A Medtech Materials Catch-22

The medical device industry is stuck in something of a Catch-22 as far as materials are concerned. Only new materials that are reasonably priced and backed by substantial data are attractive to medical device designers. After all, what good are cutting-edge new materials that are unsafe and contribute to wasteful healthcare spending? But creating new materials is a costly enterprise, as is adapting those new materials for mass-production. Furthermore, gathering substantial clinical data to demonstrate the safety of those materials is often cost prohibitive as well.

"It seems as if the material selection aspect of medical product development is stuck in vicious cycle: the lack of tried-and-true data on the properties of a novel material tested under real conditions is unappealing to the product designer, which in turn hinders the development of novel biomaterials even more," says Sophie Siahpooshan, a medical device business development consultant, in a discussion in LinkedIn's Medical Devices Group (membership required).

So we are left at a standstill: Many commonly used materials in medical devices are less than ideal. In fact, many such materials were simply repurposed from household applications. As MIT's Robert Langer has pointed out, the use of cellulose acetate for dialysis tubing was inspired by sausage tubing. And the polyether urethane for artificial hearts was used beforehand in ladies girdles. At some point in time, an inspired engineer went rooting through the house in search of a material with a good flex life and the girdle was the closest thing that could be found. Similar story for the silicone used in breast implants--the inspiration for that material came from mattress stuffing. And the Dacron used in vascular grafts had been used earlier in clothing.

Because these materials have a long history of use for medical applications, they also have lots of data behind them to show they are safe. As a result, finding better alternatives is something the medtech industry is shying away from, notes Stephane Morvan, PhD, senior European sales manager at Spineway SA in the Medical Devices Group discussion. "The medical device industry is becoming increasingly conservative as it matures," he notes. "Class action lawsuits are becoming prevalent and newer devices are held to standards designed for products that have 20+ years track records."

But the risk of lawsuits alone is too nebulous of a reason to spurn material innovation in medtech. A quantitative risk-benefit analysis of new materials specific to each medical application could provide an objective means of evaluating new materials, Siahpooshans says.

"However, there will still need to be a gold standard of medical risks and benefits to bridge material science and medical product development for regulatory purposes," she adds. "One of the roadblocks slowing down the adoption of novel materials for medical applications is the limited data availability of medically significant parameters, such as biocompatibility, in computer-based material selection programs [that] leave the product designer with the more traditional choices."

This is not to say that it is impossible to bring a new material to the market, however. "Our company recently received FDA approval for our biomaterial after years of R&D," says Mark Steedman, vice president of business development at Interface Biologics in the thread mentioned earlier. "It took a long time to convince customers that the product was safe and efficacious in a short term implant, and only now that the product has been in FDA approved patients for 2+ plus years without any recalls or adverse events are customers interested in utilizing the product for longer term implants," he says. "My experience is that it will take at least 5 years and robust patient data to convince large companies to change their validated systems and materials to something new."

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Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz and Google+.