Services
Human Factors Research
We help you identify use-related risks early, iterate with confidence, and build evidence that supports PMDA review when needed.
Compliance Is the Baseline; Safe Use Is the Goal
Human factors (HF) work starts long before validation, because safe use is shaped by the context of use. We evaluate your device within Japanese clinical workflows and care environments to identify risks early and support iteration before designs become fixed. This creates a stronger foundation for summative validation and PMDA review.
HF Support Across Every Stage
We follow an IEC 62366-1 aligned approach to generate evidence that supports both development and review.
Early Stage Exploratory Research
Mapping Real Use in Japan
We start by understanding where and how your device fits into Japanese healthcare environments, including hospitals, clinics, and home care. This phase surfaces latent risks, unmet needs, and workflow constraints before designs become rigid.
Methods:
- In-depth intervies
- Contextual inquiry
- Diary studies
Formative Evaluation
Reducing Risk Through Iteration
We test early designs, instructions, and labeling with Japanese users to identify use-related risks and usability issues while modifications are still cost-effective. Iteration at this stage strengthens your foundation for later validation.
Methods:
- Formative usability testing
- Task analysis
- Expert/Heuristic review
Summative Evaluation
Evidence for PMDA Review
We conduct high-fidelity studies in simulated-use environments that reflect Japanese clinical reality. Outputs are structured for inclusion in your HFE/UE documentation and to support PMDA review.
Methods:
- Summative validation testing
Why Clients Choose Uism for HF in Japan
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Bridging Global Standards and PMDA Expectations
As ReSight Global’s Japan hub, we bring experience from FDA and CE programs into Japan-based HF work. We help align evidence with international standards while reflecting Japanese clinical reality and PMDA expectations.
02
Access to Specialized Medical Participants in Japan
We combine trusted medical recruiters with our own long-standing network of physicians and nurses. This hybrid approach ensures access to the niche profiles your study requires.
From Scoping to Validation
We can run the full human factors research program end to end. We can also plug into specific phases.
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- Scoping and Proposal
- We design studies aligned with your clinical context and regulatory requirements. Based on IEC 62366-1 and JIS T 62366-1, we develop a plan that supports PMDA review and downstream submissions.
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- Preparation
- We develop or localize all study materials, including protocols and moderator guides. We adapt them for Japanese clinical environments to ensure studies are practical and compliant.
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- Recruitment
- Leveraging our medical network, we recruit highly targeted participants, including specialized HCPs such as surgeons and nurses, as well as patients with chronic or rare diseases.
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- Fieldwork
- We conduct studies in settings designed to reflect intended use conditions in Japan, using simulation when appropriate. Through high-resolution recording and detailed analysis, we capture user behavior and clinically relevant observations to identify risks.
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- Deliverables
- We deliver comprehensive reports with root cause analysis and actionable findings. Deliverables are structured for direct integration into your HFE/UE documentation, supporting both development and regulatory goals.
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Resources for Healthcare & HF
Our articles explore healthcare and human factors work in Japan, from PMDA expectations to medical recruitment and patient behavior.
PMDA Review Expectations
Key usability points global manufacturers should understand for Japanese PMDA submissions.
HF for Medical Devices in Japan
What global manufacturers need to know about human factors for medical devices in Japan.
Sample Size & Test Environment
How to think about sample size and simulated-use conditions for PMDA HFE validation in Japan.
Participant Recruitment in Japan
A practical guide to recruiting representative users for PMDA usability studies in Japan, including HCPs, patients, rare-disease groups, and caregivers.
Ready to plan a study?
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