Challenge: A diagnostic company developing a novel lateral flow assay for home use needed comprehensive usability engineering to satisfy both FDA and IVDR requirements for lay users.
Solution: MDx implemented a complete usability engineering program including:
- User research with target patient populations
- Iterative formative testing across three design cycles
- Comprehensive instructions for use validation & label comprehension studies
- Summative validation with 60 participants across three countries
Result: The client’s self-test IVD received both FDA clearance and IVDR certification with zero usability-related findings or deficiency letters.
