Spinning Out of Control? How Academic Spinoff Formation Overlooks Medical Device Regulations


  • Paul Scannell College of Engineering & Informatics, National University of Ireland, Galway, University Road, Galway, Ireland
  • Kathryn Cormican College of Engineering & Informatics National University of Ireland, Galway




academic spinoff formation, medical device, regulatory framework, case study.


This paper investigates the impact of the medical device regulatory framework on the academic spinoff formation process and contributes to knowledge in the domain by expanding and deepening our understanding of its underlying routines and capabilities. A detailed case study focusing on academic spinoff formation in the Irish medical device industry was conducted and found that the consideration given to the medical device regulatory framework significantly lags behind that given to other commercialisation activities. This trend has potential to both significantly delay spinoff formation and negatively impact its potential success and survival. Findings indicate that incorporating expert regulatory knowledge earlier within the process may enhance the spinoff activities within universities, particularly funding, research and capital investment.


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Author Biography

Kathryn Cormican, College of Engineering & Informatics National University of Ireland, Galway

Kathryn Cormican (Ph.D.) lectures in the College of Engineering & Informatics at the National University of Ireland Galway. Her research interests lies in the areas of enterprise integration and technology innovation management. This is an applied research area so it is essential to work closely with industry to identify and prioritize requirements, co-develop solutions and ecosystems and validate and implement new models and systems. The focus may be on a specific process, business unit, enterprise or value network which would include an enterprise and its relationship with its customers, suppliers regulatory bodies and other key stakeholders. The research area is multidisciplinary in nature and spans areas such as engineering, technology and business. Kathryn has significant experience in proposal generation, R&D project management and technology transfer. She has published widely at international conferences and peer reviewed journals. Kathryn works closely with many leading organisations and SMEs helping them to diagnose, develop and deploy new processes and systems.


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How to Cite

Scannell, P., & Cormican, K. (2019). Spinning Out of Control? How Academic Spinoff Formation Overlooks Medical Device Regulations. Journal of Technology Management & Innovation, 14(3), 82–92. https://doi.org/10.4067/S0718-27242019000300082



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