The Impact of Medical Device Regulations on Academic Spinoff Formation

This paper investigates the impact of the medical device regulatory framework on the academic spinoff formation process. A microfoundations lens that focuses on individuals, processes and structures is employed in order to... [ view full abstract ]

This paper investigates the impact of the medical device regulatory framework on the academic spinoff formation process. A microfoundations lens that focuses on individuals, processes and structures is employed in order to uncover and explain what drives behaviour in this specific context. To this end, a detailed case study focusing on academic spinoff formation in the Irish medical device industry was conducted.

This study found that, whilst there is a general awareness of, and importance attributed to, the medical device regulatory framework the consideration given to it significantly lags that given to other commercialisation activities. This trend has potential not only to significantly delay spinoff formation but also to negatively impact its potential success and survival. By incorporating expert regulatory knowledge earlier within the process the spinoff activities within universities may be enhanced particularly in terms of funding, research activities and capital investment.

The findings from this analysis contribute to knowledge in the domain by expanding and deepening our understanding of the underlying routines and capabilities for academic spinoffs when viewed through a medical device regulatory lens. Furthermore, comparing and contrasting these elements across specific samples helps to explain how differences in routines and capabilities arise.