A Hard Lesson in Materials Science
There is no doubt that the medical device industry's understanding of materials science has reached a mature status. During the past 30 years, much has been studied and documented about how materials behave, interact with the human body, and change when processed or combined with additives.
Materials suppliers have contributed to this basic knowledge through extensive publishing and the creation of databases, and device companies have devoted significant energy toward determining which processing technologies make the most of a material's properties.
Despite this wealth of information, materials science remains imperfect and incomplete. Materials still have the power to surprise us, sometimes in unfortunate ways. Such was the case in a recent, well-publicized situation where a much-tested hospital sterilization system created unanticipated and toxic by-products on certain medical instruments.
Materials science has become so sophisticated that it is in danger of being taken for granted. If medical device suppliers don't wish to confront nasty surprises down the road, they must continually question their assumptions about materials. Moreover, they must make every effort to understand materials themselves.
Recently Richard Wallin, president and CEO of the biological safety testing firm NAMSA, expressed surprise at the fact that some companies know very little about the materials they are using. "We still get samples labeled 'white plastic' to be tested, which implies that these are relatively uncharacterized materials. It's not of value to perform testing unless you understand the identity of the test sample and the reasons why the tests are necessary, and how to interpret the results." This information canand shouldbe known by the manufacturer.
His point is well made: Without knowing the material's properties, extensive testing may not prove useful. Also, with compressed product development schedules, it's not always feasible to undergo exhaustive testing of every potential material. On the other hand, adequate measures must be taken to ensure that product safety is not sacrificed in the name of shorter time to market.
One way for medical device companies to achieve this balancesafety versus immediately accessible new technologyis to accept the responsibility of developing a thorough understanding of the materials they use.