This comprehensive case study explores Kymanox’s approach to FDA Human Factors (HF) deficiency resolution and validation study remediation through rigorous task analysis and targeted user testing. Our team of Subject Matter Experts (SMEs) collaborated closely with pharmaceutical stakeholders to implement measurable improvements across use-error analysis, risk mitigation strategies, training program development, and validation study design for Dry Powder Inhalation (DPI) devices serving non-CF bronchiectasis patients.
CHALLENGE
SOLUTION
RESULTS
- Global pharmaceutical company required HF study remediation for DPI device targeting non-CF bronchiectasis patients with adults as new user group.
- Instructions for Use (IFU) modifications needed to support expanded user population and address usability concerns.
- Previous validation report rejected by FDA due to significant HF deficiencies including numerous study artifacts and inadequate root cause analysis.
- Comprehensive remediation strategy essential to achieve FDA approval and ensure patient safety across diverse user populations.
- Identified root cause of FDA rejection: insufficient task use-error analysis lacking Principal Component Analysis (PCA) methodology and comprehensive risk assessment.
- Conducted accurate and complete task use-error analysis applying rigorous Human Factors Engineering (HFE) methodologies and FDA guidance.
- Analyzed User Interface (UI) through formative evaluations, determining device and IFU alone as insuffienct mitigations for use-related risks among intended adult users.
- Developed comprehensive training program implemented through specialty pharmacies addressing identified use-related risks and knowledge gaps.
- Successfully recruited and testing surrogate users for HF validation study ensuring representative user population and robust data collection.
- HF validation study report submitted to FDA without questions, demonstrating comprehensive remediation of previous deficiencies and regulatory compliance.
- Client gained critical insight that devices design for one user group (children) cannot be assumed suitable for different populations (older adults) without validation.
- Transformed client’s HF strategy requiring HF testing across different user groups with risk-based approach rather than preference testing methodology.