This specialized case study explores Kymanox’s approach to Human Factors (HF) validation and global regulatory compliance through efficient study design and sequential testing strategies. Our team of Subject Matter Experts (SMEs) collaborated closely with medical device stakeholders to implement measurable improvements across study execution and healthcare professional user testing. This led to the concurrent 510(k) and Medical Device Reporting (MDR) submission preparation for blood collection systems.
CHALLENGE
SOLUTION
RESULTS
- Major medical device manufacturer required comprehensive HF validation study support for blood collection devices used by healthcare professionals.
- HF validation studies needed efficient timeline execution achieving concurrent results supporting FDA 510(k) submission and European MDR requirements.
- Strategic study design essential to demonstrate safe and effective use across intended user popualtions and use environments.
- Coordinated regulatory strategy required to meet both US and EU compliance standards simultaneously, optimizing development resources and timelines.
- Conducted comprehensive HF validation study for first blood collection device testing two (2) distinct Healthcare Professional (HCP) user groups ensuring representative user population.
- Leveraged data and insights from first device validation to strategically plan and efficiently execute HF validation study for second medical device.
- Optimized second validation study design with single HCP user group based on learnings from initial testing, improving efficiency while maintaining regulatory rigor.
- Coordinated study execution to meet aggressive timelines supporting concurrent regulatory submissions in the US and EU markets.
- Ensuring validation protocols aligned with FDA HF guidance and European MDR requirements.
- Successfully demonstrated both devices safe for intended users, users, and use environments with final marketed User Interface (UI) supporting safe and effective use.
- Delivered robust validation data satisfying requirements for both US FDA 510(k) submission and European MDR compliance simultaneously.
- Achieved efficient study execution through strategic sequential design, leveraging learnings from first device to optimize second validation study.
- Enabled manufacturer to meet aggressive regulatory timelines supporting global market access and commercial objectives.