ATLANTA — Can a company actually build a medical device that will go into a patient out of the biomaterials it wants to?

That was the question posed to attendees at this year's Society for Biomaterials (Mount Laurel, New Jersey) Translational Biomaterial Research conference held here last week. The answer, according to Carl McMillin, PhD, a consultant for biomaterials who heads up his own firm, Synthetic Body Parts (Brecksville, Ohio) is "Not really" – unless the company is a med-tech powerhouse.

Now smaller med-tech companies are forced into a biomaterials crisis, McMillin said, with companies taking little chance with providing their materials for fear of liability issues.

"The beginning of the biomaterials crisis began with the DuPont (Wilmington, Delaware) and Vitek series of cases in 1993," he told the audience.

It all started when Vitek altered DuPont's Teflon to create a new material, Proplast, which Vitek used to make implants to treat temporomandibular joint syndrome. Patients complained they had suffered injuries from failures of Proplast – and immediately took both companies to court.

In all, DuPont doled out nearly $26 million litigating more than 650 lawsuits.

"Even though DuPont won all the cases, with only one case won on appeal, it still cost them a great deal of money," McMillin said. "So they decided to stop providing biomaterials for medical devices – and they were then followed by other companies.

Exactly how bad was it or is it?

Well, for just a single instance, McMillin was released from AcroMed, now DePuy (Raynham, Massachusetts), a Johnson & Johnson (New Brunswick, New Jersey) company, because he was unable to get proper biomaterials to place in the medical devices that he was helping to develop.

But the bright spot was that the company wanted to keep him on as a consultant.

"Some people have to work all their lives to become a consultant. I was thrust into it," he quipped.

An equalizer for the med-tech industry came from the Biomaterials Access Assurance Act of 1998 (BAAA), which was enacted with the aim of preventing suppliers, such as DuPont, from becoming entangled in this type of product liability litigation.

Reaction to the now decade-old act is a mixed bag and still has many "flaws" and "exceptions" McMillin said.

"Most major suppliers still want to see significant tort/product liability reform before they return to the market," McMillin said.

But it's a catch-22. While most want to see the law tested, if such a case ever made it to the courtrooms, then the law would have failed to offer the protection it was designed to give.

"If your company is a [billion-dollar powerhouse] and signs a 'hold harmless' agreement, you can get the biomaterials you need," he said. But if you're a small start-up don't even bother asking. This is very bad for the biomaterials industry because it's usually the small companies that lead in innovation."

But it's not all doom and gloom – there is still some hope for small med-techs looking to get good quality biomaterials.

Royal DSM's (Heerlen, the Netherlands) acquisition of the Polymer Technology Group (PTG; Berkeley, California), a biomaterials company, is one such bright spot (Medical Device Daily April 29, 2008). Earlier this year, PTG said it expects to exceed $40 million in net sales in 2008, with above-average operating profit margin. It also said it expects more than 20% annual sales growth in the next three to five years, based on existing business and a pipeline of new products.

A high-profile company like Royal DSM will give PTG an even higher profile, McMillin said. He also touted Solvay (Brussels, Belgium), which expanded its product offerings even further, reporting its decision to enter a new sector of the healthcare market with the launch of a biomaterials line, brand-named Solviva (MDD Feb. 14, 2008).

The Solviva line – a group of "ultra" polymers – are those materials that have an extremely high performance profile in terms of thermal, mechanical, and chemical resistance.

McMillin said these companies' contributions are much-needed, adding that DuPont wasn't coming back into the business of providing biomaterials to the medical device industry anytime soon.

The comment drew a reaction from a member of the audience who identified himself as a part of the medical device division of DuPont. "We're very open to talking to companies," the DuPont representative said near the final minutes of McMillin's session. "The current policy is we're willing to sit down and talk with companies as long as we're part of the process."

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