• Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance
  • Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance

    • Speaker : Edwin Waldbusser
    • Session Code : EWJUN2524
    • Date : 25th June 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 75 Mins



Human Factors/Usability studies are essential in ensuring that medical devices are safe and effective for users. Historically, the FDA has played a pivotal role in emphasizing the importance of human factors engineering in the development of medical devices. This focus has evolved significantly, from initial guidelines that highlighted user-centered design to the comprehensive ISO 62366 standards and detailed FDA Guidance we follow today.


Initially, the FDA addressed user errors—mistakes made by users during interaction with a device. As the understanding of human factors engineering matured, the perspective shifted to viewing these mistakes as use errors, highlighting the responsibility of manufacturers to design intuitive and resilient devices. This shift underscores the need for thorough human factors analysis to anticipate and mitigate potential misuse, ensuring devices are as safe and user-friendly as possible.


In recent years, the FDA has continued to advance its guidance on human factors, culminating in the latest draft guidance that further elevates the standards for device safety and usability. This new guidance impacts existing FDA requirements for Human Factors (HF) programs, setting higher expectations for integrating human factors engineering into the device design process. For example, consider a scenario where a complex medical device interface leads to frequent use errors, potentially causing harm. Such issues highlight the critical need for rigorous human factors studies to improve device usability and safety.


This webinar will provide an exploration of conducting human factors studies throughout the design lifecycle, integrating them with risk analysis, and validating their effectiveness. You will learn about various human factors analysis methods and the necessary documentation to ensure compliance with the evolving regulatory landscape.


By attending this webinar, you will gain valuable insights into the historical and current FDA perspectives on human factors, equipping you with the knowledge to design devices that not only meet regulatory requirements but also enhance user satisfaction and safety. Whether you are dealing with challenges related to use errors, striving to create user-friendly interfaces, or seeking to stay updated with the latest regulatory changes, this session will provide you with the tools and strategies needed to succeed in the competitive medical device and pharmaceutical markets


Areas covered in the session:


  • User error versus use error
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • Human Factors validation
  • Impact of new draft guidance on the HF program


Exclusive Handouts:


  • Use Specification Template
  • User Interface Evaluation Template
  • Usability Validation Control Form


Why You Should Attend:


In the rapidly evolving medical device and pharmaceutical industries, ensuring the safety and effectiveness of your products is more critical than ever. Regulatory standards are increasingly stringent, and the need for devices that are intuitive and resistant to use errors is paramount. This webinar will provide you with the latest insights on how to comply with ISO 62366, current FDA Guidance, and the new FDA Draft Guidance, ensuring your devices meet the highest regulatory standards.


By attending, you'll gain valuable knowledge on integrating human factors engineering into your design process. This is essential for creating products that not only meet regulatory requirements but also enhance user satisfaction and safety.


Who Should Attend:


  • Medical Device Engineers
  • Usability Engineers
  • Human Factors Specialists
  • Regulatory Affairs Professionals
  • Quality Assurance Managers
  • Product Designers
  • Risk Management Professionals
  • Medical Device Manufacturers
  • Pharmaceutical Industry Professionals
  • Compliance Officers

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 11 years.

Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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Tags: Human Factors, Usability Studies, ISO 62366, FDA Guidance, FDA Draft Guidance, Medical Device Safety, Usability Engineering, Risk Analysis, Regulatory Compliance, Medical Device Design, Edwin, Waldbusser, June 2024,