Expert-involved continuous renal replacement therapy device development: addressing user needs through human factors engineering.

Background: Continuous renal replacement therapy (CRRT) devices are essential for critically ill patients but present significant usability challenges that create use-related risks affecting patient safety. This study applied expert-involved usability engineering to develop a user-centered CRRT device.

Methods: A three-phase study engaged 233 experts: Phase 1 assessed user needs through an online survey (n = 204) identifying use-related risks. Phase 2 developed and iteratively refined a CRRT prototype through expert review (n = 8) and heuristic evaluation (n = 5). Phase 3 validated the final prototype with ICU nurses (n = 16) through task performance in simulated ICU environments. Main outcomes included user satisfaction scores and use error observations.

Results: Phase 1 identified user needs and use-related risks, which were translated into user interface requirements. The initial prototype was developed and refined after iterative usability tests. The final prototype demonstrated high satisfaction scores: Overall User Experience 4.29 ± 0.53, Ease of Use 4.23 ± 0.50, and Comparative Assessment 3.56 ± 0.72. The validation test confirmed effective mitigation of use-related risks. Eight use errors and 48 use difficulties were identified for further refinement.

Conclusions: Systematic expert involvement in usability engineering successfully developed a CRRT device that effectively mitigated use-related risks while achieving high user satisfaction, demonstrating the value of expert integration in medical device development.