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

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Our ISO 13485, holistic HFE approach

Central to our mission at Design Partners is elevating human potential, and it lives and breathes through our human factors engineering. Our approach to HFE is rigorous and proven. While it is particularly associated with the formalised processes in our healthcare work, broader HFE principles are deeply embedded into our company ethos and overall approach. Importantly, it is not something that’s applied in isolation. We combine human factors engineering with industrial design creativity and engineering excellence to deliver exceptional usercentred design.  

Our healthcare team believes that HFE goes way beyond regulatory issues. Instead, we use it as a strategic product development tool that brings three main benefits.  


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, enduser 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 humancentred design process that uses sensory engagement as a driver for decision making.   

Download our HFE Process Poster

To download our poster on Integrating Human Factors Engineering into the Design Process, simply enter your details in the form below.



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