This specialized case study explores Kymanox’s approach to Human Factors Engineering (HFE) and usability validation through expert regulatory guidance and comprehensive testing strategies. Our team of Subject Matter Experts (SMEs) collaborated closely with client stakeholders to implement measurable improvements across HFE/Usability Engineering (UE) documentation, validation study design, FDA compliance, and regulatory risk mitigation for on-body injector combination products.
CHALLENGE
SOLUTION
RESULTS
- Pharmaceutical client required HFE and UE support for new on-body injector product submission.
- HFE/UE reports needed to meet stringent FDA guidelines and regulatory requirements for combination product approval.
- Data robustness and proper formatting essential to support FDA approval and minimize regulatory risks.
- Enhanced validation required to demonstrate safe and effective use of complex drug delivery device.
- Leveraged expertise from Kymanox Human Factors (HF) SMEs and device design engineers to develop compliant HFE/UE report meeting FDA standards.
- Conducted comprehensive analysis of client’s validation study results to assess demonstration of safe and effective product use.
- Generated evidence-based recommendation to conduct additional HF validation study enahcing data comprehensiveness and regulatory confidence.
- Compiled data from both validation studies, restructuring information into industry-standard format supporting FDA submission requirements.
- Applied deep knowledge of FDA HF guidance and regulatory expectations through documentation process.
- Produced robust HFE/UE report meeting FDA standards and significantly reducing regulatory risk for new product submission.
- Enhanced client confidence in submission data quality through comprehensive validation approach and expert analysis.
- Successfully demonstrated safe and effective use of on-body injector system through dual validation studies.
- Secured ongoing client satisfaction and continued collaboration with Kymanox for future HFE projects.