What to know about UX for medical device design: real cases and numbers

In June 2023, Baxter recalled nearly 23,000 infusion pumps after a software update caused them to trigger false upstream occlusion alarms. The issue wasn’t a mechanical failure or a manufacturing defect but an interface problem.

Alarms went off when they shouldn’t have, interrupting patient care and overwhelming clinicians with noise that didn’t mean anything. At least three patients were harmed before the recall was issued.

It was a breakdown in communication between the device and its users – a failure of medical UX. And in healthcare settings, when the interface fails, outcomes suffer, underscoring the crucial role of effective UX.

In our new article, we explore why designing healthcare user experience, and UX for medical devices in particular, plays such a vital role in medical device safety, adoption, and trust. We’ll unpack the unique challenges healthcare designers face and offer best practices, common pitfalls, and fresh data on why UX has become a competitive edge in MedTech.

Key takeaways

• Medical UX is high-stakes. Devices in the healthcare sector are used under pressure, by people with different roles and skill levels.
• Whether it is a clinical device or one linked to a mental health app, regulations require proper UX and a user-friendly interface. FDA and IEC 62366 demand a tested, documented, user-centered design. You also have to prioritize data security.
• Good UX means for healthcare solutions faster workflows, fewer errors, better health outcomes, and stronger trust with users.
• Better UX = lower recall risk, faster adoption, and, eventually, long-term product success and better healthcare services.

Why UX matters in medical device design

Medical devices are used in environments where time is short, emotions run high, and mistakes carry serious consequences. These tools must work reliably during real-world challenges like emergency care, fatigue, or even poor lighting.

Proper medical UX design makes devices accessible under any condition and can help improve patient outcomes.

Different users, different needs

Not all users are trained clinicians. Devices often need to work for caregivers, support staff, or patients themselves, including those managing chronic illnesses at home. Interfaces should work for different skill levels, not just power users.

Some users are experts in cutting-edge technology. Others are new. Some use the device once a week. Others use it every day. A single design must support all of them.

When UX is overlooked, problems follow. A hard-to-read screen can delay treatment. A confusing alert can lead to an error. A poor layout can make a simple task take too long. These issues are often linked to medical errors and put patient safety at risk.

UX is part of medical safety and compliance

The reality of healthcare is messy: fragmented systems, multiple data sources, and different user needs all converge in high-stress environments. Designers must bridge these gaps.

Regulations treat UX design for healthcare as a critical part of medical device safety. Standards like IEC 62366-1 require usability engineering to be part of the development process.

Design choices need to be based on research, tested with real users, and clearly documented. Even small details like the label on a button or the color of an alert can affect how someone responds during a high-pressure moment.

UX supports speed, safety, and better outcomes

Proper UX in healthcare makes devices easier to use. It helps users act quickly and confidently, even under stress. That leads to:

• Faster tasks. A clear medical device user interface reduces hesitation and speeds up decisions.
• Shorter training time. Intuitive design lowers the learning curve.
• Fewer errors. A well-structured flow guides the right actions
• Better care. Less confusion means more time focused on the patient

Healthcare UX for medical devices focuses on removing barriers. When a tool fits naturally into the hands of its users, everything works better, promoting seamless interaction. That leads to faster tasks, shorter training time, fewer errors, and even helps clinicians identify early signs of complications by enabling smoother data capture and clearer alerts.

What makes medical device UX so challenging?

There are three main challenges to pay attention to, including regulatory constraints.

Heavy regulations guide every design decision

Designers don’t have full creative freedom. Medical device UX design must align with global standards like IEC 62366 (usability engineering) and FDA human factors guidance.

These frameworks ensure that safety and usability are built into the product from the start. But they also add layers of documentation, testing, and validation that slow down iteration and limit shortcuts in the digital healthcare space.

Functionality vs. simplicity: a constant balancing act

Medical devices are often packed with features. The challenge is keeping that power available without overwhelming the user.

• Too simple, and critical features get buried.
• Too complex, and users slow down or make mistakes.

Designers have to carefully prioritize what shows up when, based on the user’s role, the task at hand, and the level of urgency. Every interaction has to earn its place.

Stress, fatigue, and urgency distort how people interact

People use such devices in trauma rooms, ICUs, or emergency calls. There’s pressure to act fast and no time to pause or re-read a screen. Users might be sleep-deprived, emotionally drained, or managing several things at once.

In these moments, even a small friction point can lead to delays or mistakes. Mental shortcuts take over. Unlike controlled test environments, real-world conditions are loud, unpredictable, and constantly shifting. Designing for this reality is one of the hardest parts of medical UX, especially when considering digital health tools that utilize natural language processing.

UX best practices for medical device interfaces

Of course, every project is different and has its own nuances. However, our experience shows that the best practices listed below are essential when designing for safety and ease of use.

Prioritize clarity

Labels, icons, and instructions should be easy to understand at a glance, and not only for healthcare professionals but for everyone. Avoid jargon, vague terms, or anything that forces users to stop and think twice.

Focus on the task, not the screen

Design around how the task is done in real settings. Look at the full workflow, not just individual screens. Support each step in a way that feels natural to the user, contributing to a seamless user experience.

Reduce mental effort

Don’t ask users to remember steps or decode unclear visuals. Use visual hierarchy, group related actions, and guide the eye to what matters most. The simpler the experience, the faster users can act.

Prevent errors early

Design choices should steer people toward safe actions. Use confirmation steps, constraints, and defaults to help prevent mistakes before they happen.

Show clear feedback

Every action should get a quick and visible response. Users should always know what’s happening and what to do next. Avoid anything that creates doubt or delays.

Plan for interruptions and edge cases

In real life, devices get unplugged, misused, or handed off mid-task. Design for those moments. Make it easy to pause, recover, or let someone else step in without confusion.

Design with accessibility in mind

Medical tools need to work for everyone, regardless of age, ability, or experience. Use readable text, high-contrast colors, large tap areas, and simple navigation patterns.

Regulatory and compliance considerations

Medical device UX is closely tied to regulatory compliance. All the healthcare products must adhere to data privacy regulations like the Health Insurance Portability and Accountability Act (HIPAA). But there are some other important standards that require every healthcare UX designer to work for real users, test for health data safety, and document every decision involving patient data.

Again, UX design professionals will guide you on specific regulations regarding your specific case. We’ll discuss the standards common to all the devices and medical products.

FDA human factors guidance

The U.S. Food and Drug Administration outlines clear expectations for human factors in device development. Healthcare providers must identify potential use-related risks, test with actual users, and make improvements based on real feedback. UX research and usability testing are key parts of this process.

IEC 62366 and usability engineering

As we’ve mentioned earlier in this article, IEC 62366 defines a formal process for integrating usability into medical device design. It covers everything from understanding the user environment to evaluating risks related to the medical device interface.

This standard treats usability as part of overall device safety and requires design decisions to be supported with evidence.

Documenting testing and risk reduction

Regulatory teams want to see proof that design choices are based on research. That includes usability test results, risk assessments, and updates made to reduce errors.

Every part of the interface, from button placement to alert wording, should be linked to real-world testing and review.

Accessibility and inclusive design

Compliance also includes digital accessibility. Standards like the Web Content Accessibility Guidelines (WCAG) help ensure interfaces work for users with different needs.

That includes people with visual, hearing, motor, or cognitive challenges, as well as those dealing with mental health issues. Accessible design is essential for inclusive care and, in many regions, a legal requirement.

Mistakes to avoid in medical device UX

Even with the best intentions, it’s easy to miss the mark on UX design for medical devices. Here are some common mistakes that, from our experience, slow down workflows, increase risk, or create barriers for users.

Skipping real-world user testing

We saw it on different projects. Lab tests aren’t enough to simplify user interactions. Devices need to be tested in the environments where they’ll actually be used: emergency rooms, clinics, homes, and everywhere in between. Without that context, it’s easy to overlook real problems that impact health outcomes.

Recent studies show that around 50% of design-led companies report enhanced customer loyalty, while 83% have formal processes to test ideas with actual users. Structured user experience practices support better outcomes while empowering patients.

Overloading the interface with options

More features can seem helpful, but too many controls on one screen lead to confusion and hesitation. Crammed layouts slow users down, especially under pressure.

Designing for experts only

Not all users are trained clinicians. Devices often need to work for caregivers, support staff, or patients themselves. Interfaces should work for different skill levels, not just power users.

Relying on unclear icons or labels

Abstract icons and technical terms cause delays. If someone has to stop and think about what a button does, the design needs a second look.

Ignoring error recovery

Mistakes will happen. If there’s no way to undo an action, pause a process, or get help, users feel stuck. That’s what can lead to bigger problems fast. So pay special attention to error recovery paths and features.

Treating accessibility as an afterthought

Poor contrast, small tap targets, or unclear focus states can make the interface unusable for some users. Accessibility needs to be built in from the start, not patched in later. Otherwise, patching will become a persistent and challenging issue.

Final takeaways: UX is a competitive advantage

So, strong UX design improves how devices are used, how they’re adopted, and how they perform in the real world. It reduces training time, prevents errors, and helps teams deliver better care.

For companies building medical devices, UX creates measurable value across every stage of the product lifecycle.

Better design supports better business outcomes

Usable interfaces help teams move faster and operate more efficiently. You get:

• Lower risk of recalls.
• Faster onboarding, fewer support calls.
• Greater trust and long-term loyalty.

UX is shaping where the industry goes next

As digital health continues to grow, design will play a bigger role in what succeeds. Several trends are already reshaping how medical devices are built and used:

• Context-aware interfaces that respond to the task, environment, or user role.
• Voice controls and AI-driven workflows to support hands-free use.
• Built-in training flows to speed up first use without external manuals.
• More inclusive design practices to meet accessibility and equity standards.

User experience is a core part of how medical devices succeed. It must be totally effortless and easy to follow for both users and healthcare providers. Otherwise, no state-of-the-art feature would save your product from failure.

Need UX help for your medical product? Let’s talk!

Designing for healthcare is hard, and you don’t have to figure it out alone. At MagicFlux, we work with product teams building complex tools that we make feel simple, safe, and seamless for real people.

Whether you're launching a new device or healthcare system, refining an existing interface, or navigating regulatory requirements on real-time patient data, we’re here to help. Our team blends user research, UX professionals' expertise, clear UX strategy, and a deep understanding of industry pitfalls.

Let’s design something that works for everyone.