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Developing a framework for managing industry 5.0 innovations in the Irish life sciences manufacturing sector
Date
2025-08-31
Abstract
This research investigates the adoption of Industry 5.0 (I5.0) innovations in the Irish life sciences manufacturing sector, emphasising the importance of balancing regulatory compliance, risk management, and stakeholder collaboration with transformative technological advancements. The study identifies systemic barriers such as regulatory constraints, organisational risk aversion, and stakeholder misalignment, which often delay the adoption of innovative technologies in highly regulated sectors. To address these challenges, the research develops a structured framework that integrates Quality Risk Management, Model-Based Design (MBD), and Open Innovation strategies, offering a scalable solution for managing I5.0 innovations.
The methodology involved iterative framework development through structured workshops with industry practitioners, followed by pilot testing and feedback analysis. The Innovation Maturity Assessment (IMA), Innovation Maturity Rubric (IMR), and Innovation Readiness Levels (IRL), developed as part of this work, provided structured tools for evaluating innovation readiness, regulatory alignment, and strategic value. MBD-driven digital validation processes streamlined compliance tasks, reduced resource burdens, and enhanced traceability, demonstrating the framework’s practicality in real-world settings.
Key findings reveal that regulatory constraints and risk-averse cultures are major barriers to early-stage innovation adoption. The developed framework mitigates these challenges by offering a clear methodology for assessing innovation potential, aligning with compliance requirements, and managing risks effectively. Early alignment between technical, regulatory, and business stakeholders enhances innovation adoption rates and enables more timely, cross-functional engagement in innovation decision-making.
The study contributes to theoretical and practical knowledge by demonstrating how structured risk management and innovation frameworks support I5.0 innovation adoption. The IMA and IMR and IRL, together offer practical tools for industry stakeholders, policymakers, and educators, supporting adaptive regulatory frameworks, enhancing innovation strategies, and providing a foundation for future research. Future work includes refining the framework through additional case studies, exploring regional regulatory barriers, and developing digital IMA versions. This research offers a structured, industry-validated approach to innovation management, bridging the gap between technological advancement and regulatory adherence in the life sciences manufacturing sector.
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University of Limerick
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Sustainable Development Goals
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Attribution-NonCommercial-ShareAlike 4.0 International