FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that 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(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.

This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.

This audio conference covers:

• Overview of key points in HE 75 and other FDA/EU guidance on human factors requirements
• In-depth review of usability testing, with examples and templates
• Creating and updating a user profile throughout the product design process
• Managing task analysis and developing plans/process to mitigate/control anticipated or observed use errors
• Performing error risk management, hazard analysis, and prioritizing user input
• Developing formative/summative user evaluations
• Assessing risk/hazard environmental considerations
• Converting user documentation into data

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?

• Human Factors Engineering
• Usability Testing
• Strategic Marketing, Marketing Services, and Market Research
• Patient Payer and Hospital Research

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.