Sustainability across the medical device lifecycle : a scoping review

Medical devices are instrumental in servicing the healthcare sector and promoting well-being in modern societies. However, their production and use contribute significantly to greenhouse gas emissions, thus causing indirect harm to global health. With a share of approximately 4.4% of global emissions, the healthcare sector exhales CO2 throughout its value chain; sources of this range from direct electricity consumption and water heating in healthcare facilities to the supply chains delivering healthcare services and products. Within this context, the environmental impact of medical devices is present across their production, distribution, usage, and eventual disposal. Each step in the lifecycle of medical devices consumes energy and natural resources, and the end product, after its often single use, is discarded, generating plastic or electronic waste. This study aims to present the key findings from a scoping review of academic research on the topic, which focuses on reducing the environmental impact of medical devices and equipment. The review, conducted according to the PRISMA checklist for scoping reviews, examined 41 studies and categorised them based on the lifecycle stages of medical devices (design and development, manufacturing, usage, and end of life) and the sustainability aspects (economic, environmental, and social) discussed by the authors. The findings suggest that while efforts have been made to enhance economic and environmental sustainability throughout the design, development, and usage of medical devices, there is still room for improvement in mitigating their ecological impact at the end of their lifecycle and maximising their social impact by design

User involvement in healthcare technology development and assessment: Structured literature review

Purpose – Medical device users are one of the principal stakeholders of medical device technologies. User involvement in medical device technology development and assessment is central to meet their needs. Design/methodology/approach – A structured review of literature, published from 1980 to 2005 in peer-reviewed journals, was carried out from social science perspective to investigate the practice of user involvement in the development and assessment of medical device technologies. This was followed by qualitative thematic analysis. Findings – It is found that users of medical devices include clinicians, patients, carers and others. Different kinds of medical devices are developed and assessed by user involvement. The user involvement occurs at different stages of the medical device technology lifecycle and the degree of user involvement is in the order of design stage > testing and trials stage > deployment stage > concept stage. Methods most commonly used for capturing users’ perspectives are usability tests, interviews and questionnaire surveys. Research limitations/implications – We did not review the relevant literature published in engineering, medical and nursing fields, which might have been useful. Practical implications – Consideration of the users’ characteristics and the context of medical device use is critical for developing and assessing medical device technologies from users’ perspectives. Originality/value – This study shows that users of medical device technologies are not homogeneous but heterogeneous, in several aspects, and their needs, skills and working environments vary. This is important consideration for incorporating users’ perspectives in medical device technologies. Paper type: Literature review

Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process

Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP).Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP.Results: The suggested framework comprises two streams of users' involvement in MDT development, that is, what might be called the end users' stream and the professional users' stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users' involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented.Conclusions: Development of medical devices from users' perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users' requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users' involvement at different stages of the MDTDP

Medical device technologies: Who is the user?

A myriad of medical devices deployed by many users play an essential role in healthcare, and they, and their users, need to be defined, classified and coded effectively. This study provides definitions of terms frequently employed to describe the users of medical device technologies (MDT) as well as a classification of such users. Devices are widely used, developed and assessed by many others than clinicians. Thus, users of medical devices need to be classified in various relevant ways, such as primary and secondary users; user groups such as healthcare professionals, patients, carers, persons with disabilities, those with special needs, as well as professionals allied with healthcare. Proper definition and classification of MDT users is particularly important for integrating the users’ perspectives in the process of MDT development and assessment, as well as in relation to the regulatory, health and safety, and insurance perspectives concerning MDT

Benefits of and barriers to involving users in medical device technology development and evaluation

Objectives: This study investigated the benefits of, and barriers to user involvement in medical device technology development and evaluation. Methods: A structured review of published literature in peer-reviewed journals. Results: This review revealed that the main benefits of user involvement were an increased access to user needs, experiences and ideas; improvements in medical device designs and user interfaces; and an increase in the functionality, usability and quality of the devices. On the other hand, resource issues, particularly those of time and money were found the key impediments to involving users in the development and evaluation of medical device technologies. This study has categorised both the benefits and barriers to user involvement also. Conclusions: The involvement of users in MDTD&E requires resources, which are limited; however, it is essential from both users and manufacturers perspectives

The Future of Medical Device Regulation and Standards: Dealing with Critical Challenges for Connected, Intelligent Medical Devices

The paper reviews the main trends in the existing standards and regulatory landscape applicable to connected, intelligent medical devices (CIMDs) and captures critical challenges and potential gaps in this area. Based on interviews and a roundtable with key experts and practitioners in the field, the White Paper identifies several critical challenges that should inform the future development of standards and guidelines applicable to CIMDs, with a specific focus on artificial intelligence, cybersecurity, and data governance issue

Strategies for Reducing Adverse Medical Events from Implanted Medical Devices

Managing medical device monitoring processes is challenging and lacks a realtime, life cycle tracking strategy to reduce adverse medical events and revision costs for hospital administrators, physicians, and patients. Understanding the malfunctions of medical devices for cardiac and orthopedic patients could save lives and reduce hospital liability. Grounded in the business process reengineering conceptual framework, the purpose of this single qualitative case study was to explore strategies hospital managers used to redesign the implant recall surveillance process at one hospital in Pennsylvania. The 5 participants selected successfully implemented a medical device surveillance process that reduced adverse medical events and revision costs. Data were collected using semistructured interviews and a review of relevant medical device surveillance workflow documents. The 4 themes that emerged from a thematic analysis were effective data communication process, central data repository integration, continuous process improvement, and end-to-end surveillance process. A key recommendation for hospital administrators, physicians, and managers is to use blockchain distributed ledger technology to assess device identification challenges as part of the surveillance process to reduce health risks. The implication for positive social change includes the potential to improve the quality of life for medical device recipients who may spend less on healthcare services

Towards safer medical device software systems: Industry-wide learning from failures and the use of safety-cases to support process compliance

© 2016 IEEE. Software safety is checked today in regulatory audits, which verify software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which software is developed but does not necessarily indicate the quality of the resultant software. Since medical device domain is facing an increasing amount of device recalls due to software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how medical device software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the medical device domain and suggest the use of systems thinking. We then propose two improvements to medical device software development where process compliance is supported by safety cases and industry-wide learning from experience

Emerging Digital Technologies in Patient Care: Dealing with connected, intelligent medical device vulnerabilities and failures in the healthcare sector

The integration of the Internet of Medical Things (IoMT) and Artificial Intelligence (AI) into clinical routines is significantly impacting organisational preparedness at the point of care, raising concerns not only about the resilience of the healthcare infrastructure, but also about how physicians, clinicians, and healthcare professionals respond to, manage, and reduce new risks associated with connected and intelligent medical devices in the interest of patient safety and care. The following report summarises findings from the workshop entitled Emerging Digital Technologies in Patient Care: Dealing with Connected, Intelligent Medical Device Vulnerabilities and Failures in the Healthcare Sector, held on 23 February 2023 at Goodenough College, London. The workshop was organised by members of the Reg-MedTech project, funded by the PETRAS National Centre of Excellence in IoT Systems Cybersecurity (EPSRC grant number EP/S035362/1), in collaboration with project partners at the BSI, the UK’s National Standards Body. Since October 2021, the Reg-MedTech project has investigated the extent to which current regulatory frameworks and standards address the critical cybersecurity, data governance, and algorithmic integrity risks posed by connected and intelligent medical devices. A critical finding from its ongoing research has been the need to develop standards, regulations, and policies that are better informed by the experiences of physicians, clinicians, and healthcare professionals dealing with software-based medical devices or software as a medical device (SaMD) in their day-to-day practice

Discrete choice experiment versus swing-weighting:A head-to-head comparison of diabetic patient preferences for glucose-monitoring devices

Introduction Limited evidence exists for how patient preference elicitation methods compare directly. This study compares a discrete choice experiment (DCE) and swing-weighting (SW) by eliciting preferences for glucose-monitoring devices in a population of diabetes patients. Methods A sample of Dutch adults with type 1 or 2 diabetes (n = 459) completed an online survey assessing their preferences for glucose-monitoring devices, consisting of both a DCE and a SW exercise. Half the sample completed the DCE first; the other half completed the SW first. For the DCE, the relative importance of the attributes of the devices was determined using a mixed-logit model. For the SW, the relative importance of the attributes was based on ranks and points allocated to the ‘swing’ from the worst to the best level of the attribute. The preference outcomes and self-reported response burden were directly compared between the two methods. Results Participants reported they perceived the DCE to be easier to understand and answer compared to the SW. Both methods revealed that cost and precision of the device were the most important attributes. However, the DCE had a 14.9-fold difference between the most and least important attribute, while the SW had a 1.4-fold difference. The weights derived from the SW were almost evenly distributed between all attributes. Conclusions The DCE was better received by participants, and generated larger weight differences between each attribute level, making it the more informative method in our case study. This method comparison provides further evidence of the degree of method suitability and trustworthiness.</p