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Technology enabling drug serialisation technology was introduced by regulators to enhance security in pharmaceutical supply chain and protect drugs from infiltration by falsified and substandard medicines. The introduction of systems for serialisation required huge financial outlays manufacturers of pharmaceuticals. This study investigated the impact of serialisation on the operational efficiency and productivity in Irish pharmaceutical sites. A qualitative study was conducted with 11 manufacturing sites in Ireland. The participating companies operated a total of 114 pack-lines, representing approximately 65% of the automated packing lines in the country. The study found that serialisation had a negative effect on packaging production line OEE and line availability and on the individuals cost per unit of packaged pharmaceuticals. The research results estimated that the capital costs of serialisation were four times greater than those estimated by the regulators. There was a 4.1 cents average cost per pack for serialisation with high volume sites reporting an annual cost of serialisation of up to €4.5 m per annum and a 2.7% increase in the average cost of goods sold. A pattern whereby where many pharmaceutical manufacturers are transitioning from smaller batch production and moving toward larger batch production sizes in order to increases efficiencies was identified. The research also proposed the use of a serialisation depreciation factor as a method to determine the impact of serialisation on the cost of goods sold. This is the first study of its kind into the cost of serialisation from a manufacturer's viewpoint and studying the effects of serialisation on productivity, line availability and operational efficiency.

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Purpose: This study aims to describe and propose an effective strategy for an industrial cluster and investigates industrial cluster-promoted growth.Design/Methodology/Approach: A qualitative study was carried out within the Irish Medtech cluster with key stakeholders from the cluster. Findings: The findings demonstrate significant opportunities for further cluster development and to potentially double the number of spin-outs and value of R&D investments while enhancing an entrepreneurial culture. This study also recommends that multiple agencies collaborate to achieve the future strategic objectives of the cluster. The soft infrastructure of regulatory and intellectual policies is as important as the hard infrastructure of roads and buildings. Practical implications: This study has implications for government policy, informing how they align the local needs of compact industrial clusters with policies to make the Irish cluster more unique and gain a sustainable competitive advantage. The approach is applicable and has implications for all industrial clusters.Originality/Value: This is one of the first studies to look at the Irish Medtech cluster in terms of its shortcomings and future opportunities.

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OBJECTIVES: This study investigates the benefits, limitations and awareness of using Real World Evidence and Real World Data for post-market clinical follow-up studies and clinical evaluation reports in the European Medical Device Regulations. METHODOLOGY: A mixed methods study was utilized with qualitative interviews and a quantitative survey. RESULTS: The findings from the study demonstrate that in the case of the Medical Device Regulations, opportunities exist for manufacturers of legacy devices to conduct Real World Evidence studies to bridge gaps in clinical evidence. The primary value of Real World Evidence lies in its ability to provide an accurate and, therefore, more reliable measure of device safety and performance. As a measure of safety and performance, it supplements clinical evidence generated from pre and post-market clinical investigations, reducing the costs associated with these studies and supporting the manufacturer's benefit: risk conclusion. CONCLUSION: This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.

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Nomex Honeycomb core is the foundational building block for manufacturing aerospace composite components. Its usage requires machining honeycomb in complex aerodynamic profiles where the quality of the core is governed by accuracy and precision of cut profiles. The assessment of accuracy and precision is directly related to forces induced in the cutting tool and cutting efficiency. These two parameters form the basis of a multi-objective function that this paper aims to optimize for the milling operation. The parameter of depth of cut considered in this paper has not been analyzed in a multi-objective optimization study of the Nomex Honeycomb core previously. A Taguchi-based array of Design of Experiments followed by Analysis of Variance and correlation analysis is utilised. The results indicate that the most significant factor is the feed rate, with a percentage contribution of 72% for the cutting forces and depth of cut, with a percentage contribution of 85% in the case of cutting efficiency. The two parameters are optimized using Desirability Function Analysis and Grey Relational Analysis. The results are validated through experimental runs with an error within 5% of the statistical predictions, with the percentage improvement in cutting forces for optimum runs as compared to the worst experimental run at 47.8%. The percentage improvement in cutting efficiency likewise is 11%.

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PURPOSE: This study explores how Lean was deployed in several hospitals in the Apulia region in Italy over 3.5 years. DESIGN/METHODOLOGY/APPROACH: An exploratory qualitative design was drawn up based on semi-structured interviews. FINDINGS: The drivers of Lean in hospitals were to increase patient satisfaction and improve workplace well-being by eliminating non-value-add waste. The participants highlighted three key elements of the pivotal implementation stages of Lean: introduction, spontaneous and informal dissemination and strategic level implementation and highlighted critical success and failure factors that emerged for each of these stages. During the introduction, training and coaching from an external consultant were among the most impactful factors in the success of pilot projects, while time constraints and the adoption of process analysis tools were the main barriers to implementation. The experiences of the Lean teams strongly influence the process of spontaneous dissemination aided by the celebration of project results and the commitment of the departmental hospital heads. PRACTICAL IMPLICATIONS: Lean culture can spread to allow many projects be conducted spontaneously, but the Lean paradigm can struggle to be adopted strategically. Lean in healthcare can fail because of the lack of alignment of Lean with leadership in healthcare and with their strategic vision, a lack of employees' project management skills and crucially the absence of a Lean steering committee. ORIGINALITY/VALUE: The absence of managerial expertise and a will to support Lean implementation do not allow for systemic adoption of Lean. This is one of the first and largest long-term case studies on a Lean cross-regional multi-hospital application in healthcare.

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This research investigates the requirement for and relationship and implementation of a total productive maintenance (TPM) and Reliability Centred Maintenance (RCM) strategy within an Active Pharmaceutical Ingredient (API) Plant. This research aimed to study the tools and techniques of TPM and Reliability Engineering and then deploy a designed model to an API plant. A case study involving Design for Lean Six Sigma phases of Define, Measure, Analyse, Design, and Verify was utilised to build an API site TPM pilot program. Data was collected using interviews across Company 'X's local and Global Engineering teams. Process runtime, downtime and plant availability metrics were compiled and a new design for Total Productive Maintenance and Reliability was proposed and verified. A maintenance framework was designed to optimally incorporate Total Productive Maintenance, Reliability and Operational Excellence with an emphasis on Overall Equipment Efficiency (OEE) realizing a 33 % reduction in planned maintenance activities, a 70 % reduction in Corrective Maintenance, Cleaning for Maintenance was reduced by 50 %, the pilot maintenance area of the centrifuge has its OEE increased by 20 % and plant availability increased by two hundred and 6 h. This research highlights the importance of Total Productive Maintenance as a key component of an effective maintenance strategy and its potential to transform maintenance practices. Based on this research and results, TPM is recommended to be applied to any API manufacturing organization. A limitation of the study is that it is a single-site case study. The novelty of this research is based upon the emphasis on Reliability Engineering to remove non-value add Maintenance time from the manufacturing schedule. The Total Productive Maintenance & Reliability model designed and implemented in this research is unique in the literature and can be leveraged by engineering professionals and academics to understand the benefits of TPM.

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The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles. The findings from the study demonstrated that the highest source of reactive Post-Market Surveillance data was customer complaints and proactive data were Post-Market Clinical Follow-Up. In contrast, the top 3 sources for generating clinical evaluation data for legacy devices under the new Medical Device Regulations were Post-Market Surveillance data, Scientific literature reviews, and Post-Market Clinical Follow-Up studies. Manufacturers' biggest challenge under the new Medical Device Regulations is determining the amount of data needed to generate sufficient clinical evidence, while over 60% of high-risk device manufacturers have outsourced the writing of their clinical evaluation reports. Manufacturers also reported a high investment in clinical evaluation training and highlighted inconsistencies in the requirements for clinical data by different notified bodies. These challenges may lead to a potential shortage of certain medical devices in the E.U. and a delay in access to new devices, negatively impacting patient quality of life (1). 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 E.U.

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Healthcare 4.0 is inspired by Industry 4.0 and its application has resulted in a paradigmatic shift in the field of healthcare. However, the impact of this digital revolution in the healthcare system on healthcare service quality is not known. The purpose of this study is to examine the impact of healthcare 4.0 on healthcare service quality. This study used the systematic literature review methodology suggested by Transfield et al. to critically examine 67 articles. The impact of healthcare 4.0 is analyzed in-depth in terms of the interpersonal, technical, environmental, and administrative aspect of healthcare service quality. This study will be useful to hospitals and other stakeholders to understand the impact of healthcare 4.0 on the service quality of health systems. Besides, this study critically analyses the existing literature and identifies research areas in this field and hence will be beneficial to researchers. Though there are few literature reviews in healthcare 4.0, this is the first study to examine the impact of Healthcare 4.0 on healthcare service quality.

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Assisted Human Reproduction (AHR) treatment is unregulated in Ireland, although it is practised there. Within Europe, Ireland is one of the only European countries without any form of AHR-specific regulation. This study aims to investigate the experiences and viewpoints of Irish women undergoing AHR treatments and establish if the lack of legislation is affecting these experiences. A quantitative survey was carried out on women undergoing AHR treatment in Irish clinics. Patients highlighted a lack of information in terms of end-to-end care and poor information around treatments and success rates. Key issues highlighted included unanticipated high treatment costs and add-on treatment costs, lack of financial support from the government, no redress process in the event of dissatisfaction, and generally an overall feeling of a lack of support both from the AHR clinics and the Irish government. This study offers a real-time view of the Irish AHR system from the patient's experience of AHR and under the lens of the lack of a legislative system. In early 2022, the Irish government announced that it would adopt its bill around AHR treatment and that subsidies for AHR treatment are to come into effect, which will alleviate some financial pressures on patients. Further studies of the legislation carried out post implementation will provide more information about the impact of having a legislated AHR process on the patients.

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BACKGROUND: Assisted human reproduction (AHR) treatment is not regulated in Ireland although it has been practiced since 1987. Thus, Ireland is one of the only European countries without any form of AHR specific regulation. This literature review research aimed to provide a comprehensive and comparative overview of AHR regulation and any associated literature to compare Ireland and other developed countries. METHODS: Systematic searches were conducted in several databases (Google Scholar, Web of Science, MEDLINE, SCOPUS and official government websites) utilising search strings in relation to AHR legislation for each country under review. A final review of 155 research articles were eligible after screening related to legislation in each country for inclusion. The findings were synthesised and summarised by legislation in each country. RESULTS: Different countries offer different levels of ART and IVF provision and services in terms of the type of services allowed, financial support, age, sex and eligibility of recipients. The UK's oversight legislation combined with the Netherlands financial legislation section provides as being most effective hybrid model of best practice for adoption in Ireland. CONCLUSIONS: This research concluded that there is no AHR legislation in any country that can be described as all-encompassing in terms of the services allowed, financial support and age of recipients. It was concluded that significant changes need to be made to the Irish draft legislation which is in limbo with the government for the last 3 years in order to meet Irish patient needs.

Ireland is one of the only European countries without any form of assisted human reproduction specific regulation. This research aimed to review of assisted human reproduction regulations to compare Ireland with other developed countries. There is no assisted reproduction legislation in any country that can be described as perfect. The UK's legislation combined with the Netherlands financial legislation section is concluded as being most effective hybrid model of best practice for adoption in Ireland. It was concluded that significant changes need to be made to the Irish draft legislation which is in limbo with the government for the last 3 years.

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