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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 between how the device performs during summative HFE testing for FDA submission and the surprising number of reported usability problems recorded after the device actually gets into the hands of patients in real-world settings. This disparity is reason for concern because a dramatic decrease in HFE performance by a device can signal significant loss of clinical effectiveness. To address this question MUS has recently executed a complex multi-city HFE field analysis to determine the source of such disparities and to aid major clients in understanding the structure and basis for identifying and resolving such outcomes during formative and summative studies. The learnings are being applied to updated and more robust summative testing methods that will deliver to the FDA more reliable HFE performance data. Request more information.

One Comment

  1. I’m particularly interested in understanding more about the methods used in this field analysis and how these findings are being integrated into the revised testing procedures. Could you provide more detailed information or resources regarding the specific changes being made to the summative testing methods based on these findings? Additionally, how does MUS plan to continue monitoring and adapting to the evolving landscape of drug delivery device usage to ensure ongoing efficacy and safety?

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