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.