Aligning Human Factors & Usability Studies with Expanding Requirements including the Lifecycle of FDA Regulatory Documentation, CE Mark Changes in Light of EU MDR and ISO 62366, Designing and Conducting Comprehensive and Coherent Studies that Provide Accurate Use Data all while Propelling User Needs into the Forefront of Design & Development
Medical device manufacturers face a wide variety of challenges in bringing safe and effective products and technology to the healthcare market, and forward-thinking organizations are integrating human factors into early-stage design and development to ensure products truly meet user requirements through comprehensive research, testing and analysis of human factors studies. These highly-complex studies require a delicate balance of cohort groups, simulation of real-life use scenarios as well as in-depth and thoughtful questions which ensure the results capture the correct perception, cognition and action being studied. Through well-rounded studies, medical device companies are able to initiate effective lifecycle risk reduction, meet expanding FDA and international regulation requirements, as well as increase the overall usability of medical products, creating higher levels of customer and brand loyalty.
The 2019 Semi-annual Medical Device Human Factors & Usability Conference will highlight the achievements of many medical device firms in this dynamic environment, providing attendees with thoughtful and practical roadmaps for designing and executing the most efficient and effective usability testing possible.