Do you know all the regulatory and compliance requirements for each market you intend to enter and the associated costs and times for approvals?
Do understand the strategic and on-going cost implications of patent protection and the impact on your commercial outcomes?
Do you know if you have the freedom to operate in your intended markets?
Do you truly know the value and scope of the intangible value your product will generate, and how you can use it to your commercial advantage?
If you have development or collaboration partners, how will IP agreements between the parties impact commercial outcomes?
What level of environmental impact will your product have? Will that impact the commercial outcomes?