A human factors validation study can test the effectiveness of a product or process. It should be performed using a constructive approach rather than a retrospective evaluation. A human factors validation study should also include the effects of a product’s design on its users. Formative studies are essential for the improvement of design quality and safety, as well as for reducing product recalls.
Formative human factors study
A formative human factors validation study is an early round of user testing. The primary audience for such a study is the FDA. However, the audience can also be a small development team, a consultant-client contract, or the CEO of a company. Identifying the intended audience before the study begins is crucial because a product development team will likely require more information than the CEO. In contrast, a CEO may only need an executive summary.
A formative human factors validation study is a …