Free On-Demand Webinar: September 22, 2022
Usability testing (a.k.a. human factors or ergonomics) has become the rule rather than the exception for most regulated medical devices.
In fact, FDA has published at least six guidance documents involving usability or human factors for medical devices and combination products since 2016. Regrettably, for many in this industry usability testing has become nothing more than a tick-box on a form!
Yet, in spite of these usability requirements (or perhaps because of them), we continue to experience significant user related problems with many important medical devices – why? And these problems are often not discovered until after the device is FDA cleared or approved and on the market – why?
This webinar will not take the typical approach to usability testing. In his signature style, Dr. Michael Drues will use actual devices as case studies to take a critical look at the way we do usability testing today and ask the seemingly simple question: does what we do make sense? Register for free today!
What is usability testing and more importantly, why is it important?
Why is usability testing the rule rather than the exception? Was it always this way?
Does usability differ for devices used by patients vs. devices used by healthcare professionals?
How does usability differ pre-market vs. post market?
How can we do usability testing better while still ticking the regulatory boxes?
What are the usability challenges in the future (i.e., personalized devices) and how do we meet them?
Geared for both experienced medical device professionals as well as those new to the industry, personnel working in the following disciplines will find this webinar particularly useful:
Regulatory Affairs Professionals
QA/QC Personnel
Design and Development Engineers and Technicians
Product and Product Development Management
Medical Device Executives
Scientists