There is No Such Thing as User Error

User Centric presents, “We Believe Experiences Matter,” a free webinar series highlighting techniques used to evaluate, measure and change the end-to-end customer experience. View entire webinar schedule.

This webinar is over, but you can access it in its entirety on YouTube, Vimeo and Slideshare.

Abstract

Medical device design necessitates an assessment of risk. The need is prudent given their ecosystem of use, but also mandated by regulatory agencies. Risk management uses analysis protocols to identify and predict situations where a device may fail and assess the consequences. Common techniques, like Failure Mode and Effects Analysis (FMEA) must expand to go beyond engineering and material failure to identify hazard risks due to user-device interactions or “use errors.”

During this webinar, we will discuss the practice of the FMEA with added upgrades, such as a Task Analysis and how integration with simulated use labs can help you and your design team be more successful at reducing patient risk.