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

Integrating human factors engineering from the start of product development changes outcomes for safety, compliance, and commercial success. This session explores when and how to embed usability practices into development lifecycles, what regulatory bodies actually expect, and how early HFE investment pays off for organizations of every size.

Key Topics Covered:

• When and how to integrate usability testing across product development stages

• What FDA, MDR, and IEC 62366 compliance looks like in practice

• How early human factors investment drives safety, compliance, and market adoption

• Scalable strategies for startups through established manufacturers