Bold Insight announced a strategic partnership with Seoul National University Bundang Hospital (SNUBH) to help Korean medical device manufacturers meet U.S. human factors (HF) requirements and move faster toward submission. SNUBH, a government-funded intermediary, advises manufacturers and supports formative work in Korea, then connects qualified teams to U.S. vendors for summative studies; Bold Insight will lead those U.S. evaluations and deliver submission-ready evidence. The partnership recognizes Bold Insight’s track record in HF and medical-device research and gives Korean manufacturers a clear, dependable pathway to U.S. market entry.
“Manufacturers want a clear, compliant pathway from formative insight to summative human factors evaluations needed for submissions,” said Korey Johnson, Managing Partner at Bold Insight. “Together with SNUBH, we provide that bridge; local support in Korea paired with U.S. execution that aligns to regulatory expectations and real-world use.”
For Korean device teams, the value is continuity: one coordinated program that preserves context from early studies through validation, avoids rework, and produces the HF documentation regulators expect. SNUBH remains the front-line advisor in Korea while Bold Insight runs U.S. studies with experienced HF moderators, disciplined quality controls, and submission-ready reporting.
To initiate a joint HF plan for U.S. submission, contact [email protected] or work with your SNUBH coordinator.
For more information about Bold Insight’s human factors services, visit https://boldinsight.com/services/human-factors-research
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