The FDA Curtain

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

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

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This article was originally published in the May 2001 print edition of Entrepreneur with the headline: The FDA Curtain.

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