Article Summary
- In HFE (Human Factors Engineering) evaluations across Asia, outcomes are influenced not only by regulatory requirements but also by execution conditions such as healthcare systems and recruitment realities.
- Cultural factors also shape how users provide feedback and interpret errors, meaning that data collection methods (including moderation) must be carefully designed.
Intro
I recently had the opportunity to participate in a panel discussion at the HFES International Symposium, where I shared perspectives from Japan on practical differences in HFE across Asia.
Together with Maffee Wan (Xplus X, China) and MinJae Kim (Hankook Research, South Korea), we discussed a wide range of topics covering the full lifecycle of human factors research—from planning to execution—including the use of overseas data, sample sizes, test environments, ethics review (IRB), and recruitment.
This discussion reinforced something important for teams working across Asia。
Beyond regulatory frameworks, healthcare systems and cultural contexts play a significant role in shaping HFE outcomes across countries.
In this article, I summarize these practical differences from a medical device development perspective. A downloadable guide comparing these markets is also provided, so I hope you’ll stay with me until the end.
1. Similar Regulations, Different Realities
While regulatory frameworks across Asia are often aligned with international standards (IEC 62366-1), the practical challenges in conducting HFE studies stem primarily from differences in healthcare systems and operational realities, not the regulations themselves.
In Japan, for example, the following structural constraints are commonly observed:
- Compensation for healthcare professionals working in larger hospitals is often treated as secondary income, requiring institutional approval.
- Scheduling HCPs is uncertain and may not be finalized until shortly before the session.
- Patient recruitment frequently depends on existing physician–patient relationships. Participation may be mediated by their physician, either through consultation or direct referral, reflecting a need for reassurance.
In addition, there are environmental constraints such as:
- Many hospitals do not allow external research activities
- Dedicated usability testing facilities are limited
One contributing factor is that participation in medical usability research is less common in Japan compared to Western markets, creating a higher psychological barrier for both institutions and participants. This leads to more cautious decision-making processes.
As a result, in Japan, HFE success depends not only on study design but also on operational design and relationship management to ensure the study can be executed in the first place.
2. Culture Directly Shapes Data Quality
Another critical factor is how cultural context affects the quality of data itself. Even within East Asia, participant behavior and feedback patterns vary significantly across countries.
South Korea:
- Users tend to have high receptivity to new technologies (early adopters)
- Issues are more likely to be identified and clearly attributed to the device
Japan:
- Users often interpret issues as their own misunderstanding
- Errors tend to be attributed to the user rather than the device
- Participants may hesitate to criticize devices used in their own institutions
| Aspect | South Korea | Japan |
|---|---|---|
| Interpretation of issues | High receptivity to new technologies | More cautious, self-adaptive mindset |
| Interpretation of issues | Attributed to the device | Attributed to user understanding |
| Feedback style | Direct and explicit | Reserved (especially for familiar families) |
Without understanding these cultural differences, studies may fail to detect critical use errors. This is especially critical in validation studies for medical devices, where moderator intervention must be minimized. In such cases, it becomes essential for the moderator to create an environment where participants feel comfortable speaking up. In medical device validation studies in Japan, for example, we explicitly communicate that errors reflect design issues, not user faults.
How to Address These Challenges
Within a similar regulatory standard, HFE evaluations in Asia require design and execution tailored to each country’s operational realities.
In Japan in particular, factors such as coordination with medical institutions, recruitment feasibility, testing environments, and cultural biases significantly influence outcomes. For this reason, study design and execution should be treated as an integrated process rather than separate phases.
At Uism, we support HFE activities in Japan, from study design and execution to reporting grounded in local clinical and operational realities. Through ReSight Global, we also collaborate with partner teams to support broader, multi-market HFE programs across regions.
In practice, we support areas such as:
- Operational design that accounts for recruitment and institutional coordination
- Localization of study design based on real-world use environments
- Moderation approaches that account for cultural factors affecting user behavior
HFE/UE in Japan, China, and Korea: Practical Comparison Guide
We’ve created a free guide that provides a practical comparison of HFE implementation across China, Japan, and Korea. This guide is designed for teams planning global HFE activities and offers actionable insights for smooth execution of medical device usability tests.
【What You’ll Learn】
Practical differences in recruitment and coordination across countries
IRB processes and testing environments
Cultural biases and how to address them
Differences in study design and moderation approaches
Want to discuss your project?
If you are planning HFE activities in Asia or have questions about conducting studies in Japan, feel free to get in touch. We would be happy to support!
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