WORK / Expertise Human Factors Engineering — a process and a mindset

Increased patient safety, optimization, and risk reduction are key. We use formative and summative testing right through the process, and usability studies are conducted and analysed according to ISO/ IEC 62366 in conjunction with ISO 14971 risk management for FDA and CE regulatory submissions as required. It’s a continuous process of verification and validation. 

More broadly, one of the principles that unites our work is the need to reach beyond the digital landscape and ensure that we create, make and feel in the real world. Very early in the process, we prototype and get products into people’s hands, maintaining a tactile, intimate, end–user perspective throughout the development process. It’s an iterative process of prototyping and testing that inform the next stage of development until the solution is optimised. A truly human–centred design process that uses sensory engagement as a driver for decision making.