Design inputs are mainly customer needs. An individual can come up with an innovative idea for a medical device, however it is the design inputs that will ultimately dictate what goes into the device itself. These design inputs are basically the desires of the end users. Dr. Simon gave us a great example of a design input: “a red door knob”. That would be an example of a design input. It offers a very generic quality about the device and is not specific. Think of what a client/customer would ask you to produce during the initial brainstorming of a device. Would a client come up to you and ask you to make “a 3-cm diameter knob dyed with Red #5” or would they ask you to make “a red door knob” with various other needs?

Nonetheless, a customer may want a specific function to the device that may not be feasible – according to the standards set out by the FDA, which @hzy2 had mentioned. Overall, the design inputs are ultimately shaped by the end users along with the standards and regulations of the FDA to ensure feasibility.