Budgets take capital to implement and the planning and signing contracts and proven ability to pay bills. Give it time and all will be pleasantly happy and rich! Who would do something foolish in advance NOT the Whelans!
but they didn't know they were only getting clearance for foot and knee.
All their preparation was based on general clearance, including preliminary discussions with major pharma distributors who I expect have said call us later when you have full clearance, hence having to do it themselves with no budget.