Usability in Medical Engineering

Medical devices and in-vitro diagnostics must meet strict usability requirements to gain approval. Our experts support you in the standard-compliant planning, implementation, and documentation of all necessary measures on the path to a safe and successful product.

Usability Engineering for Medical Products

From wrist supports to software for spinal surgery – all medical devices and in vitro diagnostics are subject to strict regulatory requirements for usability. Optimal user-friendliness ensures intuitive and efficient product use, minimizing risks for both users and patients.

The EU's Medical Device Regulation (MDR) and In vitro Diagnostic Medical Device Regulation (IVDR) define the legal framework. Various standards (ISO 13485, IEC 62366-1, ISO 14971) support implementation by providing corresponding processes.

We support you throughout the entire usability engineering process, providing comprehensive services for all development phases – from the systematic collection of stakeholder requirements and standards-compliant design development to formative and summative evaluation.

By seamlessly integrating all tasks, we ensure an efficient integration into your development process while guaranteeing that all documentation fully complies with regulatory requirements. This ensures a clear path to successful approval.

Why Is Good Usability So Important in Healthcare?

Ensuring market success

Competitive advantage through intuitive products
High patient safety

Preventing use errors and reducing risks in diagnosis and treatment
Driving digitalization

High acceptance and efficient use of intuitive and easy-to-understand products

Reduced development time and costs

Avoiding design errors
Reduced support and training costs

Less training required thanks to intuitive operation
Low need for revisions

Avoid recalls and corrections

How can we support you?

Consulting and strategy
Together with your team, we define the framework for the project and plan all usability activities.
- Consulting for an efficient project workflow: Timeline, suitable approaches and methods, and integration into your development process
- Defining milestones and resources, e.g., for requirements gathering, prototyping, and evaluations
- Defining quality goals: What should the product be able to achieve for users?
- Collaborative development of the product vision while considering business requirements: What is the desired target vision for the product?
User Research: Understanding the context of use
We help you build a deep understanding of the user profiles and use environments for your context, ensuring that your product is aligned with the user needs from the very beginning.
- Many years of experience with a wide range of research methods, such as expert interviews, field observations, job shadowing, diary studies, focus groups, and personas
- Full Service: We take care of the preparation, implementation and evaluation of the user research activities, as well as the recruitment of suitable participants.
- Standard-compliant documentation of the results for the use specification
Defining requirements
Based on the user research results, we create all the necessary documentation for development.
- Support in standards-compliant formulation of use scenarios to accurately depict interaction with the product
- Deriving specific product requirements that serve as design input for development
- Identifying potential use errors as a basis for risk management
- Collecting and prioritizing requirements from various stakeholders, including technical, data protection, and security-related aspects
- Documentation of requirements for product development and future validation
Design of digital medical devices
We create intuitive design solutions for your product that meet customer requirements as well as established usability standards.
- Translating complex processes and background operations into efficient and intuitive user flows
- Designing interactive user interfaces based on the design input document and additional requirements, such as those from risk management or hardware
- Creating prototypes for formative evaluation and alignment with decision-makers
- Documentation of the final product specifications as a basis for production (e.g. as part of the user interface specification)
- Bringing concepts to life early through prototypes at trade shows and conferences to strengthen market positioning
More about UX Design for Medical Devices
Evaluation (formative und summative)
To ensure that your product meets all usability requirements, we conduct comprehensive evaluations for you.
- Formative evaluation during development to assess the usability of the current development stage and identify any previously undetected use errors
- Summative evaluation to demonstrate usability in accordance with MDR and IVDR (validation)
- Evaluation of the information for safety using reading comprehension tests
- Many years of experience with the common evaluation methods usability test and cognitive walkthrough
More about Evaluation of Medical Devices
Click on the individual sections to take a closer look.

Would you like to learn more about how we can support you?
We are happy to advise you. Free of charge and without obligation.

Get in Touch

Usability evaluation of medical devices

The MDR and IVDR require usability validation through summative evaluation, with usability testing considered the gold standard.

Additionally, the IEC 62366-1 standard mandates formative evaluations throughout the development process. We recommend planning for multiple iterations to regularly assess the usability of the development stage. This approach helps validate decisions and minimizes the risk of severe use errors or design flaws.

By following this process, you ensure a high level of usability, avoid unnecessary costs, and establish a solid foundation for successful approval and long-term market success.

More about Evaluation of Medical Devices

Products for home use by laypersons

Bandages, medication dosing aids, blood pressure monitors, etc.
Products for professional use

Diagnostic devices, surgical instruments, therapeutic devices, etc.
Implants

Hip prostheses, pacemakers, cochlear implants, etc.
Medical software

Radiology software, software for monitoring vital functions, etc.
Digital applications (e-health)

Health apps and wearables, telemedicine, patient management systems, etc.
In-vitro diagnostics

Infection tests, pipettes, analysis devices, etc.

UX Design for Digital Medical Devices

As required by IEC 62366-1, our design follows an iterative development process (human-centered design). Based on the use specification, we create interactive prototypes early on to visualize the concept and conduct formative evaluations.

We ensure optimal usability by tailoring every interaction to the specific context. Together with your team, we iteratively refine ideas at an early stage to develop a safe, innovative, and successful product.

Lung CT with AI-generated text suggestion for a detected lesion

Defining requirements
Based on the use specification, we define product requirements and outline the interaction with the product, for example, in the form of user flows.
Concept development & prototyping
In a short time and without development effort, we create interactive prototypes that can be used for formative evaluations.

User interface design
We design aesthetic user interfaces and animations while optimizing interactions for specific scenarios, such as operating rooms.
Handover to development
We work closely with the development team, write tickets, and support the definition of user interface specifications.

More about UX Design for Medical Devices

Selected References

“A big thank you to usability.de for their great commitment, many creative workshop ideas and the UX design for the various research questions and prototypes. The concept of the radiology assistant has won colleagues and experts over, internally and on international radiology congresses. The user-centered approach from ideation to implementation has substantially contributed to this outcome.”