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People don’t make errors. Products fail to prevent errors.
Reading Time: 3 minutes No matter the product—an inhaler, a surgical robot, a medication pump, or a smartphone application—following a human factors engineering process will use usability studies. Usability testing is a research method designed to evaluate a product’s…
FDA Medical Device Approval: Why Hire a Human Factors Expert
Reading Time: 5 minutes Healthcare Human Factors Engineering Human Factors Engineering focuses on designing products that match human capabilities and account for human limitations. This makes products easier to use, more effective, and safer. This is critical when designing…
Human Factors and the FDA: Buzzwords
Reading Time: 3 minutes Human Factors and FDA Submissions Medical device manufacturers cannot legally market their products without clearance or approval from the Food and Drug Administration (FDA). Unfortunately, navigating this regulatory jungle can be a bit of a…