Summary
Material choices for the designer of medical devices are traditionally limited to those that already enjoy a proven track record. The use of truly new materials in a medical device is not only risky for the device manufacturer, but also for the material manufacturer. In particular, tissue contacting devices pose substantial litigation risks for material suppliers.
Analysis
This trade article does a fine job of highlighting the traditional issues surrounding the choice of materials for a medical device. It does not, however, address one key aspect that should be considered along with any material choice. Many manufacturers of plastics, rubbers, coatings and fibers do not wish for you to use their products in medical devices. Period, no questions asked. The issue can sometimes be so sensitive that R&D scientists and engineers are instructed not to even make an inquiring phone call to the material company. In this extreme example, the risk of litigation for the material supplier greatly out ways the potential sales volume. It is easy to get caught up in new technologies and their novel benefits. However, when evaluating a new product one must not only consider what it is made of, but also who will be willing to sell you the raw materials.
