The importance of a robust human factors engineering program in medical product development, particularly combination products

The FDA's Office of Combination Products recently finalized guidance emphasizing the critical role of human factors engineering (HFE) in the development of combination medical products. Eurofins Human Factors MD highlights the importance of a robust HFE program, stressing its necessity rather than being optional. The guidance recommends considering combination products as parts, conducting a separate Use-Related Risk Analysis, and identifying meaningful critical tasks. It provides clarity on participant training in HFE validation tests based on UI design requirements. The document encourages manufacturers to address unique attributes of combination products and recommends a pre-submission review of the HFE validation protocol with the FDA to mitigate risks in marketing submissions.