Table 1 Assessment criteria for technologies that address postpartum hemorrhage and preeclampsia and eclampsia
From: Prioritizing investments in innovations to protect women from the leading causes of maternal death
Category | Criteria | Evaluation approach (high, medium, low)* |
|---|---|---|
Gap | Gap-filling potential for health | Evaluate what layers of the treatment continuum could most greatly reduce mortality (e.g., prevention, diagnostics, treatment), the strength of the available data, and the percentage of cases that could be managed |
Technology performance | Clinical evidence (efficacy/effectiveness) | Superior to benchmark,** similar to benchmark, inferior to benchmark |
Safety (patient/health care worker) | Superior to benchmark,** similar to benchmark, inferior to benchmark | |
Ease of use | Superior to benchmark,** similar to benchmark, inferior to benchmark | |
| Â | Usage requirements (e.g., durability, shelf life, electricity, storage temperature) | Technology has two or fewer usage requirements, technology has between three and five usage requirements, technology has greater than five usage requirements |
Enabling factors | Alignment with internationally recognized guidelines (e.g., the World Health Organization, the International Federation of Gynecology and Obstetrics, and the International Confederation of Midwives) | Technology is recommended by at least one organization, divergent opinions exist, technology is not recommended |
Donor financial support (product development or implementation) | Funding greater than US$5Â M, between US$1Â M and US$5Â M, less than US$1Â M (or no funding identified) | |
Other nonfinancial support | Placeholder for other nonfinancial supporters that may not be captured elsewhere; not scored | |
Acceptability profile | Broadly acceptable, mixed, acceptable in few geographies (South Asia and sub-Saharan Africa) | |
| Â | Organizational capabilities | All key partners have experience with the technology, a subset of key partners has experience with the technology, none of the key partners has experience with the technology |
Market analysis | Manufacturing costs | Superior to benchmark** (lower cost), similar to benchmark, inferior to benchmark (higher cost) |
Distribution system requirements (warehouse, cold chain, transportation factors) | Infrastructure for a distribution channel(s) exists and high likelihood of utilization, infrastructure for distribution channel(s) exists and moderate likelihood of utilization, distribution channel(s) does not exist or a low likelihood of utilization | |
Manufacturing plan established | Capture manufacturing information including delays, hurdles, risk, and complexity; not scored | |
Target setting (community, primary health care, hospital) | Capture setting(s) where the technology would be used; not scored | |
Target provider/administrator | Community health care worker, nurse or midwife, physician | |
Potential multiple markets (additional value to the health care system) | Additional uses identified (high), no additional uses (low) | |
Technology readiness level (clinical/regulatory development) | Regulatory or commercialization, confirmatory, discovery, or exploratory | |
Cost of clinical development | Less than US$5Â M, between US$5Â M and US$50Â M, greater than US$50Â M | |
| Â | Clarity of regulatory/clinical pathways | Class I US Food and Drug Administration (USFDA) device, class II USFDA device, class III USFDA device or requires efficacy data (e.g., drugs) |
Unique considerations | System requirements (disruption) | Low system requirements (training/infrastructure), modest system requirements, high system requirements |
Product bundling | No other technologies required for impact, likely need to bundle with one technology, likely need to bundle with two or more technologies | |
| Â | Other | Placeholder for other unique considerations; not scored |