Presentation
Conduct of Human Factors Evaluations in Asia: Considerations From Local Experts - China, Japan, South Korea
DescriptionThis discussion panel brings together senior HFE practitioners from China, Japan, and South Korea to share on-the-ground tactics for planning, managing, and executing human factors (HF) research in their local markets. While all three of these markets anchor to ISO/IEC 62366-1 (and national mirrors) and link to ISO 14971 risk management, the value of this session is pragmatic: concrete lead times, recruiting realities, facility options, ethics requirements, and cultural nuances that make or break formative and summative work.
The panel chair will pose practical questions to the panelists to drive conversation around insights for practitioners seeking to conduct HF evaluations in these East-Asian countries. Example questions include:
1. How is HFE applied to the development of medical devices and combination products in your country?
2. How much local vs. international demand do you have for medical device HFE activities?
3. Logistically, how are medical device HFE evaluations typically contracted in your country?
4. What are some best practices and considerations when selecting research facilities for medical device HFE evaluations?
5. What are some considerations for conducting research with typical medical device participant populations?
6. What are some cultural considerations when conducting HFE research in your country?
And with these example questions, the following is an example of the discussion points the panelists will share for each of their countries, noting that the details of these discussion points will be refined prior to the symposium.
China—plan early, plan local. For imported devices, sponsors should assume they will need to conduct an in-country summative, especially for higher risk devices (or a strong justification otherwise), which drives timelines. Recruiting lead time typically runs 4–6 weeks for clinicians (longer for specialist roles) and 3–5 weeks for patients/caregivers, especially if conditions are low prevalence or caregiver participation is required. Weekday daytime sessions book fastest; evening/weekend access at tertiary hospitals is feasible but needs earlier scheduling. Facilities range from commercial usability labs (excellent for lay user and labeling/training studies) to hospital simulation suites for procedure realism. Booking high-fidelity hospital spaces can take 3–6 weeks, often gated by department heads’ calendars and equipment availability; commercial labs can be secured within 2–3 weeks. Ethics: non-interventional usability typically clears institutional ethics committees; if conducted in hospitals, expect local committee review and site contracts in Chinese. Consent forms, scripts, and IFUs must be localized beyond translation (units, symbols, dosage formats). Cultural dynamics favor private, one-on-one sessions that let participants “save face”; moderators should normalize error discovery and use neutral probes. However, for older adults, our practitioners advise a useful rule of thumb: participants aged 50+ may share more openly when a caregiver is present—structure sessions to gather joint context (history, routines) before private, task-based performance to avoid inadvertently coaching. Simultaneous interpretation is common—budget for an interpreter + tech in the observation room and agree up front on how to handle real-time translations of task errors. Practical tip: import logistics (batteries, controlled components) can add 1–3 weeks—ship a fully functional technical setup early and validate any necessary connectivity on local networks before pilot day.
Japan—rigor, traceability, and meticulous scheduling. Japan’s reviewers expect clause-by-clause traceability to JIS T 62366-1; that same attention to detail applies to study execution. Recruiting lead time is 6–8+ weeks for clinicians and 4–6 weeks for patients/caregivers. When working through hospital partners, schedules are often confirmed only after protocols and consent materials have been finalized, and in many cases after internal approvals are obtained. Sessions with HCPs are commonly scheduled after clinic hours (evenings) or on weekends; longer breaks between participants than we are accustomed to in the US help maintain punctuality and data quality. Facilities include high-fidelity commercial UX/HF labs (excellent audio/video capture and interpreter booths) and hospital partner rooms for equipment-intensive tasks; some sponsors run home-use simulations with carefully scripted moderator safety checks. Booking premium commercial labs in major business hubs is best done 4–6 weeks in advance. Hospital facilities, however, require substantially more lead time: internal review processes and departmental coordination often extend well beyond 8 weeks. Ethics: many clinical institutions prefer their own IRB/ethics review even for minimal-risk studies; allow translation/back-translation of consent and moderator guides, and build in pilot sessions to confirm clarity before summative. Cultural considerations: participants may offer indirect criticism and defer to device authority; moderators should build rapport, use task-based probes (“walk me through what you expected here”) and avoid leading questions. Recording patient faces can be sensitive—obscure identifiers during playback and obtain explicit consent for any media use beyond research. A practical contracting note: Japanese CROs and specialist labs are accustomed to documentation-forward engagements—decide early who owns raw media, annotated task analyses, and bilingual transcripts.
South Korea—fast access through hospital usability centers. Korea’s standout asset is the network of hospital-based usability/simulation centers that streamline HCP recruiting and give teams realistic environments (e.g., ICU/OR mock-ups, pharmacy windows, home-care setups). For these centers, HCP recruiting can be as short as 3–5 weeks once materials are final; patient/caregiver recruiting is commonly 3–4 weeks with strong incidence screening. Centers often provide in-house IRB options or well-trodden pathways for minimal-risk reviews, shortening approval cycles relative to ad-hoc hospital contracting. Commercial usability labs are also strong for lay-user tasks, packaging assessments, and training/labeling checks; booking is typically 2–3 weeks. Scheduling: clinicians favor early evenings; residents and nurses can be recruited for daytime slots with advance coordination. Cultural considerations: participants are generally candid in one-on-one settings; for group debriefs with mixed seniority, assign turns and use anonymous polling to avoid hierarchy effects. Consent and IFUs should be Korean-first, not English-with-notes; check symbol comprehension and color conventions during pilot runs.
Cross-market recruiting and incentives. Clinician incentives must respect institutional policies; where direct cash isn’t permitted, centers can route department honoraria or prepaid vouchers. Patient/caregiver incentives should cover travel and time; in all three markets, travel reimbursements need clear documentation. Build realistic no-show buffers (10–20%) into summative schedules, especially when sessions fall on weekday evenings. When critical tasks require rare specialists (e.g., interventional cardiology), identify named alternates at contracting time to protect timelines.
Facility configurations that travel well. Regardless of country, panels recommend two camera angles (face + hands), a document camera or macro lens for close-ups of controls/packaging, and a mobile overhead for procedure rooms. Always verify power/plug standards and bring step-down transformers where needed. For remote observation, secure low-latency streaming with a back-up local recording; align on what interpreters will translate live (commands vs. narrative) to reduce cognitive load in the viewing room. If running home-use simulations, pre-visit safety checks and post-visit device inventories reduce loss and data gaps.
Ethics and documentation workflow. Even when formal IRB is not legally required, institutional reviews are common in hospital settings. Plan a clean document set: localized protocol, risk disclosure, data-handling plan, consent, and a privacy script that explains video capture and storage. Across China, Japan, and Korea, reviewers appreciate seeing the trace from URRA → formative findings → risk controls → summative critical-task list, with localized labeling/training attached. Where summative is conducted outside the ultimate market (e.g., bridging rationales), ensure the dossier explicitly compares user profiles, environments, labeling differences, and shows why residual risk remains acceptable.
The panel chair will pose practical questions to the panelists to drive conversation around insights for practitioners seeking to conduct HF evaluations in these East-Asian countries. Example questions include:
1. How is HFE applied to the development of medical devices and combination products in your country?
2. How much local vs. international demand do you have for medical device HFE activities?
3. Logistically, how are medical device HFE evaluations typically contracted in your country?
4. What are some best practices and considerations when selecting research facilities for medical device HFE evaluations?
5. What are some considerations for conducting research with typical medical device participant populations?
6. What are some cultural considerations when conducting HFE research in your country?
And with these example questions, the following is an example of the discussion points the panelists will share for each of their countries, noting that the details of these discussion points will be refined prior to the symposium.
China—plan early, plan local. For imported devices, sponsors should assume they will need to conduct an in-country summative, especially for higher risk devices (or a strong justification otherwise), which drives timelines. Recruiting lead time typically runs 4–6 weeks for clinicians (longer for specialist roles) and 3–5 weeks for patients/caregivers, especially if conditions are low prevalence or caregiver participation is required. Weekday daytime sessions book fastest; evening/weekend access at tertiary hospitals is feasible but needs earlier scheduling. Facilities range from commercial usability labs (excellent for lay user and labeling/training studies) to hospital simulation suites for procedure realism. Booking high-fidelity hospital spaces can take 3–6 weeks, often gated by department heads’ calendars and equipment availability; commercial labs can be secured within 2–3 weeks. Ethics: non-interventional usability typically clears institutional ethics committees; if conducted in hospitals, expect local committee review and site contracts in Chinese. Consent forms, scripts, and IFUs must be localized beyond translation (units, symbols, dosage formats). Cultural dynamics favor private, one-on-one sessions that let participants “save face”; moderators should normalize error discovery and use neutral probes. However, for older adults, our practitioners advise a useful rule of thumb: participants aged 50+ may share more openly when a caregiver is present—structure sessions to gather joint context (history, routines) before private, task-based performance to avoid inadvertently coaching. Simultaneous interpretation is common—budget for an interpreter + tech in the observation room and agree up front on how to handle real-time translations of task errors. Practical tip: import logistics (batteries, controlled components) can add 1–3 weeks—ship a fully functional technical setup early and validate any necessary connectivity on local networks before pilot day.
Japan—rigor, traceability, and meticulous scheduling. Japan’s reviewers expect clause-by-clause traceability to JIS T 62366-1; that same attention to detail applies to study execution. Recruiting lead time is 6–8+ weeks for clinicians and 4–6 weeks for patients/caregivers. When working through hospital partners, schedules are often confirmed only after protocols and consent materials have been finalized, and in many cases after internal approvals are obtained. Sessions with HCPs are commonly scheduled after clinic hours (evenings) or on weekends; longer breaks between participants than we are accustomed to in the US help maintain punctuality and data quality. Facilities include high-fidelity commercial UX/HF labs (excellent audio/video capture and interpreter booths) and hospital partner rooms for equipment-intensive tasks; some sponsors run home-use simulations with carefully scripted moderator safety checks. Booking premium commercial labs in major business hubs is best done 4–6 weeks in advance. Hospital facilities, however, require substantially more lead time: internal review processes and departmental coordination often extend well beyond 8 weeks. Ethics: many clinical institutions prefer their own IRB/ethics review even for minimal-risk studies; allow translation/back-translation of consent and moderator guides, and build in pilot sessions to confirm clarity before summative. Cultural considerations: participants may offer indirect criticism and defer to device authority; moderators should build rapport, use task-based probes (“walk me through what you expected here”) and avoid leading questions. Recording patient faces can be sensitive—obscure identifiers during playback and obtain explicit consent for any media use beyond research. A practical contracting note: Japanese CROs and specialist labs are accustomed to documentation-forward engagements—decide early who owns raw media, annotated task analyses, and bilingual transcripts.
South Korea—fast access through hospital usability centers. Korea’s standout asset is the network of hospital-based usability/simulation centers that streamline HCP recruiting and give teams realistic environments (e.g., ICU/OR mock-ups, pharmacy windows, home-care setups). For these centers, HCP recruiting can be as short as 3–5 weeks once materials are final; patient/caregiver recruiting is commonly 3–4 weeks with strong incidence screening. Centers often provide in-house IRB options or well-trodden pathways for minimal-risk reviews, shortening approval cycles relative to ad-hoc hospital contracting. Commercial usability labs are also strong for lay-user tasks, packaging assessments, and training/labeling checks; booking is typically 2–3 weeks. Scheduling: clinicians favor early evenings; residents and nurses can be recruited for daytime slots with advance coordination. Cultural considerations: participants are generally candid in one-on-one settings; for group debriefs with mixed seniority, assign turns and use anonymous polling to avoid hierarchy effects. Consent and IFUs should be Korean-first, not English-with-notes; check symbol comprehension and color conventions during pilot runs.
Cross-market recruiting and incentives. Clinician incentives must respect institutional policies; where direct cash isn’t permitted, centers can route department honoraria or prepaid vouchers. Patient/caregiver incentives should cover travel and time; in all three markets, travel reimbursements need clear documentation. Build realistic no-show buffers (10–20%) into summative schedules, especially when sessions fall on weekday evenings. When critical tasks require rare specialists (e.g., interventional cardiology), identify named alternates at contracting time to protect timelines.
Facility configurations that travel well. Regardless of country, panels recommend two camera angles (face + hands), a document camera or macro lens for close-ups of controls/packaging, and a mobile overhead for procedure rooms. Always verify power/plug standards and bring step-down transformers where needed. For remote observation, secure low-latency streaming with a back-up local recording; align on what interpreters will translate live (commands vs. narrative) to reduce cognitive load in the viewing room. If running home-use simulations, pre-visit safety checks and post-visit device inventories reduce loss and data gaps.
Ethics and documentation workflow. Even when formal IRB is not legally required, institutional reviews are common in hospital settings. Plan a clean document set: localized protocol, risk disclosure, data-handling plan, consent, and a privacy script that explains video capture and storage. Across China, Japan, and Korea, reviewers appreciate seeing the trace from URRA → formative findings → risk controls → summative critical-task list, with localized labeling/training attached. Where summative is conducted outside the ultimate market (e.g., bridging rationales), ensure the dossier explicitly compares user profiles, environments, labeling differences, and shows why residual risk remains acceptable.
Moderator
Event Type
Discussion Panel
TimeTuesday, March 243:30pm - 4:30pm EDT
LocationGramercy
Medical and Drug Delivery Devices