The release of the FDA's draft guidance document (Applying Human Factors and Usability Engineering to Optimize Medical Device Design) has caused many medical device manufacturers to realize that adjustments to their human factors research process are necessary. Understanding how product development processes and lifecycles can be shaped to meet human factors engineering standards while minimizing the impact to overall time and cost of product development is a critical success factor for these organizations. For example, identification of representative user groups, risk analyses (FMEA), and human factors validation research may have existed previously as independent activities, but according to sound research design and FDA guidance these activities are necessarily interdependent.
Medical device manufacturers are struggling to make this adjustment in the middle of product development cycles that may have been underway for several years, as well as for future development cycles.
Join Korey Johnson, VP, User Experience, GfK, in this webinar to learn how to get answers to the questions you should be asking during exploratory research and how to use those answers to ensure safe and effective use of your medical device for your intended user population. You will leave this session with some practical ideas on changes that can be made to your product development process.
In this 60-minute webinar, Korey will provide insights and tactics to: -Identify potential user groups. -Understand the difference between unique groups and variation within a group. -Eliminate major usability issues early in the design process. -Incorporate users into risk analyses. -Choose the right tasks for a human factors validation study. -Understand potential outcomes by way of generalized real-world examples.