The challenge in manufacturing medical devices as opposed to a sky scraper or a bridge is the process of making it compatible with the body. These medical devices will be used in, on, or around the body and must be engineered as such. The involvement with the FDA makes this process all the more complex. The FDA has a very specific set of regulations and that are put in place for the safety and well-being of potential recipients. The individualized set of possible risks must be generalized and addressed by the FDA. In the case of a skyscraper, the safety concern is overall risk of structural failure. This is something that, once the building is open for the public, it is not really something that can be a further concern. However, with a medical device that is replicated for many recipients, an individual may encounter an adverse effect after the product is on the market. The whole line may have to be recalled in this case. With a building it cannot be recalled just because one person in the building does not like the way the windows face. In the case of project management for a medical device, there is a cyclic way of the project in the way that it may have to come back to square one in the case of a complaint.