Flexi-Q DV Auto-injector Case Study - DALI Medical Devices

Usability Studies• Previous Issue:– Failure to accurately aspirate 1.0 mL (±5%) of solution– Related to patient/user performance – not auto-injectorfunctionality• Mitigation- Elcam instituted design change:– Dosing graduation line color was changed– Dosing graduation line thickness was enhanced• Elcam proposes to perform Summative Usability study:– Success of the design change mitigation– 60 devices operated by 10 participants (healthy and patients)– Comparison of usability to standard syringe (predicate device) andquantitative measurements18