Bang on Recon.
The smart move would have been to use a firm with some expertise in getting FDA approvals (DOCRO for example) as consultants on this project. Such a firm might have advised Dean that it would be wise to actually have the thing working prior to submitting an FDA application. They might also have suggested that input from radiologists, doctors and the like, people who actually had a chance to use it, would be advisable. Over-prepare followed by over delivery as a corporate motto.
Dean's performance has been totally underwhelming to date (apart from the vision to develop this thing in the first place).