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Author Sophie Edmonds-Allen |
| Abstract This paper explores how applying Human Factors Engineering (HF) methodologies in the form of Early User Insights (EUI), before the well characterised medical device usability engineering process, can improve usability, reduce risk, and support regulatory compliance. Drawing on recent case studies in drug-device combination product (DDCP) development, we will highlight strategies for adapting to increased product complexity by seeking patient insight, embedding early HF work and building internal capability. |
