Training Course
Syllabus:
This session will describe techniques that, when applied appropriately, can greatly impact product safety and usability. Product developers looking to maximize safety, usability, and satisfaction with their products, as well as human factors engineers who want to help developers to accomplish this, will benefit from this course.
Objectives of the Presentation
Identifying human factors activities at all stages of development How to properly execute different types of human factors tasks When to employ different techniques to assess a device When and how to consult different types of experts for feedback (e.g. device users, human factors specialists, subject matter experts) How early-stage activities contribute to meeting FDA expectations How to translate feedback and results into design inputs
Why Should you Attend
For medical device manufacturers, human factors engineering has gradually become part of the standard expectations for products on an FDA approval pathway. Though it is possible to execute successful studies that only meet the FDA´s minimum standards for human factors, this strategy does not necessarily result in products that have been optimized for safety and usability. Incorporating a more robust approach that considers human factors concepts throughout the entire development process is much more useful, and typically results in better designs and lower costs. This course describes the benefits of incorporating human factors throughout product development lifecycle, and provides guidance on how to effectively accomplish this. Areas Covered
Major stages of the product development lifecycle from a usability perspective Key human factors activities that provide that most value at each stage of development Conducting human factors assessments in the intended use environment The systems perspective to identifying usability inputs Heuristic evaluations and usage risk analysis Executing effective user testing Details of a proper human factors validation test Post-market monitoring and data collection Examples of successful execution of human factors activities in each stage Who will Benefit Medical device manufacturers, Usability/human factors engineers, Design and development engineers, Industrial designers, Risk managers and project managers, Quality Engineers, Quality Managers, Regulatory Specialists, Regulatory Managers, Compliance Specialists, Engineers involved in managing Design Changes, Engineers involved in developing Field Modifications |