Dissertations - Medical Device Technology & Business
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Item An evaluation of orthopaedic knee implant FDA recalls (from manufacturing to market release): 2019-2023(2024-05) Selvaganapathi , ThennarasuBackground: 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) Duggan , ManusOBJECTIVE: 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) Tyndall, CathySafety 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 safetyItem The regulatory burden of Regulation 2017/745 placed on manufacturers of legacy devices and the potential impact of market shortages as manufacturers strive to comply(2024-05) Brennan, KateBACKGROUND: The MDD (Medical Device Directive 93/42/EEC) and AIMD (Active Implantable Medical Device Directive 90/385/EEC) have been repealed and replaced by MDR 2017/745. MDR 2017/745 places a significant regulatory and financial burden on medical device manufacturers as they strive to meet the new requirements. In contrast to the US regulatory scheme there are no provisions for grandfathering products certified under the previous Directives. The purpose of this research was to identify, define and describe the regulatory burden of Regulation 2017/745 placed on manufacturers of legacy implantable, intra-articular medical devices for treatment of Osteoarthritis and the potential impact of market shortages as manufacturers strive to comply. Osteoarthritis is a disease occurring mainly in adults over 50 years of age and results in reduced quality of life. Osteoarthritis is a disorder of synovial joints. Some complications of the disease include difficulty walking, performing day-to-day tasks, chronic pain and mental health issues resulting from the physical challenges and pain suffered by patients. Legacy implantable intra-articular devices such as Durolane®, Hyalgan® and Synvisc® have been available on the European market under the Medical Device Directive 93/42/EEC. Literature indicates the product is a valuable treatment option for patients in terms of efficacy and cost and contribute to an improved quality of life for Osteoarthritis sufferers. METHODS: This research explores the difficulties encountered by manufacturers as they strive to comply and also the potential knock-on effect for patients and Health Care Practitioners in the event products are in short supply. Information was collected in the form of a survey and interviews with experts. A questionnaire was developed using Microsoft Teams Form, issued to colleagues, and disseminated via LinkedIn. The data collected is qualitative and quantitative in nature and was analysed using thematic analysis and statistics. The surveys were targeted at professionals within the medical device industry to gather information on how MDR has impacted businesses specifically in clinical evaluation. Semistructured, recorded interviews were conducted with Clinicians, Pharmacists and Marketing personnel to understand the impact a market shortage would have on patients. FINDINGS: Data to comply with MDR clinical requirements is being sourced almost equally from literature searches, clinical investigations, and post market sources. Respondents agree that clinical evaluation requirements are well-expressed in guidance documents. Clinical evidence gathered for devices under MDD is lacking, resulting in revisions to intended purpose, indication statements and associated clinical benefits of the device(s), the conditions of use, specific contraindications, and risk management files. A third of surveyed manufacturers expect a decrease in patients accessing the device and 50% expect a reduction in sales. For patients, a market shortage will impact those who are ineligible for NSAIDs and have exhausted other therapeutic options. CONCLUSIONS: As a result of the cost to organisations in terms of resources needed to meet MDR requirements and potential for loss of sales, the MDR places a manufacturer in an unfavourable financial position. Manufacturers may withdraw products from the EU market. The knock-on effect for patients using intra-articular medical devices for Osteoarthritis treatment will be of significance for those who are ineligible for NSAIDs when physical therapy, basic pharmacological treatment, and first-line joint injection with corticosteroid have not given adequate relief. MDR may also be presenting a barrier to newer therapies such as PRP, both primary and secondary research has shown that although there is interest from the medical profession, there is little clinical data available. At the end of the transition period for Class III implantable intra-articular devices, May 2027, we may see a decline in these products available on the EU market and a delay in innovative products reaching the market. Considering the prevalence of OA within society, the impact of the MDR may be significant for patients.