Doctor's Orders

Getting the FDA to give your medical invention the thumbs up can be a challenge, so follow this prescription for approval.
Magazine Contributor
7 min read

This story appears in the November 2005 issue of Entrepreneur. Subscribe »

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

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

Startup: Boyd spent less than $15,000 developing the product prior to licensing it to dental supplier Heraeus Kulzer in 1998. After the supplier invested more than $100,000 in the initial product rollout and another $500,000 in clinical trials, it decided not to continue with the product for financial reasons and offered it back to Boyd in 2000 for $1 mil-lion. Heraeus Kulzer financed 70 percent of the sale, and Boyd raised the remaining 30 percent from investors.

Sales: $4 million projected for 2005

The challenge: How does an individual, even a medical professional, get a product to market if it requires FDA approval?

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

Steps to Success
1. Use the invention in your practice. Boyd used the NTI for eight years before licensing it to Heraeus Kulzer. "I had treated patients with an NTI device, and documented the results for well 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 is only 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 evidence that the NTI worked. If you're not a medical profes-sional, partner up with one who will use the product in his or her practice.

2. Get the word out. Boyd's practice specializes in migraine relief. While he couldn't advertise the device itself with a medical claim, he could promote his practice as one that offers solutions for migraine sufferers. To get the word out, Boyd placed ads in local newspapers announcing a "migraine prevention breakthrough."

3. Protect yourself in royalty agreements. Royalty agreements usually favor the company licensing the idea, but inventors can often protect themselves with a minimum per-year royalty that ensures they still collect even if the company doesn't sell the product, or that they can get the product back if minimum royalties aren't paid. Boyd used a different approach: "I was able to negotiate a deal to get 33 percent of sales as a royalty due to the product's high profit. That high royalty played a role in the company's decision to sell the patent rights back to me before the FDA clinical trials were complete," he says. "They weren't convinced that the product would ever gain FDA approval for migraine prevention, so they sold [it] back to me."

4. Start with an application that has already been approved. "FDA approvals are much simpler for medical claims that have been made by other companies vs. a first-time claim," says Boyd. "We received FDA approval to sell the NTI device with a claim of correcting jaw disorders quickly and with mini-mal clinical trials because other companies marketed devices with similar claims. Two years of the product's sales under that claim helped pay for clinical trials related to migraine testing, and the sales encouraged the dental-supply house to keep investing in trials."

5. Use professional articles to promote the concept. Clinical trials are expen-sive, but they also form the basis for technical articles that can be placed in key journals. Boyd ran an active campaign to promote his idea to dentists through professional journals. "For most of 2002 and 2003, dentists received a quarterly dental journal with a promotional wrapper describ-ing the NTI device, including large photographs of the device in place," he says. "To date, over 15,000 dentists have used the device with patients."

Lessons Learned
1. Inventors can succeed with any type of product. Many people discourage inventors from proceeding with inventions that are difficult either because of regulatory hurdles, technology challenges or strong market competition. But inventors do succeed with all types of inventions--just look at companies like Medtronic and Microsoft, which have grown into industry giants. You may need more breaks and may need to persist longer before succeeding, but there are no product categories in which an individual inventor can't succeed.

2. It may take time to get the attention of industry experts. People experienced in a market will recognize a novel product if it meets a strong customer need or demand. Exhibiting at trade shows, giving presentations at conferences, advertising where people in the market can spot your ad and running publicity programs are all techniques that will keep your idea in the public eye. It may take several years, but if your product provides a unique benefit, eventually someone who can help you launch the product will notice.

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

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

Looking For the Mother Lode?
When mompreneur Tamara Monosoff successfully marketed her invention, the TP SaverT, which keeps children from unraveling a roll of toilet paper, she realized she could probably help other mom inventors launch their products, too. So she created Mom Inventors Inc., which not only offers a supportive environment and resources for other mom inventors, but also helps "Mom-Invented" products--both those developed by Monosoff and 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 submission requirements and inspirational stories on other mom inventors.

Don Debelak is author of Entrepreneur magazine's Startup Guide #1813,Bringing Your Product to Market, and host of inventor-help website


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