Adding to what was mentioned by amandaally1029 above after the risk analysis is completed in the FMECA technique; a critical decision must then be made by the heads of the company. That decision is: does this product’s risk outweigh the potential monetary gain that we hope to achieve though marketing the final design? This critical decision must be made in some of the very first risk assessment meetings so that time/ money/ and human resources are not wasted on a product/ device that is deemed too risky for that company to undertake. Although the product may be potentially extremely lucrative, it if also poses unavoidable unnecessary high risk, it may be scrapped for a less lucrative, more legally secure option. Most of the time, this is generally not an issue, however, I believe that this is an important situation to consider any time a life altering device is being proposed.