Introduction
For low and middle-income countries (LMICs), acquiring medical devices presents unique challenges stemming from financial constraints, limited infrastructure, regulatory hurdles, and complex supply chain dynamics.
Challenges to medical device procurement in LMICs
- Limited healthcare budgets in LMICs restrict the allocation of funds for medical device procurement, leading to disparities in access to essential equipment.
- High capital costs and ongoing maintenance and consumables expenses pose significant financial barriers, making it challenging for LMICs to afford medical devices.
- Inadequate healthcare infrastructure, including an unreliable electricity supply, fragmented or low-bandwidth internet, and insufficient storage facilities, hinders the effective use of medical devices.
- A lack of skilled personnel and access to training impedes the safe and effective use of medical devices.
- Remote and rural areas often lack access to basic healthcare facilities, exacerbating disparities in medical device distribution and utilisation.
- Weak regulatory frameworks and inadequate quality assurance mechanisms in LMICs contribute to the proliferation of substandard and counterfeit medical devices, which pose risks to patient safety and efficacy.
- Limited capacity for product testing, certification, and post-market surveillance undermines confidence in the quality and reliability of procured medical devices.
- Fragmented supply chains, logistical challenges, and customs procedures impede the timely delivery of medical devices to healthcare facilities in LMICs.
- Dependence on international suppliers increases vulnerability to disruptions, such as political instability, trade barriers, and global health crises.
Opportunities to improve medical device procurement in LMICs
- Comprehensive needs assessments matched with health technology assessments aid in prioritising medical device procurement based on disease burden, healthcare priorities, and available resources.
- Developing long-term procurement plans aligned with national health policies and strategies to ensure medical devices’ equitable distribution and sustainability.
- Innovative financing models, such as public-private partnerships, leasing arrangements, and equipment donation programmes, help to overcome financial barriers to medical device procurement. Initiatives such as the Medical Equipment Modernisation Program (MEP) in Kenya demonstrate successful collaboration between government agencies, private sector stakeholders, and international donors to upgrade medical equipment infrastructure and strengthen healthcare delivery.
- Mobilising international development assistance, donor funding, and concessional financing can help support procuring medical devices necessary for implementing priority disease area interventions (such as HIV/AIDS, Tuberculosis and Malaria).
- Medical device donations of surplus or refurbished medical equipment from implementation partners and corporations can address immediate healthcare needs while promoting sustainability and capacity building. However, caution should be taken to ensure that donated equipment matches beneficiary needs and capabilities. WHO guidance on medical device donation is available.
- Investment in training programmes and capacity-building initiatives enhances the technical skills of procurement and healthcare professionals in assessing and evaluating medical devices for procurement.
- Strengthening regulatory agencies and quality control initiatives to create and enforce standards relevant to local settings and conduct product assessments to ensure conformity.
- Fostering collaborations between academic institutions, research centres, and industry stakeholders to develop indigenous solutions tailored to the healthcare needs of LMICs.
- Promoting technology transfer agreements and partnerships to facilitate the local production, assembly, and maintenance of medical devices in LMICs.
- Emerging markets including China, India, Brazil and South Africa have established local manufacturing capabilities for medical devices, enabling cost-effective production, technology transfer, and job creation while enhancing healthcare access.
- Simplifying procurement procedures, reducing bureaucratic hurdles, and streamlining customs clearance processes can expedite the acquisition and delivery of medical devices.
- Leveraging digital technologies, e-procurement platforms, and supply chain management systems improves transparency, efficiency, and accountability in the procurement process.
Conclusion
Procuring medical devices is a complex endeavour, particularly for LMICs facing resource constraints, infrastructure limitations, and regulatory challenges. However, by implementing needs-based procurement planning, innovative financing mechanisms, capacity-building initiatives, technology transfer strategies, and streamlined procurement processes, LMICs can enhance accessibility, affordability, and sustainability in medical device procurement. Collaborative efforts involving governments, international organisations, private sector partners, and civil society are essential to address the multifaceted challenges and achieve equitable healthcare access.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
- UNOPS procurement manual
- Health technology assessment of medical devices, WHO medical devices technical series, 2011
- Needs assessment for medical devices, WHO Medical device technical series, 2011
- Procurement process resource guide, WHO Medical device technical series, 2011
- Medical device donations: considerations for solicitation and provision, WHO Medical device technical series, 2011
- UNOPS procurement manual, 2020, [Online] Available: https://www.un.org/Depts/ptd/about-us/procurement-manual
- B. Wang, Strategic Health Technology Incorporation, 1 ed. (Synthesis Lectures on Biomedical Engineering), 2009.
- OECD, “Compendium of Country Examples and Lessons Learned from Applying the Methodology for Assessment of National Procurement Systems,” 2009, doi: doi:https://doi.org/10.1787/journal_dev-v9-art2-en.
- K. Bailey, Typologies and Taxonomies, Thousand Oaks, California, 1994. [Online]. Available: https://methods.sagepub.com/book/typologies-and-taxonomies. Accessed on: 2024/05/07.
- Procurement process resource guide, 2011, [Online] Available: https://www.who.int/publications/i/item/9789241501378
Capacity Building: The process of developing and enhancing the skills, abilities, and resources of individuals or organisations to improve their effectiveness and sustainability.
Healthcare Provider: An individual or organisation licensed or otherwise authorised to deliver medical, nursing, dental, or other healthcare services to patients or clients.
Health Technology: The application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives (WHO definition).
Health Technology Assessment (HTA): A systematic evaluation of the properties, effects, and impacts of health technology, such as medical interventions, pharmaceuticals or medical devices, to inform healthcare decision-making.
Health Technology Management (HTM): The systematic planning, procurement, implementation, and evaluation of medical technologies to ensure their safe, effective, and efficient use within healthcare settings.
Inventory Management: The systematic planning and control of medical supplies, devices, and equipment to ensure availability, minimise waste, and optimise resource utilisation in healthcare settings.
Lifecycle Management: The process of overseeing a product, service, or system from its initial development through its growth, maturity, and eventual decline or disposal, ensuring optimal performance and resource utilisation at each stage.
Low and Middle-Income Countries (LMICs): Countries defined based on their Gross National Income (GNI) per capita, where low-income countries have a GNI per capita below a specified threshold, and middle-income countries fall above that threshold but below the threshold for high-income countries.
Maintenance: Regular, planned actions taken to ensure that the devices remain in optimal working condition, including inspection, calibration, cleaning, and repair. Also see Preventative Maintenance and Corrective Maintenance.
Needs Assessment: A systematic process to identify and prioritise gaps or requirements in healthcare delivery that could be addressed through technological interventions.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Procurement: The process of acquiring, purchasing, or obtaining medical equipment, supplies, or technology necessary for healthcare delivery.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Stakeholder: Any individual or group with an interest or influence in the delivery, outcomes, or policies of healthcare services.
Supply Chain: Activities, processes, and entities involved in the sourcing, manufacturing, distribution, and logistics management of these devices from suppliers to end-users.
Technology Integration: The seamless incorporation of health technologies into healthcare organisations.
Total Cost of Ownership: The comprehensive sum of all expenses associated with acquiring, operating, maintaining, and eventually disposing of the device over its entire lifespan.