Services/UI/UX Design / HMI for Medical Devices
Intuitive operating concepts for medical devices
Safe operation in an environment where mistakes are not an option.
Medical devices are often operated under high stress, in critical moments, and by users with varying levels of training. At the same time, regulatory requirements such as IEC 62366 demand a traceable, documented usability engineering process. We develop HMI solutions for medical devices that actively reduce operating errors while meeting regulatory usability engineering requirements.
✔ Higher patient and user safety
✔ Usability engineering process traceably documented
✔ Reduced misoperation in critical situations
Request a Medtech project Challenges
When operational errors are particularly critical in the healthcare sector
Medical devices are subject to particular demands – technical, regulatory and human:
High safety requirements, as operating errors can have direct consequences for patients
Complex functionalities that must still be operable without error even under stress
Regulatory requirements for usability engineering, such as those set out in IEC 62366
A wide variety of users, ranging from healthcare professionals to patients themselves
Solution
Clear interaction, reliable operating logic
We design user interfaces that ensure safe use even under stress, time pressure and with changing users – and which provide evidence that this safety has been methodically established.
Clear, unambiguous interaction logic that actively prevents user errors
Reliable user guidance, particularly during critical or irreversible steps
A structured usability engineering process, including documentation for regulatory approval
Tests involving representative user groups rather than purely theoretical assumptions
Procedure
Our approach
1. Analysis —We capture the usage context, user groups, and safety-critical operating steps according to the usability engineering approach.
2. Concept —This results in an operating logic that specifically reduces risks and is traceably documented.
3. Prototype —The concept is implemented as a testable prototype, usable for formative usability tests.
4. Testing —We conduct formative and summative usability tests with representative user groups, documented for your technical file.
5. Implementation —The validated solution is finalized together with your development and regulatory team.
Request a Medtech project 
