How much information is needed in order to begin a formal project is solely dependent on what is already known about the the technologies surrounding the prospective project. Like in the above example you provided, the biomaterial that’s been in development for nearly a decade will probably not need as much research regarding the pros and cons of its application. What is probably to be provided would be whether or not if it’s feasible given all the previous research done in the past decade. Additionally, the market or business case/business assessment model is needed, otherwise there is no knowledge on whether or not this project will have some reward for the company.

In the real world, there needs to be enough information and feasibility from gathered research that this would pass the Go/Kill decision of the Stage Gate. Absolutely no design controls should even start until there is enough evidence/feasibility otherwise this poses problems and risks later on when it comes to the inputs and outputs of the project in the DID, DSD, etc. Sometimes it’s even a good idea to have a prototype and see if it’s fully functional before the formal project is even initiated.