Medical device usability testing
Find use problems early.
Refine the details.
Validate the final design.
Your progress is saved.
Resume from where you stopped.
Featured In
Trusted by medical device leaders since 2002
- Medrad
- Edwards Lifesciences
- COBE
- Thermo Fisher Scientific
- Johnson & Johnson
- DermSpectra
- Medtronic
- ANEUVO
- Life Technologies
- Alcon
- Baxter
- Enigma Diagnostics
- Ormco
- Braun
- Niche Bio
- Life Scan
- Gambro
- Wavetec Vision
- Advanced Bionics
Why Areteworks
Medical device expertise. A deeper understanding of your users.
We understand the clinical workflows surrounding a product: task sequences, handoffs, interruptions, and recovery. Our medical device usability testing examines what people do—and where they hesitate, improvise, or lose confidence.
You work directly with senior practitioners who connect research findings to practical design improvements, with documentation to support FDA submissions when needed.
Usability testing services
The right testing at the right stage.
Start with the questions your team needs answered. Engage us for a focused study or for testing throughout development.
Rapid iterative
usability testing
Early formative evaluation.
Find the larger problems early.
Short testing rounds uncover major usability problems, confusing workflows, and use errors while the design is still flexible.
We test early prototypes with intended users, make changes, and test again—helping the design team resolve the larger problems before refining the details.
Prioritized findings and practical improvements for the next design iteration.
Later formative
usability testing
Work through the detailed use errors.
Our aim is to resolve major usability problems through early iterations, so later formative studies can focus on detailed use errors in task sequences, controls, feedback, instructions, and recovery.
We aim to conduct later formative testing in conditions as close as practical to actual use, with software and UI behavior that closely represent the planned final product. This includes realistic screens, controls, feedback, workflow sequences, and recovery paths, as well as relevant lighting, noise, interruptions, and surrounding equipment.
This can help reveal use problems that simplified prototypes or settings may miss, so we can refine the design and better prepare it for summative validation.
Read why a device can look ready after formative testing and still encounter problems in human factors validation.
We check whether refinements resolve the issues, evaluate use-related risks, and investigate any larger problems that emerge.
Documented findings to guide refinements and help address remaining use-related risks.
Summative testing
Human factors validation.
Test a device that represents the final design with representative intended users, realistic use conditions, and the instructions and training they would receive in practice. The study covers all identified critical tasks and evaluates measures intended to support safe, effective use.
We document observed performance, use errors, close calls, and their underlying causes to support the validation effort and regulatory submissions when needed.
A structured study, analysis of the results, and human factors validation documentation.
Rapid iterative testing is also a form of formative evaluation. We distinguish early and later studies to show how the testing focus changes as the design develops.
For an overview of the two stages, read our guide to formative versus summative usability testing.
Summative validation
The right team for an objective evaluation.
Areteworks can conduct summative testing or coordinate with an independent consultant. When we have helped design the product, an independent evaluator can provide additional separation between design and evaluation to help reduce potential bias.
Areteworks-led testing
Work directly with us to plan the study, conduct testing with impartial moderation, analyze findings, and prepare the documentation.
Independent consultant
Bring in a separate evaluator for the summative study. We can coordinate the handoff of design context and prior research.
Understanding the hesitation
From an uncertain moment to a clearer design.
Use errors tell us where a task breaks down. Hesitation and workarounds help us understand why—and what the next design iteration should address.
Illustrative moment
“Should I press Pause?”
A user stops before selecting an unfamiliar action.
What we explore
“Will my progress be saved?”
The uncertainty is about what happens next and whether the session can resume.
What it guides
Predictable product behavior.
A clear paused state, saved progress, and an understandable path to resume—then tested with intended users.
Common questions
Planning your usability study.
Can we engage you for just one study?
Yes. You can engage us for a focused study without committing to a full design project. We define the scope with your team based on your product’s maturity, use-related risks, and the questions you need answered.
Can testing begin before the device is fully developed?
Yes. Early prototypes can reveal workflow problems and confusing interactions while the design is still easy to change. The prototype should support the tasks and questions being explored.
How does later formative testing differ from rapid iteration?
Both are formative evaluation. Early rounds aim to resolve broad usability problems. Later studies examine detailed use errors and check whether refinements resolve the issues. Use-related risks and newly identified problems remain part of the evaluation at every stage.
Can another consultant perform the summative study?
Yes. Areteworks can conduct the study or coordinate with an independent consultant when separating design involvement from final evaluation would help reduce potential design bias.
Who takes part in medical device usability testing?
We work with your team to identify participants who represent the intended users, such as clinicians, patients, or caregivers. Participant groups, tasks, and use conditions are matched to the device and the study’s purpose.