A startup team is assessing their approach to developing a new product. They are considering various factors that could impact their success. Which of the following scenarios best exemplifies a boundary condition that could influence the effectiveness of the lean startup methodology?

A boundary condition for lean startup is an external factor that limits when the methodology works well, such as a highly regulated industry that requires lengthy approval before any customer feedback can be gathered. If a startup is building a medical device, the need for FDA clearance means they cannot release an MVP to customers until a prototype passes safety tests, which breaks the rapid test‑learn loop. Because the feedback cycle is delayed, the lean startup’s assumption that you can iterate quickly no longer holds. For example, a startup wanting to launch a new insulin pump must first satisfy regulatory hurdles, so the lean approach must be adapted or replaced.