Applying Human Factors Best Practices for Medical Device Risk Management

Managing risks of use related hazards should begin early in the design cycle and continue through post market launch activities. The Design Controls process of the Quality System Regulation forms the baseline for design activities and risk management. In this webinar session, we will identify and describe human factors methods that can be used to manage use error risks at the earliest design stages We will also highlight typical manufacturer pitfalls in designing user studies and usability tests as well as common mistakes and omissions regarding use error in PMA and 510K submissions. This session will go beyond the previous session in terms of providing more detail about individual methodologies.

Areas Covered in the seminar:

• Description of common best practices in task analysis and test and evaluation methods.
• Typical examples of user profiles, usage scenarios, and environmental analyses performed in Design Input.
• Protocol development for user interaction evaluations and usability testing.
• The FDA hierarchy of preferred use error mitigation strategies.
• Manufacturer common mistakes when submitting usability and user study data to the FDA.
• Augmenting typical risk analyses with use error risks identified through test and evaluation methods.

Who will benefit:

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device. Focus is on individual activities within the Design Controls process that are considered best practices in use error management. Job functions that will benefit include:

• Research and Development functions: software, mechanical, industrial design, systems engineering.
• Regulatory and Compliance: presenting use error analysis and investigation clearly and comprehensively to regulatory bodies.
• Quality System Management teams
• Risk Management teams

Instructor Profile:
Robert A. North, PhD, is Chief Scientist of Human Centered Strategies, LLC specializing in creating strategies for applying Human Factors methods to medical device risk management and overall device effectiveness for several major manufacturers. Bob has worked as consultant to FDA/CDRH on analysis methods for use errors in adverse events, and is a member of the AAMI Human Factors Standards Committee currently developing a new standard for best practices. He has also recently served as faculty for Advamed (MTLI) in recent Design Controls seminars representing the FDA position on human factors. He is author or co-author on several articles appearing in MDDI’s Device Link (on-line) and is on the faculty of the Regulatory Affairs Professional Society’s (RAPS) 2008 Horizons Conference, presenting seminars on use error risk management strategies.