Founder, Blue Goat Cyber | MedTech Cybersecurity Leader | Speaker & Author | 24x Ironman | Securing Innovation & Patient Safety.
You can spend real money on excellent testing and still fail because excellence aimed at the wrong scope is just expensive noise.
A medical device manufacturer hands the FDA a penetration test report. The testers were skilled. The findings were real. The report was clean and thorough. Weeks later, a deficiency letter arrives asking about the test scope. The team is confused, because the testing was good. That is exactly the problem. Good testing is not the bar. Relevant testing is.
I have reviewed hundreds of premarket cybersecurity submissions. The most common reason a competent penetration test draws a deficiency has nothing to do with the quality of the testing. A reviewer is not grading your offensive skill. They are grading whether your evidence forms one unbroken line from threat model to scope to findings to patient risk. Break that line anywhere, and the test stops answering the question the submission exists to answer. Most teams break it at the very first link: scope. They test something. They just do not test the thing the reviewer is asking about.
