South Carolina Devices Supply Chain The materials used in the manufacture of Medical Devices require much higher levels of purity and quality control than in most other markets. Raw material providers for the Medical Device industry must hold themselves to the highest standards and possess specialized expertise. South Carolina companies are successful in meeting these 2. Materials Synthesis and Processing Before being used in manufacturing processes, raw materials often are altered (for example, the polymerization of monomers to polymers). This needs to be performed using stringent and internationally approved protocols, some very specific to Medical Devices, in order for the end product to be used inside or in contact with the human body. Companies like Poly-Med, Inc. have found South Carolina to be an ideal place to process materials for use in biomedical applications. Medical Devices are typically constructed of many individual parts, which may be manufactured in many different locations. This type of manufacturing again requires specialized skill and procedures. For example, capacitors to be used in defibrillators (or ICDs) are manufactured in the South Carolina by St. Jude Medical, a leading international provider of cardiac devices, and one of our South Carolina Success Stories. 4. Functional Device Manufacturing Once a Medical Device is assembled to the point of functionality, it is almost ready to go into, or have contact with, a human body. The FDA requires that manufacturers of functional devices register them in its database, and 36 companies in South Carolina fall into this category. These include emerging companies such as CreatiVasc, providers of intuitive vascular technologies that address the universal problems of kidney dialysis connectivity, and large, established companies such as Bausch & Lomb, makers of contact lenses. 5. Post-Manufacturing Processing After manufacture, functional devices need to be packaged and sterilized, and South Carolina companies are listed in the FDA database under this category. This stage often requires substantial transport of the devices for reliable and large-scale sterilization – unless you operate your Medical Device business here! STERIS Isomedix Services, a leading provider of contract sterilization services, offers gamma, EO, and E-beam technologies through 21 North American locations. Three of their facilities have both gamma and EO capabilities – and one of those locations is in Spartanburg, South Carolina. A final aspect of the Medical Device manufacturing industry is distribution and sales, and 23 Upstate companies are registered with the FDA in this part of the supply chain. Located conveniently on Interstate 85 between Atlanta and Charlotte, with good land availability, quick air access via the GSP International Airport and in-state seaport access in Charleston, many companies find our area a strategic site for their distribution activities. |