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The European Union (EU) Medical Device Regulations (MDR) 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study aims to investigate the impact of these strengthened requirements on medical device manufacturers by investigating the challenges they encounter while generating an MDR-compliant clinical evaluation report.

A systematic literature review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method of peer-reviewed literature and various government jurisdictional reports and legislation.

The findings from the study understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant clinical evaluation report. Resulting from the challenges they are facing, manufacturers of certain CE-marked medical devices are planning to remove (and have removed) devices from the EU market upon expiration of their certificate, and in the case of new and innovative devices, some manufacturers are planning to launch in other markets ahead of the EU. These challenges will lead to a potential shortage of certain medical devices in the EU and a delay in access to new devices, thereby negatively impacting patients’ quality of life.

This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the EU. A limitation is the lack of literature analysing the regulations and their effects.

This study has both theoretical contributions in that, to the best of the authors’ knowledge, it is the first detailed and systematic review of the new MDR Regulations and has implications for practice as manufacturers and policymakers can leverage it alike to understand the challenges of the new MDR.

Some studies have been reported in the past on diaphragmatic hernia (DH) surgery techniques using additive manufacturing (AM) technologies, symptoms of a hernia and post-surgery complications. But hitherto little has been reported on bibliographic analysis (BA) for health monitoring of bovine post-DH surgery for long-term management. Based on BA, this study aims to explore the sensor fabrication integrated with innovative AM technologies for health monitoring assistance of bovines post-DH surgery.

A BA based on the data extracted through the Web of Science database was performed using bibliometric tools (R-Studio and Biblioshiny).

After going through the BA and a case study, this review provides information on various 3D-printed meshes used over the sutured site and available Internet of Things-based solutions to prevent the recurrence of DH.

Research gaps exist for 3D-printed conformal sensors for health monitoring of bovine post-DH surgery.

The theory of managerial discretion and the direct insights it provides in the understanding of the varying impact strategic and operational actions have on organizational change and business fortunes is an area of research potential underexplored in the UK. This study aims to establish whether the measurement of managerial discretion is constant between the two similar societal corporate frameworks of the UK and the USA listed markets.

The extant managerial discretion ranking model, established in the USA, is empirically assessed for its validity and effectiveness across a sample of high- and low-discretion companies from the FTSE 350.

Using accounting measures, a clear and significant difference is established between UK high and low managerial discretion entities. The results prove to be significant in enabling the differential comparative analysis of the institutional characteristics of corporates.

To the best of the authors’ knowledge, no study of this nature has been conducted previously in the UK context. While the original model developed in the USA is now several decades old, the UK results reflect similar industry rankings as found originally in the USA, subject to some differences considered to be a result of the changing nature of global business since the 1990s. This study opens a new seam of novel research, which has the potential to uncover, at a granular level, the differential mores and character of management ethics, styles and practices in such issues as organizational change, corporate culture, governance and social responsibility.

The future increase of chronic diseases in the world requires new challenges in the health domain to improve patients' care from the point of view of the organizational processes, clinical pathways and technological solutions of digital health. For this reason, the present paper aims to focus on the study and application of well-known clinical practices and efficient organizational approaches through an innovative model (TALIsMAn) to support new care process redesign and digitalization for chronic patients.

In addition to specific clinical models employed to manage chronic conditions such as the Population Health Management and Chronic Care Model, we introduce a Business Process Management methodology implementation supported by a set of e-health technologies, in order to manage Care Pathways (CPs) digitalization and procedures improvement.

This study shows that telemedicine services with advanced devices and technologies are not enough to provide significant changes in the healthcare sector if other key aspects such as health processes, organizational systems, interactions between actors and responsibilities are not considered and improved. Therefore, new clinical models and organizational approaches are necessary together with a deep technological change, otherwise, theoretical benefits given by telemedicine services, which often employ advanced Information and Communication Technology (ICT) systems and devices, may not be translated into effective enhancements. They are obtained not only through the implementation of single telemedicine services, but integrating them in a wider digital ecosystem, where clinicians are supported in different clinical steps they have to perform.

The present work defines a novel methodological framework based on organizational, clinical and technological innovation, in order to redesign the territorial care for people with chronic diseases. This innovative ecosystem applied in the Italian research project TALIsMAn is based on the concept of a continuum of care and digitalization of CPs supported by Business Process Management System and telemedicine services. The main goal is to organize the different socio-medical activities in a unique and integrated IT system that should be sustainable, scalable and replicable.

Multinational enterprises (MNEs) in the agri-food sector are continuously transforming their global value chains (GVCs) to address sustainable development challenges of food security (SDG2) and climate change (SDG13). However, the central role of non-governmental organisations (NGOs) in (re)creating GVCs across multilevel stakeholders through innovative approaches to solve sustainability challenges remains under investigated. This explorative study investigates how international NGOs influence the transformation of large-scale industrial animal agriculture to a more sustainable (cell-based) agri-food GVC. The authors conducted a case study on the Good Food Institute (GFI), an international NGO, that has been an active player in the transition to alternative sources of protein to solve animal-based agriculture sustainability issues. The results show that an international NGO can contribute to the transition to a more sustainable GVC and can enhance the GVC’s innovation capabilities.

This paper aims to examine the association between the dietary inflammatory index, the consumption of Enteral Nutrition Supplemented with probiotics with certain serum inflammation markers and gastrointestinal complications among individuals diagnosed with COVID-19.

This cross-sectional investigation involved 100 COVID-19 patients who were admitted to intensive care units in hospitals. These patients were administered two different types of Enteral Nutrition, so the dietary inflammatory index (DII), gastrointestinal complications and some serum inflammation markers have been compared between two groups.

The mean DII scores in all patients were significantly pro-inflammatory (probiotic formula 2.81 ± 0.01 vs usual formula group 2.93 ± 0.14 p = 0.19). The probiotic formula consumption had an inverse association with High-sensitivity C-reactive Protein concentration (coef = −3.19, 95% CI −1.25, −5.14 p = 0.001) and lead to a reduction of 2.14 mm/h in the serum level of Erythrocyte sedimentation rate compared to normal formula. The incidence of diarrhea, abdominal pain and vomiting in probiotic formula patients was respectively 94%, 14% and 86% less than in usual formula patients (p = 0.05).

In this cross-sectional study for the first time, the authors found that probiotic formula consumption was inversely associated with serum inflammation markers and gastrointestinal complications incidence. The high DII leads to more gastrointestinal complications incidence and inflammation markers. More studies are needed to prove this relationship.

The aim was not to perform a systematic review but firstly to search in PubMed, Science Direct, Scopus and Web of Science databases on the papers published in the last five years using tools for reviewing the statement of preferred information item for systematic reviews without focusing on a randomized analysis and secondly to perform a bibliometric analysis on the properties of films and coatings added of tocopherol for food packaging.

On January 24, 2022, information was sought on the properties of films and coatings added of tocopherol for use as food packaging published in PubMed, Science Direct, Scopus and Web of Science databases. Further analysis was performed using bibliometric indicators with the VOSviewer tool.

The searches returned 33 studies concerning the properties of films and coatings added of tocopherol for food packaging, which were analyzed together for a better understanding of the results. Data analysis using the VOSviewer tool allowed a better visualization and exploration of these words and the development of maps that showed the main links between the publications.

In the area of food science and technology, the development of polymers capable of promoting the extension of the shelf life of food products is sought, so the knowledge of the properties is vital for this research area since combining a biodegradable polymeric material with a natural antioxidant active is of great interest for modern society since they associate environmental preservation with food preservation.

The purpose of this paper is to explore the determinants of entrepreneurs’ subjective social status perception (SSP) on firm international behaviors based on the upper echelons theory and social class theory.

To test the hypotheses, the authors studied a large sample of 10,823 small- and medium-sized private Chinese enterprises from 2006 to 2014.

The results showed that entrepreneurs with higher status perception prefer international activity and firms have higher export intensity and intention. In addition, the social capital of entrepreneurs and institutional environment amplifies the positive relationship between SSP and international behavior.

This paper contributes to research on the upper echelon of management and extends our understanding of how managerial social characteristics influence international strategic decision-making. Besides, it also contributes to the emerging stream of social status research in international expansion studies and expand researchers’ limited understanding of the effects of social status in business settings.

Drawing on the reasoned action theory, this study aims to examine the impact of environmental knowledge (EK) and environmental sustainability performance (EP) on environmental behavior (EB) mediated by environmental attitude (ATT). Furthermore, to examine the moderating effect of environmental advertising (ADD) on the indirect relationship between EP and EB, mediated by ATT on the one hand, and EK on EB, on the other hand, mediated by ATT.

The data were gathered within an international context for passengers from North African countries (NAC) (Egypt, Algeria, Tunisia, Libya, Morocco and Sudan) using primary quantitative data from online and self-administered questionnaires. A total of 1,052 questionnaires were collected from passengers who traveled through Egyptian airports. The collected data were analyzed through covariance-based structural equation modeling.

The findings indicated that ATT moderates the relationship between environmental knowledge and behavior. In addition, ATT mediates the airports' environmental behavior and environmental sustainability performance. Moreover, ADD moderates the indirect association between EP and individuals' environmental knowledge and behavior through the mediated effect of ATT.

This research output will help extend the theory’s scope by conceptualizing its abstract ideas using research variables and applying them in NAC countries. This can be a milestone for altering individuals' behavior toward the environment in airports.

This study aims to assist airport authorities in the development of standards for enhancing environmental performance. Enhancing environmental issues is of utmost importance, especially in the context of airports, which have been a subject of significant environmental concern. This study examined the environmental practices of airport passengers in NAC, given their significant role as the primary source of greenhouse gas emissions on the African continent. The present approach has the potential to be utilized in modifying airport conduct and enhancing stakeholder engagement, specifically within the context of NAC.

The objective of this study is to enhance the relationship between nature and humans by endeavoring to modify human attitudes toward the environment. The objective of this initiative is to bridge the current disparity in the socio-environmental connection by fostering environmental consciousness among individuals who utilize airport facilities. The objective will be accomplished by the construction of a theoretical framework that integrates crucial elements acknowledged for their substantial influence on altering human attitudes, thus fostering a greater sense of environmental consciousness and ultimately improving societal well-being.

Since the global supply chain prioritizes environmental transportation systems, this study provides a conceptual framework for airport authorities to develop and create policies to push air passengers' behavior toward environmental practices in NAC.