mémoire to those working in medical device and combination product development.
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