Challenges that project managers for medical devices face differ from those that construction project managers face in a few ways. Construction project managers and medical device mangers both have to ensure the project is on track and according to plan. They both manage the project so it is completed on time and within budget. For construction project managers Other functions may include specifying scope, budget, and schedules, selecting subcontractors and workers, developing communication strategy for resolving conflicts, etc. For devices stringent medical development regulations exist. These include regulatory requirements such as 21 CFR Part 820, the FDA’s guidelines for the regulation of quality systems related to the methods used in facilities and controls used for design, purchasing, manufacturing, packaging labeling, storing, installing, and servicing. For a building, an architect hands you a blue print, you know where everything goes and the materials are readily available. It’s like Legos, the pieces exist, and all you have to do is know how to put the pieces together. For medical devices, the material has to be biocompatible, it has to survive in vivo, and the duration of the material, when in vivo, has a time constraint due to the body’s immune system attacking the foreign material. The human immune system recognizes the foreign material as soon as it’s placed in the body and initiates an immune response. Even if the body accepts the material, at some point, one may have to operate in the near future either to replace it or remove debris from the implant. Updating a building is easily done whereas updating an implanted medical device involves tampering with one’s health. To develop an implantable device, Good Manufacturing Practice must be used. You can build a cement block anywhere, try building a hip joint outside on your lawn and see the response you receive from the FDA.