UX in medical technology: products that make a difference in everyday clinical practice

UX in medical technology (medical UX) encompasses the user-centered design of medical devices, clinical software, and interfaces for medical professionals. Unlike UX in other industries, poor design here has direct impacts on quality of care. Splore works with medical technology companies on how clinical workflows can become safer and more efficient through user-centered design, from early needs analysis with clinical professionals to validating solutions with users.

What is medical UX, and why does it require specialized expertise?

Medical UX is the application of user-centered design methods to medical devices and clinical systems. At its core are the working realities of physicians, nurses, and medical technical staff, as well as the experiences of patients who interact with these systems.

What distinguishes medical UX from UX work in other industries is the consequence of poor design: a difficult-to-use booking system frustrates. A difficult-to-use clinical system endangers the quality of care. This distinction shapes the entire methodological approach, from the depth of user research to the regulatory requirements of the design process. This becomes most tangible in the example of angiography: cardiologists can focus better on the procedure itself and on patient care when the clinical system supports them optimally — and is intuitive and easy to use.

Medical technology companies face a particular challenge. Their products must meet regulatory requirements, such as IEC 62366 for usability engineering or the MDR (medical device regulation) for market approval in Europe. At the same time, these products must fit into highly complex workflows and be operable without errors under time pressure.

Information density in the clinical environment is continuously increasing, driven by the growing digitalization of clinical processes: laboratory values, imaging data, patient histories, treatment protocols. Every additional feature that is not aligned with actual workflows in clinical practice increases the cognitive load on medical staff instead of reducing it. UX design in medical technology therefore does not mean more features, but the right information at the right time in the right place.

As a UX agency for B2B companies with a focus on complex products in regulated industries, Splore brings together the necessary disciplines: ux research in a clinical context, interaction design, user interface design, and UX concept development. These disciplines do not operate sequentially, but in parallel throughout the project, because a medical device is only successful when it solves the right problems for users and translates these insights into concrete interaction and interface concepts.

Our approach follows a clear principle that we call desirability-first: first understand what medical professionals actually need in everyday clinical practice. Then evaluate whether and how a technical solution addresses this need. Then assess it from a business perspective. This sequence is the prerequisite for ensuring that products not only function technically in clinical practice, but are also actually used.

User experience in healthcare is therefore not a downstream design step. It is an integral part of product development that determines whether a medical device facilitates or hinders the work of clinical professionals, and whether it succeeds in the market by creating real value for users.

How Splore works in medical technology in practice

Every medical UX project at Splore begins with a question that no data sheet can answer: what does the daily work of the people who will operate this product look like? What happens in the first thirty seconds after someone enters the room? Which information is needed immediately, and which can wait?

Discovery: going where the work happens

To understand this, we go where the work happens. Shadowing physicians and nursing staff during real treatment situations, interviews at the systems used every day, observation of shift changes and critical decision points. These steps are not optional extras, but the foundation for all subsequent decisions. We do not design for clinical environments, but with clinical professionals.

Splore works with medical technology manufacturers — including Siemens Healthineers — on questions such as: what does the future of specialized clinical workflows look like? How can new AI-powered assistance systems be integrated into existing processes? And what does the future of interaction with imaging therapy systems look like?

Concept development and prototyping: making ideas testable

From research insights, we develop concepts and make them testable through prototypes before a single line of production code is written. Whether as a clickable prototype for a new interface or as a simulated scenario for a clinical workflow: what matters is that medical professionals can evaluate the design before it enters development.

What differentiates Splore: we already work with concept sketches as stimuli during user interviews. In the design phase, UX designs are created and rendered so concretely in the usage context that care teams can provide feedback and stakeholders can make informed decisions.

Testing and validation: iterating with the right people

Iterative testing with clinical professionals ensures that design decisions are not based on internal assumptions, but on observed behavior. We test prototypes in realistic scenarios: time pressure, high data density, shifting attention. The results flow directly into the next design iteration.

Our workflows incorporate usability requirements so that clients can use the results of our testing as a basis for their own usability documentation in accordance with IEC 62366. Formal validation and regulatory evidence remain the responsibility of the manufacturer.

Integration: handover to development and regulatory affairs

At the end of a Splore project, the outcome includes documented design specifications, validated prototypes, and research insights that directly feed into development. Our clients can use these results for their regulatory documentation, while product responsibility and liability always remain with the manufacturer. If desired, we support implementation as a UX sparring partner over several months.

Our teams combine expertise from ux-research, interaction design, user interface design. In medical technology projects, these disciplines work closely with additional fields such as industrial design and usability engineering, which are often covered on the client side or by specialized partners. A product can only be evaluated through the interplay of all perspectives.

Are you planning a specific project in the medical technology space and considering where the right entry point is? Write to us at hello@splore.de. We will get back to you with an initial assessment.

Regulatory context: IEC 62366 and MDR

Medical devices are subject to a regulatory framework that directly affects UX work. Two sets of regulations are particularly relevant for the European market:

IEC 62366 is the international standard for applying usability engineering to medical devices. It requires the systematic analysis of use-related risks, the execution of usability tests, and the documentation of results as part of the development process. For manufacturers, this means usability engineering is not an optional addition, but a prerequisite for conformity assessment.

MDR (medical device regulation) governs the approval and post-market surveillance of medical devices in the EU. The MDR imposes increased requirements on clinical evaluation and technical documentation. Usability-related evidence is part of this documentation.

For the US market, the requirements of the FDA (21 CFR Part 820) for human factors engineering also apply, which are similar in structure to IEC 62366 but require their own documentation standards.

In this context, Splore positions itself as a UX service provider, not a certification consultant. We understand the regulatory framework and design our methodology so that the results of our work can directly feed into regulatory evidence. Formal approval and conformity assessment remain the responsibility of our clients’ internal regulatory affairs departments.