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 – the usability of all medical devices must be proven in order to obtain approval.
The EU's Medical Device Regulation (MDR) and In vitro Diagnostic Medical Device Regulation (IVDR) define the corresponding legal requirements – such as quality management, risk management and the objective evaluation of usability. Various standards (ISO 13485, IEC 62366-1, ISO 14971) support the implementation of the regulations by providing corresponding processes.
We support you throughout the entire usability engineering process on the way to a safe and easy-to-use medical device – from fundamental user research and the design of interactive operating concepts to formative and summative evaluation.
Our experts ensure that all measures are carried out and documented in compliance with the regulations, so that nothing stands in the way of a successful approval.
How can we support you?
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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: expert interviews, field observation, diary studies, focus groups, etc.
- 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
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Defining requirements
Based on the user research results, we create all the necessary documentation for development.
- Standards-compliant formulation of use scenarios to map the interaction with the product in detail
- Deriving specific product requirements that serve as design input for development
- Identifying potential use errors as a basis for risk management
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Designing user-friendly interactions
On request, we create intuitive design solutions for your product that meet the user needs as well as common usability standards.
- Designing interactive user interface concepts based on the user research results
- Creating prototypes that can be used for formative evaluation and allow for quick adjustments
- Documentation of the final product specifications as a basis for production (e.g. as part of the user interface specification)
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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.
Usability evaluation of medical devices
The MDR and IVDR require the validation of usability through a summative evaluation. The usability testing method is the gold standard for this purpose.
We also recommend conducting formative evaluations early on and, if possible, planning for multiple iterations to regularly assess the usability of the development stage. Based on these insights, the product can be continuously optimized, so that the final product is not only safe but also easy to use.
This approach ensures a high level of usability, avoids costs due to misguided developments, and enables a successful summative evaluation and approval, as well as long-term market success.
More about Evaluation of Medical Devices
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Products for home use by laypersons
Bandages, medication dosing aids, blood pressure monitors, etc.
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Products for professional use
Diagnostic devices, surgical instruments, therapeutic devices, etc.
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Implants
Hip prostheses, pacemakers, cochlear implants, etc.
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Medical software
Radiology software, software for monitoring vital functions, etc.
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Digital applications (e-health)
Health apps and wearables, telemedicine, patient management systems, etc.
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In-vitro diagnostics
Infection tests, pipettes, analysis devices, etc.
An exemplary project:
The development of an AI assistant with Siemens Healthineers
In close cooperation with Siemens Healthineers usability.de developed an AI assistant for radiologists in order to bundle knowledge through an intelligent system and support radiologists in diagnostics.
In this user-centered design process we involved users in the engineering process through various usability methods (e.g. usability tests, contextual inquiries). This approach resulted in a UX design with a convincing user experience that makes the radiologists' job a lot easier.
Why is good usability so important in healthcare?
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Ensuring market success
Competitive advantage through intuitive products
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High safety standards
Control risks and meet regulatory requirements
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Low need for revisions
Avoid recalls and corrections
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Reduced development time and costs
Avoiding design errors
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Increased productivity
Time and cost savings through efficient operation
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Reduced support and training costs
Less training required thanks to intuitive operation
Selected references
Certified Partner for Medical Usability
Do you have specific questions concerning your project? We are happy to advise you. Free of charge and without obligation.
Your contact:
- Alexander Rösler
- Senior UX Consultant, Medical Usability Engineer