Request Copyright Permission

Satisfying US and EU Human Factors Requirements for Inhaler Devices

Gupta SP.

RDD Asia 2016. Volume , 2016: 133-144.

Abstract:

Human factors engineering (HFE) used to be considered by many as merely a desirable or optional aspect of the medical product design process – but not any more. Regulatory bodies, such as the US Food and Drug Administration (FDA), require manufacturers to incorporate HFE into the design and development of their medical devices and combination products such as inhalers. The regulatory framework around HFE has become stringent with the recent publication of the FDA’s Guidance Documents of 2016, International Standard IEC 62366-1:2015, Technical Report IEC/TR 62366-2:2016, and the UK Medicines and Healthcare Products Regulatory Agency’s (MHRA’s) HFE Guidance.

Although these standards and guidance have outlined the regulators’ current thinking and expectations regarding HFE, many in the industry are still baffled by what is actually required and how one can achieve it. This is evident from the fact that basic things, such as the difference between medical devices and combination products, are ambiguous to many people, and that some still think HFE is simply a user study, which is untrue. The lack of understanding, ironically, is partly because these usability guidance documents and standards are not user friendly! This paper will provide an overview of the HFE process in a simple schematic way, clarifying the ambiguities and highlighting the pitfalls, explaining the essential elements of the process and comparing the processes for submission to different regulatory bodies.