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Who should attend Applying Human Factors and Usability Engineering Throughout the Medical Device Development Lifecycle Webinar
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
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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

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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


Applying Human Factors and Usability Engineering Throughout the Medical Device Development Lifecycle

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

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.

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 collectionv
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

Topic Background

Human factors have slowly become an integral part of medical device development. Prior to the release of the draft guidance for applying human factors and usability engineering to medical devices in 2011, the FDA's perspective on these topics was vague, and device companies were not expected to follow strict procedures. The final guidance release in 2016 provides even more detail about expectations, but still keeps requirements somewhat minimal. When device developers are new to the process, they may fail to see the benefit of going above and beyond to conduct activities that the FDA does not necessarily require. This course will describe why these activities are vital to device success, and provide a primer for developing a robust human factors process that accounts for all stages of development.

Seminar Summary:

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. (see full course description)

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