Who wants to be a millionaire inventor?

These two Thomas Edisons of medicine have succeeded beyond their wildest dreams. They've got some advice for other dreamers.

By Neil Chesanow
Northeast Editor

There was an exquisite moment in 1977 when a representative of Becton Dickinson and Company, a leading medical equipment manufacturer, visited a pair of obscure Yale medical school professors who claimed to have invented the simplest device yet for performing complete blood counts.

BD, which had just invested millions to develop its own blood analyzer, was deeply skeptical. The doctors' gadget, built on a kitchen table, consisted of a few wires, a magnifying glass, and a sheet of graph paper. It cost $100.

The BD rep handed a test tube of blood to pathologist Stephen C. Wardlaw, who had designed the device. " 'Okay,' he said, 'do a CBC,' " recalls co-inventor Robert A. Levine, an endocrinologist. "Steve took the tube, spun it in a centrifuge, measured the separated layers of blood with a hand micrometer, checked the results on a piece of graph paper, and announced that the hematocrit was 37, the white cell count was 6,000, the granulocyte count was 70 percent, the lymphocyte/monocyte count was 30 percent, and the platelet count was 242,000.

"The BD guy smiled condescendingly and took an envelope from his suit jacket pocket," Levine continues. It contained a CBC analysis of the same blood done in a reference lab using the million-dollar technology BD had just developed. When he compared the two sets of numbers, his face turned white. They were a dead match.

In the 25 years since that breakthrough invention, Levine and Wardlaw have established themselves as the Thomas Edisons of medicine. They hold nearly 400 patents for medical diagnostic devices that have generated more than $1 billion in sales, earning the doctors millions in royalties.

Their inventions range from the lowly but ingenious HemaWipe®—a chemically treated tissue paper and mailer that gets a stool sample from patients less distastefully than forcing them to fish through the toilet bowl—to the latest incarnation of their CBC analyzer, the QBC-STAR®, which was used by the US military during Operation Desert Storm and was recently purchased by NASA for use aboard the Mir International Space Station. The doctors continue to produce inventions at an awesome rate. Last year they applied for more than 20 patents.

Their successes haven't come easily, though. "Creating the inventions is probably the easiest part," reflects Wardlaw. "Patenting involves a lot of legal complications. Licensing an invention to a corporate partner can take up to a year. It's hard to appreciate how many layers of management you must convince to get anything done these days. It takes a small nuke to get their attention."

Wardlaw says partnering with a corporation has become a must—that it's virtually impossible to develop and market a medical invention on your own today (see below). While you could start a company to provide the necessary funding and infrastructure, the time involved would force you to give up medicine.

Levine and Wardlaw—whose expertise includes writing patents, licensing to corporations, and marketing, in addition to inventing—also stand ready to help other creative physicians get on the scoreboard. Their Web site, www.mdinventions.com , offers technical details of their key inventions, plus biographies of themselves and board members of their company, Medical Diagnostic Inventions. The board includes a Nobel laureate in chemistry, a Pulitzer Prize-winning science writer, medical school department heads at Harvard and Yale, and renowned scientists, engineers, and corporate chieftains.

Levine and Wardlaw will review any materials sent by a fledgling inventor, chat with him on the phone, and possibly even meet with him. "If we like your invention, we'll help you develop and market it, and even provide funding—in return for an equity interest of 25 to 30 percent," Levine says. "And if we don't like it, we'll still offer helpful suggestions."

The physician-inventors are highly selective, however. "Most people who think they have an invention really just have an idea for one," cautions Levine. "You must be able to describe how your device works so precisely that anyone with sufficient skill could build it."

The pair offers this advice to fledgling inventors:

• Don't go it alone. Work with a partner who complements your skills and can provide a forum for brainstorming, offer sanity checks, and lend emotional support. "You're most productive when bouncing an idea off someone who sees the problem from a different perspective," says Levine.

• Stick to your field of expertise. The most successful inventions solve everyday problems you experience firsthand. The idea for Levine and Wardlaw's blood analyzer, for instance, came about because Levine couldn't get CBCs expeditiously for his patients. In 1976, his options were to send patients to an ER or draw the blood himself, send it to a lab, and wait as long as 24 hours for results. The QBC-STAR® gives him accurate results in five minutes flat.

• Be patient—and selective. Great inventions are rare, even for Levine and Wardlaw. "We come up with at least five ideas for inventions per week," says Levine, "but eventually reject 99 percent."

• Find a good patent attorney. "Corporations don't want mere ideas for inventions," says Levine. "They seek actual inventions that patents have been applied for." The patenting process is complex and myth-ridden (see below). An attorney who specializes in the field—not your family lawyer—should guide you through it.

For this doctor, marketing his invention is an uphill battle

In 1999, cardiologist Sergio Sanchez Zambrano of Cleburne, TX, had an epiphany. He'd gone from the ER, where he'd seen a patient with acute pneumonia, to the ICU to see a patient who'd just had bypass surgery and was on a respirator. When the doctor reached for his stethoscope to listen to the patient's chest, he realized it could be contaminated with pneumococci.

This thought—and the rueful knowledge that like many doctors he had long been inadvertently guilty of passing germs from one patient to another—gave Sanchez Zambrano the idea for a disposable paper diaphragm to replace the one stethoscopes come with.

Sanchez Zambrano's Lub Dubs­named for the sound of a beating heart­contain a temporary adhesive and are affixed to an adapter ring that fits around the stethoscope. Since the paper diaphragm is thinner than the one that comes with the stethoscope, the instrument's acoustics are improved. And since the paper diaphragm will cling to the adapter ring for only a few minutes, a doctor is forced to replace it when seeing a new patient. Affixing a new paper diaphragm only takes a moment and is more convenient than disassembling and cleaning the stethoscope's standard diaphragm after each patient.

Developing a prototype even for so simple an invention was surprisingly expensive. In the US, the tab for two custom-made adapter rings was $30,000. In Monterrey, Mexico, a thriving industrial city, Sanchez Zambrano had better luck. "There, a mold that would cast eight rings at once cost only $4,000," he says. Nevertheless, perfecting Lub Dubs has cost an estimated $250,000 to $270,000 so far.

Marketing the invention has been a challenge, as well. When Sanchez-Zambrano sent Lub Dubs samples to a number of hospitals in Massachusetts and Texas, he received zero responses. He theorizes that many doctors resist the idea that they spread nosocomial infections by using contaminated stethoscopes. They're not too keen on replacing a stethoscope's standard diaphragm with a disposable paper one, either.

Still, it's early in the game. A Lub Dubs Web site (www.lubdubcorp.com ), operational since June, has received queries from doctors in Ireland, Spain, Japan, and Australia. Last fall, Sanchez-Zambrano introduced Lub Dubs at a World Health Organization conclave in Cairo, to Egypt's Ministry of Health, and to the Middle East's largest supplier of medical equipment. But so far, he's made just one sale.

Patents: Separating fact from fable

Patent attorney Philip M. Goldman, of Fredrikson & Byron in Minneapolis, serves as an adviser to companies seeking to fund or license inventions. He also counsels physician-inventors and others in patenting and licensing. He's found these misconceptions to be common among his new clients.

"Once I have a patent, I'm free to market my invention." Afraid not. A patent doesn't necessarily give you the right to market your invention. If the invention hinges on the use of parts or technologies invented and patented by others, as nearly all new inventions do, you need the permission of the other patentees involved. Researching and resolving conflicting patent claims is best left to an attorney.

"My invention isn't sophisticated enough to merit a patent." Doctors often think an invention is unpatentable because it's too simple. Not so. Any one-of-a kind creation is potentially patentable. Uniqueness, not complexity, is what counts. So give yourself the benefit of the doubt. Whether your invention is elegantly simple or mind-bogglingly complex, assume that it's patent-worthy. Then run it by a reputable patent attorney and see what he says.

"There's nothing like my invention on record." Don't bet on it. A search of the patent and professional literature nearly always reveals similar "prior art"—as earlier descriptions of related inventions are called. If you found nothing, your search probably wasn't thorough enough.

"There's nothing like my invention on the market." Possibly. But if similar inventions exist in the patent literature, as they nearly always do, why aren't any of them commercially available? Contacting their patent holders may uncover obstacles you haven't considered.

"It's mine, all mine!" Famous last words. If you're an employee, your employer may have the right to claim an ownership interest in your invention. Check your employment contract or employee handbook. If you bounce ideas off a colleague before your invention becomes a success, that person may have a right to call himself the co-inventor—or he may think he does. A glass blower or injection-molding firm that assists you with device design also may have a legal claim—unless it's contractually excluded, preferably before the potential claimant gets down to work.

"Forget licensing to someone else. I'll do my own marketing and get rich." Which would you rather reap—a 5 percent royalty from a $100 million market developed by a knowledgeable firm with deep pockets to which you've licensed your invention, or 50 percent of a $10 million market that you built on your own after abandoning your practice?

"If I deal with a large company, they'll steal my invention." Doctors are more afraid than they should be of getting ripped off. Manufacturers strive to be superethical. If word got out that they weren't, other inventors would shun them. On the other hand, with millions of dollars potentially at stake, even the most respected manufacturers aren't pussycats. They're hard-nosed negotiators, which novice inventors may find intimidating. That's all the more reason to have your own counsel present.

"I'll make my attorney an offer he can't refuse." Some doctors tell a patent attorney: "You do all the work and send me the bill." But with the going rate $300 an hour, that can get expensive fast. If money is an object, use your attorney as an adviser and do the grunt work yourself. Don't try to circumvent this by offering an attorney an equity stake in future profits if he'll assume patenting costs. No successful attorney is apt to say Yes.

"I should wait to get my patent before approaching potential licensees." A patent application is every bit as licensable as the patent itself, so there's no point in waiting. One reason is time. From your filing date, five years could pass before you're issued a patent, slashing the standard 20 years of patent protection to 15. Another reason is money. Figure it will cost you $8,000 to $12,000 in attorney and filing fees just to file a proper application, plus several thousand dollars more in incidental expenses before a patent is granted.

If you seek foreign patent protection as well—and you should—that could run you another $50,000 over the patent's life. The sooner you license, the sooner someone else starts footing those bills—or the sooner you can opt out and cut your losses.

"One confidentiality agreement is the same as another." The agreement that a potential licensee requires you to sign may contain onerous stipulations buried in legalese. All agreements aren't the same. Run yours by a lawyer before you whip out your pen.

"Perhaps I should sell or publish the details of my invention before patenting it." The government's incentive to issue you a patent is your willingness to disclose a unique idea. So protecting the idea's uniqueness is crucial. If you put it into the public domain—either by publishing it or offering it for sale—prior to filing an application, the idea is no longer unique and your application could be denied. First file, then spill the beans.

 

Neil Chesanow. Who wants to be a millionaire inventor?. Medical Economics 2001;7:145.