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Articles tagged FDA

A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

  A staggering report was recently released by the International Consortium of Investigative Journalists (ICIJ) indicating that 83,000 deaths and 1.7 million injuries were linked to medical device adverse events reported over the last decade. Furthermore, a 2013 report by McKinsey & Company suggested that such adverse events and associated quality issues cost the medical … Continue reading A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

Understanding Costs And Risks For Human Factors Engineering (HFE) Usability Studies – Part 2: Outsourcing HFE Usability Testing

  Many of you may have read Part 1 in our series on Understanding Costs And Risks For HFE Usability Studies, which discussed the factors that device development teams should consider when executing HFE studies internally. We recently published the second article in this series, which discusses how to optimize data quality while controlling for … Continue reading Understanding Costs And Risks For Human Factors Engineering (HFE) Usability Studies – Part 2: Outsourcing HFE Usability Testing

Recent Research: Real-World Usability Testing

MUS Executes Complex Multi-City Study to Explore Disparities in Actual Use of Complex Drug Delivery Devices vs. Expected HFE Performance Based on Summative FDA Study Data. There is an interesting phenomenon occurring in the actual real-world use of more complex drug delivery devices by patients and HCPs. The problem is there is a wide disparity … Continue reading Recent Research: Real-World Usability Testing