Apart from the abiding by the FDA rules and the medical device industry being highly regulated, the actual execution the project management cycle is very critical. If a company is building a skyscraper that it is not a novelty. The basics of architecture are already known and been applied many times over. The architect may be creative and slightly modify the shape of the building for the aesthetics. However, a medical device is almost always a novelty. Building a skyscraper is utilizing existing resources but building a medical device requires a lot of research and experimentation. The real obstacle comes in the execution phase where a certain experiment might not be producing promising results despite the research that has gone into it. The risk level is extremely high building a medical device. Even after a successful experimentation, the human genetic makeup is so diverse that it can still reject and the project can go into a huge loss.