968 resultados para Medical supplies industry.
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Pooled procurement has an important role in reducing acquisition prices of goods. A pool of buyers, which aggregates demand for its members, increases bargaining power and allows suppliers to achieve economies of scale and scope in the production. Such aggregation demand e ect lowers prices paid for buyers. However, when a buyer with a good reputation for paying suppliers in a timely manner is joined in the pool by a buyer with bad reputation may have its price paid increased due to the credit risk e ect on prices. This will happen because prices paid in a pooled procurement should refect the (higher) average buyers' credit risk. Using a data set on Brazilian public purchases of pharmaceuticals and medical supplies, we nd evidence supporting both e ects. We show that the prices paid by public bodies in Brazil are lower when they buy through pooled procurement than individually. On the other hand, federal agencies (i.e. good buyers) pay higher prices for products when they are joined by state agencies (i.e. bad buyers) in a pool. Such evidence suggests that pooled procurement should be carefully designed to avoid that prices paid increase for its members.
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Shipping list no.: 86-559-P.
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"January 1986."
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MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a new collaboration in the UK that aims to support the healthcare sector by creating methods to assess the value of medical devices from concept through to mature product. A major aim of MATCH is to encourage the inclusion of the user throughout the product lifecycle in order to achieve devices that truly meet the requirements of their users. A review of the published literature indicates that user requirements are mainly collected during the design and evaluation stage of the product lifecycle whilst other areas, including the concept stage, have less user involvement. Complementing the literature review is an in-depth consultation with the medical device industry, which has identified a number of barriers encountered by companies when attempting to capture user requirements. These will be addressed by a number of case study projects, performed in collaboration with our industrial partners, that will examine the application and utility of different approaches to collecting and analysing data on user requirements. MATCH is focused on providing advice to device developers on how to select and apply methods that have maximum theoretical strength, practical application, cost-effectiveness and likelihood of wide sector acceptance. Feedback will be sought in order to ensure that the needs of the diverse medical device sector are met.
How does the healthcare industry involve users in medical device development? Pointers for UbiHealth
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This paper introduces the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) and outlines the problem of integrating a user-centred approach for development of medical devices together with the information and communication technology environments in which they are increasingly required to operate. We highlight some of the regulatory requirements that are relevant to user needs consideration in medical device development. Finally, we reveal a range of limitations in the current practice of the medical device industry in the area of user needs capture, based on responses from interviews with MATCH’s industry partners.
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Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.
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The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^
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Effective information and knowledge management (IKM) is critical to corporate success; yet, its actual establishment and management is not yet fully understood. We identify ten organizational elements that need to be addressed to ensure the effective implementation and maintenance of information and knowledge management within organizations. We define these elements and provide key characterizations. We then discuss a case study that describes the implementation of an information system (designed to support IKM) in a medical supplies organization. We apply the framework of organizational elements in our analysis to uncover the enablers and barriers in this systems implementation project. Our analysis suggests that taking the ten organizational elements into consideration when implementing information systems will assist practitioners in managing information and knowledge processes more effectively and efficiently. We discuss implications for future research.
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Disasters, particularly those triggered by nature are often followed by a swift humanitarian relief response to address the resultant emergencies. These efforts are then transitioned through the medium recovery stage, eventually aimed at providing a long term post-disaster reconstruction solution. Emergency humanitarian relief focuses on responding to the immediate need for restoration of basic services, medical treatment and medical supplies, food and temporary shelter, and is a short term strenuous effort. Reconstruction of permanent houses, on the other hand, is a continuous process that often requires decades of effort to return a community to normality. Whilst emergency relief is generally perceived to be very effective, post-disaster housing reconstruction projects often fail to meet their set objectives. This paper outlines and discusses factors that contribute to the failure of post-disaster housing reconstruction projects and the subsequent immediate and long term negative impacts of failure on project outcomes.
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For increasing the usability of a medical device the usability engineering standards IEC 60601-1-6 and IEC 62366 suggest incorporating user information in the design and development process. However, practice shows that integrating user information and the related investigation of users, called user research, is difficult in the field of medical devices. In particular, identifying the most appropriate user research methods is a difficult process. This difficulty results from the complexity of the medical device industry, especially with respect to regulations and standards, the characteristics of this market and the broad range of potential user research methods available from various research disciplines. Against this background, this study aimed at guiding designers and engineers in selecting effective user research methods according to their stage in the design process. Two approaches are described which reduce the complexity of method selection by summarizing the high number of methods into homogenous method classes. These approaches are closely connected to the medical device industry characteristic design phases and therefore provide the possibility of selecting design-phase- specific user research methods. In the first approach potential user research methods are classified after their characteristics in the design process. The second approach suggests a method summarization according to their similarity in the data collection techniques and provides an additional linkage to design phase characteristics. Both approaches have been tested in practice and the results show that both approaches facilitate user research method selection. © 2009 Springer-Verlag.