Human Factors and Usability Testing

Reports from medical device regulators worldwide have repeatedly shown that human error in technology usage is a much more common cause of adverse incidents, including patient harm, than actual technology failure. Investigating user errors at all stages of device development is now embedded in most device regulatory systems.

Well-designed usability studies support industry in two important areas. Firstly, the MHRA ask for usability testing to be undertaken and the results included as part of the risk assessment section of the Technical File. These studies, in line with IEC 62366-1:2015, should be performed in a “realistic environment” but “not on real patients”.

Secondly, early usability studies provide insight into future clinical uptake and greater understanding of the complex realities of work carried out in busy and ever-changing clinical environment. This allows design amendments to be made to support future adoption and for “fail early” decisions.

Pre-regulatory studies in simulation do not require Regional Ethics Committee (REC) or a letter of no objection from the MHRA, therefore allowing rapid and value for money research that doesn’t place patients or volunteers at risk.