In the realm of medical research for devices, Human Factors (abbreviated to HF) is a critical phase in gaining approval for new products. It assists manufacturers in the optimisation of the device design and production process, utilising the knowledge and opinions of real people to identify issues likely to impede on performance. In addition to this, HF provides feedback as to the performance of a device within a typical user setting, ensuring opportunities for improvement are identified.
According to the BSI, completing HF research at an early stage in the design and development process is a key preventative measure against badly designed medical devices. Without HF, new products wouldn’t make it to market.