Usability Testing
Formative Evaluation for Medical Devices
Early-stage Human Factors Usability Testing helps identify use errors, optimize workflows, and refine the user interface long before final design and validation. By uncovering real usability issues early in development, teams can make informed design decisions that reduce risk, strengthen user satisfaction, and significantly increase the likelihood of market success. A product that is intuitive, safe, and easy to use not only meets regulatory expectations, but also stands out competitively and performs better in real clinical environments.
Formative Evaluation Explained
What Is Formative Evaluation?
Formative Evaluation is an early-phase Human Factors Usability Testing approach used to understand how users interact with a medical device or healthcare application while it is still under development. Instead of waiting until the design is nearly finished, formative testing brings real clinicians, technicians, and patients into the process to observe how they interpret instructions, navigate workflows, and operate the user interface. This allows teams to detect misunderstandings, task failures, and workflow inefficiencies long before they become costly or difficult to correct.
As part of an IEC 62366-1–compliant Usability Engineering process, Formative Evaluation supplies essential insights for refining the design of your medical device. It enables improvements in information architecture, interaction flows, and overall UX/UI quality, ensuring the product aligns with real clinical environments and user expectations. This reduces use-related risks and strengthens the Human Factors foundation necessary for later validation.
Both healthcare professionals and patients benefit from our in-house Human Factors expertise. With extensive experience in testing medical devices across all stages of development, we are specialists in identifying usability weaknesses early, whether they relate to workflow design, interface clarity, or risk-critical tasks. Our external perspective helps teams overcome internal “tunnel vision” or development-related blind spots that often arise after long design cycles in MedTech. By offering an impartial, expert-driven view, we ensure that usability gaps are recognized and resolved efficiently.
Our Approach
Formative Evaluation Overview
A clear and well-guided approach ensures that Formative Evaluation delivers meaningful insights at each development stage. Early user input, focused analysis, and continuous refinement help create a device that truly fits clinical needs. Bringing in an external Human Factors team adds valuable objectivity, helping you avoid internal blind spots and strengthening the overall outcome.
1.
Define the Use Specification
Clarify who will use the device, in which environment, and which tasks are safety-critical.
2.
Create Prototypes
Develop prototypes of varying fidelity to explore interaction concepts and workflow ideas.
3.
Conduct Formative Usability Tests
Observe representative users performing tasks to uncover usability challenges early.
4.
Analyze Use Errors
Evaluate where misunderstandings, mistakes, or workflow issues occur and why.
5.
Expert Review
Have Human Factors specialists assess the improvement opportunities before the next user tests.
6.
Iterate and Retest
Refine the design based on findings and validate improvements through repeated testing.
What We Do
Why Work With Human Factor Lab
Our Services
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Plan, conduct and analyze formative usability tests
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User research & contextual inquiry in real clinical environments
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UX/UI design & prototyping for medical devices and MedTech software
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Use Error Analysis (IEC 62366-1 / ISO 14971 / FDA Human Factors Guidance)
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Documentation for the Usability Engineering File (UEF)
Why Work With Us?
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Unique blend of clinical expertise, UX/UI design, and Human Factors Engineering
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Fast, realistic user testing with actionable insights
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Identification of quick wins that immediately improve usability
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Trusted MedTech usability experts
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Reduced risks, shorter development time, and lower costs
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Clear user flows instead of nested processes
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Excellent usability for research and clinical use
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Consistent look and feel
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Future-proof foundation for expansion within a highly complex system
Everything you want to know
The goal of Formative Evaluation is to uncover usability issues, use errors, workflow challenges, and UI/UX problems early in the development of a medical device. By identifying these risks before final design and validation, you ensure safer interaction, a more intuitive user interface, and a stronger Human Factors foundation for IEC 62366-1–compliant Usability Engineering and later Human Factors Validation.
Formative testing should be performed multiple times throughout development, whenever the design evolves or new features are introduced. Continuous Human Factors Usability Testing ensures that usability, workflow efficiency, and user safety stay aligned with real-world clinical needs as your medical device progresses toward final evaluation.
No. Formative Evaluation works effectively with any level of prototype, from paper sketches and wireframes to interactive digital mockups. Early-stage prototypes allow teams to explore UI concepts, test workflows, and identify Human Factors issues long before creating a fully functional medical device, accelerating development while reducing cost and risk.
While formative testing is not defined as a single mandatory activity, it is a crucial component of an IEC 62366-1–compliant Usability Engineering process. Regulators expect clear evidence that Human Factors risks were identified and addressed throughout development, which formative usability testing provides. It strengthens your usability file and sets a solid foundation for successful summative validation.
