Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.

This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.

This audio conference covers:

• What FDA guidance documents say about human factors requirements
• The current state of usability testing in the medical device industry
• Various types of usability testing available
• Complex scenarios such as multiple user groups with varying levels of competency or familiarity with devices

About the speaker:

Maria Shepherd has 20 years of leadership experience in medical device and life sciences marketing in small start-ups and Fortune 100 companies. She founded Data Decision Group after a career in industry that included serving as Vice President of Marketing for Oridion Medical, and Director of Marketing for Philips Medical and Boston Scientific. She has also served on the corporate board of the American Patient Safety Foundation.

Data Decision Group provides usability testing data, conclusions, and recommendations to answer key questions created in product design and development for medical devices and other life sciences companies. Boasting a highly experienced team with unique in-depth clinical and industry knowledge, Data Decision Group synthesizes and transfers clinical findings into product design recommendations that can be rapidly and profitably integrated into client product development.

Maria received her MBA, magna cum laude, from Babson College, cited by USA Today as the top US entrepreneurial program. She also earned a BA in Biology from University of Pennsylvania.

Who should attend?

• R&D
• Regulatory Affairs
• Quality Assurance Mangers
• Vigilance/Safety Officers/Managers
• Clinical Trial Managers
• General Management