Do you work in medical device development?
Let me ask you a quick question.
How well is human factors understood in your company? Is it just a level of understanding of what needs to be done to tick the regulatory box? Or is it ingrained in your development process alongside disciplines like design, engineering and risk management?
While catching up on the latest medical device news this week I was struck that there was almost no mention of human factors and usability.
In every sector I’ve worked, I’ve always felt the positive influence that human factors and usability engineering can have is not given sufficient publicity. Perhaps that’s because people only really notice usability when products and systems are designed poorly and do not meet the user’s needs.
I recently discussed this with a fellow medical device professional who works for a device development company that has fully engaged with the HF process. During our conversation, we reflected on the cost of usability testing and I was staggered to learn that, in his estimation, almost 20% of the budget for recent medical device development projects were HF related.
If you consider that for a full development programme, spanning 5-8 years, this might include the cost of running three or four full formative studies and a validation study, hiring research facilities, recruiting and incentivising participants, creating all the relevant documentation, reviewing and interpreting results to feed back to the design process, and creating documentation for regulatory submission. On top of the day-to-day internal HF process management, I can see how these costs begin to stack up. However, we both noted that good HF engagement can save money on a project as it ensures the device is right for the end user first time and expensive design loops are not required after a failed validation attempt.
In another conversation, with an engineer managing HF activities at a smaller medical device company, I learnt that he is always being pressured to find ways to reduce the cost of HF. The company obviously wants to create usable devices but is only recently coming to terms with the scale of budgets required.
We both agreed that while HF regulatory guidance can seem burdensome, it’s an essential part of good engineering practice. Before the increased regulatory focus on HF over the last 20 years, medical device companies had already been designing devices that are safe to use and adopting good usability practices. So HF and usability are nothing new in that respect, but the formalisation and regulatory requirements perhaps create a documentation burden that was not previously felt. In addition, HF consideration that was possibly inherent in design activities and a previously ‘hidden’ cost is now visible and seen as more than a costly tick box exercise.
The companies that seem to do it right are those that engage HF fully and early within the design cycle – they plan for it, they budget for it, and they really get value from the HF process and the design outcomes. But what I see time and again is, in many cases, a lack of adequate budget allocation during planning of medical device development, a lack of suitable staffing resource and, often, an underestimation of the time required.
I think much of this pain is a fall out from the lack of awareness of HF as a discipline. Perhaps it’s not covered enough by university courses (in fact one of the only HF undergraduate degrees in the UK has just been discontinued), or perhaps the HF guidance doesn’t target the right people. Perhaps it shouldn’t just focus on engineers and designers but project managers, risk professionals and even marketing departments.
The companies that make the most out of HF have HF champions or advocates working for them. These individuals aren’t necessarily HF experts but members of other teams that understand HF and how to involve it in their work and projects. It seems to me that companies with this sort of HF engagement reap the rewards of HF work and, for us, as HF specialists, are a joy to work with.
Companies like these have asked to run bespoke training courses and facilitate HF workshops to help ingrain HF thinking into their companies’ project teams’ psyche. This awareness building is a really positive step forward for HF in medical device development and will hopefully filter through to the mainstream media, so that we can hear more success stories about the benefits of good HF processes adopted during medical device design.
Written by Rebus Medical Director, Chris White