The regulations enforced by the FDA are definitely a large and unique consideration that sets medical device development apart from other projects. This, coupled with the demands of global regulatory bodies, makes medical device development particularly complicated. However, there are also the considerations of quality of life and ethics that come into the picture when dealing with human health. While a device may be novel and abide by all regulations, it could be inaccessible to the patients that need them. Cost of treatment and impact on lifestyle are major considerations that need to be made when developing new devices. Also, variations between person to person always makes the exact function of a device uncertain, which is a problem not seen in projects that deal with static environments.