The UK-based MHRA has released guidance for human factors and usability engineering of medical devices that details a list of deliverables they expect to see as part of a submission for selling a medical device in the UK. The guidance specifies a human factors and usability engineering process, similar to that seen in the FDA guidance for the USA. It also includes tasks that the regulatory standard IEC/ISO 62366-1:2015 includes, but not all. It’s primary focus though is on use safety, to ensure that a medical device has inherrent acceptable levels of use-based risk, and has a process through development that quantifies this.
The MHRA human factors and usability engineering process requires a set of inputs, that user research can determine. A Use Specification is the culmination of this user research alongside a Usability Risk Assessment of some form (to document where use-based risks may occur in theory). Once all inputs are defined, the medical device requires development, and once developed requires assessment in the forms of usability verification and human factors validation. Finally, a Summary Report is requested so that the whole process can be summarised and a final level of use-based risk quantified.
THAY Medical perform the sequence of this UK-based process on many medical devices. It is scalable to the amount of use-based risk the medical device carries, but is a process that will always enhance the medical device. THAY Medical can work alongside designers, engineers and medical device developers to incorporate the deliverables required for compliance to this regulation and assist to make the medical device as usable as possible, and to ensure the users will have a positive use experience in real life once the medical device is launched.