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Item Lean Validation in the Pharmaceutical Industry in Ireland(2023)In this study, it was shown that implementing Continuous Improvement (CI) initiatives has been done within Pharmaceutical Validation in Ireland, to some extent. ‘Lean Validation’ is a concept that involvesthe implementation of CI initiatives into the process of Validation. Within the Pharmaceutical Industry, there is an enduring interest for an organisation to reduce waste and improve the efficiency of a process. Validation is a core pillar of the Pharmaceutical industry and the process can often be long, tedious and inefficient. This ideology behind ‘Lean Validation’ is to use tools from principles such as Lean and Six Sigma to reduce waste and improve the Validation process. The objectives of this research were to explore the extent to which organisations are currently implementing ‘Lean Validation’ principles, what the current challenges with implementing them are, and what specific areas and tools could be the most beneficial to focus these initiatives on within the Validation process. This research was conducted using a mixed-method approach, consisting of a survey and interview. The analysis of the data showed that CI tools and initiatives have been implemented within the Validation process, with the main goal of this to improve the efficiency of the process and to remove any aspect of the process that does not add value and can be considered ‘waste’ under Lean methodologies. The data showed there is some level of reluctance to implement CI within Validation, with the main challenges being lack of time and resources, and lack of engagement from personnel due to a ‘fear of change’. The study concludes that CI initiatives can be beneficial for the Validation process in a number of areas and provides suggestions for Pharmaceutical organisations looking to implement them and recommendations for further study.Item The Disability-Adjusted Life Year (DALY) and Influenza in Ireland An evaluation of the suitability of the DALY as a metric for measuring and managing the burden of influenza in Ireland(2023)The burden of influenza in Ireland is insufficiently characterised. Quantifying the burden of influenza could lead to benefits such as informed decision-making on policy, effective healthcare planning and preparation and prioritisation of health research investments and healthcare interventions. These benefits are particularly pertinent in today’s Irish setting, as it is facing chronic resource shortages. The Disability Adjusted Life Year (DALY) is proposed as a useful metric for quantifying the burden of influenza. It is a measure of overall reduction in health due to disability before death and the decline in life expectancy due to death. This research aimed to use this metric to estimate the burden of influenza in Ireland and to investigate the feasibility, suitability, utility and validity of the estimate in practice in the Irish healthcare and health policy setting. A mixed-method approach with an overall interpretivist philosophy was employed. Using a quantitative method, the DALY calculation was performed to estimate the burden of influenza in Ireland in DALYs and to explore variability of the calculation. A qualitative method was then used to gain the views of subject matter experts on the validity, feasibility, suitability and utility of the DALY to them in practice. Both methods were combined via abduction to arrive at a conclusion. Results showed that per 100,000 population, influenza contributed 87.75 DALYs in the 2018/2019 season and 38.8 DALYs in the 2017/2018 season. The utility of this estimate depends upon the DALY’sfunction as a ”common currency” for comparison. It would be suitable and useful to inform HSE policy and highlight the burden of influenza; however, few other appropriate DALY estimates exist for comparison. Therefore, the estimate cannot be used to arrive at a conclusion regarding the burden of influenza and it is not yet feasible to be used for its intended purpose. This estimate will provide a useful comparator to future studies. The wider adoption of the DALY in Ireland is required for its utility to be realised and benefits gained.Item An Evaluation Of The Use Of 3D Technologies In Developing Patient Specific Medical Devices For Interventional Radiology, And Its Potential Use For Producing A Personalised Embolic Coil for Peripheral Vasculature Embolization.(2023)In this study it was shown that patient specific embolic coils for peripheral intervention can be produced utilising 3D patient scans and current materials and industry standard processes.The use of patient specific medical devices is growing since the invention of 3D technologies. This study investigated using this same technology to design a patient specific embolic coil. A key objective of the research was to establish if a patient specific coil could address complications and issues that are encountered with Off The Shelf (OTS) embolic coils. Literature on patient specific medical devices, 3D imaging, and embolization were reviewed to map the current landscape of embolic coiling, patient specific medical devices, costs, and regulatory considerations. There was a gap in the literature regarding patient specific embolic coils. Primary Research was conducted via individual interviews with 13 subject matter experts (SMEs) from the fields ofInterventional Radiology, Research & Development, Marketing, 3D Design and Process Development Engineering. The research found that there was no barrier to rendering a 3D anatomical scan into a patient specific embolic coil. Opinion of the SMEs was that current materials and standard manufacturing processes can be used to fabricate the same. The necessity for secondary devices, such as stents, can be overcome by producing a coil tailored to the patient’s anatomy. Prolonged procedure time can be reduced by delivering coils with a patient specific length. A wide range of OTS coils and liquid embolics exist, which provide the Interventional radiologist with a level of customization for each patient. It was found that a patient specific coil could be produced but that there may be only niche use for peripheral vascular treatment. The emergent nature of peripheral embolization procedures was deemed incompatible with the planning, design and manufacture required to produce a patient specific device. It was recommended the study be carried out in the field of Neuro Interventional Radiology as the level of planning, risk-reward and the specificity of tools required were greater than in Peripheral Vascular field. Also, it was recommended that research be conducted into the development of resorbable coils for Musculoskeletal (MSK) conditions.Item The Impact of Working Irregular Hours on Quality and Human Resources in the Irish Pharmaceutical Industry(2023)INTRODUCTION. Ireland is a hub for pharmaceutical manufacturing activity. Due to business demands and/or nature of products being manufactured some pharmaceutical manufacturers have no other option but to manufacture 24/7. This research aimed to investigate the potential impacts of working irregular hours on human resources and quality in the Irish pharmaceutical industry. This research is important as it investigated factors influencing a pharmaceutical organisation’s operational excellence and quality management systems. OBJECTIVES. This research consisted of two primary objectives. The first was to determine if working irregular hours has any effect in the area of human resources (namely staff morale and staff turnover intention) by surveying both employees that work regular hours and those that work irregular hours in the pharmaceutical industry. The second was to determine if working irregular hours has any effect in the area of quality (namely quality assurance (QA) and right first time (RFT) manufacturing) by interviewing key subject matter experts working in the pharmaceutical industry. METHODS. To address the objective focusing on human resources quantitative research was used in the form of surveys. 84 people were surveyed: 44 shift workers (SWs) and 40 non-shift workers (NSWs). Questions were focused on areas of staff morale and turnover intention. Raw data from survey respondents were analysed using Chi Square Tests of Independence to determine whether difference between group were independent of each other. The objective regarding quality within manufacturing was addressed through using qualitative research in the form of interviews. SMEs were interviewed with questions focusing on QA and RFT manufacturing. Thematic analysis was carried out on interviews which involved open coding followed by axial coding. RESULTS. There was no significant difference between the groups for self-perceived levels of staff morale. There were however significant differences between groups when it came to other negative impacts associated with shift work. SWs were more likely to feel fatigued both during and after work, feel that their work negatively impacts their personal well-being, frequently feel under pressure in their role and feel emotionally agitated upon arriving home from work. It is possible that these negative implications of shift work may gradually impact employee morale over time by wearing people down. There were no significant differences between the groups and turnover intention. SWs were significantly more likely to admit that benefits associated with their job (i.e., compressed work week and financial bonus allowance) prevented them from quitting. An overall pattern was highlighted among the two groups that the rate of turnover intention increased over time. The majority of interviewees believed that irregular working hours had no impact on QA. Interviewees emphasised that quality errors can occur at any time of day and stated that there are many possible factors at play when looking at quality errors with human root causes rather than fatigue alone. These can include but aren’t limited to; operator competency, complacency, mindfulness for task at hand and diligence to work. Similarly, the majority of interviewees believed that working shift work had no impact on the rate of RFT manufacturing. The general consensus of interviewees was that systems should be in place in order to catch mistakes before they occur and therefore set operators up for success. CONCLUSION. Maintaining positive staff morale, low staff turnover, QA and RFT manufacturing are all important factors in ensuring operational excellence, productivity and products are produced to meet regulatory quality standards. This is why investigating potential factors which may impact these is important. Although some findings for this research thesis were insignificant, it helped highlight potential research areas for the future. These may include the impact of shift work on productivity or employee absenteeism all of which effect business functions. Looking closer at costs involved in investigating quality deviations would also be a worthwhile research topic.Item The Integration of Lifestyle Factors in Clinical Research Studies – How can meaningful evidence be generated to evaluate the impact of lifestyle changes on health outcomes?(2023)The purpose of this research was to examine the current state of clinical research into how lifestyle factors can impact health outcomes in chronic disease, and to test the hypothesis that such research has lagged studies of drug therapy in terms of delivering actionable results. The research was conducted firstly by completing a thorough literature review of the topic, and then gathering primary data through a series of structured interviews with a panel of contributors drawn from Academia, Industry, and the Medical Profession. The findings were illuminating, and supported the published material but also went further; exposing a broad level of dissatisfaction with many aspects of the current clinical research process and how the results of this research is reviewed, published and disseminated to healthcare professionals and patients. The conclusion is inescapable – the field of clinical research requires a significant overhaul if it is to deliver meaningful evidence in the increasingly complex world of modern medicine. A number of pragmatic suggestions for further research were developed, including a concept to address the risk of skewed trial results arising from manufacturers sponsoring and designing trials of their own products, and an initiative to fundamentally rebalance the clinical research ecosystem by involving a broad spectrum of stakeholders at every stage in the process
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