Six groups of words: 1. FDA 401K approval (License to make laser that is substantially equal to some one else's prior design)
2. Patents
3. FDA Good Manufacturing Processes rules and immense documentation. (actually a good thing for patient safety, but expensive)
4. Cost of seven years of clinical testing
5. Investor Greed
6. Medical Marketing is not cheap, you need MDs and PHDs on your team to create peace of mind for the users. Think free vacations and seminars, booze and smooze, clinical papers proving efficacy, hot marketing chics, airfare, etc...
James already got word 7 for you.
Get caught importing and using a non-approved laser, expect to your life to be financially ruined forever. Have a non-approved laser fail during surgery, causes this effect as well. Your competitors will gladly turn you in, too.
I will openly admit 300,000$ for a heavy steel explosion and body fluid proof box on wheels, designed to prevent electrical shock to a patient that contains a 22,000$ industrial laser made in Florida to tighter spex, is a bit steep.
I understand your pain.
ROD = 900-2000$ in quantity, flashlamp = 250$, lamp cap charger, 3000$, ceramic lamp cavity = 500$, two cavity optics at 400-700$ each, Q-switch another 2000$ in quantity. All parts have to undergo incoming testing at your facility, CE and UL, CSA, approval etc.
Steve
Last edited by mixedgas; 03-30-2023 at 13:51.
Qui habet Christos, habet Vitam!
I should have rented the space under my name for advertising.
When I still could have...