MSc in Medical Device Technology and Business

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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
(Innopharma, 2024) Brennan, Kate; McMahon, Gillian
BACKGROUND: 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MDD (Medical Device Directive 93/42/EEC) and AIMD (Active Implantable Medical Device Directive 90/385/EEC) have been repealed and replaced by MDR 2017/745.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.
Staying Ahead in Patient Safety and Compliance: Assessing the awareness of Regulatory Requirements in an Irish Medical Devices Distributor
(Innopharma, 2024) Tyndall, Cathy; McMahon, Gillian
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
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.
(Innopharma, 2024) Duggan, Manus; Coghlan, Rex
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 size
An evaluation of orthopaedic knee implant FDA recalls (from manufacturing to market release): 2019-2023
(Innopharma, 2025) Selvaganapathi , Thennarasu; Behan, Áine
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.
Post Market Surveillance: Exploring Healthcare Professionals’ perception and engagement in post market surveillance of medical devices
(Innopharma, 2025) Leneghan, Theresa; Behan, Áine
Objective: Medical devices are essential to patient care. However, their use can cause unintentional harm to patients. It was this risk of harm which led the European Commission to harmonise and update regulations that govern their use and publish new regulations in 2017 known as EU MDR. A key focus within EU MDR is the post-market surveillance of medical devices once they become commercially available. Healthcare professionals use these devices daily in their work and it is their experience of device use that is critical in contributing to the post-market surveillance data. Despite this, research shows that device incidents are under reported, and that healthcare professionals make a very low level of contribution to the report rates. The objective of this research was to explore the knowledge healthcare professionals in the Irish public healthcare sector have of EU MDR and in particular post-market surveillance and its processes. It also aims to determine, what if any barriers exist to reporting medical device incidents and what they feel would support their engagement with post-market surveillance. Methods Ten qualitative interviews were conducted with experienced Irish healthcare professionals working in the Health Service Executive across a range of specialities and roles. They were asked about their knowledge of EU MDR, post-market surveillance and device serious incidents. Their opinion on device feedback and reporting of device incidents was gathered as were suggestions on the optimal approach to support their engagement with regulations and a post-market surveillance system. Results Knowledge of EU MDR and post-market surveillance was generally low. All participants recognised the relevance of monitoring and surveillance of devices and felt they would contribute to the process. However, fear of blame and consequences, time constraints, a lack of knowledge on the process and poor communication from suppliers may impact the rates of incident reporting. Healthcare professionals generally were open to learning about the regulations, providing robust solutions on how to achieve this (including increased training and awareness from the HSE, academic institutions and the regulator, the HPRA). Easy to use, intuitive and accessible systems would increase engagement with post-market surveillance. Conclusion Healthcare professionals in the Irish public healthcare system have a low level of knowledge of the medical device regulations, EU MDR. They recognise the relevance of the regulations and device incident reporting and, provided with the correct systems, education, training and awareness they could be encouraged to increase their engagement and therefore provide for more effective medical device port-market surveillance.
Unmasking Insider Threats in Electronic Health Records (Ehr): A Comprehensive Analysis of Risks, Impacts, and Strategic Mitigation Measures for Enhanced Healthcare Data Security
(Innopharma, 2025) Chemmengattuvalappil, Salini Mohandas; Ghahremanzamaneh, Mina
The difficulties that insider threats present to healthcare Electronic Health Records (EHR) systems are examined in this research, with particular attention to Kerala, India. Insider threats pose serious hazards to the security and integrity of patient data since they come from authorized persons including administrators, IT staff, and clinicians. While exterior intrusions have received a lot of attention, insider breaches tend to go unreported yet can have serious repercussions, such as financial losses, medical blunders, and data theft. This study looks into the types, prevalence, and effects of insider threats in EHR systems in an effort to pinpoint the main causes of these breaches. The study draws attention to the flaws of EHR systems, including unreliable access controls, a lack of training, and organizational shortcomings. The study investigates the efficacy of current security measures in reducing insider threats by conducting a thorough survey of Kerala's healthcare professionals. The results emphasize how important it is to have more robust security frameworks that include administrative regulations, behavioral treatments, and technical protections. This dissertation offers practical suggestions for healthcare institutions looking to improve the security of their EHRs, with an emphasis on improved monitoring, user access control, and ongoing employee education. The ultimate goal of this research is to help create stronger plans for protecting private health data and guaranteeing the privacy and accuracy of EHR systems in the medical field.
Comparative Analysis of Global Access to Computed Tomography (CT) Services: Radiographers’ Experiences in Ireland and Sub-Saharan Africa
(Innopharma, 2025) Creedon, Jill; Behan, Áine
Background: Nigatu et al. (2023) reported only 14% of developing countries have one CT scanner per million inhabitants, compared with 100% of developed countries. This research aims to address access disparities in CT imaging between developed and developing regions, taking Ireland and Sub-Saharan Africa as representative regions. The research examines the user experience of CT radiographers in each region to determine whether demographic and contextual factors may influence the user experience and/or access to CT imaging services. The research subsequently seeks to assess whether region-specific solutions could address access issues and usability challenges in each region, while advocating for inclusivity in medical imaging equipment design. Methodology: This research employed a positivist framework and an abductive approach to examine the user experience of CT radiographers in Ireland and Sub-Saharan Africa. This was achieved through a semi-structured online questionnaire containing 30/31 questions which covered attitude, behavioural, classification and pre-coding questions. The questionnaire contained primarily closed questions, with some optional open questions to add contextual information, and covered demographic and contextual factors, usability assessments and ranking questions to address critical needs and priorities. The questionnaire was sent to CT radiographers in Ireland and SSA via social media and email distribution, achieving 52 responses in total, 31 from Ireland and 21 from Sub-Saharan Africa. Results: Several notable commonalities and differences were observed between the examined regions, both in terms of CT system usability and accessibility. However, the increased abundance of CT scanners in Ireland relative to SSA meant their shared challenges were of differing impacts in each region. Radiographers in both regions were generally satisfied with their overall user experience, although they identified both shared and unique areas for improvement when asked. Both cohorts identified issues with CT scanner hardware, particularly the scan table weight limit and gantry bore size. Others identified confusing or problematic user interface features. The most significant differences were in respondents’ rankings of critical needs and priorities, specifically CT access barriers, CT-related issues, and CT system features. Radiographers in Ireland were primarily concerned with workforce and training-related issues, as well as achieving diagnostic and technical accuracy. In contrast, radiographers in SSA were focused on financial and infrastructural challenges, also demonstrating a strong commitment to patient-centred care. Conclusion: This research underscores the need to implement region-specific strategies to enhance CT imaging services in both regions, with a focus on addressing their most critical needs and priorities rather than focusing on usability challenges. This is essential to improve patient care in both regions and ensure that progress is made toward achieving equitable healthcare.
Evaluation of Factors Influencing the Utilization of Iot-Based Wearable Device Technology for Healthcare Among South Indian Population
(Innopharma, 2025) Sinha, Nancy; Mooney, Patricia
Background: In recent years, the healthcare sector has grown significantly, although according to the World Health Organization (WHO), chronic illnesses are responsible for 75% of global deaths and create significant economic hardships. IoT-based wearable devices offer an effective means for diagnosis, continuous monitoring, and management. The IoT-based wearable medical devices market in India is blooming due to a growing emphasis on healthcare technology and personal well-being. Despite its advantages, some hesitation and factors influence the adoption of wearable technology in public perception Aim and Objective: The study focused on assessing user behavioral intentions, usefulness, social influence, privacy concerns, and other external factors like infotainment, wearability, healthcare, style, and connectivity that will affect the utilization of wearable devices for healthcare in South Indian perception. Method: The study incorporated TAM and TTF models with external factors to build a conceptual framework. The study was a quantitative, cross-sectional web-based survey that included participants aged 18-64 years. The survey included questions relating to sociodemographics and the factors affecting adoption. The Pearson correlation test and regression test were used to analyze the relationship between the variables. Results: A total of 295 responses were obtained. In all, 51.2% were male users, and 59.3% of users were aged 26-50 years. 52% of users were highly qualified, and 78.9% of the middle to upper-middle income group were using wearable devices. Smart monitoring device was mainly used by females. PEOU and PU have a significant positive impact on BI. Social influence, fashionability, and wearability showed a positive influence on BI. Privacy concerns showed an insignificant effect on behavioral intention. TTF showed a strong positive correlation with PEOU and PU, while infotainment, connectivity, and healthcare had moderating effect on TTF. Conclusion: The study found that the TAMs internal factors, namely perceived usefulness, perceived ease of use had significant correlation with intention to use wearable device and other factor showed positive medium to strong effect on adoption of wearable for healthcare. Future research should focus on larger, more diverse samples and cost reduction strategies, and privacy personalization paradox.
Evaluating the Adoption of Laparoscopic Surgery in Nigerian Teaching Hospitals: Surgeons’ Perspectives and Operational Challenges
(Innopharma, 2025) Emmanuel Adeoba, Babawale; Kearney, Brian
Abstract: Laparoscopic surgery has become an important modality for contemporary surgical practice, as a minimally invasive option with its many associated advantages such as shorter recovery times, decreased post-operative complications and enhanced patient outcomes. While laparoscopic surgery has widespread use in many high income countries, Nigeria has continued to struggle with the acceptance and integration of laparoscopic surgery to regular surgical practice, especially in teaching hospitals. Objective: The study aimed to assess the experience of a cohort of surgeons using laparoscopic surgery in a selection of Nigerian Teaching Hospitals, as well as readiness, technical issues and perceptions; explore potential systemic delays to implementation, and suggest ways to sustainably introduce laparoscopic surgery into surgical training and surgical practice. Methods: A mixed-methods research approach was used in the study which comprised qualitative data from 10 in-depth structured interviews with surgeons across a number of surgical specialities and quantitative data from 84 survey responses. In considering the data, both inferential and descriptive statistical analysis was performed, and the qualitative data was analysed thematically using the Braun and Clarke qualitative methodology. Results: Findings revealed that although 78.6% of teaching hospitals reported performing laparoscopic surgery, only 4.8% conducted it daily. Technical and institutional barriers were prominent: 72.6% of surgeons had no formal training, and 81% rated training as inadequate. Equipment failure (reported by 46 respondents), power outages (49 respondents), and limited maintenance access (34.5%) were key challenges. Surgeons cited lack of institutional support, inadequate funding, and limited mentorship as key impediments. Qualitative themes included institutional inertia, inequity in access, and generational resistance from senior consultants. Many respondents called for government-funded training, insurance coverage for laparoscopic procedures, and locally produced consumables to address systemic inequities. Conclusion: The research concludes that the present establishment of laparoscopic surgery is sporadic, inconsistent, and unsustainable in Nigerian teaching hospitals, challenged by systemic infrastructural, educational, and policy impediments. Meaningful change will require deliberate institutional leadership, national policy reform, established training programs, mentorship and development of appropriate infrastructure.
Evaluating the Integration of Artificial Intelligence in Mri Systems: Impact on Diagnostic Precision And Workflow Optimization in India
(Innopharma, 2025) Sabu, Ronal; Okosun, Favour
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.
Evaluating the usability, engagement, and effectiveness of continuous glucose monitoring (CGM) systems in remote patient monitoring systems in elderly patients with type 2 diabetes
(Innopharma, 2025) Wilson, Anu Chittilappilly; Mulhall, Sue
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.
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.
Cybersecurity Vulnerabilities in Wearable Medical Devices: A Cross-sector Analysis of Risks and Mitigation Strategies Using Ireland as a Case Study
(Innopharma, 2025) Epepitimi Kalabo, Bridget; Okosun, Favour
Background: Wearable medical devices (WMDs) have become integral to healthcare delivery, providing continuous health monitoring and improving patient outcomes. However, increasing connectivity and data exchange introduces significant cybersecurity vulnerabilities, raising concerns about data privacy, device integrity, and patient safety. Understanding users’ perception and practices regarding cybersecurity risks in WMDs is essential for mitigating threats and ensuring safe device usage. Aim: This study aimed to assess respondents’ perceptions and practices on cybersecurity risks associated with wearable medical devices. Methodology: A cross-sectional descriptive survey was conducted among 108 respondents using a structured questionnaire. The survey collected data on sociodemographics, device usage, perceived vulnerabilities, awareness of cybersecurity risks, and experience of device-related issues. Statistical analyses were performed using SPSS version 27, employing descriptive statistics and chi-square tests for associations. Binary logistic regression was used to identify predictors of good cybersecurity perception, with odds ratios and confidence intervals reported. Results: The majority of respondents were aged ≤30 years (64.8%), male (61.1%), and postgraduate degree holders (68.5%). Most respondents (63.9%) reported using wearable medical devices, with 41.7% having used them for 2–3 years. Over half (56.5%) had experienced a technical or data-related issue, predominantly device malfunction (48.1%). While 62% were aware of potential cybersecurity risks, only 15.7% believed wearable devices were secure. Significant associations were found between perception and gender (χ² = 7.115, p = 0.029), occupation (χ² = 21.346, p = 0.006), educational level (χ² = 18.507, p < 0.001), and duration of device usage (χ² = 14.953, p = 0.002). Logistic regression identified educational level and duration of usage as major predictors of perception. Conclusion: The study highlights a high level of awareness of cybersecurity risks but low confidence in device security among users. Technical issues and perceived vulnerabilities, such as weak passwords and lack of software updates, pose significant concerns. Strengthening cybersecurity measures, implementing user education, and enforcing regulatory compliance are essential to mitigate risks and build trust in wearable medical devices.
Examining the Role of 3D Printing in Improving Custom Prosthetic Device Manufacturing in the Indian Pharmaceutical and Medical Device Sector
(Innopharma, 2025) Kailashbhai Patel, Ankushkumar; Okosun, Favour
This dissertation explored the role of 3D printing in the enhancement of the manufacturing of custom prosthetic devices in the Indian pharmaceutical and medical device sector. Conventional manufacturing of prosthetics in India is much centralised, labour-intensive, and expensive, and does not cater to the needs of patients, especially in the low-income areas and the rural population. It is on this backdrop that the concept of 3D printing or additive manufacturing is emerging as a disruptive technology with the potential to provide decentralised, patient-specific, and efficient solutions. This study was aimed at exploring the level of adoption, perceived benefits, challenges and enablers of 3D printing in the Indian prosthetic industry. The study used a survey-based and quantitative research design, which included professionals in pharmaceutical/medical device organisations. Analysis was carried out with a descriptive and inferential approach, like ANOVA, one-way ANOVA, correlation, regression, etc. and focused on the adoption trends, benefits perceived, such as accuracy and faster turnaround and barriers, such as regulatory ambiguity, the control of the supply chain and high capital costs. The results indicated that the level of awareness of 3D printing is high, yet at the organisational level, full-scale adoption is low, with the majority of organisations experimenting or partially adopting the technology. Respondents stated that the main advantages were decentralised delivery and speedier production, although they were less sure about cost-effectiveness and scalability. Key barriers were regulatory uncertainty and insufficient supply of materials that are validated and biocompatible, and the key enablers were viewed to be cooperation between industry and universities and training of the workforce and regulatory transparency. The present dissertation can be of help to the current body of literature as it puts the global trends of 3D printing in perspective to the environment in India, which depends upon the local challenges that are not reflected in the developed economies. The work presents policy recommendations to policymakers and the industry, such as enhancing regulatory structures and conducting supply chain resilience investments and developing workforce potential. Finally, the study shows that 3D printing has the potential to be transformational, but implementation in India is possible only with the coordinated effort of policies, organisational strategy, and technological preparedness.
An Evaluation of User Feedback on the Effectiveness of Smartwatches from a Health Perspective in Ireland
(Innopharma, 2025) Kanakaraj, Aaradana; Iqbal, Javed
This study evaluates the user feedback on the effectiveness of FDA/CE-cleared smartwatches from a health perspective in Ireland. The research adopts a mixed-method approach, employed a survey-based strategy with a cross-sectional time horizon. Primary data were collected through online questionnaires structured into five sections comprising 24 questions. Quantitative data were analyzed using descriptive statistics in Excel, while qualitative responses were examined through thematic analysis. The study aimed to evaluate the effectiveness of FDA/CE-cleared smartwatches in tracking essential health metrics, investigate their role in motivating healthier habits, evaluate their impact on health outcomes, measure user satisfaction, and explore differences in users feedback across demographics and health status. The quantitative findings showed that smartwatches were widely trusted for tracking heart rate, blood oxygen, ECG, and stress, though sleep tracking received mixed evaluations. Both healthy users and users with medical conditions reported that alerts, reminders, and fitness tracking motivated healthier behaviours, though users with health conditions emphasized disease management benefits (e.g., improved heart rate and blood pressure control, greater reassurance in monitoring), while healthy users highlighted fitness, stress reduction, and lifestyle regulation. Overall satisfaction was very high, with usability, comfort, and perceived benefits strongly endorsed, although battery life and sleep monitoring were noted as areas for improvement. Younger adults were the most frequent users, while older adults were underrepresented. While the qualitative findings showed that FDA/CE-approved smartwatches serve a dual function: For Users with medical conditions, they serve as supportive healthcare tool, aiding in disease management and offering emotional comfort and for healthy users, they serve as motivational lifestyle enhancement tool, encouraging fitness, routine-building, and wellness optimization. In conclusion, this study highlights the growing role of FDA/CE-cleared smartwatches in bridging the gap between personal health management and formal healthcare systems. While not a substitute for medical care, they are valued for their clinical and wellness needs, FDA/CE-cleared smartwatches demonstrate the potential of digital health innovation to support individuals, complement healthcare systems, and advance public health goals in Ireland.
Analysing Expert Perspectives on the Integration of Targeted Drug Delivery (TDD) Mechanisms with Wireless Capsule Endoscopy (WCE): A Quantitative Study on Opportunities and Barriers in Advancing Precision Gastrointestinal Therapies
(Innopharma, 2025) Bijal Kumaraswamy, Neehara; Iqbal, Javed
In this study we aim to examine experts’ views on the opportunities and challenges posed by this integration and the role that it might be expected to play as part of a wider move towards personalised care. The research aims were to review state-of-the-art technologies pertaining to WCE and drug delivery, gather feedback via expert opinion from clinicians, engineers and pharmaceutical scientists and identify the technical, clinical and regulatory challenges as well as the future prospects for expanded use. A quantitative research design was utilised and an ANSI structured questionnaire was proposed to be administered to a purposive sample from clinicals, engineering and pharmaceuticals. The responses were analyzed using descriptive and inferential statistics. The results demonstrate that, although WCE has considerable potential as a non-invasive and patient-acceptable diagnostic and therapeutic modality, barriers to its widespread application exist. These are restrictions in capsule navigation, power consumption, biosensor integration, drug stability, dosage control, and regulatory approval mechanisms. Still, some experts were hopeful about artificial intelligence, high-tech bio-sensors and multidisciplinary teams of researchers that could help clear these hurdles. It is argued, in this review, that effective incorporation of drug delivery strategies to WCE systems will depend on close convergence of technological innovation, clinical validation and regulatory acceptance. Strategic investment in R&D, clinician education, and global regulatory harmonization will be critical to move the needle on adoption. Finally, this study helps fill some of these gaps by providing a holistic, expert-driven assessment of WCE applications, and a roadmap for the potential role WCE play in the development of the next generation of precision GI therapies.

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