A medical device shouldn’t only perform well from a technical standpoint. It also needs to be intuitive, support safe use, ensure patient safety, and fit smoothly into the workflows of healthcare professionals. This becomes even more important in clinical environments where cognitive load is a real concern. That’s where medical device UX (user experience) comes in.
A strong user experience helps clinicians and patients use medical technology with confidence and clarity. To achieve this, designers study how people interact with the device and identify their needs. And when this work begins early in development, it contributes to improving the product at every step.
From user research to field observations, including prototyping and testing, UX provides essential insights throughout the process to ensure the device or the software is effective and easy to use.
- What medical device UX is
- Why it has become essential in product development
- How to apply it throughout the entire development process
What Is Medical Device UX?
Medical device UX (User Experience) design focuses on creating user-centered interfaces for both digital and physical medical technologies. It’s the most effective way to support safe operation and streamline workflows in environments where use errors can have serious consequences.
To achieve this, designers take a close look at how clinicians, nurses, and patients interact with the device or the software. Their work involves research, task analysis, field observations, and user testing throughout the development process. These activities help build knowledge and deepen understanding of real user behavior. All the elements gathered helps define user needs and refine the interface so it remains intuitive and effective, even in stressful situations.
What Are the Key Benefits of Medical Device UX?
First, it improves the safety and reliability of the device by reducing risks related to the user interface (incorrect inputs, misunderstandings, and confusion) which can have serious consequences in a medical setting.
Medical device UX also supports more efficient use of the interface by removing unnecessary steps and simplifying every required action. This helps users stay fully focused on their primary task: patient care. To make it possible, UX designers take real conditions into account (noise, fatigue, stress) so the interface remains effective even when the environment adds pressure or constraints.
A good user experience also strengthens compliance in the healthcare industry. UX activities contribute directly to meeting regulatory expectations such as IEC 62366-1 and FDA usability requirements.
How Does User Experience Impact Product Development?
User experience has a direct impact on product development, and an even better one when it’s integrated from the very beginning. It guides the design toward real user needs and supports continuous improvement throughout iterations. User testing also brings major value. It helps identify design issues before changes become too costly or disrupt the project timeline.
Finally, a product designed with end users in mind naturally feels more easy to use and improves their overall experience. Satisfied users adopt the product more quickly and help it gain traction faster. In a competitive market, that’s a key differentiator with a positive impact on sales or conversions.
How to Prioritize User Experience When Developing Medical Devices?
User Interviews
Individual interviews with patients, doctors, nurses, pharmacists or other healthcare professionals are ideal to get deep insights about the motivations, challenges, learning styles and conceptual models of the people who will actually use the device.
To define the use specification, it is also essential to investigate the use environment. The resulting design constraints will vary depending on whether the device will be used in an intensive care unit, operating room, consultation office, ambulance, etc. By interviewing users in their workplaces, we gain valuable information on this subject.
Alternative methods can also bring insights on the use environment and user profiles. For example, contextual inquiry combines interviewing with observing the user interacting with an existing device (e.g. a competitive product).
Focus groups with several users or a committee of experts is another related method that can be used upstream of the project. These are particularly useful when the solution to design is novel and there is no comparable product on the market.
User Interviews
Based on the user’s intention (e.g. administering an intravenous medication), a task is defined (e.g. preparing the device), which is divided into sub-tasks (e.g. setting the dosage) and then into steps. For an even more systematic approach to identifying potential use errors, a PCA task analysis can be performed. Each step is then associated with the three types of interaction, namely perception, cognition and action.
To identify potential use errors for each interaction, factors listed in the use specification will also be taken into account. For example, if the operating environment is noisy, the possibility that the operator will not hear an audible alarm will be considered. Or, if the nurse who uses a device is tired because they work long hours at night, they may read the displayed data incorrectly.
The task analysis, along with the list of potential use errors, will feed into the user interface specifications, also known as design requirements.
Prototyping
In addition to being useful to communicate user interface specification within the project team, mockups and prototypes are an essential tool for formative evaluations.
Based on a trial-and-error approach, these preliminary representations of the user interface are key to get user feedback and adapt the solution accordingly.
Expert Evaluations
The first consists of methodically analyzing the graphical interface of a system, page by page, based on a series of established criteria called heuristics. Several sets of criteria can structure such an analysis, such as the Ergonomic Criteria of Bastien and Scapin and the 10 Usability Heuristics by Jakob Nielsen.
Nielsen's 10 Usability Heuristics
- Visibility of system status
- Match between system and the real world
- User control and freedom
- Consistency and standards
- Error prevention
- Recognition rather than recall
- Flexibility and efficiency of use
- Aesthetic and minimalist design
- Help users recognize, diagnose, and recover from errors
- Help and documentation
Bastien and Scapin's Ergonomic Criteria
- Guidance
- Workload
- Explicit control
- Adaptability
- Error management
- Consistency
- Significance of codes
- Compatibility
As for cognitive walkthrough, it means that the UX specialist, based on the available information about the user, task and context, performs a task as the user. They can then detect certain weaknesses of the system.
These expert-based methods can be used on the early mockups or prototypes of a new device or to evaluate existing devices. They can be used in the first formative evaluation rounds of a usability engineering process. They typically cast light on obvious problems (low-hanging fruit) and lead to them getting fixed prior to usability testing.
Although expert-based methods are rather simple and quick to use — at least when you have access to experts — it is important to keep in mind that they have the major weakness of not being based on the experience of the users!
NEW EBOOK
Demystify the design process with 7 frequently asked questions about UX
From dynamic sketches to immersive role-playing, every discipline have to be involved in this UX approach focused on creating unforgettable interactions 🚀
Discover our insights and elevate your UX design process by downloading our free ebook!
Usability Testing
User testing (or usability testing) is a crucial method for formative evaluation and summative evaluation. In short, it consists of asking potential users to perform tasks with a prototype or finished product and observing them interacting with the device. It provides precious access to what the user actually does, and, during a debriefing session following the test, to what the user says about their experience. These sessions yield valuable insights about how to improve the design.
During the summative evaluation — which aims to get objective evidence of the safety of use following the development process — it is crucial to mimic the actual user experience as closely as possible. At that point, we will use the final product in a realistic setting, and participants will be representative of the target users.
Regulatory standards also play a central role in shaping how usability testing is planned and conducted. Guidelines like IEC 62366-1 require to follow a structured usability engineering process. These standards help ensure that every decision is supported by evidence and that the device’s interface has been assessed thoroughly. In practice, this means documenting each step, keeping clear records of test results, and showing how improvements were made based on user feedback.
Finally, keep in mind that an optimal usability engineering process implies that all evaluations are planned prior to the design and development steps. The objectives, protocol and timing of each formative evaluation, as well as the summative evaluation, should be detailed in an evaluation plan.
Sources
Develop Your Medical Devices With CLEIO!
Frequently Asked Questions About Medical Device
and User Experience
What Makes Medical Device UX Different From Consumer UX?
Unlike consumer products, medical devices are used in high-risk environments where they have a direct impact on patient health. Healthcare professionals rely on them to perform critical tasks, sometimes under urgent conditions. For this reason, the user interface must be clear, consistent, and quickly understood, leaving little room for use errors.
Why Is Iterative Testing Important In Medical Device UX?
In the design process of a medical device, each iteration helps move it toward a more refined version. Early and repeated testing confirms that users understand the interface and can perform their tasks effectively. This way, new issues can be identified and resolved before moving to the next stage of development.
How Often Should We Conduct Usability Testing?
Usability tests should be carried out regularly throughout development, not just at the end. Early tests help clarify user needs and workflow constraints. Mid-stage tests validate the interactions and how information is presented on the interface. Final tests confirm that the device can be used effectively.
