Without doubt the technology is advancing at an unbelievable rate, and technology can do more and more for us, making our lives simpler, giving us more time to do the things we like to do, and, dare I say it, removing human error from the equation.
Nowhere is this more true than in the area of healthcare. The recent publication from Jeremy Kooyman in the November 2015 edition of MEdSim highlights the advances in computer aided surgery (videos of a computer peeling a grape are cool to watch and give conﬁdence!), but the key thing to the success (and therefore safety) of all these devices is the interface that the ﬂabby, carbon based life-form (you and me) needs to operate.
The FDA recognises this is an issue and has some pretty stringent testing of user interfaces of all medical devices, ensuring that patient and operator safety is taken into account and designed out at the early stage.
Achieving this at all stages of development of the medical device involves using all sorts of techniques that are found in innovation and product development across a wide range of industries, not exclusively healthcare.
It starts with Contextual Enquiry, an in-depth interview technique, to establish what the user is trying to achieve and what their needs are. This is a more immersive technique than asking people in a focus group, where the opinions of others and the “desire to please” tends to override the real needs of the user.
When you have the needs, it is about assessing the risk, and then managing that risk. Everything we do has some sort of risk associated with it, but there are different levels of risk involved. For instance, boiling a kettle and nuclear power are both essentially about boiler water, but the risks involved and the impact of something going wrong are vastly different. Understanding the risks in any device are vital in your ability to design out those risks in the development process.
Finally it is about understanding scenarios, different usage situations which could occur. Our normal reaction with any scenario planning process is to assume “that would never happen” and to only think of positive outcomes, whereas the reality is thinking “what is the worse that could happen” is key to the development of the interface. Generally, unless a scenario is impossible to achieve, the likelihood is that someone, somewhere will make it happen, no matter how improbable that may be. In this instance, aligning the most negative scenario to the risk involved is key.
In summary, success in designing any user interface, whether it is a medical device, or another product that customers interact with, a suite of techniques is required to understand what is the job to be done that the customer wants, what are the associated risks, and how do you plan for all possible scenarios, and all this needs to be done before you start building products to show potential customers!
A good personal example of not doing this properly is a brand I worked on in 1999, called Physio Sport. In the product design we had a closure that would only work as intended when it had been rotated through 180 degrees. We didn’t test, we didn’t assess the risks, and we certainly never scenario planned. We were so close to the product that we could never foresee that customers wouldn’t understand the technology and try and open the product as a normal closure, and then complain, as they couldn’t put it back together again! It all seems obvious now, hindsight is normally like that, but it cost £1000’s to put right, and certainly cost more to rectify than it would have done to think about it in the ﬁrst place!