CORE HUMAN FACTORS, INC

CORE HUMAN FACTORS, INC. specializes in human factors research and usability evaluation for complex medical devices and drug-device combination products. The company conducts comparative use studies to assess how interface design differences impact user error rates, task performance, and safety outcomes among patient populations—particularly in diabetes care settings. Their technical expertise spans human-centered design, cognitive task analysis, usability testing protocols, and regulatory-aligned evaluation methodologies aligned with FDA guidance and ISO 14971. Core differentiators include deep domain knowledge in patient-device interaction, rigorous experimental design for real-world usage scenarios, and the ability to translate behavioral findings into actionable design improvements that support regulatory submissions and post-market surveillance. The contractor has established a consistent relationship with the Department of Health and Human Services, delivering human factors research that directly informs product safety and regulatory decision-making. Their work supports HHS initiatives focused on generic drug-device combination products and patient-centric medical device design, often in collaboration with FDA-aligned programs. This sustained engagement reflects a trusted advisory role in translating clinical and behavioral science into compliance-ready evidence. The primary NAICS classification of 541720 reflects a focused niche in social science research applied to healthcare technology. The firm positions itself at the intersection of human behavior, medical device engineering, and regulatory science, serving the pharmaceutical and medical device industries through evidence-based usability validation. Their market positioning is defined by precision in evaluating user interface variations that could compromise patient safety. CORE HUMAN FACTORS, INC. is a small business structured as a 2L entity, headquartered in Bala Cynwyd, Pennsylvania. While currently holding no formal government certifications, the company’s technical rigor and regulatory alignment establish credibility within the federal healthcare contracting space. Their geographic presence and operational focus are centered on supporting federal health agencies through specialized human factors science.