What brings you to this role?
Having been a consultant for the past 9 years, I saw the opportunity here and thought it was an exciting chance to really shape HF activities in the medical device space, but also help with the cohesion of HF and other areas of medical device development. This is an industry issue where we see HF being under-utilised in the effort to make easier and safer medical device products.
What passions have driven you within your career?
I always feel energised after running HF test sessions, people are all so fascinating and they come in many different shapes and sizes. Further to this, when I hear people talk about their personal experience trying to navigate their personal health, or providing appropriate care to others I feel enriched that the work that HF contributes to the development process is valuable in designing a better world. I find that I can bring that energy and enthusiasm to clients as well!
What changes are you excited to see within the healthcare industry?
I’m excited to see this developing area of generally more autonomy to patients and less burden on HCPs caused by inefficient products as products become simpler and manageable in a home environment.
You’re on the BSI and IEC Standards Committee governing 62366 parts 1 and 2, please can you tell us more about this?
Sure! I love being on this committee, there are many interesting suggestions for change posed by various countries and many insights into ‘why’ the documents are written the way they currently are. I have learnt great deals about how standards should be read and how they should be used. There are people on the team that have been involved since the first iteration of the standard and also those that helped develop 14971, so this has strengthened my understanding of how 62366 should feed into the risk management process.
Most importantly, I get to contribute to these conversations and help make decisions on updates to the documents and represent the UK on the international stage when it comes to changes made to 62366.
Human Factors plays a vital, fundamental role within the healthcare industry, what advancements would you like to see between HF and patient needs with combination products?
Now that Human Factors is becoming a mature practice, I would like to see the advancement of the development of use related risk assessments (URRAs or ‘uFMEAs’). By this I mean, there are many instances where risk assessments can over-estimate the reality of the risk profile of use errors. Knowing patient populations from many face to face interviews with these people, such as the community of people living with diabetes or people who require single-use catheters, I know that with the high volume of use of the single use products they use they find ways that work for their lifestyle. These ways of use often do not align with the ‘correct’ use per the manufacturers documentation but despite this they do not result in patient harms. If these behaviours were observed in usability testing, the product might ‘fail’, but in reality, in the context of actual use taking into account people, environments and lifestyles, these behaviours do not cause harm. I would like to see more nuanced and informed URRAs driven by solid early-stage human factors work and research. In my new role, I am in a position to have those conversations with clients and help them shape more advanced Human Factors programmes, and therefore risk control measures, which in turn can produce better instructions for use and finally better patient experience and control over their healthcare.
