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Item A Psychobiotic Diet For the Treatment of Stress, Anxiety & Depression(2024-04)Mental health disorders are a leading cause of the global health-related burden, with depressive and anxiety disorders the main contributors to this burden. While pharmacologic treatments exist for the treatment of anxiety and depression, up to 30% of people with depression do not respond to pharmacological therapy. There is a need therefore for additional methods to help individuals experiencing stress, depression and anxiety. The gut microbiota is the collection of individual micro-organisms including bacteria, viruses, fungi and protozoa that live in the human gastrointestinal tract. The gut, the microbiota and the brain communicate extensively with each other through direct neuronal transmission as well as indirectly via hormonal and immune signalling metabolites. This connection is called the microbiota-gut-brain axis (MGBA) and has a profound impact on mental health. The microbiota and the MGBA is strongly influenced by diet. The psychobiotic diet is a diet which is high in prebiotic and probiotic rich fermented foods which is designed to support the gut microbiota in order to exert positive effects on the brain and mental health via the MGBA while avoiding or reducing consumption of foods which have a negative effect on gut health such as sweets, processed meats, fast food and particularly ultra-processed foods. The effectiveness of the psychobiotic diet in the treatment of stress, anxiety and depression was investigated through critical evaluation of recent, peer-reviewed scientific literature. The psychobiotic diet itself is hugely under researched, with the results of only two research studies published to date investigating a psychobiotic diet or a diet high in prebiotic-rich fruits and vegetables. These demonstrate that a psychobiotic diet or a diet rich in prebiotics are an effective treatment for stress, anxiety and can improve mood. The majority of research to date has investigated the effect of psychobiotic supplementation with probiotics, prebiotics or synbiotics. There is strong evidence that psychobiotics can improve stress, depression and anxiety. Psychobiotics were found to improve mood in healthy individuals, individuals with mild to moderate distress and individuals with clinical depression. There is evidence for these effects using psychobiotics alone and in conjunction with anti-depressant therapy. There is strong evidence that psychobiotic bacterial strains can protect against worsening mental health in individuals experiencing chronic stress, this suggests that the consumption of psychobiotics can have a beneficial, mental health protective role. A wide range of variables can influence the effectiveness of psychobiotics, such as individuals’ activity levels, mental health at baseline, proclivity to healthy behaviours and genetic background. Further well-designed, large-scale, long-term research studies are required to provide greater evidence for and to quantify exactly the effectiveness of the psychobiotic diet in the treatment of stress and anxiety.Item The Cost of Own Brand Food Products as Related to their Nutritive Value(2024-04)The focus of this thesis is to establish whether there is a link between the cost of own brand retail products as related to their nutritional content. The aim of this thesis is to outline any correlation between the cost of retail own brand food products and the quantifiable nutritional properties. Dietary related diseases such as cardiovascular disease and obesity have become more prevalent in Ireland in the last decade, with dietary choices being linked as the main cause of this. Retailer own brand products were selected based on the food pyramid, with data on products obtained from public domain information published by the selected retailers. Other data was sourced from peer reviewed published research papers and other substantiated sources such as government publications and legislation. Statistical analysis was also carried out as part of this study due to the availability of raw data. Overall, the only statistically significant difference found was between the carbohydrate values between the retail own brand products at the value and core tiers. However, there is also some evidence of the correlation between the cost of retail own brand products and the nutritional content. In addition to this, from the analysis of each individual product in terms of nutrition and the ingredient contents, the premium tier products were established more often as the most beneficial across all three product tiers. Given the novelty of this research, it would be recommended that this analysis should be repeated on a larger product base. It is also recommended that further analysis should focus on the carbohydrate values between retail own brand products at the value and core tiers, given that this is where the statistical significance was found in this analysis.Item An evaluation of orthopaedic knee implant FDA recalls (from manufacturing to market release): 2019-2023(2024-05)Background: In recent years, the medical device sector has been positioned for consistent expansion, with worldwide yearly sales predicted to increase by more than 5% annually, reaching close to $800 billion by the year 2030 (van den Heuvel et al., 2018). In parallel to this growth, there is ongoing debate around the need for increased regulations and higher standards for medical device manufacturers, particularly as recalls have not decreased in frequency. The orthopaedic devices sector represents nearly 20% of the medical devices available on the global market and 16% average of these devices undergo recalls. Nonetheless, there exists a gap in the literature around investigations on orthopaedic knee implant recalls. (DeRuyter et al., 2023) This study aims to evaluate FDA recalls associated with orthopaedic knee implants, seeking to comprehend current orthopaedic knee implant recall’s trends and the reasons behind these recalls, and to determine the effectiveness of the current manufacturing quality standards and regulatory systems. Methods: A quantitative monomethod was utilized, involving the distribution of an online survey to subject matter experts on recalls within the orthopaedic implant industries. The survey, administered via Microsoft Forms, comprised of 18 questions, encompassing both closed- and open-ended formats assessing the factors contributing to orthopaedic knee implant device recalls and the effectiveness of the current system and to provide suggestions and recommendations regarding Orthopaedic manufacturing standards, regulatory frameworks, and other relevant areas. Responses from a total of 71 participants were collected and data analysis undertaken to investigate the reasons behind recalls, contributors to these recalls, and the efficiency of the current manufacturing standard and regulatory system. Secondary research was also undertaken to detect prevailing trends in the recall of orthopaedic knee implant devices. Data was sourced from the FDA database, specifying the years 2019 to 2023, and filtered for details such as manufacturer, approval process, implant type, recall classification, recall dates, reasons determined by the manufacturer, quantity affected, and more. These data points were then analyzed utilizing histograms to visualize the frequency of recalls across each year. Findings: FDA recall data has shown a significant increase in the number of recalls involving orthopaedic knee implants in recent years from different manufacturers. This increasing trend in recalls has raised concerns from both the medical community and among patients as they rely on these implants to regain mobility and improve their quality of life. These recalls, often attributed to issues such as manufacturing defects, material failures, or design flaws, underscore the challenges faced by manufacturers in ensuring the reliability and safety of these critical medical devices. Survey responses further highlight key factors contributing to orthopaedic recalls as perceived by participants. Manufacturing defects stand out as the primary concern, with a majority of respondents identifying them as the main contributors to orthopaedic recalls. This underscores the importance of addressing issues within the manufacturing process, including production errors, design flaws, and lapses in quality control, to uphold the reliability and safety of orthopaedic devices. Additionally, some respondents point to a lack of stringent FDA regulation as a significant factor contributing to orthopaedic recalls. This suggests apprehensions regarding the adequacy of regulatory oversight and enforcement, potentially resulting in compromises in product safety and quality standards. The response underscores the necessity for more robust regulatory measures to mitigate risks associated with orthopaedic devices. Conclusions: The research findings emphasize the urgent need for a comprehensive and proactive approach to managing recalls of orthopedic knee implants, highlighting the deficiencies in the current system. Stakeholder feedback reveals diverse opinions on the necessary changes in the medical device landscape. Some stakeholders are satisfied with the current system when properly followed and advocate for no changes. However, others suggest improvements such as eliminating the predicated equivalent approval process, establishing a dedicated recall committee to review and refine the approval process as needed, and improving alignment between different international Quality Management System (QMS) standards, including ISO 13485 and FDA regulations. Additionally, stakeholders recommend integrating principles from ISO 14971 into QMS requirements to help manufacturers systematically identify, assess, and mitigate risks throughout the product lifecycle. Strengthening collaboration with small and medium-sized enterprises (SMEs) is also suggested, as suppliers often do not adhere to QMS certifications. Emphasis is placed on incorporating risk management ISO 14971 principles into QMS requirements, enhancing post-market surveillance, clinical evidence requirements, and regulatory measures, particularly in competitive and dynamic industries.Item An investigation into the impact of the MDR Clinical Data Requirement for Legacy Devices & Transitional Provisions set out in Regulation EU 2023/607 on Medical Device manufacturers.(2024-05)OBJECTIVE: This study investigated the impact of the Medical Device Regulation requirement of clinical evidence for legacy devices and the transitional timelines on medical device manufacturers in Ireland. The MDR legislation which came in force on 26th May 2021, sets out the legal regulatory framework for medical device manufacturers, who wish to place their product on the EU market. Four key objectives were identified; firstly, to establish the current status regarding obtaining CE mark certification for medical devices. Secondly, to determine the status of products needing re-certification under MDR. Thirdly, to determine if the manufacturer in their opinion considers the transitional provisions set out under Regulation (EU) 2023/607 is sufficient. And finally, to obtain recommendations from industry as to improvements needed to improve the process of MDR certification. METHODS: Secondary research was conducted of peer-reviewed journals, books, newspaper articles, and organisational websites, using the terms MDR, clinical data, medical device, and legacy medical devices. Primary research was conducted by means of a survey questionnaire, which was answered by 27 people with significant knowledge of medical devices in Ireland. One of the survey respondents worked in academia. Interviews took place with two individuals one from academia, and the other with a regulatory background in a medical device company. RESULTS: In this study it was found that the introduction of the MDR legislation has had a negative impact on the medical device industry. Start-up and SMEs have been severely impacted by the requirements of the MDR, particularly the financial cost of clinical trials and access to Notified Bodies for MDR assessment. The clinical evidence requirement is ambiguous and impacts even the larger companies. Access to Notified Bodies, and the time taken by Notified Bodies to assess devices is taking much longer than under previous legislation. There have been device shortages and withdrawals warning from industry sources, but the consequence of this is unclear, and close monitoring of the situation is needed. Orphan and paediatric device shortages have already happened in the EU. CONCLUSIONS: In this study, the author found that the primary research data broadly corresponded with what was found in the secondary research data. Clinical evidence is causing the most issues for companies. The EU have not been pro-active in their response to issues encountered by the medical device industry. The primary research sample size was limited, and warrants further study with a larger sample sizeItem Staying Ahead in Patient Safety and Compliance: Assessing the awareness of Regulatory Requirements in an Irish Medical Devices Distributor(2024-05)Safety is paramount in the medical device industry. The main aim of Medical Device Regulation (MDR) is to improve patient safety. The primary aim this study was to investigation the level of awareness and perception of MDR within an Irish Medical Distributor. A mixed methodology was used in this study. Seventy four surveys and four interviews were completed to obtain qualitative and quantitative data from managers and employees at every level of the organisation. This study show a significant level of awareness and understanding of MDR among employees, particularly in the areas of adverse event reporting and CE (Conformite Europeenne) marking. However, variations in the perceived importance of MDR across different roles within the organisation suggest the need for tailored training and communication strategies to ensure uniform understanding and compliance. The research also revealed a positive overall perception of MDR among both employees and management.Qualitative findings from interviews with management highlight a positive attitude towards MDR, and recognising the commercial advantages of excellence in MDR awareness. Based on the findings of this study, several recommendations for future research and practice emerge. Firstly, there is a need for comparative research focusing on non-managerial roles across the spectrum of the medical device industry. Secondly, a longitudinal study could assess the effectiveness of formal training programs over time, tracking knowledge retention and identifying areas for improvement. Additionally, the study could be expanded to examine MDR awareness and perception levels alongside assessment of organisational culture within a company to see if there is correlation. It could also be valuable to assess the level of awareness and perception in MDR among those in the manufacturing sector of medical devices and among healthcare professionals using or implanting medical devices. In conclusion, this research contributes valuable insights into the level of MDR awareness and perception among employees and manager within an Irish Medical Devices Distributor and highlights the importance of a positive organisational culture and tailored training and communication strategies to ensure regulatory compliance and optimise patient safety
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