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

Paul Scannell,Kathryn Cormican

doi:10.4067/s0718-27242019000300082

Abstract

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.

Highlights

The commercialisation of scientific and technological knowledge is crucial to economic growth and development (Fontes, 2005; Ndonzuau et al, 2002)
Case study analysis was used to determine the relationship between regulatory knowledge and the academic spinoff formation process
Group I predominately consisted of principal investigators, postdoctoral and postgraduate academics

Summary

Introduction

The commercialisation of scientific and technological knowledge is crucial to economic growth and development (Fontes, 2005; Ndonzuau et al, 2002). Within a knowledge based economy, the university becomes a component of the innovation system where academic technology transfer can occur through several mechanisms such as licensing, publication, cooperative research and development agreements and spinoff formation (Iacobucci and Micozzi, 2014; Rogers et al, 2001). Fontes (2005) describes technology transfer as a process comprising the development of applications for new scientific concepts and turning these into viable technologies, products or services. Siegel et al (2004) investigate the process within an academic setting and defined it in terms of a linear flow model beginning with a discovery by a university scientist through to its patenting and licensing to an existing firm or start-up. Rogers et al (2001) argues that such a linear model of the process may not fully account for external environmental factors such as market demands and regulatory factors

Methods

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Discussion

Conclusion