Technology Evaluation Methodology: How We Assess Chinese Biomedical Technology
A documented methodology for evaluating Chinese biomedical technology with evidence-centered, transparent, and reproducible assessment criteria.
Evaluation Framework
Our technology evaluation methodology consists of five standardized phases:
Phase 1: Document Collection
Objective: Gather all available manufacturer and independent documentation.
- Request technical specifications, IFU, brochures
- Request regulatory certificates (NMPA, CE, FDA)
- Search for independent publications
- Collect clinical study reports
Output: Document inventory with source labeling
Phase 2: Evidence Classification
Objective: Classify each piece of evidence by source and verification status.
- Label manufacturer-provided information
- Assess independent verification status
- Identify evidence gaps
- Flag conflicting information
Output: Evidence classification matrix
Phase 3: Analytical Assessment
Objective: Assess the technology against four mandatory analytical dimensions.
- Local problem: What specific laboratory challenges does this technology address?
- Chinese solution scope: What does the Chinese manufacturer offer?
- Evidence boundary: What are the limits of the current evidence base?
- Local implementation gap: What is needed for practical implementation?
Output: Four-dimensional analytical assessment
Phase 4: Discrepancy Analysis
Objective: Identify and document any contradictions between sources.
- Cross-reference technical specifications across documents
- Compare manufacturer claims with independent data
- Document all discrepancies transparently
- Assess impact of discrepancies on clinical decisions
Output: Discrepancy report
Phase 5: Publication and Review
Objective: Publish findings with transparent labeling and schedule regular reviews.
- Label all claims by source
- State verification status explicitly
- Set review schedule (annually or when new evidence emerges)
- Publish evidence limitations
Output: Published evaluation with review schedule
Quality Standards
Reproducibility
- All evaluations follow the same methodology
- Evidence sources are documented for audit
- Assessment criteria are standardized
Transparency
- Manufacturer information is explicitly labeled
- Evidence limitations are documented, not hidden
- Discrepancies are published, not suppressed
Currency
- Evaluations are reviewed annually
- Evidence sources are checked for updates
- Verification statuses are updated as new data emerges
Limitations
- We do not conduct independent laboratory testing
- We rely on manufacturer-provided documentation
- Regulatory status is not independently verified
- Our evaluations are not a substitute for regulatory approval