The Rationale of Representativeness
By Sam Sye A key step in designing any human factors study is to define the intended user groups. User groups are determined by unique demographic characteristics that may impact how a particular user interacts with a given medical device. These characteristics may include age, gender, education level, medical literacy, prior experience with similar products, or any number of other factors. Every human factors study requires determining which of these characteristics are relevant, and subsequently, how these might be represented appropriately in a study. At the surface, it is logical that study participants should be representative of real-life end users. How else could one determine if safety mitigations and product designs facilitate treating patients safely and effectively? However, medical and pharmaceutical companies must wear many hats. On one hand, they have a responsibility to develop safe and useful products that promote health and alleviate suffering. On the other, a
