FORMATIVE USABILITY STUDIES
For compliance to the US-based FDA Human Factors guidance, the UK MHRA Human Factors and Usability Engineering guidance and IEC 62366-1:2015, performing a Formative Usability study is essential, and it has to be performed well.
A Formative Usability study is an exploratory test of the design of the medical device, using representatives of the intended users to guide the design further. Focus on use safety and hazards, user interface design, efficiency and time, the expected use experience and the simulated effectiveness of the medical device are elements of a Formative Usability study. Where user research on a new design of medical device is theoretical, a Formative Usability study is practical.
For compliance to the European MDR, a Formative Usability study is a verification test of the design and its use safety. Where usability and human factors were subjective requirements in the 93/42/EEC MDD ‘Essential Requirements’, the new 2017/45/EC MDR Annex I ‘Essential Requirements’ list requires documented evidence of acceptable human factors and usability of the designed product.
We are currently able to perform Formative Usability studies in many countries globally including Australia, Austria, France, Germany, Ireland, Lithuania, Netherlands, Spain, Switzerland, USA and the UK.