Chapter 5 Governance and technological change: the effects of regulation in medical devices
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Any process of technical change carries with it an element of uncertainty: market responses are unpredictable, technologies may not work as expected and they may have unforeseen consequences. Such uncertainty occurs both when changes relate to a specific technology operating within a given innovation or socio-technical system, or when the changes are more profound and affect the whole system. Managing such uncertainty becomes one of the functions of a governance system, and in particular of the governance of processes of technological change. One of the instruments of such systems of governance is the development and implementation of regulatory frameworks. By focusing on regulatory frameworks, this paper addresses one of the three pillars of the analysis of the governance of change in innovation systems identified by Borrás and Edler (2014): the ‘instrumentation of the governance of change’. We see regulation as a form of governance instrument, shaping the ways in which actors involved in the innovation process develop, implement and use innovations. We understand regulatory frameworks as arrangements of ‘legally binding formal regulations which constrain and regulate interaction’ in innovation systems (Borrás and Edler, 2014). In other words, regulatory frameworks affect the way in which actors involved in innovation processes coordinate their activities: they ‘guide the search’ of innovation systems (Hekkert et al., 2007), and shape the direction of technological change and the evolution of innovation systems.

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