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The Role of Regulators in Mitigating Uncertainty within the Valley of Death

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Document pages: 45 pages

Abstract: The essential cause of the ‘Valley of Death’ is the reluctance of the private sector to invest in technologies which are perceived as too risky. This risk has usually been assessed in terms of technology maturity. However, uncertainty about whether a new product or technology complies with regulatory frameworks may also have an important effect on private sector investments. We study how regulatory agencies engage with public sector researchers and the private sector actors to create new tools and guidelines to reduce regulatory uncertainty, and how their efforts impact investment across the Valley of Death. We use the cases of the Critical Path Initiative, in the pharmaceutical industry, and the Advanced General Aviation Transportation Experiments, in the general aviation industry, to analyze how the role of regulators may vary across different industry contexts. Based on our findings, we create a taxonomy with three different types of regulatory uncertainty, which we designate as ‘Framework Dynamics Uncertainty,’ ‘Final Compliance Uncertainty’ and ‘Qualification Method Uncertainty.’ Analyzing the dominant types of uncertainty in each industry and technology case may help better design public-private partnerships by incorporating the appropriate technical expertise from a variety of stakeholders, and align program outcomes to regulatory goals so that the tools created in those programs enjoy the appropriate regulatory endorsement.

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