The 5 Ws Of A Human Factors Strategy

Many biopharma and medical device companies address human factors engineering too late, impacting regulatory submissions and commercialization. A comprehensive human factors strategy, distinct from a human factors plan, ensures medical products support safe and effective use by minimizing user-related errors. Beyond regulatory compliance, it enhances product usability and market success.

A well-developed strategy integrates human factors engineering into key design, development, and post-market milestones. It is scalable, adapting to different product types, user needs, and risk levels. Companies must consider factors like intended users, use environments, device interactions, and regulatory requirements (e.g., FDA, IEC 62366-1). Early implementation aligns with design planning and risk management, preventing costly delays.

Key strategy components include use specifications, risk analysis, labeling, formative studies, validation tests, and post-market monitoring. Experienced human factors specialists should develop the strategy, ensuring regulatory alignment and navigating challenges like FDA review delays or product testing constraints. Collaboration across engineering, clinical, quality, and regulatory teams is essential.

By implementing a tailored human factors strategy early, manufacturers minimize risks, optimize resource allocation, and streamline regulatory approval. This proactive approach facilitates compliance with FDA and global regulations while improving product safety, usability, and commercial viability.