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BACKGROUND: The physical and mental health of corporate employees is equally important, especially for international salespeople in the in vitro diagnostic (IVD) medical device industry. The rapid growth of the IVD market is driven by the increasing prevalence of chronic and infectious diseases. This study aims to determine the prevalence of depression, anxiety, and somatic symptoms among international salespeople in China's IVD industry and identify the association of socio-demographic, occupational, organizational, and psychosocial factors with mental health outcomes for depression, anxiety, and somatic symptoms in Chinese IVD international salespeople. METHODS: The study was a cross-sectional survey of international salespeople (ISs) in IVD companies officially registered in China. An online survey was designed to collect data through email contact with IVD companies and social media between August 2022 and March 2023. Measured factors included effort-reward imbalance (ERI), health-promoting leadership (HPL), health climate (HC), inner strength (IS), and perceived social support (PSS). Mental health outcomes assessed using the Core Symptom Index (CSI) were depression, anxiety, and somatic symptoms. RESULTS: A total of 244 salespeople responded to the survey. CSI scores indicated that 18.4% (n = 45) and 10.2% (n = 25) of the respondents had symptoms of major depression and anxiety, respectively. ERI was positively correlated, while the IS and PSS were negatively correlated with major depression, anxiety, and somatic symptoms (p < 0.01). The health climate was negatively correlated with major depression (p < 0.05). Education background was associated with somatic symptoms (p < 0.05). ERI, IS, and gender were significant predictors of major depression, anxiety, and somatic symptoms (p < 0.05). CONCLUSION: The prevalence of depression and anxiety in China's IVD international salespeople was considered low compared with the prevalence in Chinese populations during COVID-19 but higher than those before the pandemic. Effort-reward imbalance, inner strength, and gender were significant factors in major depression, anxiety, and somatic symptoms among IVD international salespeople.
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Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.
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Sistemas de Apoio a Decisões Clínicas , Humanos , Comércio , Europa (Continente)RESUMO
AIM: To analyse the nature and extent of sponsorship of nursing professional associations and their major scientific conferences. DESIGN: Cross-sectional content analysis. METHODS: Data were extracted from the websites and conference documents of 156 national and international professional nursing associations in 2019 to identify sponsors. Sponsorship prospectuses were analysed to estimate the value and describe the nature of sponsorship arrangements. We analysed sponsorship patterns using social network analysis. RESULTS: Most associations (84/156, 54%) did not report any sponsors. Sponsorship was concentrated among specialty nursing associations in high-income countries. Half of identified sponsors promoted products used in clinical care (50%; 981/1969); the majority represented the medical device industry (69%; 681/981). Top sponsors generally favoured opportunities that promoted interaction with conference attendees. CONCLUSION: Globally, commercial sponsorship of nursing associations is a common, but not the dominant source of support for these activities. Half of sponsors were commercial entities that manufactured or distributed products used during clinical care, which presents a risk of commercial influence over education and ultimately, clinical practice. Sponsors favoured opportunities to interact directly with nurses, determine educational content, or foster continued interaction.
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Estudos Transversais , HumanosRESUMO
Since 2019, China has been the second largest medical device market in the world. At present, high-end radiotherapy equipment such as particle therapy system has a huge market potential due to the grim situation of cancer prevention and control and the growth of people's wealth in China. However, China's MedTech industry, especially the particle therapy equipment field, still faces the influence of policy, fluctuation of market demand, strengthening of industry supervision, and even geopolitical realities. This paper reviews the market prospect of particle therapy medical devices from the perspective of China's medical device policy and demand information analysis, which is conducive to the research on the industrial layout of particle therapy medical physics, and also helps high-performance medical device manufacturers to expand their business visions. MedTech manufacturers should actively adjust their business strategy and implement scientific and technological innovation on the basis of compliance with industry regulatory requirements in order to seize opportunities from challenges and gain profits growth.
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Comércio , Indústrias , China , HumanosRESUMO
The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.
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Aprovação de Equipamentos , Equipamentos e Provisões , Reforma dos Serviços de Saúde , Ortopedia , Pesquisa Comparativa da Efetividade , Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Aprovação de Equipamentos/normas , Desenho de Equipamento , Equipamentos e Provisões/economia , Regulamentação Governamental , Indústrias/legislação & jurisprudência , Indústrias/estatística & dados numéricos , Invenções , Legislação de Dispositivos Médicos , Impostos , Estados Unidos , United States Food and Drug AdministrationRESUMO
BACKGROUND: Interactions between pharmaceutical and medical device industries and students can lead to commercial influences on educational messages, with a potential to bias future treatment choice. This is the first study in the Baltic countries describing exposure and attitudes of medical, pharmacy and nursing students towards cooperation with industry. METHODS: A cross-sectional on-line survey of current medical, pharmacy and nursing students (n = 918) in three Baltic countries was carried out. RESULTS: We found that most students participate in events organized or sponsored by industry and accept a range of gifts and benefits. Students in the Baltic countries consider cooperation with industry important; at the same time, most do not feel that they have sufficient training on how to ethically interact with pharmaceutical and medical device companies and believe that these interactions can influence their prescribing or dispensing patterns. There is a tendency to rationalize cooperation with industry by referring to the current economic situation and patient benefits. Pharmacy students have higher rates of participation and they accept gifts and other benefits more often than nursing or medical students; therefore, they are likely to be more vulnerable to potential industry influence. CONCLUSIONS: The findings highlight the need to include topics on ethics and conflicts of interests in cooperation with industry in curriculum of health care students in Baltic countries. Without proper training, students continue to be at risk to industry influence and may develop habits for their further practice differing from evidence-based practice in prescribing and dispensing of medicines, as well as use of medical devices.
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Indústria Farmacêutica/ética , Equipamentos e Provisões/ética , Relações Interprofissionais/ética , Estudantes de Ciências da Saúde/estatística & dados numéricos , Atitude do Pessoal de Saúde , Estudos Transversais , Currículo , Estônia , Humanos , Letônia , Lituânia , Estudantes de Ciências da Saúde/psicologiaRESUMO
This study examines the medical device industry in the context of the Fourth Industrial Revolution and identifies the key strategies and general directions for promoting this industry through analytical hierarchy process (AHP). It is based on discussions of the key issues with specialists such as doctors, medical device companies, hospital staff, professors, and government agencies in the medical device industry. A total of 18 responses were obtained from the survey, and an analysis was conducted on the results. Among the medical device strategies identified by the surveyed specialists, clarifying the application of regulations (access strategy), increasing R&D investment for the technological development of medical devices (expansion strategy), and increasing support for global market expansion (infrastructure expansion strategy) were found to have the highest priority. Based on the above, we suggest key strategies and directions for promoting the medical device industry.
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Atitude do Pessoal de Saúde , Equipamentos e Provisões/economia , Pessoal de Saúde/psicologia , Avaliação das Necessidades/organização & administração , Serviço Hospitalar de Compras/organização & administração , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , República da Coreia , Inquéritos e Questionários , Adulto JovemRESUMO
This study analyzes the legislation process of the Korean government regarding the development of the medical device industry in the perspective of the issue network. It also aims to identify the difference in network structure between conservative and progressive governments and analyze major issues and stakeholders. It examines the network structure in the legislation process of the government to develop and support the medical device industry through social network analysis (SNA). This study conducted a policy network structure analysis of the conservative and progressive governments. SNA was used for the structure analysis, using the contents of newspaper articles as the baseline data related to the medical device industry. We analyze using the 2-mode network analysis that the node centrality is determined by eigenvector centrality. The more nodes with great power (stakeholders, information, resources) it is linked to, the greater power centrality (eigenvector centrality) it will have, which indicates that it has great influence within the network. The conservative government discussed the promotion of the medical device industry led by government departments, focusing on its potential as a future growth engine. On the contrary, the progressive government tended to have fewer stakeholders and issues around the idea, shifting the stakeholders that lead the promotion of the industry from government departments to relevant interest groups, and focusing more on policy issues like transparency than on economic issues. We identify implications to legislate the relevant act by analyzing the relevant stakeholders and issues around legislation, while reinforcing the competitiveness of Korea's medical device industry in the larger global framework. We believe that this study would comprehensively addresses the pros and cons of the government-led promotion of the medical device industry in Korea, as well as the key issues for stakeholders, which can be applicable to many other societies.
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Equipamentos e Provisões , Programas Governamentais/legislação & jurisprudência , Formulação de Políticas , Humanos , PolíticaRESUMO
PURPOSE: This study aimed to set priorities for improving the medical device distribution structure and to suggest an innovative improvement plan for the distribution structure using the analytic hierarchy process (AHP) method, focusing on stakeholders in the medical device industry. METHODS: This study conducted a survey with 35 specialists using the AHP method, which is a multiple-criteria decisionmaking methodology, in order to set priorities for improvement plans to address the problems faced by the medical device distribution structure. RESULTS: The AHP analysis showed that supply stability was the most important factor, followed by greater transparency, efficiency, smart supply, and cost reduction. CONCLUSIONS: It is necessary to establish a stable supply system and manage crises through supply stability, as well as to provide opportunities for fair trade through greater transparency. As steps towards those goals, we propose establishing a unique device identification system, an information disclosure system, online distribution, and a group purchasing organization system in Korea.
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Relationships between health care providers and industry can generate conflicts of interest with their attendant harms. However, the types of relationships that involve conflicts of interest have often been understood narrowly as material ones between individual clinicians and industry. In research we undertook with surgical teams, we found the role of industry representatives has become normalized in the context of surgical innovation. In this article, we report the findings of our study and unpack the features of both surgery and innovation which contribute to the scope and normalization of industry involvement. We argue that these relationships generate significant ethical challenges and conclude by commenting on how our conceptualization of the situation might inform change.
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Atitude do Pessoal de Saúde , Conflito de Interesses , Difusão de Inovações , Cirurgia Geral/ética , Pessoal de Saúde , Indústrias/ética , Pessoal Administrativo , Educação Continuada , Humanos , Marketing , Enfermeiras e Enfermeiros , Pesquisa Qualitativa , Cirurgiões , Inquéritos e QuestionáriosRESUMO
PURPOSE: This study aimed to set priorities for improving the medical device distribution structure and to suggest an innovative improvement plan for the distribution structure using the analytic hierarchy process (AHP) method, focusing on stakeholders in the medical device industry. METHODS: This study conducted a survey with 35 specialists using the AHP method, which is a multiple-criteria decisionmaking methodology, in order to set priorities for improvement plans to address the problems faced by the medical device distribution structure. RESULTS: The AHP analysis showed that supply stability was the most important factor, followed by greater transparency, efficiency, smart supply, and cost reduction. CONCLUSIONS: It is necessary to establish a stable supply system and manage crises through supply stability, as well as to provide opportunities for fair trade through greater transparency. As steps towards those goals, we propose establishing a unique device identification system, an information disclosure system, online distribution, and a group purchasing organization system in Korea.
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Revelação , Compras em Grupo , Coreia (Geográfico) , Métodos , Sistemas On-Line , EspecializaçãoRESUMO
The emphasis on "value" within healthcare institutions has achieved unprecedented priority, particularly around the purchase of medical products and equipment. Health systems and institutions are implementing formal decision-making processes involving clinicians and supply chain professionals to rationalize purchasing and promote cost-effective investment. One particular form of this process is the "Value Analysis" process. Drawing from fieldwork (100 h), interviews (n = 51) and focus groups (n = 4) conducted from January 2012 to October 2014 at 4 acute care hospitals in the western United States, I analyze the ways that committee members constructed and evaluated a case for a product's value. Participants (n = 72) were a purposive sample including nurses, administrators, supply chain and industry professionals. Interpretive phenomenology served as the analytic approach to generating iterative themes. While trying to be evidence-based, Value Analysis committees lacked data related to a product's price or efficacy and relied heavily on local knowledge and expertise. Sales representatives were an integral part of the process, creating interest in the product and providing product information. As vehicles for cost-savings and quality improvement, purchasing committees need unique support that emphasizes local contexts and expertise, while maintaining rigor and minimizing bias. Drawing from participants' experiences, and principles of health technology assessment and economic evaluation, a guiding framework is proposed to support this decision-making.
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Análise Custo-Benefício , Tomada de Decisões , Equipamentos e Provisões/normas , Enfermeiras e Enfermeiros/normas , Serviço Hospitalar de Compras/normas , Grupos Focais , Humanos , Enfermeiras e Enfermeiros/psicologia , Estados UnidosRESUMO
With social progress and improvement of human health consciousness,the medical device industry of China has been fast developing,and a new request for the specialized talents cultivation has been put forward.Based on the consideration of the development of medical device industry and the students,a cultivating mode for the medical engineering talents is explored in this paper through the major course reform,training double-quality teachers and cooperation between industry,university and research institutes.