Introduction
Medical device procurement is not just a process, but a pivotal step in the development of healthcare infrastructure. It plays a crucial role in ensuring access to essential diagnostic, therapeutic, and monitoring tools for patient care. The range of equipment is extensive, spanning from diagnostic imaging systems to surgical instruments, patient monitors, and laboratory devices. The procurement process, which encompasses needs assessment, budgeting, vendor selection, contract negotiation, purchasing, installation, and maintenance, is a complex and vital component of health technology management.
What is medical device procurement?
The UNOPS procurement manual defines procurement as: “the acquisition of property, plant and/or equipment, goods, works or services through purchase, hire, lease, rental or exchange”, including “all actions from planning and forecasting, identification of needs, sourcing and solicitation of offers, evaluation of offers, review and award of contracts, contracting and all phases of contract administration until delivery of the goods, the end of a contract, or the useful life of an asset.”1
Technology incorporation refers to procurement processes that include installation and commissioning 2.
The Organisation for Economic Co-operation and Development (OECD) have observed that four “pillars” are required for a good procurement system 3:
- Legislative framework
- Integrity and transparency
- Institutional and management capacity
- Operations and markets.
Bailey 4 further delineates the factors contributing to a well-functioning public procurement system as the “five rights”:
- the right product or service
- of the right quality
- and right price,
- and the right quantity,
- at the right place and time.
Benefits of well-designed procurement practices
The WHO recommends implementing health technology procurement practices *“where all stakeholders involved enjoy benefits including:
- Procurement staff gain by carrying out clear and accountable work done to internationally accepted standards;
- Funding agencies can have confidence in the right goods being procured at the right price;
- Health service professionals gain quality materials and tools;
- Most importantly, patients can receive appropriate and effective healthcare treatment.”*5
Additionally, manufacturers and suppliers are more willing to engage with organisations with good procurement processes, improving market competition and access to a broader range of technologies.
The medical device procurement process
From initial health technology assessment to ongoing lifecycle management, each step in the procurement process plays a crucial role in facilitating the seamless integration of devices into healthcare facilities.
A detailed description of the procurement process can be found here.
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
- ISO/CD TS 5137 - Medical device maintenance management for healthcare delivery organizations
- ISO 7101:2023 - Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
- Managing medical devices. London: Medicines and Healthcare Products Regulatory Agency; 2015. Medical Device Act (Act 737)
- 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
Commissioning: The process of ensuring that a device is properly installed, tested, and verified for safe and effective use in a clinical setting.
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.
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.
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.
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.