This paper examines the role of remanufacturing in healthcare as a key circular design strategy, particularly for medical devices, assessing its socio-technical, environmental, and economic dimensions of sustainability. Through a detailed case of ultrasound catheters, it demonstrates how remanufacturing can lead to resource conservation, cost savings, and enhanced product lifecycles in health care without compromising quality and patient safety. The study argues for systemic changes in healthcare practices to fully integrate remanufacturing, underscoring its role beyond a technical solution.

Cybersecurity of medical devices has become a concrete concern for regulators and policymakers in the European Union and United States. Following the COVID-19 pandemic, there has been an increase in cyber-attacks on critical healthcare infrastructures and their IT systems, which have suffered service disruptions and put patients’ health and safety at risk. The increase in cyberattacks on healthcare infrastructure, including medical devices, exacerbated by the growing digitalisation of healthcare services in the EU and the US, has led legislators and regulatory bodies to pay more attention to cybersecurity. Cybersecurity of AI-based medical devices requires the assessment of three areas subject to evolving regulatory approaches: medical devices, Artificial Intelligence (AI), and cybersecurity. Although they may appear distinguished in regulatory matters, the existence of AI-based medical devices and their possible cyber vulnerabilities makes clear that the three are intertwined and deserve closer attention from a regulatory point of view. Few scholars have devoted attention to AI and cybersecurity together. Even less, in our understanding, few comprehensive and EU/US comparative pieces of literature reflect on this specific issue. This paper aims to fill this gap and address the main implications of different regulatory approaches toward AI medical device cybersecurity in the EU and the US. The research stems from the assumption that regulation of medical devices in the EU has been historically inspired by regulatory trends in the US, although with the different cultural, societal, and legal traditions that made them adapt to the specificities of the territory. The paper observes that the US is a rule-based system reflecting a “command-and-control” approach, while the EU system is a principle-based one. While they share the main characteristic of being risk-regulation-based systems, their differences impact how AI-enhanced cybersecurity is regulated.

Interest in applying a “lean” philosophy to design has been slowly growing in recent years, but there are still few broadly applicable methodologies and illustrative cases published in the literature to guide lean design processes. Lean approaches promise cost reduction and increased product value, which could be particularly beneficial in product development for low- and middle-income country markets, where value demands are high. We use the clinical need of efficient diabetic foot risk assessment in lowresource healthcare settings to present an example of lean early-stage design of a medical device. The background of existing medical literature and commercial products is intentionally leveraged throughout the design process to streamline development and minimize the need for independent validation of product strategies and design features. Our approach resulted in an efficient design process that generated a novel, purely mechanical plantar pressure evaluation device that can indicate high risk of diabetic foot ulcer in resource-constrained settings. This case provides a practical example of how design processes can be adapted to be leaner where there are large gains from minimizing design cycle time and cost.

The aim of this systematic review is to evaluate the impact of personal protective equipment (PPE) on medical device use during public health emergency responses. We conducted a systematic literature search of peer-reviewed journals in PubMed, Web of Science, and EBSCO databases. Twenty-nine of 92 articles published between 1984 and 2015 met the inclusion criteria for the review. Although many medical device use impacts were reported, they predominantly fell into 3 categories: airway management, drug administration, and diagnostics and monitoring. Chemical, biological, radiological, and nuclear (CBRN)-PPE increased completion times for emergency clinical procedures by as much as 130% and first attempt failure rates by 35% (anesthetist) versus 55% (non-anesthetist). Effects of CBRN-PPE use depend on device, CBRN-PPE level, and clinician experience and training. Continuous clinical training of responders in CBRN-PPE and device modifications can improve safety and effectiveness of medical device use during public health emergency response.

Technological advancements in medical devices developed for adults far outpace the development of technologies designed for pediatric patients in the USA and other countries. This technology lag was previously reflected in a lack of pediatric-specific innovation within our academic institution. To address the institutional deficit of device innovation around pediatric patients, we formed unique partnerships both within our university and extending to the medical device industry, and developed novel programmatic approaches. The Pediatric Device Innovation Consortium (PDIC) bridges the medical device community and the University of Minnesota. Since 2014, the PDIC has supported 22 pediatric medical technology innovation projects, provided funds totaling more than $500,000, licensed two technologies, and advanced two technologies to patient use. Here, we describe the PDIC model and method, the PDIC approach to common challenges that arise in the development of small-market medical technologies at an academic institution, and iterations to our collaborative, multidisciplinary approach that have matured throughout our experience. The PDIC model continues to evolve to reflect the special needs of innovation for smaller markets and the unique role of clinician innovators. Our approach serves as a successful model for other institutions interested in creating support mechanisms for pediatric or small-market technology development.

Objectives: For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being, but a standardized method for measuring these benefits is unavailable. The objective was to explore potential patient benefits provided by medical devices, and to assess the relative preferences of these benefits in the general Swedish population.

Methods: To identify attributes of patient benefit, healthcare personnel within a wide range of disease areas were interviewed. The generalized attributes were then validated among healthcare personnel, patient organizations, and manufacturers; in two pilot studies in the general population; and in two rounds of cognitive interviews. The general population's preferences of the attributes were measured with a usability-tested questionnaire in a final responding sample of 3,802 individuals, representative of the Swedish population.

Results: Twenty attributes were identified, encompassing aspects of integrity, sense of security, social participation, and convenience. When measuring the relative preferences, the response rate was 37.0 percent, and the results showed that the attributes with the highest preferences concerned reliability, reduced need for assistance, and sense of control of the illness/disability.

Conclusions: A set of twenty attributes of patient benefit relevant to users of medical devices was identified and validated. A questionnaire for patient-reported assessment of the benefits provided by a medical device was developed, based on the attributes. The questionnaire, designated MedTech20, provides a generic measurement method for the evaluation of medical devices used in a wide range of diseases/disabilities.

Objectives: Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers’ insights into Hb-HTA processes.

Methods: A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers’ market access strategies was administered.

Results: Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity.

Conclusions: Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

Objectives: This study aims to analyze the key factors considered for the first application of the National Committee for the Evaluation of Medical Devices (CNEDiMTS) for achieving reimbursement through registration in the list of products and services qualifying for reimbursement (LPPR).

Methods: All the appraisals studied on medical devices (MD) for first inclusion in the LPPR during 2011 and 2012 were retrieved from the French National Authority for Health or Haute Autorité de santé (HAS) Web site. A list of relevant factors was analyzed for each included opinion, followed by univariate and multivariate analyses to highlight the key factors that impacted the expected benefit (EB) provided by HAS.

Results: A total of 151 appraisals were included in the study. Of them, 94 (62 percent) were granted with sufficient EB. The manufacturers were mostly from the United States (36 percent), while most of the applicants were from France (84 percent). After adjusting for other retrieved factors, it was observed that MDs complying with the technical standards, requests supported by opinion(s) from previous generation of MD, and the presence of recommendations or guidelines had more probability to obtain a sufficient EB. A lower probability was related to MDs supported by low-quality studies and with no specific health public benefit.

Conclusions: Our results confirmed that manufacturers seeking reimbursement should be aware of the expectations of the health authorities (level of evidence, technical standard, etc.) and foresee their plan of sending requests for funding so that they can provide evidence of good quality.

Objectives: Economic evaluations, although not formally used in purchasing decisions for medical devices in Canada, are still being conducted and published. The aim of this study was to examine the way that prices have been included in Canadian economic evaluations of medical devices.

Methods: We conducted a review of the economic concepts and implications of methods used for economic evaluations of the eleven most implanted medical devices from the Canadian perspective.

Results: We found Canadian economic studies for five of the eleven medical devices and identified nineteen Canadian studies. Overall, the device costs were important components of total procedure cost, with an average ratio of 44.1 %. Observational estimates of the device costs were obtained from buyers or sellers in 13 of the 19 studies. Although most of the devices last more than 1 year, standard costing methods for capital equipment was never used. In addition, only eight studies included a sensitivity analysis for the device cost. None of the sensitivity analyses were based on actual price distributions.

Conclusions: Economic evaluations are potentially important for policy making, but although they are being conducted, there is no standardized approach for incorporating medical device prices in economic analyses. Our review provides suggestions for improvements in how the prices are incorporated for economic evaluations of medical devices.

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.

Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.

Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.

Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.

Rationale: Bayesian methods provide an interesting approach to assessing an implantable medical device (IMD) that has evolved through successive versions because they allow for explicit incorporation of prior knowledge into the analysis. However, the literature is sparse on the feasibility and reliability of elicitation in cases where expert beliefs are used to form priors.

Objectives: To develop an Internet-based method for eliciting experts’ beliefs about the success rate of an intracranial stenting procedure and to assess their impact on the estimated benefit of the latest version.

Study Design and Setting: The elicitation questionnaire was administered to a group of nineteen experts. Elicited experts’ beliefs were used to inform the prior distributions of a Bayesian hierarchical meta-analysis model, allowing for the estimation of the success rate of each version. RESULTS: Experts believed that the success rate of the latest version was slightly higher than that of the previous one (median: 80.8 percent versus 75.9 percent). When using noninformative priors in the model, the latest version was found to have a lower success rate (median: 83.1 percent versus 86.0 percent), while no difference between the two versions was detected with informative priors (median: 85.3 percent versus 85.6 percent).

Conclusions: We proposed a practical method to elicit experts’ beliefs on the success rates of successive IMD versions and to explicitly combine all available evidence in the evaluation of the latest one. Our results suggest that the experts were overoptimistic about this last version. Nevertheless, the proposed method should be simplified and assessed in larger, representative samples.

Objectives: The objectives of this systematic literature review were to identify all published literature on wearable defibrillators, assess the wearable defibrillator's efficacy and effectiveness in general and among specific patient groups, including post-myocardial infarction, post coronary artery bypass grafting or percutaneous coronary intervention, non-ischemic cardiomyopathy, and ischemic cardiomyopathy, and to evaluate the quality of evidence.

Methods: The search and synthesis was informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation and the Newcastle Ottawa Scale.

Results: A total of thirty-six articles and conference abstracts from thirty-three studies were included in the review. It appears that wearable defibrillator use compared with no defibrillator use reduces the chance of ventricular tachycardia and ventricular fibrillation (VT/VF) associated deaths by an absolute risk reduction of approximately 1 percent, achieved by averting approximately 4/5th of all VT/VF associated deaths. The quality of evidence was low to very low quality, such that our confidence in the reported estimates is weak.

Conclusions: To validate beneficial results, further investigation using robust study designs conducted by independent researchers is warranted.