From Bottleneck to Opportunity: Embedding Regulations into The Innovation Process to Gain a Competitive Advantage.
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2023-07-03
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en
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This thesis analyses how organisations should embed regulations into their innovation process, in order to gain a competitive advantage. The literature on the effects of regulations on innovations itself is quite substantial, however there is a lack of papers on the embedding of regulations into the innovation process. To fill this gap, the data is gathered through qualitative methods. Through a single-case study concerning the Medical Device Regulation, 8 interviews have been conducted. The analysis finds that the implementation of a Quality Management System (QMS) before the start of an innovation is crucial. Additionally, before the process starts it is imperative for organisations to already communicate with stakeholders. By informing them on both the regulatory requirements and the workings of the organisation’s innovation process, unnecessary delays i.e., caused by misunderstanding can be prevented. Such communication is also a prerequisite for engaging stakeholders throughout the innovation process. With continuous stakeholder engagement organisations are able to combine knowledge, and demands in order to comply to regulatory and normative pressures more efficiently. For the aforementioned to succeed, knowledge exchange with both intra-, and inter-organisational stakeholders is necessary. These findings have both theoretical and practical implications.
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Faculteit der Managementwetenschappen