In recent years, we have witnessed a remarkable shift in global regulatory agencies and industries, recognizing the immense value and importance of Human Factors Engineering. This field, which focuses on understanding how people interact with products, systems, and environments, has become an integral part of ensuring the safety, effectiveness, and usability of various products and services. We have witnessed firsthand the increasing investment in this discipline. While the growth in Human Factors Engineering is undoubtedly positive, it also presents us with new challenges. With the rise in demand for efficiency and cost-effectiveness, there is a parallel need to strike a balance—a balance between conducting thorough studies and not overburdening our budgets. Part 1 of this session aims to explore the strategies for achieving effective and efficient human factors work – how to bridge and leverage human factors data in drug-led combination product development.

In September 2023, FDA issued the final guidance of Application of Human Factors Engineering Principles for Combination Products. In part 2, we will be engaging in questions and answers during this session. This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.