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The FDA Curtain

How to keep your medical invention out of the rejected-product gulag
May 1, 2001
URL: http://www.entrepreneur.com/article/39770

All inventors know it takes a lot of hard work to get ideas to market. But have you ever thought about what it takes when your product also requires FDA approval?

Despite what you may think, getting FDA approval isn't limited to huge corporations-entrepreneurs new to the game can get it, too. Case in point: Chris Lipper, founder of idea-development firm Chris Co. Inc. Back in 1995, Lipper launched his Morristown, New Jersey, business selling temporary tattoos and temporary tattoo hang tags for branded and licensed apparel products. At the time, he was also trying to quit smoking. When he noticed his daughter was reluctant to take her medicine, he thought of adapting the technology at work in nicotine patches to temporary tattoos. "[I thought,] 'Why not use temporary tattoos to dispense medicine, especially to children?'" says Lipper, 37. He hoped one day to design temporary tattoos for kids who needed medications such as Insulin and Ritalin. "I wanted to have the tattoo change colors as the medicine left it, so children's parents would know when the medication ran out."

A great idea, sure, but dispensing drugs through temporary tattoos calls for FDA approval. Unwilling to give up, Lipper is going through the process and hopes to receive the FDA's blessing for his vitamin-dispensing Medicated Tattoos, or, as he likes to call them, "Med-Tats," sometime in 2001 or early 2002, about two or three years since starting the process. In order to get approval for dispensing over-the-counter and prescription drugs, though, he expects to wait another three to four years.

First Steps

Lipper started by ironing out what he wanted his product to be: a tattoo with medication that would enter the skin on a time-release basis, over anywhere from eight hours to one week. He wanted the tattoo to have color-changing ability as well. Then he was off to meet with his patent attorney to see if any prior patents for similar ideas existed. The search didn't turn up anything, so Lipper was ready to start developing his idea.

He ran into several problems, though. First, he didn't know a chemist who could create a prototype. Second, he didn't know anyone who was familiar with submitting ideas to the FDA. And finally, most chemists and FDA consultants in the market prefer working with large companies that can offer big checks for services.

Lipper turned to his patent attorney for help, and his attorney referred him to consultants who recommended a recently retired chemist who was well-connected to the FDA. After meeting with Lipper, the chemist agreed to work on the project because he believed it was a great idea.

Unfortunately, inventors often don't realize what a valuable resource the right patent attorney can be-especially patent attorneys who specialize in a particular market. They have other clients and can frequently steer you to useful contacts. You can find a patent attorney by asking other entrepreneurs in the same field who their patent attorneys are, by checking for similar patents on the PTO Web site and finding out what attorneys handle them, and by checking with the American Intellectual Property Law Association (AIPLA) for attorneys who handle products similar to yours. Visit AIPLA's Web site for details.

You've Got Questions . . .
FDA regulations require manufacturers (also called sponsors) to submit INDs (investigational new drug applications) for approval. Because the process can be complicated, the FDA schedules pre-IND meetings to help sponsors figure out what clinical trials and testing are required and what to include in the IND submission. Your best bet at getting the help you need to set up an initial meeting is to contact one of the FDA's five regional offices, which are specifically created to help businesses:
Northeast
Herman Janiger
Jamaica, New York
phone: (718) 340-7000, ext. 5618
fax: (718) 662-5434
e-mail: hjaniger@ora.fda.gov

Central
Marie T. Falcone
Philadelphia
phone: (215) 597-4390, ext. 4003
fax: (215) 597-5798
e-mail: mfalcone@ora.fda.gov

Southeast
Barbara Ward-Groves
Atlanta
phone: (404) 253-0258
fax: (404) 253-1207
e-mail: bgroves@ora.fda.gov

Southwest
Brenda C. Baumert
Dallas
phone: (214) 655-8100, ext. 133
fax: (214) 655-8130
e-mail: bbaumert@ora/fda.gov

Pacific
Mark S. Roh
Oakland, California
phone: (510) 637-3960, ext. 701
fax: (510) 637-3976
e-mail: mroh@ora.fda.gov

Step By Step

Every invention has unknowns that should be looked at before you start spending big money, and medical products face the added challenge of winning FDA approval. Sure, Lipper worried about the FDA, but he also worried about every other unknown confronting inventors. Here are some areas to investigate in the early stages:

Patent rights: Lipper had his patent attorney conduct a search to ensure he could get a patent that would severely restrict competitors. He didn't want to spend time and effort on a product without having a strong patent position first.

Distribution: Next, Lipper looked at whether his product would sell and how he could do it. He discovered that pharmaceutical companies were willing to have their products dispensed via alternative drug-delivery methods and that the companies would buy his product for distribution. "I couldn't afford to market a consumer drug product," says Lipper. "I had to be able to sell it through other companies."

Cost analysis: Lipper had to figure out whether the product could be made with two prime features-time-released medicine and color changing as the medicine was released. Lipper found a chemist who explained that these features were indeed feasible. Lipper also worked with that chemist to figure out if the processes could be done at a reasonable cost.

Regulatory concerns: Lipper's product had to get FDA approval. But there are other common regulations entrepreneurs should be aware of, such as UL (Underwriter's Laboratories) approval, which is required on products that use electricity. Check it out at www.ul.com.

Money issues: Lipper didn't want to exhaust his resources only to find out he couldn't get enough money to introduce the product. So he struck up a joint venture with a manufacturer in China to ensure he had the financial backing to succeed and the means to manufacture.

One of the biggest mistakes inventors make is to misjudge which markets they can penetrate. Many inventors think mass merchants like Wal-Mart or Kmart are easy money, but the fact is, huge retailers are extremely difficult to break into. Another misconception: Inventors often think the drug and medical-device markets are impossible to crack. They're not. Never assume which markets will be best for your new product. Instead, check with your local inventors club or SBDC to make sure you know what you're getting into. Any market is open to novel products that meet a real need. Just find out ahead of time what you need to do to introduce your product. That simple step will save you bundles of money-and give you a real chance at success.


Don Debelak is a new-business marketing consultant and the author of Think Big: Make Millions From Your Ideas (Entrepreneur Press). Send him your invention questions at dondebelak@qwest.net.

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