In 2016, the FDA finalized its human factors guidance for medical devices.
This guidance document cleared up some of the uncertainty about how manufacturers should implement human factors into their product development process.
However, due to the wide diversity of medical devices manufactured today (auto-injector vs. infusion pump vs. robotic surgical system etc.), manufacturers often struggle to understand how the guidelines apply to their own specific device(s).
This webinar will break down FDA’s human factors guidance into a list of actionable steps.
In this free 60 minute webinar our presenter Bryant Foster, VP Research & Design at Research Collective, will describe proven strategies that will help manufacturers: (1) improve their time to market and overall design through early implementation of human factors and (2) pass their human factors validation test for FDA clearance.
specifically, YOU WILL learn:
- An understanding of usability testing and its role within the field of human factors
- How to improve overall product design and speed to market by implementing human factors into design controls
- Strategies to pass a human factors validation test on the first attempt
- The importance of including in their human factors strategy all of the tasks impacted by the device use (device setup, instructions for use, cleaning, disposal, etc.)
- The first step a manufacturer should take after receiving a deficiency letter that mentions a lack of human factors
- The future of post-market usability surveillance
Who should attend?
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Medical Device Executives
- Human Factors and UX Professionals
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Regulatory Affairs Professionals and Management
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Quality Professionals and Management
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Clinical Affairs Professionals and Management
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R&D Engineers and Management
About the presenter:
Bryant is the Vice President of Research & Design at Research Collective. He guides human factors efforts for medical device manufacturers, pharmaceutical companies, automakers, consumer product manufacturers and more.
His healthcare experience includes a wide range of products: surgical instruments, diagnostic equipment, combination products, pump programmers, artificial organs, home-use devices, and over-the-counter products. He has also led research and design efforts for in-car infotainment systems, automated/driverless systems, and audio/visual navigation tools.
As a UX researcher at Google X, Bryant performed research for products like Google Glass and Project Loon. He has a Bachelor’s degree in Spanish and a Master’s degree in Applied Psychology (Human Factors), both from Arizona State University.
