This comprehensive case study explores Kymanox’s approach to Human Factors (HF) process development and organization capability through gap analysis, procedure integration, and comprehensive training programs. Our team of Subject Matter Experts (SMEs) collaborated closely with medical device stakeholders to implement measurable improvements across design assurance processes, risk management integration, Standard Operating Procedure (SOP) development, and internal training for diverse product portfolios spanning simple devices to complex hardware-software systems.
CHALLENGE
SOLUTION
RESULTS
- Global medical device company required expert support creating HF procedures and templates for integration into existing design assurance and risk management processes.
- Organization previously outsourced HF work but sought thorough internal understanding of HF requirements, best practices, and process integration strategies.
- Diverse product portfolio spanning simple physical devices to complex systems incorporating hardware and software components required scalable HF approach.
- Team capability building essential to ensure confident, efficient HF documentation support future FDA submissions and technical file reviews.
- Conducted comprehensive gap analysis of existing procedures identifying improvement areas in both short-term and long-term timeframes across product portfolio.
- Developed strategic plan integrating HF activities into client’s existing design and risk management processes ensuring seamless workflow incorporation.
- Collaborated with cross-functional client stakeholders to execute integration plan including development of SOPs and documentation templates.
- Created customized internal training program ensuring team members trained on HF process updates. FDA guidance requirements, and IEC 62366 guidelines.
- Delivered scalable templates and procedures applicable across diverse device complexity levels from simple tools to sophisticated medical systems.
- Client developed thorough understanding of proper HF activity conduct and documentation aligned with FDA guidance and IEC 62366 international standards.
- Team members gained confidence and capability to efficiently document HF-related activities supporting future regulatory submissions and technical file review.
- Successfully internalized HF expertise reducing dependency on external resources while maintaining regulatory compliance documentation quality across product portfolio.