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A recently published international standard requires manufacturers of medical devices to follow a systematic usability process. To comply, manufacturers of medical devices will need to change the way they design, develop, test and manufacture their systems.
Most companies know they cannot risk launching products with poor usability. They know that ultimately there will be a price to pay — expensive redesigns, poor customer experience, high volumes of customer service calls and complaints, lost user productivity and lost revenue.
But there are some industries in which the stakes are very much higher. For companies designing and manufacturing medical devices, poor usability is literally a matter of life or death. More than a third of medical device incidents involve usability issues and, on average, 195,000 people die in American hospitals annually because of medical errors. While not all of those cases are attributable to specific user interface design problems, increasingly complex user interfaces are unquestionably a part of the problem.
Enter ISO/IEC 62366: Medical Devices Application of Usability Engineering to Medical Devices. This is a new international standard aimed squarely at reducing the risk of medical errors due to poor interface design.
ISO/IEC 62366 is a process-based standard that aims to help manufacturers of medical devices ‘design in’ usability and 'design out’ use errors. The standard also applies to documentation that may accompany a device, and to the training of intended users. However, it does not apply to clinical decision-making that may be related to the use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. In doing so, ISO/IEC 62366 expands the scope to include all medical devices — not just electrical ones.
Manufacturers that follow the standard must adopt a user centred design process (called a Usability Engineering Process in the standard) that spans the design and development life cycle of the device. To comply, manufacturers must document the process in some detail in a Usability Engineering File.
The standard itself comprises just 6 pages. A further 80 pages present a number of detailed annexes along with useful worked examples — a veritable usability training course, in fact! — to help companies understand how to institutionalise the usability process and to guide them through the standard.
We still encounter development teams — across a range of industries, not just in the medical field — who are uncertain of what usability actually involves. For some companies usability still consists of little more than 'checking a box': medical companies in particular often assume that usability is accounted for by extensive pre-market clinical trials. Project teams are sometimes surprised to learn that you cannot 'do usability' just by running a focus group, collecting customer opinions, tagging a few questions on the end of a market research survey, or simply conducting a test prior to launch. ISO/IEC 62366 corrects these misconceptions for manufacturers of medical devices in much the same way that ISO 9241-210 corrected the same misconceptions for other industries.
The standard describes a Usability Engineering Process with 9 stages:
Usability is an iterative process. If the acceptance criteria described in the usability validation plan are not met the process loops back to the user interface design stage. Note that the stages parallel those in ISO 14971: Medical devices - Application of risk management to medical devices. If you comply with the Usability Engineering Process, the residual risks associated with the usability of a medical device, as defined in ISO 14971, are presumed to be acceptable, unless there is objective evidence to the contrary.
To comply with the standard, you need to document all aspects of the process in a Usability Engineering File. This file provides traceability to demonstrate that you have followed the Usability Engineering Process.
The file can be part of the risk management file, or it may be part of the product design file, or it can be an independent document or set of documents. The file itself does not need to contain all of the records and other documents produced by the Usability Engineering Process, but it should contain references and pointers to the whereabouts of all required documentation. The file enables efficient auditing of the design and development process.
In the USA, the Food and Drug Administration (FDA) has recognized ISO/IEC 62366 and has issued a list describing the minimum documentation that must accompany any declaration of conformance to the standard. So here are three steps you can take now:
Thanks to Ben Stokes and David Travis for comments on this article.
Dr. Philip Hodgson (@bpusability on Twitter) has been a UX researcher for over 25 years. His work has influenced design for the US, European and Asian markets, for everything from banking software and medical devices to store displays, packaging and even baby care products. His book, Think Like a UX Researcher, was published in January 2019.
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