During my years in Human Factors engineering, I had the opportunity to work with a vast variety of drug device combination products, and today I’d like to share one specific experience with you.
It is a very well-known and, at first glance, a very simple device. It requires nine steps to be successfully operated, it involves one hand and one or both nostrils. Yes, I am talking about none other than a simple nasal spray.
When talking about nasal sprays, the first thing that pops into my mind is one of those you use to help with a runny, itchy, sneezy, swampy, dribbly, watery, cloggy or simply irritated nose. This condition is extremely annoying, and it must go! A few bursts of the magic substance and you are free to breath, sniff, smell and fully experience the pleasure of air intake.
As horrible as it is for some of you poor souls that have to go through the pollen infested season, at least for the majority, it is not a life threatening situation. As long as the severity of harm of the problem is low and occurrence repeats once or twice a year then the approach towards the medication becomes as important as the problem.
I am not trying to say here that the approach towards the condition should be laidback, no, I am simply trying you to agree with me that in a situation where you are in the car packed for a trip to the mall, where the kids are on the back seat, all seat belts are attached and everyone is ready to hit the road, when suddenly you remember that your allergy nasal spray is still on your nightstand, in your bedroom, on the second floor. Now you are in a pickle, as to go and get the spray would require some intense labor. You would have to un-belt the kids and grab one in each hand as they have not reached the age of walking nor the age of self-awareness. You would have to somehow open the door and try to avoid your dear good family friend and “Coming back home” enthusiast, your dog Mountain, whose name was not chosen because of his deep blue eyes. And let’s not forget the narrow stairs leading to the second floor.
But even if you do reach “The Mount Olympus – Bedroom” , it is then when your deepest fears, that the nasal spray might not be on the nightstand at all, start to take shape.
So, with all that horror in mind, the further sequence of actions suddenly becomes quite clear as you quickly turn that key and start the car engine.
Now, what if that nasal spray would be something more? Something that would be assisting with your condition, something that would be part of your daily treatment, something that is vital for your daily life functions. I am quite sure you would be climbing those stairs right about now.
I had the opportunity to perform a Human Factors Summative/Validation study with patients in the United States (US) with US citizens, that had a mild-moderate to severe cognitive impairment and were relying on their daily medication intake. Obviously, caregivers were involved, where patients with a severe condition could not be responsible for their medication intake. But let us focus, on the ones that were self medicating with little to none supervision. At the time of the study, each and every one of them were receiving their daily dose in a form of a pill. To no one’s surprise usability challenges were observed when a nasal spray was introduced in oppose to their well-known pill format.
The most complicated part for the participants was the identification of the importance element. As all participants did understand the concept of a ‘Nasal Spray’ majority had an already formed metal model that dictated a lower importance approach towards the nasal spray.
With respect to that, once again we find ourselves in a similar situation to the one faced in the car. To change someone’s perspective, which was practiced for years, is not an easy task and it would require all relevant stakeholders to join forces in achieving it.
How to approach such a change of mindset from a manufacturer’s point of view?
Firstly, based on countless interviews with patients in the US, I can safely draw a conclusion that Americans tend to have a close relationship with their doctors and their pharmacists. These professionals should be guided by the medical device manufacturers to deliver the correct message and adequately inform the patient about the importance of a new product.
Secondly, manufacturers must address certain design features, which can assist the user in avoiding potential hazards that might occur in their day-to-day life. For this project specifically, we have conducted a study with participants with cognitive impairment (still responsible of their medication intake), where it was discovered that a specific color was identified as being more “Serious” and that it represents more of an important message when it comes to selecting the right drug device combination product.
And this is only one from many other valuable design elements that have been identified, through variously implemented Human Factors methods, which are already being used by the same people that helped to identify them.
The road of R&D can be long and bumpy, but tools like Human Factors Engineering can be a very valuable and helpful sidekicks in developing safe, usable and robust products.
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