Abstract:Several barriers challenge development, adoption and scale-up of diagnostics in low and middle income countries. An innovative global health discussion platform allows capturing insights from the global health community on factors driving demand and supply for diagnostics. We conducted a qualitative content analysis of the online discussion ‘Advancing Care Delivery: Driving Demand and Supply of Diagnostics’ organised by the Global Health Delivery Project (GHD) (http://www.ghdonline.org/) at Harvard University.… Show more
“…Given that elements such as manufacturability, cost, distribution and product support greatly affect success, it is vital at this stage to consult delivery stakeholders (manufacturers if different from developer, procurers and distributors) to create realistic TPPs that are well aligned with the real implementation and scale-up needs 6. For example, challenges around affordability might require developers to explore technologies and formats with very low manufacturing costs in order to deliver the required product performance at significantly lower prices.…”
Section: Product Feasibility Definition and Planningmentioning
confidence: 99%
“…During the design process, the developer identifies an optimal product design that closely meets the desired performance specifications. End users and other stakeholders can provide valuable feedback on the prototype instrument in order to refine its design 6 24. In some cases, the relative importance of different features may need to be reassessed and used to make decisions on product design priorities.…”
Section: Design Development and Transfer To Manufacturingmentioning
confidence: 99%
“…Diagnostics developers from high-income countries (HICs) often struggle with identifying and assessing end-user needs, navigating policy and regulatory requirements, developing pricing strategies, ascertaining funding mechanisms and implementing and supporting products in healthcare systems with limited infrastructure 4 5. A structured approach to product development that creates more clarity around the types of activities required in low- and middle-income countries (LMICs) could help developers better navigate these challenges 6…”
Diagnostics developers often face challenges introducing in-vitro diagnostic (IVD) products to low- and middle-income countries (LMICs) because of difficulty in accessing robust market data, navigating policy and regulatory requirements and implementing and supporting products in healthcare systems with limited infrastructure. Best practices recommend the use of a phase-gate model with defined activities and milestones by phase to successfully move a product from concept to commercialisation. While activities for commercialisation of products in high-income countries (HICs) are well understood, the activities required for introduction of IVDs in LMICs are not. In this paper, we identify the key activities needed for IVD product development and implementation and map them to the various phases of the model, paying particular attention to those activities that might be conducted differently in LMICs.
“…Given that elements such as manufacturability, cost, distribution and product support greatly affect success, it is vital at this stage to consult delivery stakeholders (manufacturers if different from developer, procurers and distributors) to create realistic TPPs that are well aligned with the real implementation and scale-up needs 6. For example, challenges around affordability might require developers to explore technologies and formats with very low manufacturing costs in order to deliver the required product performance at significantly lower prices.…”
Section: Product Feasibility Definition and Planningmentioning
confidence: 99%
“…During the design process, the developer identifies an optimal product design that closely meets the desired performance specifications. End users and other stakeholders can provide valuable feedback on the prototype instrument in order to refine its design 6 24. In some cases, the relative importance of different features may need to be reassessed and used to make decisions on product design priorities.…”
Section: Design Development and Transfer To Manufacturingmentioning
confidence: 99%
“…Diagnostics developers from high-income countries (HICs) often struggle with identifying and assessing end-user needs, navigating policy and regulatory requirements, developing pricing strategies, ascertaining funding mechanisms and implementing and supporting products in healthcare systems with limited infrastructure 4 5. A structured approach to product development that creates more clarity around the types of activities required in low- and middle-income countries (LMICs) could help developers better navigate these challenges 6…”
Diagnostics developers often face challenges introducing in-vitro diagnostic (IVD) products to low- and middle-income countries (LMICs) because of difficulty in accessing robust market data, navigating policy and regulatory requirements and implementing and supporting products in healthcare systems with limited infrastructure. Best practices recommend the use of a phase-gate model with defined activities and milestones by phase to successfully move a product from concept to commercialisation. While activities for commercialisation of products in high-income countries (HICs) are well understood, the activities required for introduction of IVDs in LMICs are not. In this paper, we identify the key activities needed for IVD product development and implementation and map them to the various phases of the model, paying particular attention to those activities that might be conducted differently in LMICs.
“…Recent advances in bacteria preconcentration and the diagnosis of TB and multi-drug resistant tuberculosis (MDR-TB) include sophisticated techniques such as Xpert MTB/RIF, TB beads, liquid culture, centrifugation, filtration, and line probe assays [43][44][45][46][47]. However, these techniques are not necessarily accessible or affordable for those who need them the most [48]. Considering the high accuracy (~97%) and specificity (~99%) of the Xpert system relative to the culture standard [36], the World Health Organization issued a recommendation in 2010 to use Xpert MTB/RIF for the diagnosis of all persons with signs and symptoms of TB.…”
Section: Early Assessment Of Tuberculosis In Vulnerable Populationsmentioning
In this manuscript, we discuss relevant socioeconomic factors for developing and implementing sensor analytic point solutions (SNAPS) as point-of-care tools to serve impoverished communities. The distinct economic, environmental, cultural, and ethical paradigms that affect economically disadvantaged users add complexity to the process of technology development and deployment beyond the science and engineering issues. We begin by contextualizing the environmental burden of disease in select low-income regions around the world, including environmental hazards at work, home, and the broader community environment, where SNAPS may be helpful in the prevention and mitigation of human exposure to harmful biological vectors and chemical agents. We offer examples of SNAPS designed for economically disadvantaged users, specifically for supporting decision-making in cases of tuberculosis (TB) infection and mercury exposure. We follow-up by discussing the economic challenges that are involved in the phased implementation of diagnostic tools in low-income markets and describe a micropayment-based systems-as-a-service approach (pay-a-penny-per-use—PAPPU), which may be catalytic for the adoption of low-end, low-margin, low-research, and the development SNAPS. Finally, we provide some insights into the social and ethical considerations for the assimilation of SNAPS to improve health outcomes in marginalized communities.
“…While these immunodiagnostic technologies are relatively unsophisticated, development of sensitive and specific antibodies and antigens required for an immunoassay is often a rate-limiting step. These immunodiagnostic reagents must be sensitive, specific, robust, and most importantly, sustainable (4).…”
14There is a pressing need for sustainable and sensitive immunodiagnostics for use in public health 15 efforts to understand and combat the threat of endemic and emerging infectious diseases. We 16 describe a novel approach to immunodiagnostics based on virus-like particles (VLPs) attached to 17 magnetic beads. This flexible, innovative immunoassay system, based on the MAGPIX® 18 platform, improves sensitivity by up to 2-logs and has faster sample-to-answer time over 19 traditional methods. As a proof of concept, a retroviral-based VLP, that presents the Venezuelan 20 equine encephalitis virus E1/E2 glycoprotein antigen on its surface, was generated and coupled 21 to magnetic beads to create VLP-conjugated microspheres (VCMs). Using these VCMs, IgG and 22IgM antibodies were detectable in nonhuman primate (NHP) and human clinical serum samples 23 at dilutions of 1 × 10 4 and greater. We extended the VCM methodology to two other New-World 24 alphaviruses, eastern and western equine encephalitis viruses, as well as an Old-World 25 alphavirus, Chikungunya virus, demonstrating the flexibility of this approach toward different 26 VLP architectures. When multiplexed on the MAGPIX platform, the VCMs provided 27 differential diagnosis between Old-World and New-World alphaviruses and well as a route 28 toward assessing the humoral response to both natural infection and vaccination. This VCM 29 system will allow more rapid and efficient detection of endemic and emerging viral pathogens in 30 human populations. 31
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