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  • I see a lot of posts on here citing the FDA as a huge difference between a medical device project and a construction project. However, this is just one of many huge differences. The FDA makes life hard for BME’s yes, but there is one huge elephant in the room when comparing projects… Medical devices are used to go inside someone. There are so many implications to that little statement that makes the projects whole different worlds. First off, the device has to be sealed. It doesn’t need to support 1000 tons of steel it needs to be resistant to all the types of corrosion that different bodily fluids can do. It has to be inert to the human body as opposed to resisting high winds. It has to be modular, able to be used on everyone, regardless of individual anatomical differences, instead of housing plumbing and electrical wires. While it is arrogant and wrong to say one type of project is harder/more costly than the other, some differences in goals are clear. Buildings have to function as fully functional and equipped shelters. Medical devices have to function such that they accomplish a task while interacting with a human body and not have adverse effects on said human body.