Global Human Factors Strategy for MedTech

Human factors challenges rarely surface at the start of a program. They emerge during regulatory review, when timelines and budgets are already under pressure. This session examines how human factors strategy supports regulatory success across global markets, where companies most commonly encounter friction, and how early planning decisions reduce rework and cost. High-level considerations for China are included to support global program planning.

Key Topics Covered:

• Regulatory expectations for human factors across the US, EU, and UK

• How global sequencing of formative and validation work affects cost and timelines

• Common gaps that trigger regulatory questions or re-testing

• "Good, better, best" human factors approaches for startups and larger organizations

• How to build a defensible global strategy that supports internal alignment