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Item Innopharma Insights - Volume 2(2025-12)Volume 2 of Innopharma Insights compiles key contributions from Innopharma Education learners and staff, focusing on advancements in Ireland's biopharmaceutical sector, digital health compliance, vaccine hesitancy strategies, antiviral drug discovery, medical imaging equity, clinical trial digitalisation, and psychobiotic interventions for mental health. Highlights include a review of the 2025 BioPharmaChem Impact Conference, emphasising talent development, sustainability, and Innopharma Technical Services' award for Best Talent Strategy; analyses of regulatory challenges in diabetes management technologies; empirical studies on parental trust in measles vaccination sources amid Ireland's outbreaks; computational optimisation of Tinosporaside derivatives as dual SARS-CoV-2 protease inhibitors; comparative radiographer experiences with CT scanners in Ireland and Sub-Saharan Africa; feasibility of wearable sensors in 6-minute walk tests for trials; and psychobiotic diets targeting the gut-brain axis for stress and depression. These interdisciplinary works underscore Innopharma's role in bridging education, industry needs, and innovative research to address regulatory, technological, and health equity challenges in life.Item Regulatory Strategy and Market Access Challenges under EU IVDR 2017/746: A Case Study of Indian IVD Exporters of Rapid Diagnostic Kits(2025)The introduction of the In Vitro Diagnostic Regulation (IVDR) is one of the most significant regulatory shifts, affecting the European diagnostics industry. The regulation aims to increase patient safety, reliability, and transparency, but with this has come very strict demands that have overwhelmed the preparedness of many organisations. Nevertheless, there is a scarcity of empirical studies focused on how firms manage the new demands and address them, especially in terms of resource allocation, impediments to compliance, and adaptation to strategic change. Therefore, this research was conducted to critically reflect upon the preparation of organisations to comply with the IVDR and their policy margins, as well as the policy implications of the regulation. It used mixed methods, which included both quantitative survey responses as well as qualitative interviews, analysed using qualitative content analysis. This integration offered not only statistical data, but also a deep contextual knowledge of the industry experiences. The results indicated that there are three main themes: regulatory barriers focused on Notified Body scarcity and vague guidance; organisational preparedness that linked to resource endowment, re-strategising QMS, and digitalisation; and perceived benefits linked to greater market credibility, quality assurance, and patient confidence. As per analysis, it was identified that even though larger firms were more resilient, SMEs were over-represented in being burdened, which causes the problem of innovation and diversity in the competitive market. Furthermore, this research recommended that increasing the capacity of Notified Bodies, harmonising the regulatory guidelines as well, and implementing SME-specific compliance facilitating measures to reduce regulatory burdens. They also include proactive organisational strategies such as the use of digital traceability tools and the rationalisation of portfolios that can be addressed by organisations in order to enhance preparedness. Using empirical findings and practical recommendations, this study can make a contribution both to the understanding of the academic field and the practice of regulation, with foundations for future additional research and adaptation to the industryItem SMART WHEELCHAIR SAFETY AND ACCESSIBILITY IN PUBLIC TRANSPORT: A DATA-DRIVEN EVALUATION OF DESIGN LIMITATIONS AND REAL-WORLD CHALLENGES(2025)The mobility of people with disabilities is increased and safety is enhanced when modern technology like self-navigation, obstacle avoidance sensors, or automatic brakes is incorporated into smart wheelchairs. Yet, despite such a raw deal, we continue to encounter accessibility problems with the Irish public transport system resulting from a lack of facilities, variable performance, and social attitudes. This mixed-methods study aims to provide evidence, from the identification of persistent environmental and design barriers present on buses, trams, and trains to the development of a broader sensor-audio alert system, and to determine whether this will improve safety for getting on board smart wheelchair technology. The views of wheelchair users, carers, clinicians, and commuters were gathered through a cross-sectional survey (n = 56) that combined open-ended questions with Likert-scale measurements. Quantitative analysis revealed that 50% of respondents were uncertain about boarding without assistance (mean score = 2.41%), and the most frequent obstacles were platform gaps (44.6%), high ramp slopes (60.7%), and railing or door interference (53.6%). Sensor-based systems may increase safety, according to 69.6% of interviewees; they preferred spoken alerts (48.2%), auditory tones (46.4%), and visible signs (60.7%). The thematic study revealed six recurrent needs: automation and hazard identification, experienced people support, improved stop-ramp alignment, routine maintenance, public awareness, and inclusive design. The suggested prototype, a modular ultrasonic/infrared sensor with configurable visual, audio, and vibration alerts, was well received for its potential to increase confidence and decrease incidents, even though participants emphasised the importance of affordability, dependability in bad weather, and customisable alert settings to avoid false alarms or stigma. The results show that although smart wheelchairs promote safety, they cannot completely eradicate accessibility inequalities without further advancements in operational procedures, public perceptions, and transportation systems. Policy recommendations, operational instructions for transit providers, and design advice for wheelchair manufacturers are provided in this study to assist the safe, respectful, and inclusive mobility of wheelchair users in Ireland's public transit systems.Item Perceptions and Impact of Wearable Glucose Monitor In Urban and Rural Diabetes Management in Kerala and Ireland(2025)Diabetes mellitus is a growing global health challenge, with marked differences in prevalence, management, and access to technology across countries. Continuous glucose monitoring (CGM) devices have transformed diabetes care by enabling real-time monitoring, improved glycaemic control, and patient self-management. This study compares the perceptions, adoption, and impacts of wearable glucose monitors of two locations. The first location is Kerala, India. In India diabetes prevalence is among the highest worldwide but CGM adoption remains limited. The second location is Ireland, where national strategies and reimbursement policies have facilitated wider uptake. Using a mixed-methods approach, surveys and interviews were conducted with healthcare professionals across urban and rural settings to identify barriers, enablers, and perceived patient outcomes. Findings indicate that CGM use is substantially higher in Ireland, supported by structured care pathways, reimbursement schemes, and integration into clinical workflows. In contrast, Kerala demonstrates sporadic adoption, constrained by high out-of-pocket costs, limited availability, and gaps in provider education. Despite these disparities, both contexts reported high clinician confidence in device efficacy, with over 80% perceiving improvements in glycaemic control, reduced hypoglycaemic episodes, and increased patient engagement. Barriers were context-specific: economic and infrastructural in Kerala, and workforce capacity and workflow integration in Ireland. Notably, noninternet CGMs emerged as a partial solution to connectivity challenges in Kerala, though supply and interpretation gaps persist. The study concludes that equitable CGM diffusion requires bundled strategies, including financing, workforce training, and reliable supply chains, tailored to local contexts. These findings provide actionable evidence for policymakers and clinicians seeking to scale wearable glucose monitoring in diverse healthcare environments.Item COMPARING HIS BUNDLE BRANCH AND LEFT BUNDLE BRANCH AREA PACING IN CARDIAC RESYNCHRONIZATION THERAPY: SAFETY, FEASIBILITY AND PREDICTORS OF RESPONSE(2025)This study explored the use of two advanced pacing techniques, His Bundle Pacing (HBP) and Left Bundle Branch Area Pacing (LBBAP), for cardiac resynchronization therapy (CRT). The goal was to compare their pacing performance, safety, feasibility, and predictors of response using thematic analysis of semi structured interview conducted with electrophysiologists, cardiologists, nurses, and cardiac rhythm management technicians who have hands-on experience with these pacing methods. The findings revealed that both HBP and LBBAP improve the heart’s electrical activation more naturally than traditional biventricular pacing. However, LBBAP showed several advantages, including more consistent and narrower QRS complexes in ECG, lower pacing thresholds, and better sensing effectiveness. These features contribute to longer device life and fewer complications in future. LBBAP was also found to be easier to implant, with faster procedure times and more reproducible results after initial training. Its use was preferred especially in elderly or frail patients and those with complex heart anatomy. In contrast, HBP was often technically demanding and less predictable, requiring precise placement in the HIS bundle area and sometimes leading to re-interventions due to loss of heart rhythm capture. The study identified key factors that guide the decision to use one method over the other, such as the heart’s anatomy, the patient’s overall health, and the history of prior leads or devices. Narrowing of the QRS complex, a marker of synchronized ventricular contraction, stable pacing thresholds, and strong sensed signals were important predictors of successful therapy. Clinicians noted that LBBAP generally met these criteria across a wider range of patients. Recommendations were made to adopt LBBAP as the preferred approach in routine clinical practice while reserving HBP for select cases. Further research was encouraged to investigate long-term outcomes and complicated patient groups. Overall, this work provides valuable insights into the practical use of both conduction system pacing therap
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