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Sector-specific training: what medical device manufacturers want

Over the last few years, the user experience, human factors and usability sector has grown exponentially and more companies are seeking out in depth, sector-specific human factors and ergonomics expertise.

There has been a rise and surge in demand for human factors experts in verification and validation, especially in the medical sector, where the FDA guidance and the harmonised international standard IEC62366 stipulates rigid guidance on how usability engineering (UE) activities should be carried out.

At a recent human factors for medical devices conference I attended, the majority of delegates were medical device manufacturers. The event gave an in-depth overview of what human factors is, how regulation plays a part in it, the tools and techniques which are used and how companies should be structuring their usability engineering files. While the event was extremely informative, sessions were as interactive as possible and facilitators answered questions on demand, there was still some disappointment amongst the attendees. This stemmed from medical device manufacturers stating that they understood the basic foundations of human factors and that they knew what was required of them. What they actually wanted was clearer guidance on exactly how to implement everything they have learned into the projects and products they are developing.

The problem with this request is that a lot of the guidance and standards made readily available in the public domain are written at a high level and are purposely ambiguous to try and encapsulate the wide variety of different sectors and organisations seeking human factors and usability guidance. This means that varying sectors and organisations are left to appropriate this guidance to suit their individual needs, which often leads to a wide variety of different approaches to conducting human factors research. Quite often if these approaches are not suitably managed and carefully scoped by human factors specialists then companies can misinterpret guidance and in some cases become detached from what they initially set out to achieve.

Sometimes the approach itself can contribute to its own failings. If not appropriately adopted or not fully understood, even simple methods such as conducting expert reviews on devices can lead to potential bias in reporting inaccurate or misleading results. Common mistakes companies make is not acknowledging human factors as its own discipline and seeking to ‘bolt on’ human factors activities to other roles within R&D, where individuals within these roles have a duty to maintain and uphold their own area of expertise first and foremost.

While foundation courses are readily available in human factors, undergoing these courses does not make individuals within organisations experts.

There are a number of common mistakes made during conducting usability evaluations and interviews. These mistakes include asking engineering/design-led questions, asking leading questions, or encouraging certain behaviours due to body language cues. Other mistakes include not reporting findings correctly due to inaccurately distilling observations and not probing the root causes of areas of confusion or error.

Another issue with using foundation training to effectively integrate human factors thinking into projects and products is that the successful adoption of human factors research and techniques cannot just be put into practice based on theory only; experience is just as important. However, standardising experiences to provide more sector-specific training is extremely difficult as quite often the successful adoption of techniques require human factors professionals to apply learning on a project by project basis.

While manufacturers want more guidance on how to practically implement human factors into their individual sectors, doing so without help from human factors specialists may be quite tricky! There is definitely a need for more sector-specific training and guidance on how to implement human factors on a project and product based level. However due to the variety of products and devices on the market, giving broad, high level sector-specific human factors training may still not be addressing the needs of manufacturers. What may be more beneficial is to devise training programmes that are not only sector-specific but also provided manufacturers with clearer guidance and examples of what has not worked well in the past, as opposed to focusing solely on what has worked.

Both the FDA and European standards institutes are aware of these issues and in February of this year, the FDA published their guidance document, to start trying to alleviate some of these issues. 2016 is also set to be a big year with IEC62366 due to publish part 2 of their 2-part amendment to the standard (IEC62366-1 and IEC62366-2). Part 2 is said to be a lot more specific and give clearer templates and guidance on what regulatory bodies look for in medical device design. AAMI have also revised their training course content to provide greater clarity and focus on implementing human factors activities into product design. Their course towards the end of this year should be timed perfectly around the release of part 2 of IEC62366.

Paula Wood, human factors and user research expert at PA Consulting Group




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