To address the demands of worldwide demographic and epidemiologic changes and globalization, as well as their effects on population health, the Ministry of Health in Oman developed a long-term plan for its health system called Health Vision 2050. The plan was shaped by international consultants, who sought to augment the vision with up-to-date evidence and achieve alignment with international standards. The Health Vision 2050 main document was anchored by 24 separate strategic studies covering different dimensions and pillars of the health system, one of which was the strategic study of medical equipment and healthcare technology (MEHT). This study analyzed the current status of MEHT, highlighted the achievements and bottlenecks, anticipated future challenges, and determined the future vision through pragmatic, contextualized, and actionable objectives and strategies that will provide a platform for comprehensive MEHT planning. Of note, pharmacological technologies, pharmaceutical drugs, and information technology have not been covered under the scope of this vision. By shedding light on this important strategic study about MEHT, the aim of this article is to assist other countries that are seeking to improve their MEHT based on the latest international guidelines and standards.
The provision of equitable, reliable, efficient, and cost-effective healthcare to any population requires a robust system of properly managed resources. A high standard of healthcare cannot be achieved without medical equipment and healthcare technology (MEHT), which serves as a pillar of modern healthcare. Combined knowledge of planning, engineering, management, and financial skills has become integral to the complex system of MEHT. Embracing rapid advances in technology and integrating them through the application of engineering methods and informatics are vital elements of effective healthcare delivery.1
In the delivery of healthcare, MEHT plays a vital role in, for example, disease prevention, earlier diagnosis, less invasive treatment options, and reduced hospital stays and rehabilitation times.2 Innovations in MEHT are fundamentally transforming the health-care landscape, providing new solutions to address chronic diseases and revolutionizing the way treatments are administered.
Finding the optimal mix of cost-effective interventions to meet the needs of growing populations with evolving disease burdens while staying within cost parameters and ensuring service sustainability can be a formidable challenge. Achieving this optimal mix requires adequately resourced processes, systems, and structures for managing the complete life cycle of MEHT—from needs assessment, planning, and budgeting to formal evaluation, procurement, warehousing, distribution, utilization, maintenance, replacement, and disposal—all of which must be overseen by governance systems for asset, cost, risk, and quality management.
Challenges of MEHT
Healthcare technology has become an integral and increasingly important component of the health sector in governments around the world, especially those witnessing demographic and epidemiological transitions. However, ensuring access to MEHT (due to various factors, including lack of availability, cost, and remote area accessibility) for specific epidemiological purposes has been challenging.
The costs of healthcare are multidimensional and complex, and medical technologies represent a considerable portion of overall spending. Trends during the previous two to three decades show that MEHT-related costs continue to increase as a result of the mushrooming of high-end technologies (e.g., advanced diagnostic imaging, laboratory-based analytical techniques, cancer treatment).
Before resource ceilings are reached, an evidence-based MEHT assessment will be needed to ensure optimal acquisition and utilization of proven, cost-effective medical technologies. Of note, the top 10 healthcare technology hazards identified by the ECRI Institute in 2018 included ransomware and cybersecurity threats, flaws in medical networking, improper cleaning causing device malfunctions, and inadequate use of digital imaging tools.3 The weaknesses facing Oman include a cumbersome tendering process, acquisition of technology without any health technology assessment (HTA), and lack of a long-term strategy for MEHT. These potential risks and challenges need to be minimized through the development of a policy and careful management of technologies. To this end, a SWOT (strengths, weaknesses, opportunities, and threats) analysis (Figure 1) was carried out.
Vision 2050 for MEHT
Predicting the future of healthcare delivery can be fraught with uncertainty and risk, especially given the high number of determinants (e.g., demographic, political, economic, social, technological, environmental, legal) affecting healthcare. With the help of international consultants and guidance from the World Health Organization (WHO), the Omani Ministry of Health created a long-term plan for the health system called Health Vision 2050. The slogan for the vision is “Quality Care, Sustained Health.”
The Health Vision 2050 main document is anchored by 24 strategic studies covering different dimensions of healthcare.4,5 Overarching issues, such as health equity, safety, quality of service, and innovation, are addressed in this vision for MEHT. The strategic study has a vision of “attainment of state-of-the-art healthcare technologies and the highest technological competencies” and a mission of “facilitating the planning, development, and implementation of sustainable national healthcare technology programs and guidelines that are safe, reliable, efficient and cost effective.”
To regulate healthcare technology and ensure efficacy, quality, and safety, it was determined that the Ministry of Health should adopt suitable quality standards for all aspects of healthcare technology. In addition, systems should be established to ensure that standards are met and that wide-ranging policies covering all aspects of the planning, utilization, effectiveness, and safety of healthcare technology are considered. To achieve the vision, establishing systems to ensure that these policies can be implemented was thought to be of paramount importance. (Of note, surgical and therapeutic procedures, pharmaceutical drugs, and information technology were not included in the scope of this vision.)
To achieve the vision and mission for MEHT, the following eight objectives, which are further described below, were developed:
Developing comprehensive national policies
Performing a needs assessment
Building capacity for deployment, management, and maintenance
Developing a healthcare technology management (HTM) system
Developing a financing system
Supporting and promoting research and development (R&D)
Establishing an advanced monitoring and evaluation system
Developing Comprehensive National Policies
Public policies should complement the drive toward universal health coverage and service delivery reform. Policy making must be based on the core values of the health system, and wide-ranging policies must be established to cover all aspects of the planning, utilization, effectiveness, needs assessment, and safety of healthcare technology. Policies also must be reviewed periodically to respond to the ever-changing nature of healthcare technology and incorporate suitable modifications.6 Figure 2 illustrates the role of medical devices within the national health policy via their interlinked functionality with various phases (i.e., R&D, regulation, management, assessment) and expected outcomes (i.e., safety, quality, universal coverage, equity).
By incorporating a number of variables, a needs assessment allows decision makers to prioritize and select appropriate medical devices at a national, regional, or hospital level.
The Ministry of Health oversees efforts of manufacturers to ensure that medical devices are effective and safe. The safety and continued performance of MEHT are two critical elements that encompass the need for appropriate and stringent regulations.7 To achieve this, an autonomous regulatory body—with a specific focus on MEHT—must be established to develop national norms and standards for quality assurance, as well as to design an accreditation system. A national coordinating agency (which, preferably, should be the same agency that regulates the manufacture and distribution of medical devices) must also be established to receive and manage problem reports from all sources, thereby providing valuable feedback for the agency to improve its decision making.
Vendor control must be established to allow the government to have knowledge of the devices sold by manufacturers, with the goal of communicating with vendors in case of adverse events and regarding their after-sales responsibilities. A robust postmarket surveillance system also should be introduced.
Promotional activity by the Ministry of Health must be carried out to encourage cooperation among all stakeholders, enforce compliance, and reduce burden of enforcement. This will be achieved through proper dissemination of the policy to stakeholders by the regulatory authority and user education that addresses the misuse and misrepresentation of medical devices.
Regulations should be set to establish accreditation of hospitals and clinical engineering departments. Some hospitals in Oman have sought international accreditation. For example, the Royal Hospital, a large, tertiary-level, acute care hospital of the Ministry of Health, recently received Qmentum International Accreditation from Accreditation Canada. In addition, a quality assurance center is responsible for monitoring the quality of healthcare services among Ministry of Health institutions. The Ministry of Health must help ensure regional cooperation through the facilitation of interactions among regulators. It also should set priorities for regulatory program development according to the needs of the country.
Performing a Needs Assessment
A needs assessment can help determine and address gaps between a current and desired state. By incorporating a number of variables, a needs assessment allows decision makers to prioritize and select appropriate medical devices at a national, regional, or hospital level.8
A thorough needs assessment by the Ministry of Health should include the potential impact on performance of medical equipment users and their facilities, as well as on delivery of services within the context of health system capabilities and service delivery priorities. Before MEHT is purchased, the needs assessment should take into account the overall objectives of the institution, existing facilities and infrastructures, long-term plan of use, research studies, cost effectiveness, innovation, and human resources (HR) development. Considering the needs of end-users during the assessment is also critically important. Overall needs are determined by the gaps that are identified.8
To achieve this objective, baseline information needs to be acquired by evaluating suitable health service delivery requirements based on epidemiological needs (disease priorities), population issues (current demographics and trends), protocols/national recommendations, internationally recognized guidelines on prevention (e.g., WHO medical device guidelines), diagnosis and treatment of various diseases, and prioritization of health-care needs. Baseline information on health service availability must be acquired by constructing a map that includes availability and accessibility, gathering opinions on health service delivery from the target population and providers, and devising a map that includes the number, type, geographical location, conditions, and current staffing levels of facilities.
Baseline information will be needed on medical device inventory, including availability, status/condition, and related infrastructure. From the outset, the inventory should be cataloged using a unified nomenclature with specific information and parameters. Similarly, information related to HR (e.g., creating a staffing plan, devising an education and training map) must be gathered and developed. An outline of HTM positions, including the types of jobs, managerial structure, and responsibilities, also should be devised. Finally, baseline information on finances must be collected by assessing the budget and expenses from previous periods, as well as by assessing the current budget, performing budget forecasts, and determining a system for monitoring/controlling the budget.
The needs assessment objective also should include a strategy for comparing the current inventory lists with internationally or regionally recognized guidelines (that use a unified nomenclature) for the type of facility and/or intervention being reviewed. Then, the respective gaps need to be assessed with careful adaptation to the local setting. Resource gaps need to be prioritized to determine areas of greatest need, and operational targets should be set based on the goals of the management team and the healthcare facilities. The operational plan should be integrated into the overall plan for healthcare technology, appraising the various options by weighing the evidence and implementing strategies through use of an action plan and timetable.8
Building Capacity for Deployment, Management, and Maintenance
To achieve this objective, infrastructure capacity for MEHT must be enhanced by improving the financial, human, and material resources capabilities of the Medical Technologies department in the Ministry of Health. Infrastructure capacity should be further strengthened by establishing an appropriate unit for healthcare technology in all regions of the country, as well as by improving the design and development of facilities hosting biomedical equipment. A robust infrastructure also will include improved coordination with other ministries and agencies, with the goal of achieving cost savings. Another important aspect of this objective is developing a nationwide organizational structure for the deployment of MEHT.
HR capacity must be fortified through the development of an educational infrastructure that will generate qualified technical personnel. This will be done by collaborating with universities, as well as with other nations, on the development of formal degree programs and providing continuing education for technical personnel. In Oman, the Ministry of Higher Education requires that each university be affiliated with an international university. Graduate studies and internships abroad also would be helpful means of enhancing HR capacity.
Further enhancements should include the support of management personnel in providing leadership to set department policies, provide budget recommendations, supervise technical staff, arrange for training, set priorities for department activities, and administer overall programs. Promoting good clinical practice during operation of healthcare technology through self-study, training, and workshops led by national and international experts also will be beneficial in building capacity.
Promoting good clinical practice during operation of healthcare technology through self-study, training, and workshops led by national and international experts also will be beneficial in building capacity.
Developing an HTM System
HTM encompasses a wide range of functions, beginning with input from the regulatory, assessment, and innovation stages and ending with the safe and effective support of clinical services. HTM is a field that requires the involvement of staff from many disciplines (e.g., technical, clinical, financial, administrative).9 The Ministry of Health should manage MEHT through its five phases: 1) strategic planning, 2) procurement and commissioning, 3) inventory management, 4) maintenance program management, and 5) decommissioning.
The strategic planning phase is the foundation of a comprehensive HTM process. Planning and acquisition of medical equipment, collectively called technology incorporation, is centered on a conceptual framework consisting of in-depth analysis of the basic principles that govern each stage of the technology life cycle. The planning step involves establishing a plan using data collected from an existing technology audit and cost-benefit evaluation. The acquisition step involves implementing the plan and procuring the assets through selection based on technical, financial, and regulatory considerations.10
The procurement and commissioning phase would involve restructuring the current administrative and procurement processes by following the five rights of procurement: 1) right product or service, 2) right quality, 3) right price, 4) right time, and 5) right place.11 Future procurement needs for health technologies must be estimated by building an asset management system to track equipment status and include various parameters (e.g., operation, reliability, return on investment, patient safety, repair cost, useful life). Guidelines also should be set for establishing, and in some cases limiting, the numbers and geographic distribution of “big ticket” items (i.e., high-value equipment with implications toward national wealth control), consistent with the “Certificate of Need” mechanism recommended by the WHO.6
Through electronic data interchanges and web-based bidding, a system of electronic procurement—with an eye toward the future—must be developed. Proper management also requires that ethics are upheld during the procurement of medical devices. A procurement strategy that could be followed is to allow for autonomy and decentralization in the procurement of medical equipment by large hospitals (≥500 beds).11,12 In Oman, some major regional hospitals already function as autonomous entities, each with a separate management board constituted by the Ministry of Health. These hospitals have budgets of their own and enjoy a certain degree of financial and administrative autonomy.
The inventory management phase requires updating and standardizing the current medical equipment inventory at the national and regional levels through an appropriately linked digital system. An adequate system of inventory management, following the three stages of initial data collection, information update, and annual audit/review, also should be followed. Risk assessment inclusion criteria, using algorithms and models such as Wang's collective risk management model,13 should be adapted and followed.14
The “golden rule” approach can be considered for assessing overall asset status in terms of age, as the current inventory list assumes a five-year lifetime for MEHT.15 Although the golden rule method is overly simplistic, it provides an initial approach to assess asset status for replacement planning. From this initial assessment, considerations such as equipment usage, reliability, availability of backups, and availability of replacement parts, will allow for more objective replacement planning. Equipment that is aged up to five years reflects the current state of technology and offers opportunities for economically reasonable upgrade measures. Equipment aged between six and 10 years is still fit for use but requires replacement strategies to be developed. Equipment older than 10 years is no longer state of the art, meaning that replacement is essential.15 From these rules and the experience of studies into the age profile of medical equipment, a set of golden rules should be used as a guideline for investment policies and budget allocation (but not purchases).
To ensure the safe and effective functioning of medical equipment, an equipment spare parts inventory should be implemented. This process also could be useful in estimating the annual maintenance costs of the medical equipment stock. The main inventory should be further defined by cataloging other inventories (e.g., workshop tools and test equipment inventory, industrial and hospital equipment items inventory, safety equipment inventory, radioactive and hazardous materials, waste). The medical equipment inventory also should be used in forecasting and developing budgets, planning and equipping technical workshops, determining required staffing, identifying training needs, managing service contracts, planning for spare parts and consumables, developing replacement and disposal policies and goals, developing purchasing goals, planning for disasters and emergencies, performing risk analysis, determining management and mitigation, and helping to identify potential benefits in standardizing equipment.14
An effective medical equipment maintenance program consists of three main elements.16 First, the Ministry of Health must identify the medical devices that need to be included in the maintenance program. This planning should consider providing autonomy to large hospitals to enable them to plan and implement their maintenance programs.16 Second, appropriate management for the maintenance program must be achieved through effective financial management,16 personnel management,17 operational management, performance monitoring, and performance improvement.16 In addition to the performance of maintenance activities, the safety and reliability of the maintenance program must be evaluated to ensure its success. Third, proper implementation of the maintenance program by the Ministry of Health is critical to ensuring optimal equipment functionality. This involves using pre-established procedures for equipment maintenance and inspection and preventive maintenance activities.17
In addition to the performance of maintenance activities, the safety and reliability of the maintenance program must be evaluated to ensure its success.
The process of decommissioning equipment when it is no longer safe or useful should focus on clinical considerations, type of equipment, quality, safety, reliability, repair cost, and life expectancy.18 As appropriate, redistributing equipment to areas of lower demand may be a means of reducing capital investment need.
Developing a Financing System
Effective financial management is essential to proper MEHT management.19,20 To achieve this objective, healthcare technology needs should be prioritized based on the available budget. The operational plan must consider the financial resources required for implementation of MEHT at the national and regional levels and those required for equipment management activities. Effective budgeting as a financial planning tool is needed to ensure accurate forecasts of expenditures during operational activities (both direct and indirect operational expenditures).21–23
The financial system must make sound financial decisions and take appropriate actions based on analysis of available funds and use of financial management tools and economic concepts.24 To this end, the Ministry of Health should follow three steps: 1) analyze financial data and make financial decisions; 2) set a multiyear follow-up plan according to population needs and expected price changes due to inflation, technology evolution, and other international and local factors; and 3) continuously monitor progress. Also of note, achieving this objective requires allocation and improvement of financial resources for capacity development programs, in order to better respond to training needs at the national and regional levels.19
Supporting and Promoting R&D
To realize this objective, the R&D capabilities needed to drive innovation would need to be developed by transforming R&D infrastructure to meet changing healthcare facility needs; attracting, motivating, and mobilizing the best talent; and developing innovative products/healthcare technologies that offer benefits over existing therapies.25 Solutions appropriate to the local MEHT needs in Oman must be developed, which also would lessen the dependence on imported technology. This objective would involve setting a strategy to improve productivity and performance through appropriate research on maintenance and implementation techniques, medical instrumentation, diagnostic imaging, biomaterials and bioengineering, as well as supporting the use of research evidence in developing health policy.26
Rather than finding information, the greatest challenge is developing the capacity to use existing health technology assessment information considering [Oman's] circumstances and needs.
Oman has a number of engineering colleges, including Sultan Qaboos University, Salalah College of Technology, Nizwa College of Technology, and Higher College of Technology. Some of these institutions already offer biomedical engineering specialization.
Another key component is ensuring that ethical considerations for medical device R&D are followed by setting guidelines and measures.27
Establishing an Advanced Monitoring and Evaluation System
For a proper system of follow-up and control to exist, the Ministry of Health needs a mechanism to advise on planning, selection, use, and evaluation of health technology. Linking knowledge with action is one of the greatest challenges of the global health system. This linkage often is achieved through innovation, which usually starts with basic research that is translated into new health technologies. These technologies must be delivered to the system appropriately.21
HTA provides a basis for priority setting and informed decision making and has become a key tool for supporting the core functions of an effective global health system. HTA is the systematic evaluation of properties and/or effects of health technology. Its chief purpose is to inform technology-related policy making in healthcare, thereby improving the uptake of cost-effective technologies while bypassing technologies that are of doubtful value to the health system.28
Health technology regulation, HTA, and HTM are linked and complementary functions that ensure the appropriate introduction and use of medical devices. Thus, the Ministry of Health can rely on HTA to guide policy that is accountable to the population. Rather than finding information, the greatest challenge is developing the capacity to use existing HTA information considering the country's circumstances and needs.
To achieve this objective, an HTA unit must be established within the medical technology department to provide recommendations on public policies regarding medical devices (based on the needs of the population and national priorities). The health system should be strengthened by ensuring the central role of evidence-based decision making, both at the level of service delivery/community intervention and for planning and policy-making purposes.29,30 The HTA unit would need to develop the appropriate use of HTA by linking it to the resource capacity of the country. It also should be responsible for finding solutions to lower and balance costs of establishing and maintaining HTA functions and capabilities. HTA focal points (e.g., national research organization, universities) must be allocated for advancing the use of HTA for good governance in policy and decision making. The basic role of the HTA focal point would be to develop awareness of HTA and increase the uptake and appropriate use of HTA within the country.28
A progressive approach to disseminating knowledge and skills associated with HTA could involve organizing workshops for health professionals to become familiar with the concept, methods, and results of HTA; participating in HTA and policy networks; improving individuals' capabilities in accessing, assessing, applying, and contextualizing HTA for specific settings; and building self-sufficiency in the knowledge and skills through mentorships, distance education, in situ graduate study, and postdoctoral work.17
A toolkit also could be used to facilitate adaptation of HTA reports for different contexts. The use of toolkits, such as the WP5 toolkit from EUnetHTA,31 could benefit the Ministry of Health by providing time savings and an up-to-date collection of resources. The toolkit would provide checklists and resources for the HTA report domains, such as technology use; development, safety, efficacy, and effectiveness; and cost effectiveness.31
Patient and public involvement in HTA programs by the Ministry of Health will help ensure relevant topics and identification and prioritization of processes.32 Joint HTA in the region, following the model of EUnetHTA, also could be a future opportunity. Joint HTA uses existing networks or links for HTA across countries, thereby allowing the countries to share resources and provide assistance. Social, economic, and political ties in the region could lead to greater collaboration and perhaps joint HTA for allocating healthcare resources.33
The Health Vision 2050 for MEHT necessitates continuous planning and management of infrastructure that is vital to Oman's ability to keep pace with rapid advancements in health-care technology. This vision seeks to prioritize the most pressing health challenges and consider, for example, financial resources, material resources, personnel needs, and healthcare trends. An important part of healthcare technology is developing solutions appropriate to local needs.
The vision described in this article supports the use of research evidence, as well as building and promoting R&D capabilities, in an effort to drive healthcare technology innovation. MEHT plays an invaluable role in the delivery of healthcare, and by drawing on a wealth of experience from around the world in the creation of Health Vision 2050, the Ministry of Health is poised to realize its true potential.
The Health Vision 2050 for MEHT necessitates continuous planning and management of infrastructure that is vital to Oman's ability to keep pace with rapid advancements in healthcare technology.
To Enrico Nunziata, Bassel Tawfik, Sabria Al-Hashmi, Waleed Al-Naddabi, and Rashid Al-Hijri for their input and expertise in formulating the content in the manuscript.
Adhra Al-Mawali, PhD, is director of the Centre of Studies & Research in the Ministry of Health of the Sultanate of Oman. E-mail: email@example.com
Avinash Daniel Pinto, MSc, is technical manager of health information and researcher at the Centre of Studies & Research of the Ministry of Health of the Sultanate of Oman. E-mail: firstname.lastname@example.org
Ali Talib Al-Hinai, MD, is undersecretary of planning affairs at the Ministry of Health of the Sultanate of Oman. E-mail: email@example.com