The release of the FDA's draft guidance document (“Applying Human Factors and Usability Engineering to Optimize Medical Device Design”) has caused many medical device manufacturers to adjust their product development processes. While incorporating human factors research and user-centered design in the product development process is not a new concept, medical device manufacturers going to market in the US now have specific guidance on what is expected from these activities to ensure safe and effective use of their devices. It is critical to understand how these processes can be carried out in order to meet the requirements for human factors validation.
To help organizations discover the right questions to ask during exploratory research and inform the design of robust validation studies, GfK will host a free webinar, “Medical Device Human Factors: Catching up to the FDA,” on April 11, 2013 at 11AM CDT.
In this webinar, Associate Director Korey Johnson of GfK User Centric will discuss a number of exploratory research methods used to identify potential user groups, define appropriate tasks for human factors validation studies, and eliminate major usability issues early in the design process.
“Exploratory and formative human factors studies should not be considered optional activities,” says Johnson. “These are critical steps in the overall device development process that inform early product design. By identifying user needs, environments, and experiences as they relate to the device, these steps also inform the design of a robust human factors validation study.”
GfK User Centric specializes in usability verification and validation for medical devices, as well as use-FMEAs that help identify risks based on simulated use. In addition to UX services, GfK offers uniquely comprehensive research programs that provide the full picture for the medical devices and diagnostics market.
To register for the webinar, visit GfK-events.