Insights from real people that have had to use a medical device in an emergency situation will place manufacturers in a better position when it comes to developing emergency use medical devices.
Pharmapack Europe
At Pharmapack Europe 2025 this past January, Alper Hulusi – Head of Market Insights at ClariMed, gave a Lightning Talk on ‘Designing for an Emergency: Considerations for emergency use product design. He shared a real-life story about his son that forced him to have to use the life-saving device, a Glucagon pen. Through the experience he learned that even with all of the necessary experience and knowledge about the product, he still faltered, because “a real emergency setting is far different from the simulation scenarios.” And while Clarimed works in simulating these emergency scenarios for designing for human factors, through this, Hulusi learned that we cannot fully and accurately simulate an emergency.
“We need to look beyond the physical device. We need a better understanding of the experience and emotion of real-life emergency use,” said Hulusi at Pharmapack.
He also talked a lot about incorporating empathy into medical device design through not only the packaging but the product itself, as well as the instructions, to help users handle them correctly.
Here’s what else he shared:
Alper Hulusi is the Head of Market Insights at ClariMed.defacto
Q) At Pharmapack you spoke on emergency use devices, and even shared a personal story about your son – can you tell us a little more about this?
“The issue we see here is that medical device companies obviously try to design for real-world situations. Take a Glucagon pen for example, which is used to save lives during a glucose slump. In a formative or summative research session, we strive to have people handle the device in an environment that, as accurately as possible, mimics the real deal! But how can we successfully simulate the emotional and cognitive burden someone experiences when they use a device like this? Imagine, a parent confronted by their son or daughter mid-seizure, having to prepare and inject a Glucagon pen, as intended by the manufacturer. It’s an acutely stressful event and medical products need to be designed with that in mind. But how do we develop and ‘test’ these devices in a simulated scenario and know that they’ve been designed in a way that will give people a fighting chance of handling them correctly?”
Q) Can you explain a bit more what an emergency scenario might look like?
“More often than not, this takes the form of a study moderator introducing the study to the participant and, at some point in the session, asking the participant to imagine they are in a certain scenario. They are then asked to go ahead and use the product (and anything available to them), imagining this is real life. So, there’s an attempt to recreate the pressure someone might experience during an emergency, maybe even stating the time in which they need to complete the device handling steps. An effort is also made to recreate environmental and audio conditions that someone might experience in this situation – so if they were at home, there might be a TV sounding in the background, or children playing. In the case of a Glucagon pen, the person will have the instructions in front of them, should they choose to use them, and will then likely go through the steps of opening the packaging, reading the instructions, preparing and then injecting the device into a mannequin. The question here is, during device development and ultimately, summative testing, how do we accurately replicate real-life situations? And how do we ensure a dose of reality is incorporated into product design, from the outset? It’s an important question, and one that needs further attention.”
Q) So, what might be the lessons we can take forward?
“One of the many things we can do is to speak directly with people that have in the past administered emergency care and learn from their experience. What did it feel like? How did they find handling the device? What did they find easy, what did they find challenging, and why? It’s these insights that will place us in a better position when it comes to developing emergency use medical devices and instructions.”
Q) Shifting gears, what are the overall trends in devices you expect to see this year?
“The big trend we continue to see is the increased focus on device connectivity – as this technology provides a potentially rich source of data and information that can benefit people who live with medical conditions. To take just one real-world example, for people who live with Type 1 Diabetes, monitoring of glucose levels can now not only be done automatically, but the devices themselves can gather and transmit data to the wearer and their HCP team and provide all parties with information and data to help optimise how they manage their glucose levels. Increased connectivity, as well as the way that data is used, is absolutely the big trend and a proven approach to improve clinical outcomes and quality of life. More widely, sustainability is another enduring trend concerning the production, recyclability and appeal of medical products.”
Q) Do you see any trends in behaviors and the usability of devices – are patients changing how they manage conditions?
“One big shift we see is the empowerment of people with conditions, as they increasingly take ownership of their condition through better devices, connectivity and device/therapy-related data. This places people with conditions and HCP teams in a far better position to make positive condition and therapy decisions. The only slight risk I see here is that developers need to be careful not to over-design devices and avoid building in features and functions that either aren’t needed, won’t be used or, at worst, compromise device usability.
But there are many positives, especially in the world of Type 1 Diabetes, as these devices not only provide condition management insights, but also provide therapy recommendations.”
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Alper Hulusi is the Head of Market Insights at ClariMed.defacto
