Introduction
The procurement process, includes a comprehensive range of activities such as health technology, needs assessment, budgeting, vendor selection, contract negotiation, purchasing, installation, and maintenance. It is a complex and vital part of health technology management. A comprehensive approach ensures that every aspect of the procurement process is covered, leaving little room for oversight or error.
The procurement process
The journey begins with health technology assessment (HTA), where procurement teams identify emerging technologies that have the potential to impact healthcare. HTA is defined as “A multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner” 1.
This process involves evaluating health technologies’ efficacy, safety, cost and value, considering factors such as clinical evidence, regulatory approvals, and compatibility with existing infrastructure and processes. The collaborative efforts of procurement specialists, clinicians, biomedical engineers and administrators are not just essential, but they are the backbone of this process, ensuring a holistic evaluation that aligns with the organisation’s strategic objectives and budgetary constraints. High-quality data sources such as peer-reviewed or nationally certified assessments ensure that technology assessments can support evidence-based decision-making.
Further information on Health Technology Assessment, including sources for existing HTAs and HTA methodology.
Following technology assessment, device evaluation scrutinises the performance and usability of shortlisted technologies through pilot studies, clinical investigations, or demonstrations. This stage allows stakeholders, including frontline healthcare professionals, to gain firsthand experience with the devices, assessing user interface, interoperability, and scalability factors. Their feedback is not just valuable, but it’s also crucial in identifying potential challenges and opportunities for optimisation. This feedback guides informed decision-making regarding the selection of devices that best meet the organisation’s clinical needs and preferences, making their role in the process significant.
Market research also forms an important aspect of device evaluation. Academic institutions and other organisations conduct market landscapes and performance reviews of medical devices, which can be accessed through their websites or peer-reviewed literature.
A thorough planning and needs assessment is integral to laying the groundwork for successful technology implementation. This involves conducting a comprehensive analysis of current workflows, infrastructure requirements, and resource allocation strategies to identify gaps and prioritise areas for improvement. National health policies are often the foundation on which planning is based.
Engaging key stakeholders, including clinical staff, IT personnel, biomedical engineers, and facility managers, fosters collaboration and ensures that the procurement process aligns with the organisation’s strategic priorities, tender rules, and patient care objectives. By proactively addressing logistical challenges and establishing clear project milestones, healthcare providers can minimise disruptions and optimise the deployment of new technologies. The plan should encompass the entire acquisition cycle.
Examples of procurement plans can be found in:
How to manage series
With insights from technology assessment, device evaluation, and needs assessment, healthcare organisations proceed to the procurement phase, where contracts are negotiated and purchasing decisions are finalised. Procurement in this context is defined as ”the process of obtaining what is required by the plans”2. This process involves soliciting vendor bids, conducting competitive evaluations, and negotiating favourable terms and pricing structures.
Collaboration between procurement professionals, legal experts, and clinical stakeholders is essential to navigate complex regulatory requirements, mitigate risks, and secure optimal value for investment. The aim is to ensure the best value for the organisation, which is not necessarily the lowest price.
With procurement completed, the focus shifts to integrating health technologies within the healthcare environment.
Installation is defined as “the process of fixing equipment into place”3 but also involves related processes such as delivery and storage. Installation entails coordinating logistics, scheduling installation timelines, and ensuring compliance with regulatory standards and manufacturer specifications.
Technology integration may also include configuration or customisation of a new technology to ensure integration and interoperability with existing systems. Initial user education and training is an important aspect of technology integration, promoting adoption of new technologies with end-users.
Close collaboration between vendors, technical experts, and facility personnel is critical to minimise downtime and mitigate disruptions to clinical operations. Rigorous testing and validation processes verify the functionality and interoperability of the installed devices, laying the foundation for seamless integration into existing workflows.
Key takeaways
The procurement process for health technologies is a complex, multi-faceted journey that requires careful planning, collaboration, and execution across various stages. By leveraging a systematic approach and engaging key stakeholders, healthcare organisations can navigate the complexities of procurement and maximise the value of their investments.
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)
- Health technology assessment of medical devices, WHO medical devices technical series, 2011
- Procurement process resource guide, 2011, [Online] Available: https://www.who.int/publications/i/item/9789241501378
- M. Kaur, T. Fagerli, C. Temple-Bird, A. Lebnel, and W. Kawohl. Guide 3 How to Procure and Commission Your Healthcare Technology, ‘HOW TO MANAGE’ SERIES FOR HEALTHCARE TECHNOLOGY, 2005.
Clinical workflow: The systematic sequence of processes and tasks that healthcare professionals follow when using medical devices to ensure efficient, safe, and effective patient care.
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.
Interoperability: The ability of different systems, devices, applications, or products to connect, communicate, and work together effectively without requiring special effort by the user.
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.
Key Performance Indicators (KPIs): Measurable values that demonstrate how effectively an organisation achieves key objectives.
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.