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Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool to guide development, allowing you to improve your products by turning risk into a value-add type of activity.In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Shannon Hoste, President of Agilis Consulting Group and former lead for the FDA’s Human Factors Team.Shannon explains her philosophy and approach on how the pieces of human factors, risk management, and product development come together. It’s all about user-related risks and making the right design decisions early on during product development.Some of the highlights of this episode include:Human factors is a risk management activity that the FDA and International Organization for Standardization (ISO) requests. It’s all about use-related risk.Risk management helps make design decisions around safety and efficacy, and human factors provide a focus