Human Factors
Human Factors & Medical Device Usability
We evaluate how intended users interact with medical devices, instructions, packaging and labelling. Our research identifies use-related risks, evaluates critical tasks and supports safe and effective device use in accordance with IEC 62366-1.
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Usability Engineering
Assessment of intended users, use environments, critical tasks and potential use errors across the device, packaging, labelling and instructions to support safe and effective use.
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Formative Usability Evaluation
Early evaluation of device interactions, use scenarios and potential use errors, using expert reviews, checklists and user testing to guide design improvements.
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Summative Usability Evaluation
Risk-based testing of the final user interface to evaluate safety-related tasks and provide evidence supporting safe and effective use.
What You Receive
Structured research documentation supporting medical device usability engineering.
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Study Protocol & Test Scenarios
Defined user groups, use environments, training conditions, critical tasks, risk-related scenarios and evaluation criteria.
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Results & Recommendations
Documented task performance, use errors, participant feedback and practical recommendations to address identified usability and safety concerns.
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Usability Engineering Report
Prepared in accordance with IEC 62366-1:2015, including Amendment 1:2020, where applicable. A structured report covering user and task analysis, use-related risks, formative and summative evaluation results, and conclusions on safe and effective device use. The report supports the manufacturer's Usability Engineering File.
Planning a Medical Device Usability Study?
Share your device, instructions for use, intended users and risk documentation. We'll help define the appropriate scope, from focused IFU testing to a comprehensive usability evaluation.
What You Need to Know about Human Factors
1. Why is human factors evaluation important for medical devices?
Human factors evaluation examines how people interact with medical devices. It helps identify use errors, assess safety-related tasks and reduce risks associated with device use, supporting the usability engineering process under IEC 62366-1.
2. When should usability evaluation be conducted?
Usability evaluation should be integrated into device development. Formative studies identify problems and guide improvements, while summative evaluation provides evidence that the final user interface supports safe use.
3. What is the difference between formative and summative evaluation?
Formative evaluation identifies usability problems during development and supports design improvements. Summative evaluation assesses the final user interface, focusing on selected hazard-related use scenarios and the ability of intended users to perform tasks safely.
4. Can you test only our Instructions for Use (IFU)?
Yes. In many projects, focused IFU testing is sufficient for the specific research objective. However, evaluating the safe use of a medical device may also require testing the product, packaging and labelling. We define the scope based on intended use and identified risks.
5. What is included in a medical device user interface?
The user interface includes everything people interact with when using a device. Depending on the product, this may include the device itself, controls, displays, packaging, labels, symbols, instructions for use and training materials.
6. What are critical tasks and how are they identified?
Critical tasks are activities where incorrect performance or failure could result in serious harm. We analyse user interactions and relevant risk documentation to identify safety-related tasks and develop realistic evaluation scenarios.
7. How do you assess use-related risks?
We review potential use errors, hazard-related scenarios and relevant risk control measures. Testing examines how users perform tasks, follow safety instructions and respond to warnings, precautions and contraindications.
8. How many participants are needed?
The sample size depends on the device, intended user groups, study objectives and applicable regulatory expectations. We define the recruitment approach individually, considering the identified risks and evaluation scenarios.
9. Who participates in usability studies?
We recruit participants representing the intended users, including healthcare professionals, patients or caregivers. Recruitment considers their experience, abilities, training and expected use environments.
10. What happens if participants make use errors?
We document the errors, investigate their causes and assess their potential safety implications. Where necessary, we recommend improvements to the device, instructions, packaging or labelling, followed by further evaluation.
11. What documentation will we receive?
Depending on the study, we provide protocols, test scenarios, results and recommendations. For comprehensive evaluations, we prepare a Usability Engineering Report in accordance with IEC 62366-1:2015, supporting the manufacturer's Usability Engineering File and regulatory documentation.
12. What do we need to get started?
Please share the device or prototype, available IFU, intended use, target user groups and relevant risk documentation. We normally sign an NDA and a service agreement or purchase order, depending on the cooperation model.
Have a project in mind? Get in touch to discuss your needs and discover how our research can help.