According to a recent analysis of the U.S. life sciences sector in MD+DI Magazine, the industry “consistently devotes significant revenues to innovation; from 2007-2009, R&D investment in medical devices increased by 9%.” That’s good news—for American manufacturing, for device makers and for the suppliers that serve them.
But while the highly competitive marketplace means big opportunities, it also means medtech design teams are often racing to reduce time-to-market, which means somewhere, something, (hopefully not someone) will be compromised. In practice, it generally means that OEMs are often squeezed into subpar sourcing relationships because of these shrinking deadlines and budget allocation constraints. In minimally invasive and diagnostic devices, as well as drug delivery and life support systems, for example, raw materials often mean specialty or precious metals. Not only are these materials subject to speculative pricing—a sure fire way to deplete your budget—but many of them are also considered conflict metals and require scrupulous validation.
And yet, some devices simply require an incomparable level of biocompatibility only available in precious metals like gold. (Gold is often found in drug delivery systems and stents because of the combination of a high resistivity to bacterial colonization, and radiopacity.) But how do OEMs produce quality devices efficiently and on budget? Well, one way is to build good, strong relationships with experienced, innovative contract partners and suppliers.
Did you know, for example, that there are cost affective alternatives to metals such as gold, platinum and palladium? Hopefully your sourcing partner does. In applications where material toughness and radiopacity are crucial, tungsten has become an attractive alternative. With a density equivalent to gold, a comparatively high tensile strength and mineral hardness, and a low vapor pressure at high temperatures (tungsten has the highest melting point of any metal), it’s strong, radiopaque, virtually heat resistant and, when alloyed, flexible.
As a result, tungsten is currently used in a variety of medical applications. It’s regularly incorporated into polymers for high visibility catheters. It can be expertly machined into close tolerance tungsten pins and rods for use in dental implants and arthroscopy. And because of its low coefficient of thermal expansion, it can be readily used in hermetically sealed assemblies. For some of the added biocompatibility of pure gold, tungsten wire is often plated for use in cauterization applications, guide wires and probes used in deep brain studies.
While it’s not always an appropriate substitute, your materials supplier should have a thorough understanding of how, when and what composition would be the right, cost effective alternative solution to your precious metal predicament. In an era of one-stop-shopping, many suppliers also offer secondary capabilities like precision cutting, grinding, or surface treatments like passivation and sandblasting. Remember, tungsten, like gold, is considered a conflict metal (as per Section 1502 of the Dodd-Frank act) and your supplier should comply with all US regulatory standards, have an in-place quality system, and provide accurate measuring and metrology.
As biomaterials have continued to evolve, OEM’s have come to expect their contract partners to evolve with them. That means more than simply providing a quality product, efficiently and at competitive prices. It means education, experience and innovation. The life sciences sector will likely continue to allocate more funds to R&D in the years to come. The question is: will your device team have the quality sourcing relationships to bring your expert concepts to market?