Formative and summative evaluations with Chinese healthcare professionals and patients — designed in line with FDA human factors guidance, IEC 62366-1, and NMPA usability expectations.
Global regulatory consultancies write the strategy; someone still has to run the study — recruit the nurses and physicians, build the simulated-use environment, moderate in Mandarin, document use errors, and deliver a report your regulatory team can use. That on-the-ground execution in China is what XplusX does.
Three reasons bring device manufacturers to us. First, the China market itself: devices registered in China face growing usability-engineering expectations from NMPA, and use-related risk evidence should involve Chinese users, use environments, and labeling in Chinese. Second, development speed: China offers fast access to large pools of healthcare professionals and patients for formative work, at fieldwork costs generally below the US and Western Europe. Third, multi-market programs: manufacturers increasingly validate across the US, Europe, Japan, and China with one coordinated protocol — we run the China arm and coordinate with human factors partners across the ReSight Global network for the rest.
FDA expects human factors validation under its guidance Applying Human Factors and Usability Engineering to Medical Devices, with participants representative of the intended US population — so US submissions normally need US summative data; China-based work supports formative stages and global risk analysis. IEC 62366-1 defines the usability engineering process internationally. NMPA has been strengthening human factors requirements for China registration — the Chinese standard YY/T 1474 mirrors IEC 62366, and human factors design review guidance means manufacturers should be ready to show usability evidence for the Chinese market. We design each study so the evidence lands where your submission needs it.
Formative evaluations — early usability studies on prototypes, instructions for use, and labeling; use-error and close-call documentation; iterative rounds during development. Summative (validation) evaluations — simulated-use studies with representative Chinese users, critical-task analysis, root-cause interviews, and reporting structured for regulatory review. Contextual research — ethnographic studies in hospitals, clinics, and homes to understand real use environments, workflows, and off-label workarounds before requirements are frozen.
Devices we have tested include infusion systems (LVP, syringe pumps, infusion workstations), ventilators, CT equipment, patient monitors, insulin pens, and digital therapeutics. See our infusion pump summative evaluation and amblyopia digital treatment study case studies.
Human factors studies live or die on recruitment. We recruit Chinese physicians by specialty, nurses by department and seniority, pharmacists, technicians, and lay users including patients with specific conditions and their caregivers — through hospital relationships and clinical channels built over years. Consent, recording, and data handling follow China's PIPL data protection law, with raw data kept in China and anonymized findings delivered internationally when required.
You get a bilingual team: study design and moderation in Mandarin, documentation and reporting in English, with your human factors or regulatory consultants looped in as observers via live streaming or interpreted sessions. We can execute your existing protocol, adapt it for Chinese users and environments, or design the study from your use-related risk analysis.
XplusX is a Shanghai-based human factors and UX research team founded in 2019, part of the ReSight Global network with human factors partners in the United States, Germany, and Japan. Learn more about our healthcare research or about the team.