Here in Design Partners, Human Factors Engineering (HFE) has been integral to our work for years. Although it’s a mature process there’s always room for improvement. I was reminded of this at this week’s Medical Technology Ireland conference in Galway where there was some great thought leadership on the topic, not least from our Medical Device Director, Eugene Canavan.
The overarching theme of his talk was that you won’t do justice to HFE if it’s applied retrospectively or as a tick box exercise to comply with FDA guidelines. A well-applied HFE process does of course help with regulatory compliance, informs cost reductions and can provide market intelligence to guide strategic advantage, but only if it’s integral to the process from the outset.
During any well-applied HFE process there will be several rounds of usability testing where the outcomes, positive or negative, can be used to drive the direction of future development. Essential in obtaining accurate information based on true user insight is the manner in which this information is obtained. Poorly conducted or moderated sessions can yield results that steer the development process in a way that is not reflective of actual needs or requirements.
Consider the way in which a question is posed. Quite often what we’re looking for is the motivation behind the answer, not just the answer itself. We need to fully understand the thought process involved in making the decision, so we can drill down into the detail of what is understood to have led to this behaviour or understanding. So ensure that early questions are open ended. This allows stakeholders the opportunity to put across a point of view and then expand on it, thereby giving real visibility to their motivations and expectations.
It’s important to ensure that bias does not creep into the testing protocol. By this we mean ensuring that questions are not leading or imposing a point of view upon the interviewee. Such practice can negatively impact on a response by making people feel obliged to align with the question posed, or it may lead them to question their own point of view based on the bias. The big risk is that they will fully deviate from their own thought process, ultimately screening out the opportunity for insight that could determine the path of development.
The product development process can be long and the temptation to find the answer to unknowns internally within the team can be tempting, but it’s essential to maintain user perspective through the entire process. It may sound obvious, but it’s important that focus is retained and that the team are always designing the product for the people who will operate it, interact with it and are ultimately responsible for its acquisition. The focus should not be on the people responsible for developing it. They inevitably have vested interests, so expecting absolute impartiality may not be realistic.
Group think can also be a problem with any team that works in close proximity and strives for a mutual goal over a prolonged period. This is why it’s so essential to retain unbiased and objective perspectives through frequent engagement with external stakeholders.
Retrospectively applied Human Factors Engineering can only raise issues when it is too late to do anything about them. You’re ultimately reduced to trying to fix larger inherent problems through cosmetic means. Integrated from the start, a correctly applied HFE process supports and informs decision-making right through the product development process.
At Design Partners we ensure we include a sufficient number of opportunities to engage in user testing throughout the process. This allows us to propose solutions, validate them and identify new usability failure modes. All this leads to a methodical, traceable process where design, marketing and engineering decisions are based on a solid foundation of actual understanding.
A perfect example of this process is our engagement with NUIG & TCD, where we were involved in the development of a delivery system for a bio-prosthetic implant used in the treatment of Mitral Valve Regurgitation (MR). Here we were able to leverage the knowledge and experience of their team of cardio vascular surgeons to inform the process through sprints. The project team could move forward rapidly, confident that decisions were made on a solid understanding of users’ needs and expectations.
Often overlooked is the opportunity to positively impact on usability through the look and feel of a product. Aesthetics are not just a matter of taste; they can make a measurable impact. When a person first engages with a product or service, visually or through touch, a perception is immediately formed which can work for or against you.
By creating a strong first impression, for example, you encourage a positive mindset where users are more likely to forgive misunderstandings or errors in the learning phase. You immediately put the device beyond blame. Good aesthetics can also help mitigate against error. Correct usability can be subtly imparted to users through careful crafting of touch points, with surfaces honed to meet the ergonomic needs of the operator and a more intuitive interface that simplifies the learning curve.
Sometimes HFE may feel like an added burden or overhead on top of a seemingly endless list of demands, but applied correctly it can positively inform the development process, avoiding pitfalls that can be time consuming and expensive to resolve further down the road. Here at Design Partners, we have developed a robust methodology, seamlessly plugging into the product development process to deliver better outcomes for users and developers.
Learn more about how Design Partners apply HFE when dealing with surgical tools and interventional devices.