Program

Day 2 September 16 (Wed)

Session

Learning Practical FDA Human Factors Engineering (HFE) Requirements Through Global Case Studies:From the Latest FDA Guidance to Supplementary Review Cases and HFE Responses

This session reviews the latest FDA HFE requirements and contrasts them with IEC 62366‑1–based approaches.
It also introduces strategies for responding to usability evaluation findings through real supplementary review cases.

Partner Organizations
Time Title Speaker
15:30 – 15:35 (05’) Opening Remarks KHIDI
15:35 – 17:45 (130’) Human factors considerations for US FDA medical device commercialization Korey Johnson
Bold Insight
CEO
17:45 – 18:00 (15’) Q&A

Speakers

You can click on each speaker to view their Professional Experience and Abstract.

  • Korey Johnson
    15:35 - 17:45 Human factors considerations for US FDA medical device commercialization
    Korey Johnson
    Bold Insight
    CEO
    Close
    Korey Johnson
    Korey Johnson

    Bold Insight
    CEO

    15:35 - 17:45
    • Professional Experience

      He is an expert with more than 20 years of experience in medical device human factors and usability engineering. As the President of Bold Insight, he leads human factors research and evaluation for medical devices. He has been an active member of the AAMI Human Factors Engineering Committee and recently contributed to the revision of ANSI/AAMI HE75:2025.

    • Abstract

      This presentation reviews the core requirements of FDA human factors and usability evaluation for medical devices, highlighting key considerations through real global case examples. It will cover formative evaluations, human factors validation, use related risks and mitigation strategies, and practical issues companies must address to meet FDA expectations during the review process.