The product is not the hardest part of a product launch. The hardest part is the commercial ecosystem — the network of stakeholders whose needs, behaviors, and decisions must be aligned before a product can achieve the adoption it was designed to produce.

The value proposition is not a statement. It is a commercial hypothesis — a testable claim about who needs what, why this product provides it better than any alternative, and why that matters to the specific customer whose behavior the organization needs to change.

Regulatory approval is a milestone. Commercial viability is a design problem. And like all design problems, it requires the right kind of thinking, applied far earlier than most organizations begin.