I think that risk/benefit ratio is something that comes up throughout the entire lifecycle of the project. Risk is a major concern regarding medical devices because an issue could lead to serious injury or death if the device malfunctions. The greater the risk that comes up is the more difficult the decision becomes to make for the company. With a greater risk the company would need to foresee a significant benefit to even consider the risk. At the same time risks may exist that are too risky to take, no matter what the perceived benefit may be.