This topic brings to mind the end of any commercial and how there is a long list of things that may happen based on their statistical analysis. For devices, their risks seem to incorporate an entire warning’s page (or something of the sort). I can think that the only reason why the product is on the market is because the warnings, or risks, scarcely happen and worth the benefit they bring over the potential danger. I think companies should always have this risk to benefit ratio. In the beginning, they can use it to determine the fate of their product (to continue with it or drop it). Then it can be used throughout their research to meet guidelines and regulations. I think this falls on both the risk management and project management responsibilities.