To add to what was said above by both Mark and amandaally1029 in the above comments, another factor to consider would be the “Availability of alternative treatments or diagnostics”. This is a critical factor to consider because it would not only directly affect the need for your product, but the likelihood of the FDA signing off on the project. If other treatments are readily available to treat the same symptoms cheaper, then it would not be financial beneficial to design and produce the device in question. Similarly, if a device already exists that is able to treat the same symptoms with lower possible health risks, the FDA will not sign off on the proposed new project idea. Ideally, the proposed device would fill a major need in the market with little to no other comparable competition in both the financial and benefit sectors. Lastly, it is important to note that although a product may be deemed to have potentially dangerous side effects towards the patient, the FDA may still sign off on the device if there are no other options available on the market. This goes by the hope that the “the probable benefits outweigh the probable risks”.