Regulation – Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

Clare O'Dwyer, Kathryn Cormican


This study explores new product development in a strict regulatory and historically secretive environment. Adopting a systems perspective and a mixed methods approach in our research, we examine medical device development in Ireland. Findings indicate that the possession of a regulatory strategy expedites the rate of commercialization, so too does the generation of clear product definitions and marketing claims in the earliest developmental phases. Moreover, results suggest that if the regulated industry strengthens its culture for regulation by prioritizing regulation over speed to market, by encouraging cross-functional team collaborations, and by taking a more proactive approach in post-marketing surveillance activities, it has the potential to improve customer satisfaction and enhance product innovation. This study provides unique empirical data enriched by the homogeneity of its sample. It also contributes guidance to practitioners of new product development within a regulatory context.


new product development; NPD; medical device development; MDD; innovation; technology innovation management; regulation management; regulatory culture; intended use(s); marketing claims; post- marketing surveillance.

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