What Happens if You Add Delay Risks to Planned Product Timelines?

The answer is that you will get a forecast instead of a plan, as the product plan only shows what the company wants to happen, whereas a forecast shows what is likely to happen.

The product plan includes a planned launch date, which tells the company when it will launch unless something unforeseen happens. A plan assumes that everything goes as expected, e.g., the recruitment for all remaining studies is completed on schedule, the clinical effect meets the expectations, and there are no problems with FDA, amendments, compliance, site startup, safety, toxicology, manufacturing, or budget.

On the other hand, a forecast considers all risks and adjusts the planned launch accordingly (see Figure A, below). Since there is now uncertainty in the timeline, the forecast replaces the launch date with a window. It's also possible to use the same method to evaluate competitors!

With this uncertainty in the output, the company can create excellent decision-supporting material: "We have a 60% chance of being first to market. If we can mitigate the recruitment risk by adding more centers, this will increase to 75%. This takes the value of this asset from X to Y."

Figure A