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Doctor's Orders Getting the FDA to give your medical invention the thumbs up can be a challenge, so follow this prescription for approval.

By Don Debelak

Opinions expressed by Entrepreneur contributors are their own.

The entrepreneur: Dr. Jim Boyd, 46, a dentist in SanDiego and founder of NTI-TSS Inc. in Misha-waka, Indiana, maker of theNTI

Product description: FDA-approved for migraineprevention, the NTI device is an inch-wide, custom-fitted nightguard that snaps onto the two front teeth to prevent back teethfrom clenching during sleep. The product sells to dentists for $20per blank device; dentists typically purchase 10 blanks at a time,then customize the product for each patient. (Fitting andcustomization costs about $500, depending on the dentist.)

Startup: Boyd spent less than $15,000 developing theproduct prior to licensing it to dental supplier Heraeus Kulzer in1998. After the supplier invested more than $100,000 in the initialproduct rollout and another $500,000 in clinical trials, it decidednot to continue with the product for financial reasons and offeredit back to Boyd in 2000 for $1 mil-lion. Heraeus Kulzer financed 70percent of the sale, and Boyd raised the remaining 30 percent frominvestors.

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