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This paper analyzes how information systems (IS) can serve as tools of neo-colonial control in offshore outsourcing of research and development work. It draws on critical work examining business and knowledge process outsourcing.

The paper reports an empirical study of how laboratory information management systems (LIMS) shape offshore outsourcing practices involving Western client firms and Indian contract research organizations (CROs) in the pharmaceutical industry. The study adopted a multi-actor perspective, involving interviews with representatives of Western clients, Indian CROs, system validation auditors, and software vendors. The analysis was iterative and interpretative, guided by postcolonial sensitivity to themes of power and control.

The study found that LIMS act as tools of neo-colonial control at three levels. As Western clients specify particular brands of LIMS, they create a hierarchy among local CROs and impact the development of the local LIMS industry. At inter-organizational level, LIMS shape relationships by allowing remote, real-time and retrospective surveillance of CROs’ work. At individual level, the ability of LIMS to support micro-modularizing of research leads to routinization of scientific discovery, negatively impacting scientists’ work satisfaction.

By examining multiple actors’ perceptions of IS, this paper looks beyond the rhetoric of system efficiency characteristic of most international business research. As it explores dynamics of power and control surrounding IS, it also questions the proposition that outsourcing of high-end work will move emerging economies upstream in the value chain.

The main objective of this study is to investigate what are the critical success factors that exist for continuous improvement (CI) methodology deployment in the Irish medical technology (MedTech) industry. The research will, in particular, seek to establish if the highly regulated nature of the global MedTech industry is an additional critical failure factor (CFF) for the deployment of CI methodology. The study involves the analysis of the benefits, challenges, CFFs and tools most utilised for the application to the deployment of CI methodologies in the Irish medical device (MD) industry.

A quantitative survey was utilised in this study. The main participants were made up of senior quality professionals working in operational excellence, quality consultants, quality directors, quality engineers, quality managers and quality supervisors working in both manufacturing and service sectors from Irish MD companies. A total of 94 participants from the Irish MedTech industry responded to the survey.

The main finding of this study is that 42% of participants perceived that a highly regulated environment was a CFF to CI, whilst 79% of respondents utilised Lean Six Sigma in their organisations, and productivity and financial factors were found to be the highest reasons for CI deployment amongst the Irish MedTech industry. The top CFFs highlighted for CI in regulated industries were fear of extra validation activity, compliance versus quality culture and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that just over 48% of participants felt that CI tools are very strongly integrated into the industries quality management systems (QMSs) such as the corrective and preventative action system, non-conformance and audit systems.

All data collected in the survey came from professionals working for Irish indigenous and multinational MedTech companies. It is important to highlight that n = 94 is a low sample size, which is enough for a preliminary survey but reinforcing the limitation in terms of generalisation of the results. A further study on a wider European and global scale as well as a comparison with the highly regulated pharma industry would be informative.

The authors understand that this is the very first research focussed on the CFFs for CI in the MedTech/MD manufacturing industry with a specific focus on the highly regulated nature of the industry as a potential CFF. The results of this study represent an important first step towards a full understanding of the applicability and use of CI in the medical-device-manufacturing industries on a global scale.

This study aims to access, analyze and highlight opportunities and problems of the Indian pharmaceutical sector in the broader national health-care industry. The recent changes in the field, at the institutional and corporate levels, have placed India in the spotlight of the global pharmaceutical market, but several threats and weaknesses could limit this expansion.

Descriptive and inferential analyses have been based on empirical data extracted from authenticated data sources. Subsequently, a narrative strengths, weaknesses, opportunities and threats analysis was performed based on the results of prior investigations and on qualitative data that were retrieved from a marketing intelligence examination to generate an overall scenario analysis.

Indian pharmaceutical companies have faced several challenges on various fronts. In the home market, drug prices are controlled by the drug price control order; therefore, there is strong pressure on revenues and subsequently on costs. In the international market, threats derived from pharmaceutical multinational companies are emerging as tough obstacles to overcome.

More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs. There is a need for policymakers to work on the sustainability and development of the industry, while the companies must redesign their orientation toward enhancing innovation capabilities. In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.

This study provides a global overview of the potential growth and development of the Indian pharmaceutical sector, comparing it with internal trends and external competition. The most relevant contribution of the research relies on the shift to innovative production that Indian companies must adopt (after years of focusing only on generic drugs), and in this vein, appropriate industrial marketing solutions are indispensable.

This paper explores different approaches to regulating corporate social responsibility (CSR) patterns of adopting codes of conduct, and discusses the approach that courts should embrace.

Case studies from various legal systems will be examined. The paper presents new typology relating to different patterns of the Corporate Social Performance (CSP) model, based on aspects of the CSR pyramid, namely, legislative CSR and ethical CSR. Legislative CSR includes adoption of thin codes which reflect compliance within current legal standards of the criminal code, while ethical CSR includes codes reflecting ethical norms and corporate social citizenship beyond mere compliance. The paper also includes the interplay of different patterns of CSR and three approaches to regulation regarding these patterns.

Both the Israeli negative CSR regulatory approach and the American legislative CSR regulatory approach present difficulties.

The paper introduces a theory for regulating CSR within criminal law, drawing on the pyramid of CSR. It presents an original discussion of distinct approaches to regulation of corporate liability, while further developing the institutional theory of CSR and the interplay of regulation and CSR. The paper suggests a novel solution regarding the regulation and acceptance of CSR: the granting of protection from criminal liability to corporations who adopt CSR.

The COVID-19 pandemic caused global supply disruptions and shortages that resulted in countries battling over desperately needed (medical) supplies. In this mayhem, additive manufacturing (AM) provided relief to the strained healthcare systems and manufacturing environments by offering an alternative way to rapidly produce desired products. This study sheds light on how AM was used globally in response to the COVID-19 pandemic.

The study undertakes a systematic and content-centric review of 289 additively manufactured products made in response to the COVID-19 pandemic. Additionally, quantitative frequency-based text mining and various descriptive analyses were applied that support the investigation of the subject under regard.

Results show that AM was primarily used in the medical domain for the production of standard medical items, such as personal protective equipment (PPE) but also for non-obvious and new applications (e.g. swab simulator, rapid diagnostic kits, etc.). Also, certain paradigm shifts were observed, as the effective move to mass production and the mitigation of problems related to certification and standardization emerged as prominent management prospects. Nevertheless, various obstacles arose and remained in the path of lasting AM success, especially with respect to print quality, raw material supply and technological versatility.

Due to the actuality of the topic under investigation, no comparable study has so far been conducted. The systematic review provides a conclusive and precise foundation for further analysis and subsequent discussions. Additionally, no comparable study mapping such a wide array of different AM products exists today.