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 Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011).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.

This audio conference covers:

• Setting appropriate goals and learning what constitutes success
• What you need to know about the relevant standards IEC 62366, HE 75 and FDA draft guidance
• Concrete, real-world examples of how to design and conduct formative and summative usability studies
• How to conduct a successful usability study vs. one that will derail your product
• How to differentiate between what must be tested, should be tested, and could be tested

About the speaker:

Adam R. Shames has an M.BA in international business from the Fox School of Business and Management at Temple University and a B.S. in human factors engineering and psychology (double major) from Tufts University, where he received the De-Florez Prize in Human Engineering. He also has a Certificate in Applied Ergonomics Training from the United States Army Center for Health Promotion and Preventive Medicine.

He is the Director of Human Factors Research at Design Science and his work at Design Science includes usability testing, heuristic analysis, and assisting firms with adherence to federal verification and validation regulations concerning the design of their products.

Who should attend?

• Engineers & Designers
• Marketing Specialists
• Market Research
• Product Managers
• Clinical
• Regulatory
• Legal
• R&D