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Griffith Open collects, preserves and makes freely available research publications by Griffith College staff and learners. These can include, but are not limited to, theses, peer-reviewed articles, book chapters, working papers and conference papers, professional presentations, exhibitions and teaching resources. Where material has already been published it is made available subject to the open-access policies of the original publishers. This service is maintained by Griffith College Library.

Recent Submissions

Awareness and Use of Home-Based Medical Devices Among Patients With Chronic Diseases (Hypertension And Diabetes) in Pakistan
(Innopharma, 2025) Khan, Wajih Ur Rehman; Rice, Nicola
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.
Public Awareness and Feedback on Scalp Cooling Devices for Chemotherapy induced Alopecia In Southern India: Implications for Medical Device Innovation
(Innopharma, 2025) 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
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
(Innopharma, 2025) Walsh, Clodagh; Conneely, Martin
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
Developing a Strategic Regulatory Framework for Compliance of AIEnabled Medical Devices under EU MDR 2017/745 and EU AI Act 2024/1689
(Innopharma, 2025) Caldwell, Robert; Behan, Áine
Since the enactment of EU MDR and the EU AI Act 1689, Artificial Intelligence enabled medical devices (AIeMD) now must ensure compliance with dual regulatory requirements. This research dissertation examined the current regulatory landscape that exists for developers and deployers of AI enabled medical devices (AIeMD) and sought to identify if the need exists for the development of a Strategic Framework of Compliance for AI enabled medical devices to EU MDR 745, the EU AI Act 1689. The primary research undertaken consisted of qualitative semi-structured interviews with MedTech industry professionals involved in the research, development, and regulation of AIeMD. A mixed methods approach was undertaken, with the data gathered from an industry survey of similar industry professionals used to compliment or present alternative views to those identified during the thematic analysis. In addition to this, secondary research was undertaken to assess the current landscape for AI enabled medical device conformity pathways and status of CE marking for a sample of AIeMD in each medical field using the FDA AI Medical Device Database and EUDAMED,A case study of the Medtronic O-Arm Surgical Imaging System which forms part of the “AiBle™” product offering from Medtronic was also used. Finally, a document analysis of EU MDR 745, and the EU AI Act 1689 was conducted to outline areas of harmonisation, and divergence within the two pieces of EU legislation. This mixed methods approach allowed for the delivery of a comprehensive interpretation of the current regulatory challenges that developers and deployers of AIeMD face, while also presenting the opportunities that AI technology now places on the global healthcare system to achieve the elusive quadruple aims in healthcare. The research revealed a strong lack of, and demand for, harmonised compliance frameworks that aid organisations in navigating a complex regulatory landscape, and the criticality that standards and guidance play in dual regulatory compliance.
Public Perceptions and Utilisation of Automated External Defibrillators(AEDs) in Ireland: A quantitative and qualitative analysis of awareness, confidence and barriers to AED use in 2025
(Innopharma, 2025) McDermott, Rachel; Keogan, Justin
Out-of-hospital cardiac arrest (OHCA) affects approximately 5,000 people annually in Ireland, with survival rates as low as 8.4%. Automated External Defibrillators (AEDs) can significantly improve survival outcomes if utilised within 3-5 minutes of cardiac arrest. Despite approximately 9,000 AEDs nationwide, public utilisation rates remain critically low at 11% pre-emergency medical services arrival, highlighting a significant gap between device availability and effective public intervention. This study comprehensively investigated public perceptions and utilisation patterns of AEDs across Ireland in 2025. Key objectives examined: (1) associations between demographics and AED knowledge, (2) perceived barriers versus understanding levels, and (3) relationships between awareness levels and demographic responses. A mixed-methods approach employed both electronic (n=379) and hard copy (n=6) surveys. The predominantly quantitative questionnaire assessed AED awareness, confidence levels, training exposure, and perceived barriers, analysed using descriptive and inferential statistics. Qualitative data, from the open-ended questions, were analysed using Braun and Clarke's six-phase thematic analysis framework. Results revealed significant knowledge and confidence gaps. Only 76.1% of respondents knew AED locations within their community, while confidence in recognising when to use an AED was low (average self-efficacy score: 2.8 on a 5-point scale). Willingness to intervene varied by social context, demonstrating a bystander effect: 37% were very likely to use an AED when alone versus 27% in large groups. Key barriers included lack of knowledge or training (56%), fear of causing harm (47%), anxiety about taking responsibility (22%), and legal concerns (18%). Training emerged as the strongest predictor of intervention likelihood (66%). Gender disparities were evident, with females showing significantly higher fear of causing harm (86% vs 36% for males). Geographic concentration in Dublin (76%) limited rural representation. These findings underscore persistent deficits in AED awareness, confidence, and action readiness. Current public education approaches appear insufficient to overcome complex utilisation barriers. Effective AED utilisation requires multi-modal strategies simultaneously addressing legal, technical, and psychological barriers through demographic-responsive training, policy initiatives, and awareness campaigns to bridge the critical knowledge-action gap and improve OHCA survival outcomes.