Navigating Trauma in Medical Device Usability Testing: A Human-Centered Approach

Contributor - Bhavana Ramesh
September 3, 2024
7 min read

In the world of medical device development, safety and efficacy aren’t just buzzwords—they’re imperatives. To ensure devices perform as expected in real-world conditions, human factors engineers conduct rigorous usability tests. These studies, often featuring both healthcare professionals and patients, aim to replicate actual use scenarios in what are known as simulated-use environments, spaces crafted to mirror the realities of medical settings. Per regulatory guidance, this method offers a crucial glimpse into how devices function, ensuring that manufacturers can refine designs before entering the market.

But while these environments are invaluable for uncovering use-related issues, they can unintentionally resurface past trauma for participants, putting them in emotionally vulnerable positions. It’s here that human factors engineers must tread carefully, learning to recognize and manage participant distress. After all, the goal is not only to gather accurate data but also to safeguard the well-being of those involved.

Trauma: An Unseen Variable in Testing

Trauma isn’t always a glaring, dramatic event. Sometimes it lurks in the most mundane of experiences, quietly clinging to the sensory cues present at the time of distress. Watson’s infamous “Little Albert” experiment (1920) demonstrated that fear can be learned—fear, trauma, and association become intertwined. Neutral stimuli, such as sounds, smells, or visuals, encountered during a traumatic moment, can be mentally tethered to that event. Imagine a patient who endured painful treatments while a heart monitor beeped in the background. The sound, harmless on its own, could later trigger distress whenever encountered, even in a seemingly neutral environment like a usability test. While it’s not feasible to eliminate all triggering elements in simulated-use environments, what we can do is be vigilant. We must identify potential distress triggers early on and manage them in real-time to protect the participant’s mental and emotional health, while still capturing the critical data needed.

Identifying Vulnerable Participants

Not all participants are affected equally by trauma. Certain groups are more prone to distress:

Patients with chronic conditions: Living with a chronic illness often means enduring repeated exposure to distressing medical environments—diagnoses, long hospital stays, invasive treatments, or complications. A staggering 40 million Americans live with chronic conditions that limit their daily activities, and a third of these individuals juggle multiple chronic illnesses. These patients frequently interact with medical devices making them prime participants for usability studies. However, the stimuli in these environments, like medical devices or procedural settings, can easily evoke memories of their previous traumatic encounters.
Healthcare professionals: Trauma doesn’t spare those administering care either. These professionals dedicate themselves to improving patient outcomes, but the emotional toll of negative outcomes, medical errors, and high-pressure situations can be significant. They, too, are susceptible to trauma and may experience triggers during a simulated-use study—whether through the devices being tested or the settings in which they’re tested.
Parents of sick children: Parents who’ve watched their children battle illness are particularly vulnerable. Usability tests involving pediatric medical devices can bring up memories of fear, grief, or helplessness, especially if the child is present during the session.

Understanding these vulnerabilities allows medical device development companies to anticipate potential triggers and ensure more compassionate usability testing.

Real-Life Scenarios of Trauma Recall

Let’s look at some real-life situations. When studying parents of children with chronic illnesses, researchers often witnessed strong emotional responses during interviews. These reactions were sometimes triggered by their child’s presence, the questions asked, or simply being at home—a place filled with reminders of their child’s illness. The moderators were sensitive to these emotions, ensuring the parents felt understood while keeping the conversation focused on the research goals. It’s crucial to remember that while data is important, the people sharing their experiences are equally valuable.

Then there’s the example of a caregiver who participated in a usability study shortly after their child passed away from cancer. Despite the loss, the caregiver chose to participate. The session was held in a living room-like setting, complete with a mannequin acting as the patient. As the study progressed, the participant became visibly emotional, openly weeping by the session’s end. Though the participant wanted to continue, the moderator was prepared to pause or stop the session if necessary. Trauma, especially when recent, often surfaces unexpectedly, and it’s the moderator’s job to know when to step in.

In another case, the use of actors in simulated environments proved to be too real. During a study of a drug delivery device used in overdose intervention, actors played the role of overdose victims. The realism of the scene triggered one participant, who had family members affected by drug overdoses, causing them to cry. The session was halted, prioritizing the participant’s emotional health over data collection. It was a reminder that while simulation is critical for testing devices, sensitivity to personal trauma must always be top of mind.

Proactive Planning: Shielding Participants from Trauma

The key to mitigating trauma is foresight. Usability testing must be designed with participants’ emotional well-being in mind:

Inform and Protect Participants: Before the session, inform participants about the nature of the study, including any potentially distressing elements. Transparency helps participants mentally prepare and reduces the likelihood of an emotional response.
Stay Vigilant During Testing: While observing participants, be mindful of signs of discomfort—physical tension, hesitation, or emotional distress. If a participant shows signs of trauma, acknowledge their feelings and give them space to recover. Listening with empathy is critical. If needed, gently guide the session back on track without forcing the conversation.
Tailored Environments: Where possible, make adjustments to the simulated-use environment to avoid unnecessary distress while maintaining the integrity of the study.
Language Sensitivity: The way questions are framed can affect the participant’s emotional state. Especially in root-cause interviews, the tone and language should be chosen carefully to avoid triggering distress.

Ultimately, while usability studies must reflect real-world scenarios, it’s imperative that the participant’s emotional well-being is safeguarded. By keeping empathy and awareness at the forefront, we can ensure that medical device testing remains humane, ethical, and effective.

When Trauma Affects Your Data

When a participant experiences trauma during testing, the data might seem compromised. But rather than discarding their results, consider the context. Conduct a root cause analysis to determine the impact of their emotional state on the data. Was there a significant deviation from other participants’ results? What specific stimulus triggered their reaction?

Usability is about people and how they understand and use things, not about technology

This process can offer valuable insights into the medical device’s interaction with real-world scenarios, providing a more complete picture of its performance. Summarize these observations in your study report, and include any adjustments made during the session. This preserves both the integrity of the study and the emotional well-being of the participant.

Balancing Compassion and Data Integrity

At the heart of usability testing lies a delicate balance: understanding that the participants are not just test subjects, but human beings with lived experiences. While it’s vital to gather data to improve medical device design, it’s equally important to acknowledge the emotional weight some participants carry.

When testing health devices, medical device software development companies must recognize the human aspect. With careful planning, empathetic moderation, and thoughtful analysis, testing can remain both effective and humane.

As medical device companies advance the design and functionality of health devices, they must also remain conscious of the human cost involved. In a field that deals with life-saving tools and technologies, usability studies should prioritize both data integrity and participant well-being, ensuring that the process remains as safe emotionally as it is physically.

At Bang Design, we understand that developing cutting-edge medical devices is a delicate balance between innovation and human impact. Whether you’re navigating the complexities of usability testing or looking to refine the next generation of healthcare tools, we’re here to help. With our focus on empathetic design and rigorous testing, we aim to create devices that improve lives without compromising emotional well-being. Let’s work together to build a healthier, more compassionate future.

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