HFE is a lot like bone, airport security and kittens playing with yarn, not just litigation and paintball
Our HF team attended the HFES Healthcare Symposium, held in Chicago back in March. Here Claire Roberts and Oisin Minogue (HF Consultants) tell us more about their insights into this event and explain a cryptic LinkedIn post from the team…
“I guess it’s about time we explained just what we meant by our reference on LinkedIn, that HFE is a lot like bone, airport security and kittens playing with yarn, not just litigation and paintball.
The first point, about HFE and bone came from a great opening talk from Dr Richard Cook (Adaptive Capacity Labs, The Ohio State University). It was inspirational to have such a seasoned speaker and passionate presenter open the symposium. He spoke of the parallels we HF engineers could draw between bone and human factors engineering. How individual system sub-parts respond to global pressures, and how elements change over time to better support their counterparts within a truly resilient system. Not to mention, how there’s no better way than assessing articles in real life, with/in real people and real environments, after all, lab-based testing often involves people making things that shouldn’t work, work.
Kittens. Thinking about it, there were many a mention of cats (and dogs!) at this year’s symposium. We heard from Hanniebey Wiyor (FDA) of the latest developments with the FDA’s Digital Health Software Pre-Cert Program It was interesting to hear how the two approval routes can be likened to the navigation of an airport; either straight to the plane or subject to several checkpoints first. The program is currently being piloted (if you’ll pardon the pun!), and it looks like an exciting area to keep an eye on over the coming months!
Within a similar space, we also discussed the recent release of draft guidelines for mHealth apps (Natalie Abts, National Centre for Human Factors in Healthcare). In particular, how this guidance will aid in the design of safe and easy to use medical health products; incorporating the five key quality aspects of usability: learnability, efficiency, memorability, prevention of errors, and user satisfaction.
Elizabeth Roche (Ximedica) gave a great presentation of the translation of user needs to meaningful and measurable user requirements. Entitled ‘Bridging the Gap from Research to Requirements’ her talk focussed on the lack of guidance in the FDA’s documents on how to unearth user needs. Elizabeth proposed a framework/methodology of how best to approach user need elicitation and how one can ensure they are best placed to craft user requirements that can be validated.
Likening this journey, from needs to requirements to a ball of yarn, she went on to explain, how as part of this process, it is likely that a kitten may get involved and have some fun! By mapping out preliminary user needs and methodically approaching both micro and macro task analyses, we can ensure we are best placed to handle ‘the kitten’. She highlighted the importance of full traceability, and how, in translation to quantifiable user requirements one must ensure that key influential factors remain part of the design brief so as to not be over-looked.
A fascinating talk by Allison Strochlic and Andrea Dwyer from Emergo by UL about ‘Simulating Stressful Emergency Use Scenarios during Usability Tests’. It was really exciting to see how the boundaries of classic simulation testing can be pushed, and how different factors can aid in achieving a more realistic context of use. While I appreciate, there will be a time and a place for this sort of work, most likely as part of formative studies with fairly robust prototype devices, it was really interesting to hear the ladies share their experiences to date. Of course, if you’re going to expose a participant to a stressful situation in a bid to elicit more natural, ‘real-life’ behaviour, there’s a big consideration to be given towards the ethical review of the protocol! Nonetheless, Alison and Andrea spoke of how they had tested a military use AI in a pseudo-real environment, with combat sounds, fog, and flashing lights at a paintball arena. This certainly got us thinking about how we could go about increasing the fidelity of our use environments, including the use of real-life patients, and more substantial props. Perhaps virtual reality could play a part during studies too, we certainly heard much of how VR can aid in storytelling and creating truly immersive experiences.
Finally, now to litigation, a tense topic for all involved in medical device development. The conclusion is daunting; manufactures must accept the inevitability of litigation cases. We have moved on swiftly from kittens and yarn. Preparation is key for litigation cases. A diligent risk analysis process will help reduce design deficiencies and ensure that the product provides adequate warning to users.
Risk documentation becomes crucial evidence during a litigation battle. Proactive steps must therefore be taken to anticipate off-label use; whether this involves scrutinising post-market surveillance databases, monitoring social media, or better researching the end user. Manufacturers can still be liable for product misuse that is reasonably foreseeable. Xin Feng of CDRH further elaborated on this when speaking on the common deficiencies in FDA submissions. Risk analyses conducted by manufactures often fail to include reasonably foreseeable misuse. While the FDA regulate the device design and development and not healthcare practice, a pattern of use may become apparent, which must be addressed by the manufacturer, be it through design, training, and/or redefining the intended use.”
Claire Roberts and Oisin Minogue.