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Background: Investing in late-stage clinical trials, trial sites, and production capacity for new health products could improve access to vaccines, therapeutics, and infectious disease diagnostics in middle-income countries. This study assesses the case for such investment in three of these countries: India, Kenya, and South Africa., Methods: We applied investment case modelling and assessed how many cases, deaths, and disability-adjusted life years (DALYs) could be averted from the development and manufacturing of new technologies (therapeutics and vaccines) in these countries from 2021 to 2036, for five diseases-HIV, tuberculosis, malaria, pneumonia, and diarrhoeal diseases. We also estimated the economic benefits that might accrue from making these investments and we developed benefit-cost ratios for each of the three middle-income countries. Our modelling applies two investment case perspectives: a societal perspective with all costs and benefits measured at the societal level, and a country perspective to estimate how much health and economic benefit accrues to each middle-income country for every dollar invested in clinical trials and manufacturing by the middle-income country government. For each perspective, we modelled two scenarios: one that considers only domestic health and economic benefits; and one that includes regional health and economic benefits. In the regional scenarios, we assumed that new products developed and manufactured in India would benefit eight countries in south Asia, whereas new products developed and manufactured in Kenya would benefit all 21 countries in the Common Market for Eastern and Southern Africa (COMESA). We also assumed that all 16 countries in the Southern African Development Community (SADC) would benefit from products developed and manufactured in South Africa., Findings: From 2021 to 2036, product development and manufacturing in Kenya could avert 4·44 million deaths and 206·27 million DALYs in the COMESA region. In South Africa, it could prevent 5·19 million deaths and 253·83 million DALYs in the SADC region. In India, it could avert 9·76 million deaths and 374·42 million DALYs in south Asia. Economic returns would be especially high if new tools were produced for regional markets rather than for domestic markets only. Under a societal perspective, regional returns outweigh investments by a factor of 20·51 in Kenya, 33·27 in South Africa, and 66·56 in India. Under a country perspective, the regional benefit-cost ratios amount to 60·71 in India, 8·78 in Kenya, and 11·88 in South Africa., Interpretation: Our study supports the creation of regional hubs for clinical trials and product manufacturing compared with narrow national efforts., Funding: Bill & Melinda Gates Foundation., Competing Interests: Declaration of interests All authors report grants from the Bill & Melinda Gates Foundation during the conduct of the study. RK also serves as chairman of the steering committee of the Coalition for Health Research & Development, a policy and advocacy coalition that is funded by the Bill & Melinda Gates Foundation. This is a voluntary position that does not have any direct renumeration., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Obstetric hemorrhage (OH), which includes hemorrhage from multiple etiologies during pregnancy, childbirth, or postpartum, is the leading cause of maternal mortality and accounts for one-quarter of global maternal deaths. The Non-pneumatic Anti-Shock Garment (NASG) is a first-aid device for obstetric hemorrhage that can be applied for post-partum/post miscarriage and for ectopic pregnancies to buy time for a woman to reach a health care facility for definitive treatment. Despite successful field trials, and endorsement by safe motherhood organizations and the World Health Organization (WHO), scale-up has been slow in some countries. This qualitative study explores contextual factors affecting uptake., Methods: From March 2013 to April 2013, we conducted 13 key informant interviews across four countries with a large burden of maternal mortality that had achieved varying success in scaling up the NASG: Ethiopia, India, Nigeria, and Zimbabwe. These key informants were health providers or program specialists working with the NASG. We applied a health policy analysis framework to organize the results. The framework has five domains: attributes of the intervention, attributes of the implementers, delivery strategy, attributes of the adopting community, the socio-political context, and the research context., Results: The interviews from our study found that relevant facilitators for scale-up are the simplicity of the device, local and international champions, well-developed training sessions, recommendations by WHO and the International Federation of Gynecology and Obstetrics, and dissemination of NASG clinical trial results. Barriers to scaling up the NASG included limited health infrastructure, relatively high upfront cost of the NASG, initial resistance by providers and policy makers, lack of in-country champions or policy makers advocating for NASG implementation, inadequate return and exchange programs, and lack of political will., Conclusions: There was a continuum of uptake ranging in both speed and scale. Ethiopia while not the first country to use the NASG has the most rapid scale-up, followed by Nigeria, then India, and finally Zimbabwe. Increasing the coverage of the NASG will require collaboration with local NASG champions, greater NASG awareness among clinicians and policymakers, as well as stronger political will and advocacy.