This specialized case study explores Kymanox’s approach to Human Factors (HF) remediation and instructional material optimization through iterative formative evaluation and rapid prototyping. Our team of Subject Matter Experts (SMEs) collaborated closely with diagnostic device stakeholders to implement measurable improvements across low-literacy user support, critical task design, use error mitigation, and validation study success for in vitro diagnostic cancer screening systems.
CHALLENGE
SOLUTION
RESULTS
- In Vitro Diagnostic (IVD) cancer screening device manufacturer required HF support following failed validation study.
- Previous validation failure primarily attributed to instructiona materials inadequately supporting perofmrnacein low-literacy user groups.
- Critical task redesign necessary to eliminate persisten use errors identified throughout development process.
- Comprehensive optimization strategy essential to achieve FDA clearance with on-time market submission and ensure patient safety.
- Conducted two (2) sequential formative evaluations iterating and optimizing instructional materials based on comprehensive study data and user feedback.
- Analyzed low-literacy user performance identifying specific barriers to comprehension and successful task completion.
- Implemented rapid prototypting methodology for critical task demonstrating persistent use errors throughout formative evaluations.
- Gathered iterative user feedback through rapid prototyping cycles to finalize successful design subsequently validated in summative study.
- Developed instructional materials supporting diverse literacy levels while maintaining clarity and regulatory compliance.
- Successfully achieved FDA device clearance with on-time market submission following comprehensive instructional material optimization.
- Residual risk assessment confirmed instructional materials iteration reached optimization threshold with no further improvements possible.
- Eliminted use errors in critical tasks through systematic rapid prototyping and user-centered design approach.
- Delivered instructional materials effectively supporting low-literacy user groups ensuring safe and effective device use across target population.