The late 1980s and 1990s represented a major transition period for medical plastics. Major resin producers were scared off by litigation issues following failures of silicone implants. At the same time, markets such as catheters were just emerging and needed development partners.
Regulation of surgical devices in the United States is by the FDA, and materials of construction are often an integral part of the regulatory submission process. Changing such materials can be costly and time consuming. Accordingly, medical device manufacturers are highly attentive to ensuring ongoing supply of key materials once devices meet regulatory filing requirements and sell commercially. Commonly used to manage supply risks are contractual agreements between material suppliers and manufacturers.
The performance capabilities of orthopedic implants can be significantly increased by utilizing enhanced polymers that have been precision blended with additives using specialized processes and equipment. Long term implantable and bioresorbable polymers are enhanced with radiopaque fillers, bioactive bone growth additives and active pharmaceutical ingredients (API). These enhancements can increase therapeutic effect and reduce side effects, but special equipment and processes are required to realize their full potential.