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

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 exp...

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Autores principales:	O'Dwyer,Clare, Cormican,Kathryn
Lenguaje:	English
Publicado:	Universidad Alberto Hurtado. Facultad de Economía y Negocios 2017
Materias:	new product development medical device development innovation technology innovation management regulation management regulatory culture post-marketing surveillance
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0718-27242017000100004
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spelling	oai:scielo:S0718-272420170001000042017-05-15Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory ContextO'Dwyer,ClareCormican,Kathryn new product development medical device development innovation technology innovation management regulation management regulatory culture post-marketing surveillance 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.info:eu-repo/semantics/openAccessUniversidad Alberto Hurtado. Facultad de Economía y NegociosJournal of technology management & innovation v.12 n.1 20172017-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0718-27242017000100004en10.4067/S0718-27242017000100004
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	new product development medical device development innovation technology innovation management regulation management regulatory culture post-marketing surveillance
spellingShingle	new product development medical device development innovation technology innovation management regulation management regulatory culture post-marketing surveillance O'Dwyer,Clare Cormican,Kathryn Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context
description	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.
author	O'Dwyer,Clare Cormican,Kathryn
author_facet	O'Dwyer,Clare Cormican,Kathryn
author_sort	O'Dwyer,Clare
title	Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context
title_short	Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context
title_full	Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context
title_fullStr	Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context
title_full_unstemmed	Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context
title_sort	regulation - do or die: an analysis of factors critical to new product development in a regulatory context
publisher	Universidad Alberto Hurtado. Facultad de Economía y Negocios
publishDate	2017
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0718-27242017000100004
work_keys_str_mv	AT odwyerclare regulationdoordieananalysisoffactorscriticaltonewproductdevelopmentinaregulatorycontext AT cormicankathryn regulationdoordieananalysisoffactorscriticaltonewproductdevelopmentinaregulatorycontext
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Regulation - Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

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