Optimizing diagnostic procurement and waste management in low- and middle-income countries during emerging infectious disease threats: a scoping review

Introduction

Timely and effective procurement of diagnostic devices is crucial for strengthening healthcare systems in low- and middle-income countries (LMICs) and improving health outcomes, especially in the face of emerging infectious diseases (Adhikari et al., 2024; Okojie et al., 2024). Technological advancements such as microfluidics, lab-on-chip systems, and point-of-care (POC) diagnostics provide transformative opportunities to increase testing and surveillance access (Miller and Sikes, 2015). However, adopting these innovations in LMICs is hindered by numerous challenges, including limited financial resources, underdeveloped infrastructure, regulatory hurdles, and growing concerns about medical waste (Diaconu et al., 2017; Fortune favours the prepared, 2022; Smyth, 2024). The World Health Organization (WHO), for example, in 2022 reported that approximately 140 million COVID-19 test kits distributed through the UN portal were ultimately incinerated or landfilled, illustrating the environmental risks of misaligned procurement practices (Fortune favours the prepared, 2022). This study aims to examine the key challenges associated with diagnostic procurement and waste disposal in LMICs, while identifying practical and sustainable solutions.

While high-income countries (HICs) have made rapid strides in deploying molecular diagnostics through agile regulatory and legislative frameworks, many LMICs have relied on vertical disease control programs, particularly those targeting HIV, tuberculosis, and malaria, as platforms for diagnostic innovation (Muttamba et al., 2022). This pragmatic approach leverages existing public health infrastructure, yet LMICs remain heavily dependent on imported diagnostic equipment. This reliance introduces additional constraints, including high procurement costs driven by tariffs, shipping expenses, and currency fluctuations (Zezai et al., 2024; Zhu, 2021). In addition to formal procurement channels, donated diagnostic equipment represents a significant share of medical devices in many LMICs. However, such donations often consist of outdated or incompatible devices that are ultimately discarded due to a lack of reagents, inadequate support, or obsolete technology (Davis et al., 2022; Diaconu et al., 2017; Duwiejua et al., 2025).

Procurement inefficiencies in LMICs are further exacerbated by the absence of centralized systems capable of accurate demand forecasting and coordinated purchasing (Duwiejua et al., 2025). As a result, many LMICs experience inconsistent access to essential diagnostic tools (Kelly-Cirino et al., 2019), while fragmented procurement pathways often lead to surplus stock, underutilization, or premature disposal, amplifying the burden of medical waste (Fortune favours the prepared, 2022; Smyth, 2024). Operational challenges such as insufficient training, poor maintenance knowledge, lack of spare parts, and irregular supply of reagents further hinder the functionality and sustainability of diagnostic devices (Diaconu et al., 2017; Kebede, 2021; Smyth, 2024). Strategies such as pooled procurement, donor-funded programs, public-private partnerships, and local manufacturing are being explored to reduce costs and strengthen supply chain resilience (Muttamba et al., 2022; Zhu, 2021). Concurrently, regulatory efforts, including WHO-led prequalification programs, are helping ensure that diagnostic tools meet international standards for safety, quality, and waste minimization (Kelly-Cirino et al., 2019; Yimer et al., 2024).

As future pandemics remain an ongoing threat, robust diagnostic systems must form a cornerstone of national preparedness and response plans. This is particularly urgent in LMICs, where fragmented procurement, limited resources, and logistical barriers threaten the scalability and effectiveness of diagnostic deployment (Kelly-Cirino et al., 2019; Kumar et al., 2024). Addressing these systemic challenges will require coordinated efforts to improve procurement governance, streamline supply chains, expand local manufacturing, and align diagnostic investments with sustainable development goals (Ongesa et al., 2025). This review, therefore, aims to explore innovative strategies for optimizing diagnostic device procurement in LMICs, with a focus on enhancing pandemic preparedness, increasing access to timely diagnostics, and minimizing environmental waste.

Methodology

To investigate the dynamics of diagnostic procurement in the context of emerging infectious diseases in low- and middle-income countries (LMICs), we performed a scoping search of the PubMed database, and other search sites like DOAJ (Directory of Open Access Journals, https://doaj.org), and Web of Science using the optimized query: “(((procurement) AND diagnostic devices) AND ((low and middle-income countries))) AND emerging infectious diseases” from January 2015 to August 2025. This yielded 275 relevant articles, of which 49 were selected for the study. The search strategy was collaboratively developed and refined with the Molecular Diagnostic Research Group (MDRG). Article screening and final selection followed a structured, multi-reviewer process to ensure methodological rigor and consistency. The forthcoming article synthesizes key challenges and proposes actionable pathways for more sustainable diagnostic procurement models, particularly during outbreak scenarios, where urgency often compromises environmental considerations.

Initial screening was primarily conducted by reviewing the titles of the papers, followed by the abstracts and discussion sections of each article, using the following inclusion and exclusion criteria. To ensure the relevance and scientific rigor of the articles included in this review, a set of clearly defined inclusion and exclusion criteria was applied during the screening and selection process.

Inclusion criteria: articles were included if they met one or more of the following criteria

• Reported on key stakeholders involved in the procurement of diagnostic devices in low- and middle-income countries (LMICs), particularly during public health emergencies or disease outbreaks.
• Described medical or diagnostic devices procured in LMICs in the context of infectious disease threats or emergency response.
• Identified systemic gaps, barriers, or challenges in the procurement process for diagnostic devices in LMICs.
• Provided evidence-based insights or case studies on improved practices, strategic management, or sustainable procurement of diagnostic devices in LMIC settings.
• Addressed regulatory frameworks, quality assurance, safety protocols, or standardization procedures relevant to the procurement of diagnostic technologies.
• Included discussions on the post-use handling, disposal, or waste management of diagnostic devices in LMICs, with emphasis on environmental and public health implications.

Exclusion criteria: articles were excluded from the review if they

• Focused exclusively on the procurement of diagnostic or medical devices in high-income countries.
• Did not explicitly relate to the procurement of diagnostic devices in the context of infectious disease threats, public health emergencies, or LMIC-specific scenarios.

Results

All the included articles in this scoping review presented evidence of at least an aspect of device procurement in LMICs. Our search strategy involved keywords, and a total of 275 papers were returned, of which 49 were selected for the study, as shown in Figure 1 below.

Bridging the diagnostic gap for emerging diseases in LMICs: a strategic imperative

Accurate and timely diagnostics are the cornerstone of effective outbreak containment, especially for priority pathogens with high epidemic potential such as Ebola, Zika, Yellow Fever, and SARS-CoV-2 (Kelly-Cirino et al., 2019; Polgreen and Polgreen, 2017; Possas et al., 2020; Zhu, 2021). However, low- and middle-income countries (LMICs) face persistent and multifaceted challenges in diagnostic preparedness (Diaconu et al., 2016). These include fragmented and unpredictable funding mechanisms, bureaucratic procurement processes, constrained access to specimens and reagents, insufficient testing capacity at both national and community levels, and a lack of commercial incentives for diagnostic development outside of outbreak periods (Diaconu et al., 2017; Kelly-Cirino et al., 2019; Nsanzimana et al., 2022).

In LMICs, the epidemiological landscape is characterized by volatility and rapid shifts in disease burden, necessitating a transformation in diagnostic strategy from generalized, broad-spectrum approaches to agile, pathogen-specific solutions that can be rapidly deployed in the face of emerging threats (Emperador et al., 2020; Pandemic Prevention, 2025; Polgreen and Polgreen, 2016). Such a shift is critical for enabling swift identification of infectious agents, curtailing transmission, and minimizing morbidity and mortality, particularly in resource-limited and decentralized healthcare settings. Building on this need, industries have adopted specialized risk frameworks, such as ISO 35001:2019 for biorisk management, which provide structured tools to identify, evaluate, control, and monitor risks associated with hazardous biological materials (Callihan et al., 2021).

In May 2025, all 194 Member States of the World Health Organization (WHO) reached a historic consensus to initiate the drafting and negotiation of a legally binding convention, agreement, or other international instrument under the WHO Constitution (Pandemic Prevention, 2025). This decision was aimed at strengthening global capacities for pandemic prevention, preparedness, and response (Pandemic Prevention, 2025). The profound global disruption caused by the COVID-19 pandemic, including the significant loss of human life, the breakdown of societal systems, and widespread economic hardship, served as a critical catalyst for this collective action (Zezai et al., 2024). Governments around the world recognized the urgent need for sustained and coordinated efforts to mitigate the risk of future pandemics and prevent a recurrence of such a catastrophic event (Pandemic Prevention, 2025).

A central tenet of the proposed agreement is the principle of equity, particularly in ensuring timely and universal access to essential pandemic-related tools and resources (Pandemic Prevention, 2025). These include, but are not limited to, vaccines, diagnostics, personal protective equipment, information sharing mechanisms, technological capabilities, and healthcare services (Pandemic Prevention, 2025). Equitable access is not only a moral imperative but a practical necessity for effective global health security. This commitment is further underscored by the persistent threat posed by emerging and re-emerging pathogens, many of which continue to challenge global health stability (Polgreen and Polgreen, 2016). A summary of key microbial threats of concern updated by WHO 2024, on the list of emerging pathogens for potential future pandemic, could be found on (Ukoaka, 2024).

To close the diagnostics gap and strengthen outbreak responsiveness, coordinated action is required across multiple stakeholders, including governments, international organizations, academia, and the private sector (Possas et al., 2020). A holistic, systems-based approach that aligns diagnostic procurement, waste management, and development with real-time epidemiological intelligence is essential. By integrating innovation with strategic investment and policy reform, LMICs can enhance diagnostic equity, resilience, and public health security, ultimately transforming vulnerability into preparedness.

Stakeholder engagement in sustainable diagnostic procurement during disease outbreaks

The identification and strategic engagement of stakeholders is fundamental to ensuring the sustainable procurement, distribution, and availability of diagnostic devices during emergent disease outbreaks (Kelly-Cirino et al., 2019; Ongesa et al., 2025). Stakeholders operate across local, national, and international levels, encompassing governmental bodies, non-governmental organizations, private sector entities, healthcare facilities, and civil society (Ongesa et al., 2025; Pereno and Eriksson, 2020). Their coordinated involvement is critical to building resilient diagnostic supply chains that are responsive under crisis conditions.

A design-driven approach to procurement, one that emphasizes stakeholder collaboration, data sharing, and context-specific innovation, can redefine traditional roles and responsibilities, fostering more adaptive and efficient systems for the deployment of diagnostics during emergencies (Muttamba et al., 2022; Odiase et al., 2024). This approach not only enhances accessibility and distribution but also contributes to minimizing resource wastage by aligning procurement practices with real-time needs and capacities (Pereno and Eriksson, 2020). For example, the global vaccine market is broadly segmented into four categories: Gavi (the Global Alliance for Vaccines and Immunization), UNICEF, the PAHO Revolving Fund (RF), and the Rest of the World (ROW) (Possas et al., 2020). Gavi supports vaccine financing for approximately 70% of low- and middle-income countries (LMICs), with UNICEF serving as the primary procurement agency for these nations (Possas et al., 2020). The PAHO RF facilitates pooled procurement and financial support for around 40 countries and territories in the Americas (Possas et al., 2020). In contrast, the ROW comprises countries across all income levels that primarily self-finance and self-procure vaccines, receiving limited, often indirect, support through market shaping, procurement, or financing mechanisms (Possas et al., 2020).

At the international level, the World Health Organization (WHO) plays a pivotal role in outbreak preparedness and response (Pandemic Prevention, 2025). In line with its constitutional mandate, the WHO has championed global efforts toward pandemic readiness (Pandemic Prevention, 2025). Notably, member states have reached a consensus to establish an intergovernmental negotiating body tasked with drafting a legally binding instrument for pandemic preparedness and response (Pandemic Prevention, 2025). This initiative aims to strengthen international cooperation, particularly in the equitable development and distribution of critical medical countermeasures such as vaccines and, by extension, diagnostic technologies (Daems and Maes, 2022). The major stakeholders are listed in the chart below, Figure 2.

Medical/diagnostic devices procured in LMICs in cases of emergencies, a waste minimization model

The procurement of diagnostic devices in LMICs during emergencies presents unique challenges based on the difficulties faced by most of these countries. An appropriate procurement process is therefore crucial, especially in cases of disease threats (Fortune favours the prepared, 2022). Figure 3 below summarizes a sustainable waste minimization approach model for the procurement of diagnostic devices (De Maria et al., 2022; Diaconu et al., 2017; Ensuring Procurement Activities Best Serve Your Institution, 2021; Fortune favours the prepared, 2022; Yimer et al., 2024).

Challenges and gaps in the procurement of diagnostic devices in the LMICs in cases of emergencies

Effective procurement of diagnostic devices is critical during disease threats or emergencies, especially in LMICs where resources and supply chains are limited (Kelly-Cirino et al., 2019; Miller and Sikes, 2015). Identifying gaps in procurement, understanding procurement priorities, and assessing the strengths and weaknesses of procurement leaders and their teams will help map procurement procedures, align training to meet future skill needs, and identify key stakeholders, particularly during crises. Some of the constraints faced by LMICs include: Financial constraints: Limited national budget, reliance on donor funding, which can be inconsistent or tied to specific diseases, high acquisition cost, and high competition with HICs for limited supplies, especially during a crisis like the case of COVID-19 (Davis et al., 2022; Diaconu et al., 2017; Hanson et al., 2022; Muttamba et al., 2022). Rapid technological changes and inappropriate devices and specifications: Devices designed for HIC settings require stable electricity, specific consumables, and a controlled environment (Davis et al., 2022; Diaconu et al., 2017). In the early stages, there is often an absence of harmonized regulation oversight, which leads to the proliferation of “backyard” manufacturers. This results in the availability of inexpensive and sub-optimal products in the market (Miller and Sikes, 2015).

Other constrain include, lack of formal education pathways/training: Devices designed for HICs require advanced technical skills, and outdated training, lack of clear guidelines or criteria for device selection based on local needs and context, lack of maintenance technicians, insufficient training for end users (lab staff and clinicians) (Diaconu et al., 2017; Ensuring Procurement Activities Best Serve Your Institution, 2021; Pigoga et al., 2020). Poor communication, logistic issues, and supply chain: unreliable electricity and water supply, fragmented procurement system (centralized vs. decentralized), lack of robust distribution networks, especially to remote areas, poor inventory management and forecasting, changes or challenges in sourcing spare parts and consumables (Diaconu et al., 2017; Kumar et al., 2024). During the COVID-19 pandemic, nearly half of the facilities in LMICs experienced shortages of POC tests due to inadequate communication and procurement systems (Pigoga et al., 2020).

Finally, the lack of appropriate infrastructure and human resources: The devices procured should be adaptable to the structure, availability of consistent electricity, especially in remote communities, and the appropriate human resources should be available to ensure the sustainability of the device (Bressan et al., 2022; De Maria et al., 2022; Diaconu et al., 2017; Kruk et al., 2018; Muttamba et al., 2022). Prioritizing appropriate technologies that are suitable for the local context, while ensuring the usage, maintenance requirements, and compatibility with existing infrastructure are essential (Barasa et al., 2021; Davis et al., 2022; Diaconu et al., 2017), and Market failure: limited local manufacturing capacity, leading to import reliance, lack of market data and transparency, unorganized demand, and fragmented purchasing, manufacturers prioritizing HIC markets due to higher profit margins (Miller and Sikes, 2015).

Improvement, management, and proper procurement of diagnostic devices in LMICs

Needs assessment and prioritization of devices based on local disease burden, public health priorities, and clinical needs are important factors to reduce total cost and waste by selecting devices that match available infrastructure, human resources, and maintenance, such as POC diagnostics (Bressan et al., 2022; De Maria et al., 2022; Diaconu et al., 2017; Fortune favours the prepared, 2022; Hanson et al., 2022). Solving sustainability and over-reliance on donor support by including end users in the design and developmental processes of diagnostic devices could be a good way forward (Diaconu et al., 2017; Engel et al., 2016). Stakeholder engagement involving everyone in the decision-making process, from clinicians to laboratory technicians, biomedical engineers, procurement specialists, and policymakers, is important (Diaconu et al., 2017; Pereno and Eriksson, 2020). Regulatory preparedness is also a major issue in many LMICs as they lack the regulatory frameworks necessary to approve medical products swiftly during public health emergencies, and this has hampered the timely access to critical medical products during crises (De Maria et al., 2022; Kumar et al., 2024). Streamlining bureaucratic procurement processes during pandemics strengthened regulatory preparedness (Nsanzimana et al., 2022).

Greater efficiency in the delivery of quality goods and services could assist with product innovation by advocating for a long-term service agreement with manufacturers while ensuring the production of new, adaptable, and environmentally friendly devices (Ampofo et al., 2012; De Maria et al., 2022; Engel et al., 2016; Ghodake et al., 2021). Mitigating supplier risk by combating counterfeit products, developing local expertise for repair and maintenance, promoting responsible donations that align with the country’s needs and sustainability, and engaging with diagnostic developers to promote products suitable for LMICs are equally important (Barasa et al., 2021; Callihan et al., 2021; Daems and Maes, 2022). Finally, enhancing the supply chain by optimizing procurement methods, increasing transparency and competitive bidding, managing the supply chain effectively, deploying robust inventory systems, improving forecasting and logistics, promoting sustainable partnerships, expanding the number of laboratories, and establishing mobile testing units could improve and ensure proper usage of diagnostic devices (Kumar et al., 2024; Luo and Liao, 2022; Muttamba et al., 2022; Simen-Kapeu et al., 2021).

Regulations, quality control, assurance, and safety procedures in procuring diagnostic devices

Reducing waste from diagnostic devices in LMICs, where regulatory structures, quality control and assurance teams, and effective waste management and safety systems are often limited, is a significant concern. To minimize waste while ensuring that procured devices are adaptable, necessary, and useful, it is essential to integrate these considerations into the procurement process.

Firstly, strengthening regulatory frameworks and policies is critical in minimizing waste and ensuring appropriate procurement practices (Engel et al., 2016; Fortune favours the prepared, 2022). Complementing this, the development and enforcement of national, regional, and local healthcare waste and electrical (E-waste) management legislations in LMICs that align with international agreements such as the Basel Convention is equally important ¹ . Adherence to such conventions supports more efficient and effective procurement of diagnostic devices in LMICs, particularly during disease threats.

In addition, LMICs should implement robust monitoring and oversight systems for diagnostic devices across e-waste sites and healthcare facilities to ensure compliance (Kitney et al., 2021). Emerging technologies such as blockchain offer promising solutions by enabling secure traceability, enhancing data security, supporting regulatory enforcement, and facilitating information-sharing frameworks (Kitney et al., 2021).

Finally, extended producer responsibilities should be encouraged, requiring manufacturers that supply diagnostic devices to LMICs to take responsibility and accountability for the entire lifecycle of their products, including end-of-life management (Diaconu et al., 2017).

Waste management of diagnostic devices in LMICs

Waste management of diagnostic devices in LMICs presents significant challenges due to the confluence of different factors, including limited resources, inadequate infrastructure, and a surge in diagnostic testing, and the improper disposal of these devices poses serious threats to human health and the environment (Bressan et al., 2022; Fortune favours the prepared, 2022). Some of the main challenges affecting waste management of diagnostic devices in LMICs include, and are not limited to, Lack of infrastructure, increased volume of waste, inadequate segregation of waste, donated equipment challenge, Regulatory gaps and enforcement, and occupational and public health risk (Bressan et al., 2022; Giakoumakis et al., 2021; Luo and Liao, 2022). For example, in Ethiopia, the wastage rate of laboratory commodities due to expiration and damage per year for 16 selected laboratories was 12.94%, which, in terms of value, was $37,488.78, as reported by Boche and collaborators (Boche et al., 2022). Therefore, waste management is an important process that needs to be incorporated into decision-making when procuring a diagnostic device, especially in LMICs. Ensuring the proper management and minimization of diagnostic-related waste requires a combination of waste-prevention strategies, innovative solutions (Figure 4), and the adoption of best practices. These approaches include, but are not limited to, the following:

First, waste minimization and green procurement play a central role. Sustainable procurement practices help reduce waste accumulation by prioritizing devices with minimal packaging and those made from environmentally friendly materials (Bressan et al., 2022). Embedding circular economy principles into device design, ensuring longevity, reusability, refurbishment, and eventual recycling, is equally critical.

Second, environmentally sound treatment and disposal are essential to preventing environmental contamination. Establishing centralized biomedical waste treatment facilities at regional and national levels, equipped with advanced technologies such as gasification, pyrolysis, or plasma arc systems, can significantly improve waste handling (Fortune favours the prepared, 2022). Promoting non-incineration technologies, including autoclaving, microwaving, and chemical treatment, further reduces hazardous emissions (Giakoumakis et al., 2021). Proper disposal of ash and other residues from treated waste is also vital for minimizing ecological harm.

Third, improved waste segregation and collection strengthen overall waste management. Training and awareness programs on proper waste handling and segregation ensure safer treatment processes (Bressan et al., 2022; Giakoumakis et al., 2021). Establishing secure collection points and appropriate storage facilities helps prevent accidents and scavenging (Fortune favours the prepared, 2022; Luo and Liao, 2022). Clear categorization of waste into hazardous and non-hazardous streams is an indispensable part of this system (Giakoumakis et al., 2021).

Fourth, leveraging technology and innovation offers opportunities to increase efficiency and reduce environmental impact. This includes developing new materials and assays, optimizing instrumentation, and implementing smart waste management systems that use modern technologies, such as sensors and GPS-enabled vehicles, to streamline waste collection routes (Anahtar et al., 2021; Giakoumakis et al., 2021; Ongesa et al., 2025).

Finally, international collaboration and support are crucial, particularly for LMICs. Capacity building through technical assistance and training helps strengthen local waste management systems (Kumar et al., 2024). Financial support and resource mobilization facilitate investments in appropriate infrastructure and technologies (Fortune favours the prepared, 2022; Kitney et al., 2021). Additionally, knowledge sharing, through exchanging successful strategies and innovative solutions across organizations and countries, enhances global learning and adoption of best practices (Anahtar et al., 2021).

Discussion

Accurate and timely diagnostics are crucial for effectively controlling infectious disease outbreaks, especially those caused by high-risk pathogens with significant epidemic potential, such as Ebola, Zika, Yellow Fever, and SARS-CoV-2 (Kelly-Cirino et al., 2019; Polgreen and Polgreen, 2016). However, as shown during recent global health crises, low- and middle-income countries (LMICs) continue to face serious challenges in diagnostic readiness and response (Ramírez Varela et al., 2023). These challenges include systemic issues related to procurement, infrastructure, market constraints, training, regulatory systems, and waste management (Ramírez Varela et al., 2023). Solving these interconnected problems requires not only technical fixes but also coordinated global efforts focused on equity and sustainability.

The ongoing fragility of diagnostic systems in LMICs results from fragmented funding, bureaucratic delays, and limited commercial incentives to develop or distribute diagnostics during inter-epidemic periods (Ramírez Varela et al., 2023). Additionally, supply chains remain fragile, and healthcare facilities, especially those in decentralized and rural areas, often lack the necessary infrastructure and personnel to support the effective deployment of diagnostics (Zezai et al., 2024). These problems were exacerbated during the COVID-19 pandemic, when delays in point-of-care test availability in LMICs significantly hindered outbreak control efforts (ElAteek et al., 2021).

The rapidly changing epidemiological landscape in many LMICs calls for a strategic overhaul in diagnostic planning, shifting from broad, generalist models to nimble, pathogen-specific approaches that can be quickly deployed (ElAteek et al., 2021). Risk frameworks, such as ISO 35001:2019, provide useful guidance for managing biological hazards; however, implementing these tools in resource-limited settings remains inconsistent (Callihan et al., 2021). Therefore, strengthening diagnostic systems in LMICs requires a system-wide transformation that incorporates innovation with real-time surveillance, procurement reform, and local capacity development (Muttamba et al., 2022).

The WHO-led Pandemic Prevention, Preparedness and Response (PPPR) Agreement marks a significant step towards global solidarity and coordination in pandemic response (Ramírez Varela et al., 2023; “Updated WHO list of emerging pathogens for a potential future pandemic,” 2024). Its emphasis on equity, particularly in the timely and fair distribution of diagnostics, vaccines, and protective equipment, reflects a long-overdue recognition of the practical and moral imperatives of inclusive global health security (Odiase et al., 2024). However, operationalizing equity will demand sustained investment and the active engagement of a wide range of stakeholders, including governments, academic institutions, civil society, and the private sector.

Stakeholder engagement is critical to overcoming procurement and supply chain bottlenecks (Ongesa et al., 2025). In LMICs, procurement processes are often hindered by a lack of regulatory oversight, unharmonized technical specifications, poor inventory systems, and challenges in forecasting demand (Muttamba et al., 2022). The absence of context-specific procurement frameworks has led to the proliferation of inappropriate diagnostic devices that are difficult to operate, maintain, or integrate into existing healthcare systems. A design-driven procurement model, emphasizing co-creation, end-user involvement, and context-specific innovation, offers a viable solution. Such models can reduce waste, enhance usability, and ensure better alignment between device capabilities and local needs.

Waste management of diagnostic devices poses another critical but often overlooked challenge. As diagnostic use surges during outbreaks, so too does the generation of biomedical and electronic waste, often in settings that lack proper disposal infrastructure or regulatory oversight (Zhu, 2021). Improper segregation, storage, and disposal practices expose healthcare workers and communities to significant environmental and health risks. Implementing green procurement principles and sustainable waste management practices is therefore imperative (Bressan et al., 2022). Prioritizing circular economic principles, such as reuse, repair, and recycling, can help minimize environmental impacts and improve the sustainability of diagnostics in LMICs.

Furthermore, a robust regulatory ecosystem is crucial for supporting rapid yet safe access to diagnostics during public health emergencies. Many LMICs lack harmonized, responsive regulatory systems capable of accelerating emergency approvals or ensuring the quality and safety of diagnostic products (Kitney et al., 2021). Strengthening regulatory preparedness must be viewed as integral to overall outbreak response, enabling both local and global actors to respond more swiftly and safely.

Ultimately, reducing the dependency of LMICs on donor-driven models of procurement is crucial for long-term sustainability (Simen-Kapeu et al., 2021). This includes supporting local manufacturing and innovation ecosystems, enabling countries to adapt and scale technologies that are appropriate for their specific contexts (Baker et al., 2022). Capacity-building efforts should also focus on workforce development, with particular attention to the training of laboratory staff, technicians, and procurement officers (Simen-Kapeu et al., 2021). Greater transparency in market dynamics, improved data systems, and international knowledge-sharing platforms will further support better forecasting, planning, and coordination.

Study limitations

This manuscript is mainly based on secondary data sources, policy documents, and academic literature, which might not reflect all real-time challenges or country-specific details. The diversity among LMICs in infrastructure, political will, and regulatory maturity could limit how widely some recommendations are applicable. Additionally, new developments after 2025, such as updates to the PPPR framework, changes in pathogen landscapes, or shifts in global health financing, might affect diagnostic priorities and preparedness strategies. Future research should include primary data from key stakeholders, including procurement officers, healthcare workers, regulators, and patients, to validate proposed frameworks and recommendations.

Conclusion

In conclusion, closing the diagnostics gap in LMICs will require multi-sectoral collaboration, political will, and systemic reform. It is not simply a matter of acquiring diagnostic tools but ensuring that these tools are accessible, sustainable, and tailored to local needs. By investing in inclusive procurement models, robust regulatory frameworks, sustainable waste management, and equitable access strategies, LMICs can shift from a posture of vulnerability to one of resilience and readiness. In doing so, the global community can take a decisive step toward achieving true pandemic preparedness, rooted in shared responsibility and mutual security.

Recommendations

Policy Reform and Investment: National governments in LMICs should prioritize investments in diagnostic infrastructure, training, and supply chains. Policies must incentivize private sector engagement in the development of context-appropriate diagnostics, even outside outbreak periods.

Stakeholder Engagement: Establish multi-sectoral platforms that include end-users, biomedical engineers, procurement officers, regulators, and policymakers to guide diagnostic device selection and deployment. Engage with international partners to facilitate equitable access to diagnostic technologies through transparent procurement and distribution mechanisms.

Regulatory Strengthening: Develop harmonized and agile regulatory frameworks that enable expedited approval of diagnostics during emergencies. Implement monitoring and post-market surveillance systems to ensure quality and safety.

Sustainable and Green Procurement: Prioritize environmentally friendly devices through green procurement frameworks, integrating circular economy principles. Encourage manufacturers to adopt extended producer responsibility (EPR) for the lifecycle of diagnostic devices.

Waste Management Infrastructure: Invest in centralized biomedical waste treatment facilities using non-incineration technologies (e.g., autoclaving, microwaving). Enhance waste segregation training and classification standards at the point of care.

International Collaboration and Knowledge Sharing: Facilitate knowledge exchange on best practices in diagnostic procurement and waste management. Strengthen international financial and technical assistance to support LMICs in building resilient diagnostic ecosystems.

Implications

The findings underscore the importance of diagnostics not only as a technical component of disease control but also as a strategic public health priority requiring cross-sectoral coordination. Strengthening diagnostic systems in LMICs has direct implications for global health security, pandemic preparedness, and the attainment of equity in healthcare delivery. A failure to address diagnostic inequity perpetuates vulnerability, delays the containment of outbreaks, and exacerbates the human and economic toll of health crises.

Furthermore, integrating waste minimization into procurement policies can significantly reduce environmental hazards, improve occupational health, and promote the sustainability of diagnostic interventions. Prioritizing innovation, capacity building, and governance reform in diagnostics will enable LMICs to transition from reactive crisis response to proactive health system resilience.

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Footnotes

Edited by: Maïwenn Kersaudy-Kerhoas, Heriot-Watt University, United Kingdom

Reviewed by: Zibusiso Ndlovu, Médecins Sans Frontières, South Africa

Getachew Tedla, Yekatit 12 Hospital Medical College, Ethiopia

Footnotes

https://www.state.gov/key-topics-office-of-environmental-quality-and-transboundary-issues/basel-convention-on-hazardous-wastes/.