We uncover real user needs and use-related risks through targeted research - enabling you to design products that improve safety, address real-world demands and unlock market potential.
Why User Research is Essential for Medical Devices
User Research is the foundation of every user-centered medical device design. To create truly safe and effective products, it’s crucial to understand who will use them, how they will be used, and under what conditions – especially in clinical environments where time, stress and complexity are daily realities.
As part of the Usability Engineering process defined by IEC 62366-1, User Research helps identify and mitigate risks caused by poor usability early in the development cycle. Instead of relying on assumptions, we generate concrete insights into real-world usage – providing a solid basis for informed design, risk management, and regulatory compliance.
Identifies use errors early to reduce safety risks
Reveals real user needs instead of relying on assumptions
Improves usability and efficiency in complex clinical settings
Supports regulatory approval with clear documentation
Fulfills IEC 62366-1 and ISO 14971 requirements
Know Your Users: The Foundation of Great Design
A core component of the Usability Engineering process is gaining a deep understanding of the people who will interact with your medical device. Through focused user research, we identify who the users are, what tasks they need to perform and the environments in which the device will be used.
This understanding is essential—not only for designing intuitive and accessible interfaces, but also for identifying potential use-related risks early in development.
These user insights form the foundation for defining clear user needs, guiding design decisions and ensuring that the device functions safely and effectively in real-world conditions—not just under test scenarios.
User groups
Who are the primary and secondary users?
Tasks
What tasks do users perform with the product?
Environments
Where and under what conditions is the device used?
Our Services for Insight-Driven User Research
We support you in planning and conducting user research that not only delivers valuable insights—but also produces the documentation required by IEC 62366-1. From defining the Use Specification to developing user profiles, use scenarios and evaluating potential use-related risks, we help you generate traceable, audit-ready records. These form the foundation of a compliant Usability Engineering File and support the development of medical devices that are safe, intuitive and meet regulatory requirements.
We investigate how, where and by whom your medical device is used – forming the foundation for all usability activities in line with IEC 62366-1.
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Identification of user groups, tasks and use environments
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On-site observations, interviews and shadowing
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Documentation of physical, social and organizational context
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Validation of user needs and usage assumptions
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We gather perspectives from key stakeholders to align user research with product goals and regulatory needs.
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Stakeholder mapping and prioritization
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Interview planning and execution
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Structured documentation in the Usability Engineering File
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User journeys and touchpoint analysis
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We analyze user workflows to identify critical steps, tasks, and potential for use-related errors.
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Breakdown of user tasks and sequences
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Mapping of interaction steps to possible use errors
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Input for risk-based design and formative evaluations
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We translate research findings into actionable tools for design and validation by creating realistic user profiles and scenarios.
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Creation of evidence-based personas
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Definition of typical and critical use cases
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Workshops with clinical users and experts
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Application in design, testing, and risk analysis
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We support you in identifying and controlling usability-related risks in compliance with ISO 14971 and IEC 62366-1.
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Integration of findings into the Hazard Analysis File
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Moderation of interdisciplinary risk assessments
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Planning of usability-related risk control measures
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Everything about Usability and UX for Medical Devices
Explore our full range of services across the entire usability engineering process. Whether you need targeted support in a specific phase or guidance throughout the full development cycle – our services adapt to your needs. Learn more about each offering and find the right support for your project.
Usability Engineering
Design medical devices that are safe, intuitive and compliant. We guide you through the usability engineering process – from concept to submission.
UX/UI Design
Make complex technology easy to use. We design intuitive interfaces for medical devices and digital health solutions.
Usability Testing
Test your product with real users. We validate safety, usability and regulatory readiness through formative and summative testing.
Your Benefits from Effective User Research
Fewer use errors and safer products
Early research uncovers risks before they impact safety or compliance.
Decisions based on real needs
Insights from actual users lead to intuitive and clinically relevant solutions.
Stronger regulatory documentation
Structured user research supports your Usability Engineering File and risk management.
Efficient development and validation
A clear understanding of users prevents costly redesigns and streamlines evaluations.
Frequently Asked Questions
We support medical device manufacturers of all sizes – from early-stage start-ups to global MedTech companies. Whether you’re developing software, hardware, or a combination product, we tailor our usability engineering support to your needs.
Yes. Both the MDR (EU) and the FDA (US) require usability engineering as part of the product development process. IEC 62366-1 outlines the expected steps. Skipping them can lead to delays or rejection during submission.
Ideally, usability activities start in early development – but it’s never too late. We adapt our support whether you’re starting from scratch or need to fix gaps before a submission.
We combine strong design and UX expertise with deep knowledge of regulatory standards like IEC 62366-1. You get hands-on support from a team that understands both usability and compliance.
Absolutely. We create or review all required documentation, including use specifications, task analysis, formative/summative test reports, and the full Usability Engineering File – ready for your auditors or Notified Body.
