Human Factors Engineering in MedTech: Why Usability Matters From Day One

Overview

Kay explored how early integration of human factors engineering transforms both product outcomes and regulatory success, covering:

• Integration timing and methodology - When and how to embed usability testing into product development lifecycles, moving beyond late-stage validation approaches

• Regulatory expectations in practice - What FDA, MDR, and ISO 62366 compliance actually looks like, with examples of documentation that meets regulatory standards

• ROI of early HFE investment - How human factors drives safety, compliance, and market adoption while becoming a competitive differentiator

• Scalable strategies - Practical approaches for different company sizes and development stages, from startups to established manufacturers

This session provides insights into ClariMed's methodology and demonstrates our expertise to the broader MedTech community through real-world examples from our diverse client portfolio.