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Optimizing Healthcare Delivery: Innovations and Economic Strategies in Medical Device Management

Written By

Ricardo Marcão, Stéphanie Monteiro, Vasco Santos, Filipa Martinho, Maria José Sousa, António Dionísio and Pedro Ramos

Submitted: 23 May 2024 Reviewed: 11 July 2024 Published: 13 December 2024

DOI: 10.5772/intechopen.1007476

Electronic Health Records - Issues and Challenges in Healthcare Systems IntechOpen
Electronic Health Records - Issues and Challenges in Healthcare S... Edited by Venkata Krishna Parimala

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Electronic Health Records - Issues and Challenges in Healthcare Systems [Working Title]

Dr. Venkata Krishna Parimala

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Abstract

The global healthcare industry is currently undergoing a significant technological transformation, with the digitization of medical devices and systems at the forefront of revolutionizing healthcare delivery. This evolution aims to make healthcare more accessible, effective, and cost-efficient, necessitating healthcare providers to strategically evaluate and embrace new technologies along with procedural changes. This paper offers a comprehensive analysis of optimizing healthcare delivery, focusing on the crucial aspect of medical device management throughout its lifecycle. It distills academic research into practical guidance for healthcare providers and medical professionals, emphasizing the importance of patient-centric care, risk management, regulatory compliance, safety standards, and vigilant post-market surveillance. The lifecycle approach, covering development, testing, manufacturing, marketing, supply chain, device management, and eventual retirement, underscores the importance of safe and effective medical device management. It demonstrates that modern healthcare’s reliance on medical technology demands thoughtful and robust management processes for the efficient, safe, and innovative utilization of devices, benefiting both patients and organizations. Through discussions on research and case studies, the paper outlines a strategic process for achieving an economical and patient-centric healthcare delivery system, addressing the impact of healthcare costs on the utilization of medical devices and promoting studies on advancing patient-oriented healthcare systems.

Keywords

  • medical device management
  • healthcare delivery
  • technological innovation
  • patient-centric care
  • regulatory compliance
  • predictive maintenance
  • economic strategies
  • telemedicine

1. Introduction

The healthcare industry is at a pivotal moment, driven by the rapid pace of technological advancements and the increasing demand for patient-centered care. Medical devices, from basic instruments to advanced digital systems, have become critical in enhancing diagnostics, treatment, and patient management. These devices not only improve clinical outcomes but also facilitate access to care across diverse populations, particularly as healthcare moves toward more personalized and preventive models [1]. However, effectively managing these devices throughout their lifecycle—from procurement and maintenance to compliance with regulatory standards and eventual decommissioning—presents several challenges for healthcare providers [2]. These challenges are further compounded by rising healthcare costs, the need for technological integration, and the imperative of ensuring safety and efficacy in device management [3].

The overarching goal of this chapter is to provide a comprehensive strategic analysis of medical device management as a key element in optimizing healthcare delivery. This chapter will focus on the integration of technological innovations, economic strategies, and a forward-looking approach to future trends. Technological advancements such as artificial intelligence (AI), the Internet of Things (IoT), and predictive maintenance systems are transforming not only how medical devices are managed but also how healthcare is delivered. These technologies offer opportunities to reduce costs, enhance operational efficiency, and improve patient outcomes by enabling more precise, real-time, data-driven decision-making [1]. The economic implications of these advancements are equally significant, as healthcare providers must navigate the complexities of managing the high costs associated with device acquisition, operation, and maintenance while upholding high standards of care [3].

The first section of this chapter will explore the current challenges in medical device management. These challenges include escalating costs, inefficient resource utilization, limited access to advanced medical technologies, and the pressing need for regulatory compliance. The healthcare sector, in particular, faces significant hurdles in maintaining up-to-date inventories of medical devices, ensuring proper maintenance, and adhering to the regulatory requirements that govern device safety and efficacy [2]. Additionally, global disparities in access to essential medical devices, particularly in developing countries, further complicate efforts to optimize healthcare delivery [3]. The discussion will also highlight how the COVID-19 pandemic exposed vulnerabilities in global healthcare systems, particularly in medical device supply chains, amplifying the need for more resilient and innovative device management strategies [4].

Following the examination of these challenges, the chapter will present solutions through detailed case studies that demonstrate both successful and unsuccessful implementations of medical device management strategies. These case studies will offer real-world insights into how healthcare organizations have addressed operational inefficiencies, improved device utilization, and navigated regulatory barriers. For instance, the use of centralized inventory management systems has been shown to reduce device downtime and improve resource allocation in several leading healthcare institutions. Conversely, examples of failed initiatives will provide valuable lessons on the importance of stakeholder engagement, transparent communication, and the need for continuous monitoring and evaluation of medical device management systems [3].

The chapter will also delve into the critical regulatory considerations governing the medical device industry, emphasizing the importance of compliance with both national and international standards. These regulations, such as those enforced by the U.S. Food and Drug Administration (FDA) and the European Union’s CE marking, ensure the safety, efficacy, and quality of medical devices throughout their lifecycle. The complexity of these regulatory frameworks highlights the need for healthcare providers to remain informed about evolving standards, particularly as new technologies such as AI-driven diagnostic tools and IoT-enabled medical devices enter the market. Additionally, data security and patient privacy, especially concerning connected devices, remain paramount concerns that must be addressed through stringent cybersecurity measures [4].

Lastly, the chapter will examine future trends in medical device management, focusing on the potential of emerging technologies to revolutionize healthcare delivery. AI, IoT, robotics, and 3D printing are just a few of the innovations that promise to enhance device functionality, improve diagnostic accuracy, and allow for the development of personalized medical devices tailored to individual patient needs. Predictive maintenance, enabled by AI and IoT, will continue to play a crucial role in minimizing device downtime, reducing costs, and improving overall care quality [3]. These trends underscore the need for continuous investment in research and development, regulatory innovation, and workforce training to ensure that healthcare providers can fully leverage the potential of these technologies in delivering more efficient and equitable healthcare [4].

By examining these critical areas, this chapter aims to provide healthcare providers, policymakers, and industry stakeholders with actionable insights and strategies to optimize healthcare delivery through more effective and innovative medical device management. The integration of new technologies, economic strategies, and regulatory compliance will not only improve operational efficiency but also enhance patient outcomes, ultimately leading to a more sustainable and patient-centered healthcare system [4].

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2. Current challenges in healthcare delivery

The landscape of healthcare delivery is fraught with challenges, notably heightened by the expansion of international activities in the medical device industry. This globalization has prompted a push toward more efficient production processes, stringent safety and quality controls by government agencies, and cost containment strategies by healthcare providers, with significant attention on optimizing medical device management. The pivotal role of advanced medical technologies, such as intelligent devices including infusion pumps and cardiac pacemakers, has shifted the paradigm from traditional hospital-based care to more economical, patient-centered models. This shift underscores the urgency for rational device management to ensure safety, efficacy, and cost-efficiency, especially as the industry navigates increased market volatility and the evolving demands of both developed and developing economies [5, 6].

Concurrently, healthcare in the United States faces escalating expenditures, with projections suggesting an alarming rise to $6 trillion by 2027, or 19% of GDP. This surge is driven by an aging population, more expensive healthcare services and drugs, the prevalence of chronic diseases, defensive medicine practices, and substantial administrative costs. These factors collectively underscore the necessity for innovative strategies in medical device management to mitigate rising costs and improve system efficiency [7, 8]. Additionally, global access to medical devices remains uneven, highlighting disparities exacerbated by socio-economic and structural barriers, particularly in less developed territories, challenging the globalization of medical device supply and underlining the health inequalities across different populations [9, 10, 11]. This increase is multifaceted, rooted in an aging population that demands more medical services, escalating prices of healthcare services and prescription drugs, and the widespread prevalence of chronic diseases, which alone consume about 90% of the country’s healthcare spending. Moreover, the fragmented healthcare system exacerbates these costs, leading to inefficient resource use and suboptimal patient outcomes. Defensive medicine practices and the complex administrative burdens of the multi-payer insurance system further inflate these expenditures. Addressing these escalating costs is crucial, necessitating innovative approaches in medical device management to enhance efficiency and curb unnecessary spending [7, 8].

Moreover, inefficiencies in device management within healthcare facilities, such as unclear allocation processes, inadequate stock visibility, and subpar device recall management, compromise the quality of patient care and resource utilization. The absence of streamlined processes and reliance on outdated management methods underscore the critical need for improvement in inventory and asset management systems to enhance care delivery and operational efficiency [12, 13, 14].

The global disparity in access to medical devices underscores a critical yet underexplored issue in healthcare delivery. While advancements and the need for innovation in medical device development have garnered attention, particularly in economically advanced regions, this focus does not fully capture the challenges faced by many worldwide. A significant number of healthcare patients, practitioners, and providers across various regions struggle to access essential medical devices. This gap is primarily driven by the growing demand for innovative devices needed to tackle contemporary health issues—a demand influenced heavily by the rising prevalence of chronic conditions in aging populations. These challenges to the globalization of medical device manufacture and supply are further compounded by socio-economic and structural barriers, particularly in less developed areas. These regions often lack the robust healthcare infrastructure and regulatory frameworks essential for the advancement and maintenance of medical devices, thus perpetuating the divide between ‘innovator’ and ‘adopter’ countries. This not only diminishes the attractiveness of different healthcare markets to medical device manufacturers but also exacerbates health inequalities across patient populations [9, 10, 11].

Inefficient device management in hospitals, characterized by unclear allocation processes and the absence of standardized procedures, results in operational inefficiencies and increased costs. Lack of clear priorities and protocols often leaves high-demand services without essential devices, complicating emergency responses [12]. The management of device recalls suffers due to inadequate monitoring, leading to incomplete maintenance tasks and poorly regulated inventory, heightening the risk of shortages or surplus stock [13]. Additionally, the reorder process is hampered by inefficiencies such as outdated automation and lack of digitalization, further strained by improper handling of expired items, affecting inventory accuracy and storage conditions [14]. The absence of an effective asset management system and data-driven optimization exacerbates these challenges, with staff wasting time on device location and maintenance scheduling, thereby impacting patient care and device utilization.

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3. Importance of optimizing healthcare delivery

Optimizing healthcare delivery is increasingly recognized as a crucial step toward enhancing patient care and addressing the rising costs associated with healthcare services. This optimization is not only beneficial for achieving commercial and financial success but is fundamentally about improving patient outcomes. Effective healthcare delivery focuses on ensuring patient care takes precedence, facilitated by technological advancements and the strategic management of healthcare resources. Interoperability and seamless access to electronic health records (EHRs) significantly enhance care delivery, improving both effectiveness and efficiency across various healthcare settings. Despite challenges, such as delays in compliance and legislative pushbacks, the integration of EHRs is vital for enabling patient-centered outcomes. The drive toward optimized healthcare involves a comprehensive approach that aligns patient experiences with the expertise of medical staff and effective protocol implementation. Highlighting the complexity of this endeavor, there are substantial positive impacts achievable through meticulous planning and execution. Furthermore, leveraging advanced data analytics, including probabilistic linkage and data mining, fosters quality improvement and integrates patient records across the healthcare spectrum [15].

Enhancing patient care stands at the forefront of optimizing healthcare delivery, underlining the essence of patient-centric approaches within the healthcare system. A pivotal element in this optimization is the reduction of medical errors, a concern highlighted across various studies. For instance, research indicates that suboptimal equipment management practices significantly contribute to medical errors, with estimates suggesting that medical device issues lead to approximately 155,000 errors and 1300 fatalities annually [16]. The integration of advanced technologies, such as barcoding systems in surgical supply chains, demonstrates a tangible reduction in human errors, ensuring the correct utilization of medical equipment for each procedure and enhancing patient safety. Furthermore, intelligent systems capable of diagnosing issues and predicting equipment failures mark a substantial advancement in medical device management, moving toward a model of ‘preventive maintenance’ over traditional methods. This shift not only maximizes equipment uptime but also significantly improves clinical care quality. The deployment of such technologies since their introduction by diagnostic imaging centers reflects the critical role of innovative medical device management in bolstering healthcare delivery and patient care outcomes [17, 18].

Reducing healthcare costs while enhancing the quality of care is a pivotal goal for healthcare organizations. They aim to utilize accurate data on device use and inventory to pinpoint and eliminate inefficiencies in medical device management [19]. By cutting down on unnecessary activities and equipment redundancy, organizations can boost resource efficiency and lower overall healthcare costs without compromising care delivery or quality. This strategy emphasizes the significance of integrating technology and information advancements to enhance patient care and operational productivity [20]. However, these innovations bring their own costs, including the expense of adopting new “smart” devices equipped with advanced diagnostic and treatment capabilities. Such expenses necessitate careful planning to ensure that investments in new technology genuinely contribute to cost reduction and enhanced patient care outcomes. Engaging leaders and forming a multidisciplinary team early in the cost reduction process is critical for ensuring clinical relevance and comprehensive cost-saving strategies [21].

The evolution of medical technology, while offering significant improvements in healthcare delivery, also requires strategic management to balance innovation with cost-effectiveness. The challenge of technology obsolescence, where new models quickly replace the old, needs a planned increase in the utilization of newer models to avoid productivity dilution [22]. Furthermore, other authors emphasize the importance of leveraging new technologies for strategic cost reduction, suggesting that meaningful use and evidence-based treatment practices can offer unique value opportunities in medical device management [23, 24].

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4. Innovations in medical device management

The landscape of medical device management is continually evolving, marked by significant innovations that aim to enhance healthcare delivery and patient outcomes. These advancements range from the adoption of electronic health records (EHRs) and telemedicine to the integration of the Internet of Things (IoT) in healthcare practices. EHRs, or electronic medical records (EMRs), serve as digital versions of patients’ traditional paper charts, offering a comprehensive record that supports treatment and care delivery across various healthcare settings. This digital transition not only facilitates global collaboration among healthcare providers but also reduces unnecessary patient testing and medication exposure, thereby improving patient safety and reducing costs. The proliferation of EHRs, propelled by the Health Information Technology for Economic and Clinical Health (HITECH) Act in the USA, signifies a critical shift toward digital healthcare systems that prioritize efficiency and patient privacy [25, 26, 27].

Telemedicine has emerged as a pivotal innovation, extending healthcare’s reach to remote and underserved populations while enhancing the patient-doctor relationship through cost-effective and accessible services. Supported by over 200 research articles, telemedicine’s effectiveness in managing chronic illnesses is increasingly acknowledged worldwide, fostering its adoption and global diffusion [28, 29].

Remote patient monitoring (RPM) technologies represent another significant stride in healthcare innovation, enabling real-time health data transmission from patients to healthcare providers. This technology empowers patients to actively participate in their health management, offering a blend of privacy, security, and convenience. RPM is anticipated to redefine medical practice by fostering closer patient-provider connections and facilitating home-based patient care and rehabilitation, supported by federal initiatives like the Centers for Medicare & Medicaid Services Chronic Care Management program [30, 31].

Artificial Intelligence (AI) in medical device management is revolutionizing healthcare by enhancing device efficiency and patient care outcomes. AI technologies facilitate predictive maintenance, remote monitoring, and energy optimization of medical devices, offering a smarter approach to healthcare service delivery. Despite the potential benefits, the full realization of AI in healthcare faces challenges due to the industry’s regulated nature and the hesitance of users to adopt new technologies [32, 33].

Predictive maintenance systems stand out as a cost-effective solution to medical device management, shifting away from traditional maintenance strategies to a more data-driven approach. This method improves device reliability, optimizes performance, and extends the useful life of medical equipment, aligning with the healthcare industry’s goal of enhancing efficiency and reducing costs [34].

Together, these innovations in medical device management underscore a transformative period in healthcare, driving toward a future where technology and data analytics play central roles in delivering patient-centered, efficient, and effective care.

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5. Economic strategies for medical device management

Economic strategies in medical device management are pivotal for healthcare providers to navigate the complexities and high costs associated with the deployment, operation, and maintenance of these critical tools. The transition from reactive to proactive management strategies, facilitated by advancements in technology and the Internet of Things (IoT), offers a promising avenue for reducing the economic burden associated with medical devices.

Value-based purchasing emerges as a strategic approach encouraging healthcare providers to select medical devices not only based on cost-effectiveness but also on their long-term value in patient care and operational efficiency. This method necessitates a comprehensive understanding of device lifecycle costs, demanding an initial investment and potentially additional staff training to achieve optimal outcomes. The emphasis on long-term patient care impact and efficiency aligns with a broader industry shift toward value-oriented healthcare delivery [35, 36].

Equipment standardization represents another key strategy, advocating for uniformity in device selection to streamline operations, reduce training requirements, and minimize maintenance complexity. Despite its initial perceived limitations, standardization can lead to significant long-term benefits, including cost savings through bulk purchasing agreements and improved operational efficiency [37].

Asset tracking and utilization, facilitated by digital systems, provides real-time insights into device location and usage patterns. This strategy enhances the ability to allocate resources effectively, ensuring devices are utilized where they are most needed and supporting strategic planning for future purchases based on actual usage data. Such granular visibility into device utilization patterns is instrumental in optimizing patient care delivery and operational efficiency within healthcare settings [38].

These economic strategies, encompassing maintenance optimization, lifecycle cost analysis, and strategic device placement, require careful consideration of the unique needs of patient populations and healthcare providers. They must be tailored to fit within the broader regulatory, financial, and technological landscape of the healthcare industry. Successful implementation hinges on the adaptability of healthcare providers to these innovative strategies, promising significant benefits in terms of cost savings, improved patient outcomes, and enhanced operational efficiency [39].

The exploration of these strategies within this chapter underscores their potential to transform medical device management in healthcare. By adopting a comprehensive, forward-thinking approach to purchasing, standardization, and asset tracking, healthcare organizations can navigate the challenges of high costs and complex logistics associated with medical devices, moving toward a more efficient, patient-centered, and economically sustainable model of care delivery.

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6. Integration of technology in healthcare delivery

The integration of technology into healthcare delivery heralds a pivotal transformation toward a system that is more efficient, accessible, and tailored to individual needs. The inception of this transformation began with the digitalization of healthcare facilities, aiming for a “paperless” environment. This foundational shift made possible the development and integration of advanced technologies such as artificial intelligence (AI), virtual clinics, and natural language processing (NLP) into the healthcare system. These technologies have significantly enhanced the direct interaction between patients and care providers through the adoption of standardized health informatics and telemedicine systems.

Telemedicine and remote patient monitoring stand out as key examples of how technology can extend healthcare beyond traditional settings. Leveraging rapid internet access and advancements in technology, these systems enable continuous, real-time monitoring of patients through wearable and portable devices. This has facilitated care delivery in a variety of settings, thereby improving access to expert healthcare advice and enhancing the personalization of healthcare services. The evolution toward modern maintenance strategies for medical devices, shifting from reactive to predictive maintenance enabled by AI and the Industrial Internet of Things (IIoT), exemplifies this trend. Predictive maintenance systems anticipate the needs for device maintenance, significantly reducing downtime and associated costs, which in turn improves the quality of patient care [40].

Electronic Health Records (EHRs) have become a cornerstone in this technological integration, providing a longitudinal digital record of patient medical histories that can be shared across various healthcare settings. The widespread adoption of EHRs, spurred by the Health Information Technology for Economic and Clinical Health (HITECH) Act, emphasizes the critical role of digital records in improving care coordination, enhancing diagnosis and patient outcomes, and ensuring patient safety. This transition toward digitalization aligns with broader trends toward optimizing healthcare delivery through innovations in medical device management, highlighting the emphasis on efficiency, data analytics, and a patient-centered approach to care [41].

Furthermore, telemedicine epitomizes the technological integration in healthcare by reducing medical costs and enhancing the accessibility of services. It provides a cost-effective model for healthcare delivery by reducing patient travel and facility capital investment, thereby improving service quality and flexibility. This modality is particularly beneficial in outpatient and home settings, indicating a shift toward more accessible and efficient healthcare delivery modalities [42].

The Internet of Things (IoT) introduces a network of interconnected devices capable of collecting and exchanging data, ranging from wearable technologies to implantable medical devices. The potential benefits of IoT in healthcare are vast, offering improved patient monitoring, preventive care, and insights into disease progression, which can contribute to a shift toward a more personalized healthcare system. Nonetheless, the realization of IoT’s full potential in healthcare necessitates addressing challenges related to data management, privacy, and regulation of IoT devices [43, 44, 45, 46, 47].

As these technologies continue to advance and become further integrated into healthcare delivery, the vision of a healthcare system that is more efficient, accessible, and personalized becomes increasingly attainable. The ongoing innovation and adoption of digital health technologies, underpinned by advancements in AI, telemedicine, and IoT, promise a future where healthcare delivery is optimized to meet the varied needs of patients and providers alike.

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7. Regulatory considerations in medical device management

Navigating the regulatory landscape is crucial for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. This complex environment encompasses a variety of national and international standards and regulations that manufacturers and healthcare organizations must adhere to, from product development to post-market surveillance [48].

The regulatory framework varies significantly across different jurisdictions, highlighting the importance of a nuanced approach to compliance. For instance, in the United States, the Food and Drug Administration (FDA) sets forth rigorous guidelines for device registration, approval, and quality controls [49]. Similarly, the European Union requires medical devices to attain CE Marking as a demonstration of safety and performance, underlining the global diversity in regulatory requirements [50].

Intelligent medical devices, which are increasingly prevalent in healthcare for applications like remote monitoring, must not only meet safety and performance standards but also ensure data accuracy and protection. This necessitates robust security measures and standards to safeguard sensitive patient information and justify clinical decisions based on device-generated data [51].

Manufacturers must also navigate the challenges posed by technological advancements, ensuring that devices on the market remain compliant through active post-market surveillance. This involves systematic data collection and analysis to monitor product performance and safety and to take corrective actions if necessary [52].

Compliance with FDA regulations, a cornerstone of medical device management in the U.S., involves several key steps, including premarket notification (510(k)), premarket approval (PMA), and the De Novo classification for novel devices. These processes underscore the complexity of bringing medical devices to market and the critical role of compliance in safeguarding patient health [53].

Data security and privacy are paramount, with regulations like the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. setting standards for the protection of personal health information. The increasing threat of cyber-attacks on the medical device sector amplifies the need for comprehensive cybersecurity risk management strategies to protect patient data [54].

Quality assurance (QA) and quality control (QC) are integral to maintaining high standards in medical device management, focusing on process and product quality to ensure that devices are safe, effective, and fit for their intended use. Adherence to global medical device regulations and standards, such as those set by the FDA and CE marking, is essential for patient safety, regulatory compliance, market access, and organizational reputation in the healthcare sector [55, 56, 57, 58].

Overall, the regulatory considerations in medical device management encompass a broad spectrum of activities and standards, from compliance and data security to quality assurance and control, underscoring the critical role of regulation in ensuring the safe and effective use of medical devices in healthcare.

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8. Case studies in optimizing healthcare delivery

Case studies are valuable tools for understanding how theoretical strategies can be successfully or unsuccessfully applied in real-world scenarios. This section presents two contrasting case studies that highlight both the benefits and challenges of medical device management. Through these examples, we explore how different healthcare organizations implemented centralized and decentralized device management strategies, offering insights into best practices and lessons learned.

8.1 Case study: MacNeal Hospital’s centralized device management system

MacNeal Hospital, a prominent healthcare facility in Illinois, undertook a comprehensive overhaul of its medical device management strategy in response to operational inefficiencies caused by a decentralized system. Previously, the hospital struggled with maintaining accurate records of device usage, timely maintenance, and equipment availability, which led to prolonged downtime for essential medical devices. These issues negatively impacted patient care and led to increased operational costs.

Recognizing the need for improvement, MacNeal Hospital implemented a centralized inventory and device management system. This new system allowed for real-time tracking of devices, predictive maintenance scheduling, and a streamlined process for handling device recalls. By centralizing their management system, the hospital could reduce the downtime of critical equipment, ensuring that devices were available when needed for patient care. Additionally, the centralized system enabled better compliance with regulatory standards, as it allowed for more consistent monitoring of device performance and documentation of maintenance activities.

The results were significant: MacNeal Hospital saw a 20% reduction in equipment downtime, a 30% increase in operational efficiency, and an improvement in patient outcomes due to the timely availability of devices for diagnostics and treatment. Furthermore, the hospital experienced cost savings by reducing unnecessary purchases and eliminating equipment redundancies. The successful implementation of the centralized device management system at MacNeal Hospital serves as a model for other healthcare institutions looking to improve their operations through better resource allocation and management practices [59].

8.2 Case study: Health information technology project failure

Not all attempts to optimize medical device management have yielded positive outcomes. A notable example of this is the failure of a large-scale health information technology project at a multi-hospital system in the United States. The project aimed to integrate medical device management with the hospitals’ electronic health record (EHR) system to improve interoperability, device tracking, and patient data accuracy.

The integration was intended to streamline workflows, enabling healthcare staff to monitor devices and patient data from a single interface. However, the project encountered significant issues due to a lack of stakeholder engagement, poor communication between IT and clinical teams, and inadequate training for end-users. These factors led to widespread user resistance, and the system was not fully adopted by the healthcare staff.

The failure to fully implement the system resulted in continued inefficiencies, including inaccurate device tracking, delayed maintenance, and ongoing compliance issues with regulatory standards. Furthermore, the lack of proper training contributed to staff frustration and misuse of the new system, exacerbating existing problems rather than solving them.

One of the key lessons learned from this failure was the importance of involving all stakeholders—from IT professionals to clinical staff—in the planning and implementation phases of technology integration projects. Additionally, the project highlighted the need for comprehensive training programs to ensure that healthcare staff can fully utilize new systems and workflows. This case study underscores the fact that even with advanced technology, successful implementation requires clear communication, effective training, and ongoing support to ensure adoption and long-term sustainability [60].

These two case studies illustrate the challenges and potential benefits of medical device management strategies. MacNeal Hospital’s success with centralized management underscores the importance of resource visibility, predictive maintenance, and real-time monitoring in achieving operational efficiency and cost savings. On the other hand, the failure of the health information technology integration project highlights the dangers of underestimating the human factors involved in implementing new technologies.

Healthcare providers aiming to optimize device management must carefully plan their strategies, ensuring that stakeholders are engaged, training programs are robust, and technological solutions are tailored to the needs of both staff and patients. By learning from both successful and failed implementations, healthcare organizations can better navigate the complexities of medical device management and improve their overall healthcare delivery systems [61, 62, 63].

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9. Future trends in medical device management

The healthcare landscape is rapidly evolving, with emerging technologies poised to transform the management of medical devices and revolutionize healthcare delivery. In the coming decade, innovations such as artificial intelligence (AI), the Internet of Things (IoT), robotics, and personalized medical devices are expected to significantly improve operational efficiency, reduce costs, and enhance patient outcomes. These advancements promise to address some of the most pressing challenges in healthcare, including the rising costs of care, the need for real-time monitoring, and the growing demand for personalized treatment options.

9.1 Artificial intelligence (AI) in medical device management

Artificial intelligence is playing an increasingly vital role in medical device management, offering the potential to drastically improve efficiency and safety through predictive maintenance systems. By analyzing vast amounts of data from connected medical devices, AI algorithms can predict when a device is likely to fail, allowing for preemptive maintenance and reducing the risk of downtime. This shift from reactive to predictive maintenance has been shown to reduce costs, increase device uptime, and improve overall patient care quality [64].

AI also enhances decision-making in healthcare by providing insights into device usage patterns and operational inefficiencies. For instance, AI-powered analytics can help healthcare providers optimize the allocation of devices, ensuring that critical equipment is available where and when it is needed. Additionally, AI can be integrated into diagnostic tools, enabling devices to assist clinicians in detecting diseases earlier and more accurately, leading to better patient outcomes. Over the next decade, AI’s role in optimizing device management is expected to expand as healthcare organizations increasingly adopt AI-driven solutions to improve both the operational and clinical aspects of device usage [64].

9.2 Internet of things (IoT) and real-time device monitoring

The Internet of Things is another technology that will significantly impact medical device management, particularly in the areas of real-time monitoring and data exchange. IoT-enabled devices are capable of transmitting real-time data to healthcare providers, allowing for continuous monitoring of patient health. This technology enables clinicians to track vital signs, device performance, and treatment progress remotely, leading to more proactive interventions and reducing the need for in-person hospital visits [65].

In the context of medical device management, IoT devices can streamline workflows by automating the process of tracking device status, usage, and location. Hospitals and clinics can use this information to ensure that devices are maintained properly, reducing the risk of malfunctions and extending the lifespan of the equipment. IoT also offers the potential for enhanced interoperability between devices, improving communication across healthcare systems, and facilitating the integration of data from multiple sources. As IoT adoption grows, healthcare providers will be able to harness this data to optimize care delivery, reduce operational costs, and improve patient outcomes [65].

9.3 Robotics in healthcare and medical device management

Robotics is becoming increasingly prevalent in healthcare, particularly in surgical settings where robotic systems assist surgeons in performing complex procedures with greater precision and control. In medical device management, robotics plays a key role in automating routine tasks, such as sterilization, device assembly, and even distribution within hospitals. The use of robotic systems can reduce human error, improve efficiency, and enhance the quality of care by ensuring that medical devices are properly maintained and available when needed [66].

Additionally, telerobotics—where surgeons can perform operations remotely using robotic systems—opens up new possibilities for healthcare delivery in rural and underserved areas. This technology allows highly skilled specialists to perform procedures without being physically present, reducing geographical barriers to quality care. As robotics continues to advance, its integration into both clinical and operational aspects of medical device management will significantly enhance healthcare delivery [66].

9.4 Impact of emerging technologies on healthcare delivery

The integration of AI, IoT, robotics, and personalized devices will fundamentally alter the healthcare landscape in the coming years. These technologies will enable healthcare providers to deliver more efficient, cost-effective, and patient-centered care. Predictive maintenance systems powered by AI will reduce device downtime, lower operational costs, and improve patient safety by ensuring that critical devices are always functional when needed. IoT-enabled devices will allow for continuous patient monitoring, facilitating early detection of health issues and enabling timely interventions that improve patient outcomes [65].

Robotics will automate routine tasks and enable remote surgeries, reducing the burden on healthcare workers and expanding access to specialized care in underserved regions. Personalized devices created through 3D printing will transform the way healthcare providers meet the unique needs of patients, offering better customization and improving the quality of life for those with complex medical conditions. As these technologies continue to develop and become more widely adopted, they will redefine how healthcare is delivered, ultimately leading to a more efficient, accessible, and patient-centric system [66, 67].

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10. Conclusion

Optimizing healthcare delivery is essential for enhancing patient care and addressing rising healthcare costs. This chapter has highlighted the critical role of strategic medical device management, facilitated by technological advancements such as artificial intelligence (AI), the Internet of Things (IoT), and predictive maintenance systems. By adopting these innovations, healthcare organizations can improve both operational efficiency and patient outcomes.

A primary focus in healthcare delivery optimization is enhancing patient care through better management processes. The integration of AI and IoT into medical device management offers significant advantages, such as predictive maintenance systems, which can reduce device downtime and improve safety. Predictive analytics also enable proactive identification of device failures, ensuring critical equipment remains operational and improving clinical care quality. The incorporation of these advanced technologies fosters a safer and more efficient healthcare environment [16, 17, 18].

Reducing medical errors is another crucial goal. Research shows that improper device management contributes significantly to medical errors, with estimates suggesting that device-related issues lead to approximately 155,000 errors and 1300 fatalities annually. Implementing barcoding systems in surgical supply chains and healthcare operations can minimize human error, ensuring proper device usage and improving patient safety. By adopting preventive maintenance strategies, healthcare providers can further reduce equipment failures and maximize device uptime, directly enhancing patient care [16, 17, 18].

From an economic perspective, optimizing device management not only improves safety but also leads to substantial cost savings. Investing in value-based purchasing, which considers the long-term value of devices in addition to their upfront costs, is key to sustainable healthcare delivery. Moreover, standardizing medical devices across healthcare facilities can streamline operations, reduce training times, and simplify maintenance, all while minimizing operational expenses. Effective asset tracking systems provide real-time data on device usage, improving resource allocation and reducing unnecessary expenditures [19].

Looking ahead, emerging technologies such as robotics, 3D printing, and advanced data analytics will further reshape the healthcare landscape. These innovations promise to personalize patient care, improve diagnostic and therapeutic precision, and make healthcare more accessible and cost-effective. However, their successful adoption will require careful planning, regulatory compliance, and investment in workforce training and infrastructure [66].

Recommendations: To fully realize the benefits of optimized healthcare delivery, healthcare providers and policymakers should focus on:

  1. Predictive maintenance: Invest in AI-driven predictive maintenance systems to reduce equipment downtime and ensure critical devices are operational when needed.

  2. Regulatory compliance: Prioritize compliance with national and international regulatory standards to ensure safety and quality in device management.

  3. Technology integration: Embrace AI, IoT, and robotics to improve device management and healthcare delivery. These technologies not only enhance operational efficiency but also contribute to better patient outcomes.

  4. Resource allocation: Implement data-driven asset tracking and resource allocation strategies to optimize device usage and reduce operational inefficiencies.

  5. Standardization and interoperability: Standardize medical devices and ensure seamless integration of electronic health records (EHRs) to improve care coordination and patient outcomes [67].

In conclusion, optimizing healthcare delivery requires a multifaceted approach that integrates advanced technologies, patient-centered care, and strategic resource management. By focusing on predictive maintenance, regulatory compliance, and technological innovation, healthcare providers can enhance patient safety, reduce costs, and improve overall system efficiency. This chapter underscores the importance of addressing these areas to ensure that healthcare delivery is not only optimized but also sustainable and equitable [67].

Acknowledgments

The authors acknowledge the use of Grammarly Writing Assistant for language polishing of the manuscript.

References

  1. 1. Raihan A, Begum RA, Said MNM, Pereira JJ. Relationship between economic growth, renewable energy use, technological innovation, and carbon emission toward achieving Malaysia's Paris agreement. Environment Systems and Decisions. 2022;42(4):586-607
  2. 2. Harputlugil T, de Wilde P. The interaction between humans and buildings for energy efficiency: A critical review. Energy Research & Social Science. 1 Jan 2021;71:101828
  3. 3. Narula S, Kumar A, Prakash S, Dwivedy M, Puppala H, Talwar V. Modelling and analysis of challenges for industry 4.0 implementation in medical device industry to post COVID-19 scenario. International Journal of Supply and Operations Management. 2023;10(2):117-135
  4. 4. Romagnoli A, Ferrara F, Langella R, Zovi A. Healthcare systems and artificial intelligence: Focus on challenges and the international regulatory framework. Pharmaceutical Research. Apr 2024;41(4):721-730
  5. 5. Jakovljevic M, Liu Y, Cerda A, Simonyan M, Correia T, Mariita RM, et al. The global south political economy of health financing and spending landscape-history and presence. Journal of Medical Economics. 2021;24(Suppl. 1):25-33
  6. 6. Karabag SF. An unprecedented global crisis! The global, regional, national, political, economic and commercial impact of the coronavirus pandemic. Journal of Applied Economics and Business Research. 2020;10(1):1-6
  7. 7. Mantus J, Pang G, Warshawsky MJ. A Unified Long-Run Macroeconomic Projection of Health Care Spending, the Federal Budget, and Benefit Programs in the US. AEI Economics Working Paper; 2023
  8. 8. Hartman M, Martin AB, Whittle L, Catlin A, National Health Expenditure Accounts Team. National Health Care Spending in 2022: Growth similar to prepandemic rates. Health Affairs. 2024;43(1):6-17
  9. 9. Pradhan B, Bhattacharyya S, Pal K. IoT-based applications in healthcare devices. Journal of Healthcare Engineering. 2021;2021(1):6632599
  10. 10. Chauhan V, Galwankar S, Arquilla B, Garg M, Di Somma S, El-Menyar A, et al. Novel coronavirus (COVID-19): Leveraging telemedicine to optimize care while minimizing exposures and viral transmission. Journal of Emergencies, Trauma, and Shock. 2020;13(1):20-24
  11. 11. Ratta P, Kaur A, Sharma S, Shabaz M, Dhiman G. Application of blockchain and internet of things in healthcare and medical sector: Applications, challenges, and future perspectives. Journal of Food Quality. 2021;2021(1):7608296
  12. 12. Shahid J, Ahmad R, Kiani AK, Ahmad T, Saeed S, Almuhaideb AM. Data protection and privacy of the internet of healthcare things (IoHTs). Applied Sciences. 2022;12(4):1927
  13. 13. Spieske A, Gebhardt M, Kopyto M, Birkel H. Improving resilience of the healthcare supply chain in a pandemic: Evidence from Europe during the COVID-19 crisis. Journal of Purchasing and Supply Management. 2022;28(5):100748
  14. 14. Jiang L, Wu Z, Xu X, Zhan Y, Jin X, Wang L, et al. Opportunities and challenges of artificial intelligence in the medical field: Current application, emerging problems, and problem-solving strategies. Journal of International Medical Research. 2021;49(3):03000605211000157
  15. 15. Omotayo P, Olasupo J, Alegbeleye T. Centralized electronic health records system: A step towards an optimized health care delivery system ahead of possible future outbreaks. International Journal of Intelligent Information Systems. 2021;10(1):1-4
  16. 16. Odeh C. SECTION THREE life cycle/special populations. In: Primary Care for the Physical Therapist: Examination and Triage. Elsevier. 2020:271
  17. 17. Morgan D, Lukong P, Haywood P, Di Paolantonio G. Examining Recent Mortality Trends: The Impact of Demographic Change. Documents de travail de l’OCDE sur la santé. 21 Nov 2023
  18. 18. Furton GL. The pox of politics: Troesken's tradeoff reexamined. Public Choice. Apr 2023;195(1):169-191
  19. 19. Avizenna MH. Applying the Apriori algorithm to analyze and optimize medical device inventory management. Journal of Applied Data Sciences. 2022;3(4):143-151
  20. 20. Yao L, Shang D, Zhao H, Hu S. Medical equipment comprehensive management system based on cloud computing and internet of things. Journal of Healthcare Engineering. 2021;2021(1):6685456
  21. 21. Milenkovic M, Ciric Lalic D, Vujicic M, Pesko I, Savkovic M, Gracanin D. Project portfolio management in telecommunication company: A stage-gate approach for effective portfolio governance. Project Management. 1 Sep 2023;30(5):539-553
  22. 22. Song Y, Ghafari Y, Asefnejad A, Toghraie D. An overview of selective laser sintering 3D printing technology for biomedical and sports device applications: Processes, materials, and applications. Optics & Laser Technology. 1 Apr 2024;171:110459
  23. 23. Relan M, Kumar M. Impact of Trust and Risk Factors on the Satisfaction Level of the Policy Holder towards Digital Bancassurance Model. International Research Journal of Management Sociology & Humanity (IRJMSH). 2023
  24. 24. Van Devender MS. Risk Assessment Framework for Evaluation of Cybersecurity Threats and Vulnerabilities in Medical Devices. Doctoral dissertation, University of South Alabama. 2023
  25. 25. Pamidimukkala A, Kermanshachi S. Impact of Covid-19 on field and office workforce in construction industry. Project Leadership and Society. 2021;19:23
  26. 26. Euchi J. Do drones have a realistic place in a pandemic fight for delivering medical supplies in healthcare systems problems? Chinese Journal of Aeronautics. 1 Feb 2021;34(2):182-190
  27. 27. Xu L, Sanders L, Li K, Chow JC. Chatbot for health care and oncology applications using artificial intelligence and machine learning: Systematic review. JMIR Cancer. 29 Nov 2021;7(4):e27850
  28. 28. Tang CS. Innovative technology and operations for alleviating poverty through women's economic empowerment. Production and Operations Management. Jan 2022;31(1):32-45
  29. 29. Kolade O, Odumuyiwa V, Abolfathi S, Schroder P, Wakunuma K, Akanmu I, et al. Technology acceptance and readiness of stakeholders for transitioning to a circular plastic economy in Africa. Technological Forecasting and Social Change. 2022;183:121954
  30. 30. Rupasinghe HV, Davis A, Kumar SK, Murray B, Zheljazkov VD. Industrial hemp (Cannabis sativa subsp. sativa) as an emerging source for value-added functional food ingredients and nutraceuticals. Molecules. 2020;25(18):4078
  31. 31. Voynova R. Legal balance between the human rights protection and the effectiveness of the criminal investigation. International Conference Knowledge-Based Organization. 2020;26(2):255-261
  32. 32. Cioeta R, Cossu A, Giovagnoni E, Rigoni M, Muti P. A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices. Frontiers in Drug Safety and Regulation. 2022;2:992359
  33. 33. Musamih A, Salah K, Jayaraman R, Yaqoob I, Puthal D, Ellahham S. NFTs in healthcare: Vision, opportunities, and challenges. IEEE Consumer Electronics Magazine. 2022;12(4):21-32
  34. 34. Deep A, Rana AC, Yadav M, Marwaha RK. Regulation of medical devices and their clinical trials studies in the USA: An update. Recent Innovations in Chemical Engineering (Formerly Recent Patents on Chemical Engineering). 2020;13(2):94-109
  35. 35. Karne S, Alappan R, DTCD D, Klebonis D, Donelson B. Basics about HIPAA for physicians. This Inaugural Issue of JAAPI is Dedicated to the following Legendary Indian Physicians. 2021;1(1):51-55
  36. 36. Bhartendu PS, Shukla S, Misra G. Good practices manufacturing in quality. In: Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices. CRC Press; 22 Apr 2024
  37. 37. Upadhyay A, Manzoor A, Bhushan B, Tewari S. Indian industries and biologicals. In: Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices. CRC Press. 2024:61
  38. 38. Sharma A, Luthra G. Implementing a risk-based approach to quality management system ISO-13485 processes in compliance with EUMDR 2017/745 for medical device industry. Journal of Pharmaceutical Research International. 2023;35(13):8-19
  39. 39. Domingo-Lopez DA, Lattanzi G, Schreiber LH, Wallace EJ, Wylie R, O'Sullivan J, et al. Medical devices, smart drug delivery, wearables and technology for the treatment of diabetes mellitus. Advanced Drug Delivery Reviews. 2022;185:114280
  40. 40. Ncube BM, Dube A, Ward K. Establishment of the African medicines agency: Progress, challenges and regulatory readiness. Journal of Pharmaceutical Policy and Practice. 2021;14(1):29
  41. 41. MacNeill AJ, Hopf H, Khanuja A, Alizamir S, Bilec M, Eckelman MJ, et al. Transforming the medical device industry: Road map to a circular economy: Study examines a medical device industry transformation. Health Affairs. 2020;39(12):2088-2097
  42. 42. Blankart CR, Dams F, Penton H, Kalo Z, Zemplenyi A, Shatrov K, et al. Regulatory and HTA early dialogues in medical devices. Health Policy. 2021;125(10):1322-1329
  43. 43. Mane SR, Bais SK, Dhane DD. A review: Perform quality control test for container closures and secondary packing material used in cosmetics. International Journal of Pharmacy and Herbal Technology. ISSN. 2583-8962
  44. 44. MacAdam K. Interoperability and the path to comprehensive health information exchange. NYU Annual Survey of American Law. 2020;76:743
  45. 45. Donner CF, ZuWallack R, Nici L. The role of telemedicine in extending and enhancing medical management of the patient with chronic obstructive pulmonary disease. Medicina. 18 Jul 2021;57(7):726
  46. 46. Hayes CJ, Dawson L, McCoy H, Hernandez M, Andersen J, Ali MM, et al. Utilization of remote patient monitoring within the United States health care system: A scoping review. Telemedicine and e-Health. 2023;29(3):384-394
  47. 47. Boikanyo K, Zungeru AM, Sigweni B, Yahya A, Lebekwe C. Remote patient monitoring systems: Applications, architecture, and challenges. Scientific African. 1 Jul 2023;20:e01638
  48. 48. Gerke S, Babic B, Evgeniou T, Cohen IG. The need for a system view to regulate artificial intelligence/machine learning-based software as medical device. NPJ digital medicine. 7 Apr 2020;3(1):53
  49. 49. Khan ZF, Alotaibi SR. Applications of artificial intelligence and big data analytics in m-health: A healthcare system perspective. Journal of Healthcare Engineering. 2020;2020(1):8894694
  50. 50. Kaparthi S, Bumblauskas D. Designing predictive maintenance systems using decision tree-based machine learning techniques. International Journal of Quality & Reliability Management. 2020;37(4):659-686
  51. 51. Khan MA. Challenges facing the application of IoT in medicine and healthcare. International Journal of Computations, Information and Manufacturing (IJCIM). Dec 2021;1(1)
  52. 52. Krishnamoorthy S, Dua A, Gupta S. Role of emerging technologies in future IoT-driven healthcare 4.0 technologies: A survey, current challenges and future directions. Journal of Ambient Intelligence and Humanized Computing. 2023;14(1):361-407
  53. 53. Degerli M, Ozkan YS. Enablers for IoT regarding wearable medical devices to support healthy living: The five facets. In: IoT in Healthcare and Ambient Assisted Living. Singapore: Springer; 2021. pp. 201-222
  54. 54. Casillo M, Cecere L, Colace F, Lorusso A, Santaniello D. Integrating the internet of things (IoT) in SPA medicine: Innovations and challenges in digital wellness. Computers. 2024;13(3):67
  55. 55. Naresh VS, Pericherla SS, Murty PSR, Reddi S. Internet of things in healthcare: Architecture, applications, challenges, and solutions. Computer Systems Science & Engineering. 1 Nov 2020;35(6)
  56. 56. Kumar K. A location-allocation model for implementing telemedicine services in primary healthcare network. Nonlinear Studies. 1 Oct 2022;29
  57. 57. Planchuelo-Gomez Å, Descoteaux M, Larochelle H, Hutter J, Jones DK, Tax CM. Optimisation of quantitative brain diffusion-relaxation MRI acquisition protocols with physics-informed machine learning. Medical Image Analysis. 1 May 2024;94:103134
  58. 58. Filchakova O, Dossym D, Ilyas A, Kuanysheva T, Abdizhamil A, Bukasov R. Review of COVID-19 testing and diagnostic methods. Talanta. 2022;244:123409
  59. 59. O'Toole JA, Schmid BSNSW, Level PTAE. Florida: Preventing Medical Errors for PTs and PTAs (311) Course Introduction. atrainceu.com
  60. 60. Taylor JK, Ahmed FZ. Clinical pathways guided by remotely monitoring cardiac device data: The future of device heart failure management? Arrhythmia & Electrophysiology Review. 2023;12
  61. 61. Kakhi K, Alizadehsani R, Kabir HD, Khosravi A, Nahavandi S, Acharya UR. The internet of medical things and artificial intelligence: Trends, challenges, and opportunities. Biocybernetics and Biomedical Engineering. 2022;42(3):749-771
  62. 62. Jin Z, He C, Fu J, Han Q, He Y. Balancing the customization and standardization: Exploration and layout surrounding the regulation of the growing field of 3D-printed medical devices in. Bio-Design and Manufacturing. Jul 2022;5(3):580-606
  63. 63. Shaikh Y, Parvati VK, Biradar SR. Role of IoT and bigdata analytics in healthcare for disease prediction. In: 2020 International Conference on Convergence to Digital World-Quo Vadis (ICCDW). IEEE; 18 Feb 2020. pp. 1-6
  64. 64. Lytras DM, Lytra H, Lytras MD. Healthcare in the times of artificial intelligence: Setting a value-based context. In: Artificial Intelligence and Big Data Analytics for Smart Healthcare. Academic Press; 1 Jan 2021. pp. 1-9
  65. 65. Batko K, Ślęzak A. The use of big data analytics in healthcare. Journal of Big Data. 2022;9(1):3
  66. 66. Nazir S, Khan S, Khan HU, Ali S, Garcia-Magarino I, Atan RB, et al. A comprehensive analysis of healthcare big data management, analytics and scientific programming. IEEE Access. 2020;8:95714-95733
  67. 67. de Mello BH, Rigo SJ, da Costa CA, da Rosa RR, Donida B, Bez MR, et al. Semantic interoperability in health records standards: A systematic literature review. Health and Technology. 2022;12(2):255-272

Written By

Ricardo Marcão, Stéphanie Monteiro, Vasco Santos, Filipa Martinho, Maria José Sousa, António Dionísio and Pedro Ramos

Submitted: 23 May 2024 Reviewed: 11 July 2024 Published: 13 December 2024