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Governance and technological change: the effects of regulation in medical devices

AuthorsBarberá Tomás, David ; Molas Gallart, Jordi
KeywordsInnovation patterns
Medical devices
Incremental innovation
Issue Date2013
PublisherUniversidad Autónoma de Madrid
CSIC-UPV - Instituto de Gestión de la Innovación y del Conocimiento (INGENIO)
CitationProceedings of the 2013 EU-SPRI Forum Conference
AbstractRegulatory frameworks are a key institutional instrument for governance of change in socio-technical systems. One of the main problems in the extant literature on the role of regulation in innovation systems is that it assumes a static framework, often overlooking the dynamic relationship between innovation and regulation. In this chapter we show the dynamic interaction between US regulation in medical devices and the technological evolution of a surgical implant, the hip prosthesis, first introduced in the market in the early 1970s’. We suggest that the burdensome regulatory requirements imposed on the deployment of radical innovations in medical devices have led to the exhaustion of the search path for safe incremental innovations: as hip prosthesis have entered the mature stages of their technological evolutions, incremental improvements have become riskier and have ultimately failed.
DescriptionTrabajo presentado al EU-SPRI Forum Conference: Management of Innovation Policies: new forms of collaboration in policy design, implementation and evaluation, celebrado en Madrid (España) del 10 al 12 de Abril de 2013.
Publisher version (URL)http://www.euspri-madrid2013.org/
Identifiersisbn: 978-84-695-7408-9
Appears in Collections:(INGENIO) Libros y partes de libros
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