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.
Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
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.
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Research Collective is a full-service human factors and user experience research firm. We do early design, formative and validation studies for medical device companies seeking better designs and FDA clearance. We believe rigorous, human-centered design is a critical component to the success and to the safety of a product or procedure.
Our team of researchers have MS and PhD degrees in human factors and cognitive science, with significant experience in research design, fielding, advanced statistical analysis and reporting. We've worked with medical device clients, large and small, including: Bard, BD, Medtronic, Mayo Clinic, SynCardia, Everist Health and Intuitive Surgical. Click here to learn more