You can't compare it to other imaging technologies, train radiologists on it, or do trials for specific diagnostics until you've wired it up and built the device. If you demand that you do that before building the thing you can literally never create anything new.

A theranos situation is one where you're lying about what you have reason to believe the new device will do - saying it will do things that you have no reason to think are even plausible - that you have prototypes doing the thing even. Not one where you're merely experimenting with something new that might or might not pan out.