Enhancing Usability Testing for Medical Devices Designed for Children
by Olga Solonowicz
Imagine being a child who has to use a medical device every day whether it’s a blood glucose meter, an insulin pen, or something else crucial to your health. Now, imagine that device isn’t easy to use. It’s confusing, frustrating, and maybe even scary. For a child already dealing with an illness they don’t fully understand, this experience can be overwhelming. The emotional toll on both the child and their parents is immense.
As parents, we want to protect our kids from fear and discomfort. But for children with chronic diseases, this is their reality. And for kids who rely on medical devices to manage their health, usability isn’t just a nice-to-have feature, it’s the difference between feeling empowered and secure versus anxious and uncertain. It can mean the difference between managing their condition properly or missing out on essential care.
At Design Science, we get it. That’s why we’re passionate about improving healthcare outcomes by designing devices that are not only functional but also intuitive and easy to use for kids. Our mission is simple: to create medical devices that are as safe, effective, and as user-friendly as possible through comprehensive usability testing.
I had the privilege of discussing this very topic at the International Symposium on Human Factors and Ergonomics in Healthcare, where we delved into the strategies to enhance usability testing of medical devices designed for children. In this post, I’ll explore why usability testing with children is so important, share strategies for creating child-friendly testing environments, and offer insights into how we can overcome the obstacles of working with young patients.
Why Usability Testing for Children Matters
Usability testing with children is about more than just meeting regulatory requirements. It’s about making sure that a device is functional and comfortable for the child. It’s about designing something that keeps them safe, healthy, and confident in managing their own care.
Based on ongoing discussions and feedback from the FDA, they have referenced Hollan-Hall and Burstein (2016) that highlights that children as young as 10 can perform mental operations and thoughts using formal concrete concepts. This suggests that despite the common definition of adolescents being age 13+, the FDA expects usability data for children as young as 10. But we also know that usability testing for even younger children, sometimes as young as 6, can be just as important. Take kids with chronic conditions like hemophilia, for example. Some may need to perform self-injections by this age, even though they’re still developing both cognitively and physically.
This highlights a crucial point: children aren’t just small adults. Their cognitive and developmental stages are different, which means the way we design and test devices for them must reflect that reality.
Key Challenges in Usability Testing with Children
Testing with children comes with a unique set of challenges. Their developmental differences, from cognitive to emotional maturity, mean they experience and express frustration, excitement, and confusion differently than adults. Younger children might struggle to articulate their thoughts, while older children might become disengaged if they feel the testing process doesn’t resonate with them. Getting specific feedback can also be difficult, as kids often give vague responses. These challenges require us to be flexible and creative in our approach to testing.
Current Best Practices for Usability Testing
Over time, usability testing with children has evolved to be more child-centered and developmentally appropriate. At the heart of it all is building trust. It’s about creating a space that’s safe, comfortable, and encouraging. One of the best ways to do this is by using age-appropriate language and positive reinforcement. Incorporating fun icebreakers can also help children feel confident and engaged from the start. And, of course, keeping sessions brief is essential for maintaining their focus without overwhelming them.
Testing medical devices for children, especially those that are used every day, requires reflecting the realities of their everyday routines. Devices like insulin pens or blood glucose meters are integral to their lives, and testing needs to mimic these real-world experiences as closely as possible. Emotional resistance, especially with devices that involve needles, can be a big hurdle. By creating a supportive, stress-free environment and following strict safety protocols, we can reduce anxiety and help both children and parents feel more comfortable offering feedback.
Creating a child-friendly testing environment is also crucial for building rapport and trust. Think of it as setting the stage for success—warm introductions, a playful atmosphere, and fun decor all help children feel more at ease. Clear, transparent communication with both the child and their parents ensures everyone is on the same page and allows the child to explore the device at their own pace, knowing they have the support they need.
Parental involvement is key, not just for informed consent, but also for ensuring the child feels secure. Having a familiar face in the room can make all the difference, providing emotional support and reassurance when needed. While we encourage children to take the lead and build their autonomy, it’s also essential that parents fully understand the testing process so they can provide the right kind of support.
Striking the right balance between realism and emotional comfort is especially important here. We want to simulate real-world situations to gather the most accurate data, but we also need to protect the child’s emotional well-being. Parents must be informed about the realistic aspects of the testing process, especially when certain devices or situations might cause discomfort or stress. This balance helps ensure the testing environment feels authentic but doesn’t overwhelm the child.
Moderators play a crucial role in this process. They need to maintain a neutral, supportive demeanor while encouraging the child to explore the device independently. Patience and flexibility are essential, as children may need more time to adjust. By celebrating their efforts and observing non-verbal cues like frustration or excitement, moderators can create an environment where kids feel comfortable and are more likely to provide genuine feedback.
Practical techniques such as incorporating playful activities, simplifying tasks, and offering frequent breaks keep children engaged and focused. Limiting session length is essential to prevent fatigue and overstimulation, ensuring that the child remains comfortable throughout the process. Additionally, recruiting participants who accurately reflect the target user group is key to gathering meaningful insights that lead to safer, more effective devices.
Recruitment Strategies for Testing
Effective recruitment starts with building strong relationships within the community. In partnering with patient advocacy groups, Design Science finds that we're able to connect with families who already understand the challenges kids with chronic conditions face. These groups can help us find participants who are not only willing but also capable of providing valuable feedback on the products that matter most to them.
To make participation as easy as possible, it’s important to be flexible with scheduling. For instance, scheduling sessions after school hours or during school breaks can help ensure that children don’t miss out on their regular activities. Offering flexibility for parents’ work schedules can further reduce any barriers to participation.
Finally, diversity is key. To create devices that work for all children, we need to test them with a broad group of participants. Reaching out to families from different backgrounds helps us gather a range of perspectives, ensuring that our designs are accessible and effective for everyone.
Conclusion
Designing medical devices for children is about more than just meeting technical requirements. It’s about creating tools that genuinely support their health and well-being. When we conduct usability testing, our goal isn’t just to check off a box. We want to make sure these devices empower kids to take control of their health and navigate their conditions with confidence.
Effective usability testing goes beyond regulatory standards. It’s about designing devices that help children feel safe, independent, and capable of managing their health. We’re dedicated to improving the healthcare experience for young patients, making sure the products they rely on are intuitive, comforting, and easy to use.
At Design Science, we’re committed to driving innovation in healthcare. Our focus is on shaping a future where medical devices aren’t just functional but also designed with empathy and the unique needs of children in mind. We’re here to create solutions that make a meaningful difference in the lives of young patients and their families.
If your team is developing pediatric-focused drugs or devices, let’s work together to ensure your product meets the highest standards of usability, empathy, and innovation. Reach out to learn more about how we can partner to improve healthcare outcomes for the youngest—and often most vulnerable—users.
Key Information:
Why Usability Testing for Children Matters
Key Challenges in Usability Testing with Children
Current Best Practices for Usability Testing
Recruitment Strategies for Testing
Hollan-Hall, C., & Burstein, G. (2016). Adolescent Development. In R. Kliegman, B. Stanton, J. Geme, & N. Schor, Nelson Textbook of Pediatrics 20th edition (pp. 926-936). Elsevier.
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