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

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.

Sales: $4 million projected for 2005

The challenge: How does an individual, even a medicalprofessional, get a product to market if it requires FDAapproval?

Waking up with headaches and dealing with migraines severaltimes per week is a way of life for many people. These headachesoften result from the jaw clenching while sleeping. Dr. Jim Boyd,who suffered from migraines himself, found in 1990 that putting asmall, custom-fitted device over the front teeth at night sets offa reflex that stops clenching, greatly reducing or even eliminatinghead-aches and migraines. Boyd figured a lot of people couldbenefit from the NTI, so he set out to get the product to market--adifficult task, considering it would need FDA approval. But Boyddidn't back down, especially since he knew the product couldhelp a lot of people: According to NTI-TSS, 23 million peoplesuffer from severe migraine pain, and the NTI device helps morethan 75 percent of patients reduce migraines by more than 75percent.

Steps to Success
1. Use the invention in your practice. Boyd used the NTI foreight years before licensing it to Heraeus Kulzer. "I hadtreated patients with an NTI device, and documented the results forwell over 100 patients in my private practice," he says."Professionals are able to use a device without FDA approval[known as off-label use] in their own practice. FDA approval isonly needed if you market the device with a medical claim."While his records weren't used by the FDA for their approval,they were available in case a potential licensee wanted evidencethat the NTI worked. If you're not a medical profes-sional,partner up with one who will use the product in his or herpractice.

2. Get the word out. Boyd's practice specializes inmigraine relief. While he couldn't advertise the device itselfwith a medical claim, he could promote his practice as one thatoffers solutions for migraine sufferers. To get the word out, Boydplaced ads in local newspapers announcing a "migraineprevention breakthrough."

3. Protect yourself in royalty agreements. Royaltyagreements usually favor the company licensing the idea, butinventors can often protect themselves with a minimum per-yearroyalty that ensures they still collect even if the companydoesn't sell the product, or that they can get the product backif minimum royalties aren't paid. Boyd used a differentapproach: "I was able to negotiate a deal to get 33 percent ofsales as a royalty due to the product's high profit. That highroyalty played a role in the company's decision to sell thepatent rights back to me before the FDA clinical trials werecomplete," he says. "They weren't convinced that theproduct would ever gain FDA approval for migraine prevention, sothey sold [it] back to me."

4. Start with an application that has already beenapproved. "FDA approvals are much simpler for medicalclaims that have been made by other companies vs. a first-timeclaim," says Boyd. "We received FDA approval to sell theNTI device with a claim of correcting jaw disorders quickly andwith mini-mal clinical trials because other companies marketeddevices with similar claims. Two years of the product's salesunder that claim helped pay for clinical trials related to migrainetesting, and the sales encouraged the dental-supply house to keepinvesting in trials."

5. Use professional articles to promote the concept.Clinical trials are expen-sive, but they also form the basis fortechnical articles that can be placed in key journals. Boyd ran anactive campaign to promote his idea to dentists throughprofessional journals. "For most of 2002 and 2003, dentistsreceived a quarterly dental journal with a promotional wrapperdescrib-ing the NTI device, including large photographs of thedevice in place," he says. "To date, over 15,000 dentistshave used the device with patients."

Lessons Learned
1. Inventors can succeed with any type of product. Manypeople discourage inventors from proceeding with inventions thatare difficult either because of regulatory hurdles, technologychallenges or strong market competition. But inventors do succeedwith all types of inventions--just look at companies like Medtronicand Microsoft, which have grown into industry giants. You may needmore breaks and may need to persist longer before succeeding, butthere are no product categories in which an individual inventorcan't succeed.

2. It may take time to get the attention of industryexperts. People experienced in a market will recognize a novelproduct if it meets a strong customer need or demand. Exhibiting attrade shows, giving presentations at conferences, advertising wherepeople in the market can spot your ad and running publicityprograms are all techniques that will keep your idea in the publiceye. It may take several years, but if your product provides aunique benefit, eventually someone who can help you launch theproduct will notice.

3. When an inventor faces tremendous challenges, there areoften profits to be had. When Boyd needed to raise a large sumof money, he could do it because the clinical trials showed theproduct could provide relief to millions of migraine suffers. Thechallenge was getting the trials conducted, but once Boyd had them,he could target a large market. And he knew any potentialcompetitors would face a delay in seeking FDA approval.

4. You can almost always find a low-cost promotionmethod. Articles published in professional dental journalsprovided a great, low-cost promotion method for Boyd. Mostinventors use similar low-cost marketing strategies, such as PR inconsumer magazines, low-cost trade shows, or joint promotions aninventor runs with other companies selling to the same market.Check out the various promotional opportunities available beforeyou run an expensive promotional program, such as TV ads.

Looking For the MotherLode?
When mompreneur Tamara Monosoff successfully marketed herinvention, the TP SaverT, which keeps children from unraveling aroll of toilet paper, she realized she could probably help othermom inventors launch their products, too. So she created MomInventors Inc., which not only offers a supportive environment andresources for other mom inventors, but also helps"Mom-Invented" products--both those developed by Monosoffand those licensed by Mom Inventors Inc.--crack the retail market.Monosoff recently wrote The Mom Inventors Handbook, (McGraw-Hill,$16.95). Check out her website for resources, product submissionrequirements and inspirational stories on other mom inventors.