Conducting Formative and Summative Usability Studies for Medical Devices

is being presented by Adam R. Shames, Director, Human Factors Research, with Design Science Consulting, Inc. and airs on Wednesday, August 24th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.

Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.