Investors' nightmare >>
What you want to avoid.

The idea was brilliant, the business plan convincing. The market potential promising. The feasibility in the lab had been demonstrated by the engineers.
It would be a hot-selling item. Even the time to market seemed to be well-founded and reasonable. Additional loops were included..
Costs were reasonable, a superior ROI within reach.

First, only minor delays occurred, ordered items arrived later than expected, externally produced parts did not meet the specifications completely, but nothing that would delay the major milestones. Everything under control.
Then, in addition to the different minor delays, other problems; unfortunately, these were internal. The required know-how regarding specific materials and technologies was not internally available and could not be acquired fast enough. Specifications were missed. The project fell behind schedule.

Suddenly new requirements regarding bio-compatibility and electrical safety surfaced. Certificates were requested. Additional tests had to be conducted. Even the software now had to be certified as a medical product.
Why didn’t anyone know about this beforehand and speak up sooner? At that point, the project was already one year behind schedule.
And suddenly the notified body said that a clinical study would be required. Was this true? That would mean another delay of at least one year, not to mention the costs. How could it be that nobody had realized this in advance? This was never mentioned in the business plan. The costs were rising and rising, the end of the project suddenly out of sight.

Why wasn't there someone out there with the requisite expertise who could have given him competent, independent advice in advance?