Hardware Podcasts

055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

Let's Combinate · 19 Oct 2022 · 50m

What this episode covers

Alexandra Benbadis, Usability Leader at Sanofi and former Senior Human Factors Consultant at Emergo by UL, explains the regulatory distinctions between critical and knowledge tasks in combination product human factors studies. She details how the FDA's CDRH and CDR definitions of 'harm' expand the scope of critical tasks to include compromised medical care, such as underdoses in maintenance medications, requiring rigorous residual risk commentary. Benbadis also describes the evolution of knowledge task protocols, specifically the two-part approach to evaluate Instructions for Use (IFU) findability and comprehension without requiring their use during initial open-ended questioning.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Sanofi, Emergo by UL
Products
Design of Everyday Things
Also
Tufts University, FDA, CDRH, CDER, IEC 62366, HG 75, Don Norman

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