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

Lessons learned• Formative Study vs. Summative Study• No need for quantitative measurements in the usabilitystudy!!!• 100% success only in steps which were identified as critical(Risk Assessment). In other steps failures are allowed aslong as they are not systemic.• HAQ as acceptable approach for disease level classification.• Provide documentation in a format that is consistent with therecent release of the New Draft Human Factors Guidanceeven-though still a “draft”.• Pre-IDE does not guarantee zero issues with FDA…32