A Modern David Goes the Distance
This is my story. I am an oral and maxillofacial surgeon who has invented several important, breakthrough medical device innovations and this book tells of my unbelievable battles with the U.S. Food and Drug Administration in attempts to get approvals for the devices which had been in use some 40 years, even at Mayo Clinic. It tells a dramatic and often shocking story of a surgeon who had to become the David in a story much like the biblical story of DAVID VS. GOLIATH I worked as a successful and innovative oral surgeon for over forty years when, in 2000, I was called to the carpet by the FDA. When they told me my patented TMJ device was being taken off the market, a device endorsed by the Mayo Clinic, it was a declaration of war. Like a modern-day David taking on a modern-Day Goliath, I marshaled my resources as a small business owner, often both praying for God’s wisdom and devising innovative strategies with which to fight back as well as keep my business afloat. After a decade of hand-to-hand combat with the FDA, though, my resources were exhausted, and I had to raise the white flag of bankruptcy. Though it appeared that this was the end, it was only a new beginning, for I found my ultimate victory in the publication of my book, a book that reveals the FDA for who they really are and how they actually operate. You see, I stood my ground.