Human Factors and Medical Device Instructions for Use: It’s Not Just Good Business and Good Science, It’s the Law

Abstract

The stated purpose of this panel was to discuss how the application of human factors science to the design, evaluation and development of medical device labeling and instructions for use is both good business and consistent with the law. Specific examples of the law were briefly discussed in the panel and are described in more detail in this paper. Questions posed by the audience quickly made it apparent that a higher-level conversation around risk was desired. One of the main topics addressed was that of unintended misuse; a summary of that discussion is also included in the paper. The overarching theme of the panel was as follows: The best we can do as human factors professionals is perform good science, document the work that we’ve done and the reasons for decisions that were made. We should also always strive to create the best product which requires balancing numerous constraints and competing goals.