Building a Better Surgical Glove

A late-night phone call from a worried friend got novice inventor Robin Beck thinking about a problem with surgical gloves.

Beck’s friend, the wife of a surgeon, knew that the thin gloves that allowed her husband to wield his scalpel so delicately couldn’t protect him against punctures by disease-contaminated suture needles. It’s a troubling fact that concerns health-care professionals worldwide.

Glove makers have tried to solve the problem with thicker gloves. One company even developed a chain-mail glove of stainless-steel “fish scales.” But thicker materials make it difficult for health professionals to maintain their all-important sense of touch.

Lacking a medical background, Beck was free to think about the problem from a fresh perspective. That, she said, is the key to successful inventing.

“They weren’t asking the right questions,” said Beck, who loved to invent things as a child. “A clean needle won’t hurt you. So the objective wasn’t to stop the needle, but to stop the disease carried on the end of it.”

Her idea: A thin layer of a chemical biocide within the glove’s latex film that would act as a barrier against a virus or bacteria.

Since receiving that phone call more than five years ago, Beck has secured nearly 30 domestic and international patents related to her idea. She formed BioBarrier Inc. to commercialize the concept, and has raised $2 million from family and friends based on the promising results of preliminary tests.

Her three-employee company, based in West Los Angeles, is now working on a second round of financing to raise $5 million. The money will be used in part to pay for additional testing expected to be required by the U.S. Food and Drug Administration. BioBarrier must receive FDA approval before it can sell its gloves.

A former advertising copywriter would seem an unlikely candidate to tackle a problem that has stumped big biomedical companies. Beck credits the Internet in part for helping her find the experts needed to move her idea toward the marketplace.

“Through the Internet one can . . . quickly access those scientists who are pushing the envelope,” Beck said.

To learn about existing research and to locate key individuals working in her area of interest, Beck relied on Medline, a database of 4,300 biomedical journals. Located online at https://www.nlm.nih.gov, Medline is published by the U.S. National Library of Medicine. The library, a service of the National Institutes of Health, offers a wealth of online information, including a database of clinical trials.

In one case, Beck came across a paper by a former Stanford researcher, Dr. Gregory Johnson, that supported her concept. When she contacted him, the orthopedic surgeon had moved to the East Coast. Johnson agreed to test her materials in the AIDS lab at the Harvard School of Public Health.

“The results have been very positive,” said Johnson, who has since become a BioBarrier shareholder. “The more layers, the safer you are, and the antimicrobial layer is the safest combination.”

For leads on other research and testing laboratories, Beck used the online version of the Thomas Register of American Manufacturers (https://www.thomasregister.com), a business directory found in most libraries.

Beck has used a combination of university and commercial labs for testing and prototype development. At more than $500,000 so far, it has been a major expense for her small company.

Early on, there were tests to ensure that putting a chemical in the middle of a latex film would not degrade the latex. There were tests to determine which chemicals remained active when trapped in the latex. There were tests to see which chemicals leached to the surface of the latex. And, among many others, there were tests to discover which chemicals were most effective against various pathogens.

“It’s very, very hard for the single inventor in the present day society,” said Howard Kaye, director of Houston-based Polyhedron Laboratories, which specializes in plastics, polymers and rubber. “Once you put a lab into an R&D; situation, you can spend really a very large amount of money, very fast.”

But without preliminary test results showing a reduction in pathogens, including HIV, Beck knew it would be difficult to convince medical experts and potential investors that her idea was viable.

However, even with the promising early feedback, some experts have reservations.

“Obviously she has something there because she has some good preliminary results,” said Len Czuba, director of medical services for Herbst, LaZar & Bell, a contract industrial and engineering firm in Chicago.

“But right now, I would be quite skeptical of it,” said Czuba, when the BioBarrier concept was described to him. “Because if you understand how antimicrobials work, they usually require more than just a fraction of a second of exposure to a pathogen” to eradicate it.

Austin Brewin, a doctor and former head of infectious disease services at San Francisco General Hospital, was similarly skeptical.

“I flat out didn’t believe her and I told her that,” said Brewin, now principal of Piedmont Consulting Group in Oakland. His contract research company advises drug and medical device companies on how to navigate the FDA approval process.

He changed his mind when Beck, who contacted him recently about helping BioBarrier with the FDA process and joining her advisory board, shared her preliminary results with him.

“Using a model that has been around for a while . . . she [has been] able to reduce the infectious load, if you will, that gets transmitted through needle sticks,” Brewin said.

He’s not sure yet why it works. Neither is Beck, although she saidit’s probably a combination of the wiping effect of the glove as the needle passes through the latexand the effect of the biocide on the pathogen.

Beck expects to sell her gloves, which will come in different versions, for between 50 cents and $2.50 a pair. Today’s specialty latex gloves can cost more than $2 per pair, she said, while standard latex gloves cost between 35 cents to 75 cents.

Because they are cheap, some health-care workers wear two pairs at once to increase their protection against infection. But because standard gloves are the same size and not made to be worn on top of one another, that arrangement can be uncomfortable and can cause hand fatigue.

So, among her other prototypes, Beck has developed a double glove, one layer slightly larger than the other, joined at the wrist. She plans initially to market a version without a biocide layer, because it may be easier and faster to get FDA approval. That would mean the glove could hit the market sooner and generate needed cash flow.

BioBarrier is negotiating with an FDA-approved manufacturer, Beck said. She’s also investigating whether a biocide barrier and double layering might work for condoms.

Beck, who earned the bulk of her patents under her former last name of Shlenker, has tried to build a patent portfolio broad enough to cover future products in the area of protective films--a hot research focus.

Examples include protective clothing designed for individuals who work with toxic waste or for military personnel under the threat of chemical or biological warfare.

More testing lies ahead. Again she’ll have to prove the concept, prove that the prototypes work and prove that there is a benefit for which the market is prepared to pay.

“Between patent and profitability are a lot of proofs,” Beck said.

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Resources

* Thomas Register of American Manufacturers. The online version allows free searches of the Thomas database of industrial product manufacturers and service providers, including research and testing laboratories.

Many listings are linked to the companies’ Web pages. Visit

https://www.thomasregister.com.

* Medline. This journal article database is published by the U.S. National Library of Medicine, a service of the National Institutes of Health.

The library offers a wealth of online information, including access to 4,300 biomedical journals and information on clinical trials, at

https://www.nlm.nih.gov. Use it to learn about existing research and to locate key individuals doing research in your area of interest.

(Medline is not related to private manufacturer Medline Industries, at https://www.medline.com.)

* Food and Drug Administration. This is the government agency that must approve a medical device before it can be sold to the public.

Its Web site, at https://www.fda.gov, offers links to the FDA’s five centers, including the Center for Devices and Radiological Health. The CDRH site provides information on all aspects of getting a device to market.

The FDA site also offers online access to the FDA’s regional small-business representatives. The Pacific Region contact is Marcia Madrigal in Oakland at (510) 637-3980.