Dissertations - Medical Device Technology & Business

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    A Comparative Analysis of Paper-Based vs. Electronic-Based Equipment Qualifications in Medical Device Manufacturing of Implantable Orthopedic Devices within the European Union: Technological, Regulatory, and Operational Impacts
    (2025-05) Walsh, Clodagh
    The medical device industry is highly regulated, where documented evidence of medical device manufacturing equipment qualification is a critical step to ensuring regulatory compliance, patient safety and device performance. This study undertook a comprehensive comparative analysis of paper-based and electronic-based equipment qualification (EQ) processes in the manufacturing of implantable orthopedic devices, assessed under the regulatory framework of the European Union Medical Device Regulation (MDR). The study critically evaluated the technological, regulatory, and operational impacts, with a particular emphasis on compliance, operational efficiency, and data integrity. The research was guided by the hypothesis that electronic-based EQ systems demonstrate superior capability in meeting the stringent regulatory requirements of the MDR, provide enhanced operational efficiencies, improve traceability, and documentation practices compared to traditional paper-based systems. A positivist philosophy, using a deductive approach, mono-method, quantitative research strategy in the form of a survey with a cross-sectional timeline, supported the aim of this research study. The survey/questionnaire was created using Microsoft Forms. The target audience were eligible participants with experience, either directly or indirectly, of paperbased and/or electronic-based EQ systems within the medical device industry. The survey was distributed via email and LinkedIn, a shortened URL link to the questionnaire was embedded within the invitation. The survey achieved 187 responses in total. The data was analysed using Minitab software application. The findings offered critical insights into the advantages and challenges associated with transitioning to or maintaining electronic-based EQ systems in highly regulated medical device manufacturing environments. Although the implementation of electronic systems requires upfront investment and training which can be seen as time-consuming, electronic systems significantly reduce major challenges such as human error. The transition from paper-based to electronic-based qualification systems has been overwhelmingly positive from a regulatory, operational, and quality standpoint. 74.43% of the participants agreed that technology has positively influenced the EQ process. The impact of the MDR has been felt to varying degrees across manufacturing facilities. Approximately 96% of the respondents reported no impact/positive impact on the EQ process since the introduction of the MDR. The study concluded that electronic-based EQ systems are not only justified but increasingly essential for manufacturers of implantable orthopedic devices within the European Union. Transitioning to electronic-based EQ systems optimises compliance and operational agility
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    Public Awareness and Feedback on Scalp Cooling Devices for Chemotherapy induced Alopecia In Southern India: Implications for Medical Device Innovation
    (2025-05) Jiji Johnson, Meghana
    Chemotherapy-induced alopecia is a common and psychologically distressing side effect of cancer treatment, with a major influence on patients' quality of life. Studies have shown that scalp cooling devices have the potential to reduce chemotherapy-related hair loss. This study aims to examine public awareness, attitudes, and willingness to use scalp cooling devices in Southern India, while also addressing cultural, economic, and informational barriers. It also seeks feedback on potential device improvements to enhance accessibility and acceptance in oncology care. Motivated by a clear knowledge gap surrounding the use of scalp cooling in Southern India, this study employed a mixed-methods approach to collect both quantitative and qualitative data. A survey was distributed, focusing general population, including healthcare professionals, and individuals affected by cancer. Descriptive statistical analysis and visualisation were performed using Microsoft Excel and Minitab, while thematic analysis was used to analyse open-ended responses and identify recommendations from participants. Key findings indicate that public awareness of scalp cooling devices in Southern India is low, with many respondents hearing about the technology for the first time during the survey. However, after being informed, a majority expressed positive attitudes and interest in the potential emotional benefits of reducing hair loss during chemotherapy. Participants identified high cost, limited access to information, and discomfort with the device design as key barriers to adoption. Also, suggested that increasing affordability through subsidies or insurance, expanding local access, and providing clearer information on effectiveness and safety could improve adoption. The study highlights the need for awareness campaigns, training programs for healthcare providers, and the provision of financial assistance programs to improve access and adoption of these devices. By addressing the notable gap in understanding regarding the awareness and use of scalp cooling devices in Southern India, this study enhances regional knowledge, offers practical recommendations for healthcare providers, policymakers, and manufacturers, and lays the groundwork for future studies on medical device adoption in India and comparable settings
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    Awareness and Use of Home-Based Medical Devices Among Patients With Chronic Diseases (Hypertension And Diabetes) in Pakistan
    (2025-05) Khan, Wajih Ur Rehman
    This study examined the awareness, usage, and barriers related to Home-Based Medical Devices (HBMDs), such as glucometers and blood pressure monitors, among patients with diabetes and hypertension in Pakistan. The findings indicated that awareness and utilization of HBMDs were generally low, particularly among rural and underserved populations. Semi-structured interviews were conducted with healthcare professionals, including general practitioners, cardiologists, and endocrinologists, who confirmed that patients often lacked the knowledge, training, and confidence required for effective use of these devices. Additionally, the results revealed that the adoption of HBMDs was significantly hindered by cultural resistance, high costs, limited digital literacy, and concerns regarding data privacy. Furthermore, although healthcare professionals were identified as crucial in promoting the use of these devices, many lacked the necessary resources and training to adequately support patients. According to the findings, enhancing the adoption of HBMDs in Pakistan necessitated a coordinated strategy that included focused patient education, affordability-enhancing subsidies, culturally appropriate awareness campaigns, professional development for healthcare professionals and strengthened safeguards for patient data. These findings offer valuable insights for policymakers and healthcare professionals aiming to improve chronic disease management through the use of home-based medical technology.
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    Evaluating the usability, engagement, and effectiveness of continuous glucose monitoring (CGM) systems in remote patient monitoring systems in elderly patients with type 2 diabetes
    (2025-05) Wilson, Anu Chittilappilly
    This research examines the usability, effectiveness, and involvement of Continuous Glucose Monitoring (CGM) systems in the Remote Patient Monitoring (RPM) platform for elderly people with Type 2 Diabetes Mellitus (T2DM). With the rise of global populations, along with the rise in chronic illnesses such as diabetes, it is an increasingly pressing need that technological solutions are both effective and accessible for older adults. CGM technology provides glucose tracking in real time, with improved glycaemic control and less invasive finger-prick testing. However, adoption among elderly users is not uniform as age-related issues, such as dexterity, cognitive decline, and digital illiteracy, continue to be challenging. This research explores the way older adults use the CGM systems, device usability, engagement behaviours, and therapeutic effects. In a quantitative, survey-based approach, the study gathers and reviews data from CGM users from the aging population, caregivers, and healthcare providers. Key findings indicate that while CGM systems can dramatically change glycaemic management and patient autonomy, usability problems related to complex interface usage and trouble with insertion of the sensor create important barriers. Engagement levels differ, and long-term adherence is frequently interfered with by the presence of alert fatigue, cost, and inadequate training. Besides listing reasons such as psychological, technical, and financial, hindering successful CGM adoption, the study proposes strategies to boost CGM user engagement and retention. These are easy-to-use interface designs, customization of alert settings, constant education, caregiver support, and enhanced insurance coverage. Statistical findings prove that there is a correlation between CGM use and improved glycaemic results, especially with those systems tailored to the physical and cognitive needs of elderly users. Finally, the study makes a contribution to the emerging field of digital health by providing evidence-based recommendations for the design and delivery of CGM technologies for aging populations. It illustrates the need for health tech solutions that are inclusive and relevant in elderly patients’ care in remote and digitally-enabled healthcare ecosystems.
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    Evaluating the Integration of Artificial Intelligence in Mri Systems: Impact on Diagnostic Precision And Workflow Optimization in India
    (2025-05) Sabu, Ronal
    The purpose of this paper is to analyse the development of MRI systems with AI concepts within the overall context of healthcare systems in India. By employing secondary data collection complemented with the primary data collected through a structured survey conducted among a sample of radiologists, technicians, and healthcare administrators in India, the study investigates the effects of AI on diagnostic accuracy, authorized work, and productivity in MRI diagnostics. In contrast to the prior global studies, this paper explores the key issues in India such as infrastructure gaps, workforce repletion, and regulations and policies. It is evident from the study that the implementation of AI can improve diagnostic competencies and also minimize procedure time in MRI, which is in sync with the trends across the world. Early stage anomaly: The respondents also indicated that the early stage anomaly was detected in time and the amount of work done by the radiologists was reduced. Thus, the implementation of AI in India is even more problematic due to a deficiency in the technical basis, AI-oriented staff education, and an underdeveloped structure of legislation for AI in medical imaging. This is due to a lack of clear regulatory directions from Indian regulatory bodies like the “Central Drugs Standard Control Organization (CDSCO)” or the inadequate clarity around data protection under the “Digital Personal Data Protection Act (DPDPA)”. The research indicates that, while the participants did not regard AI as a threat to radiologists jobs, it is viewed as a strong support tool if applied properly. It underlines that there is a strong requirement for India-specific AI regulation policies for AI solutions, proper institutional training programs for employees, and better IOT connections. Specific recommendations are directed to the heads and managers of Indian health care centers, AI developers, and policymakers as to cooperation in the AIincorporated MRI diagnostics being safe, efficient, and suitable for patients needs. It adds contextual understanding to India’s preparedness and issues, which forms the basis for more culturally appropriate advancements and use of AI in health imaging.