Depending on who you ask and how you define the product, there are by some counts only two manufacturers of long-term implantable silicones for the medical device industry. One of those, Applied Silicone Corp. of Santa Paula, Calif., announced a series of investments to its facilities, including an addition of space and equipment that will increase its silicone elastomer base production by 50%.
Long-term implantable silicones are a class of materials that can be in the body for 30 days or more, and when Dow Corning exited the market in 1993 after becoming ensnared in litigation over breast implants (it settled in 1998 after forking over $3.2 billion in damages), Applied Silicone and NuSil (Carpinteria, Calif.) stepped into the supply vacuum.
An Applied Silicone spokesperson told Plastics Technology that membership in that rarefied supply club has helped the company enjoy double-digit annual growth in each of its 26 years.
“Today, Applied is running at 80%-plus capacity,” the spokesperson said, “and we know that is inadequate for future demands.” To meet that demand, the company has broken ground on 31,000 sq ft of additional warehousing, manufacturing, research, and laboratory space at its 90-acre campus, and that’s just for openers:
Applied will also bring on line a new 12,000-sq-ft facility specifically designed for medical grade silicone polymer synthesis and a 4000-sq-ft office laboratory facility in the first quarter of 2014.
The spokesperson said that construction is also in progress for an additional 15,000-sq-ft of production and R&D facilities. “Applied’s growth is not just about buildings though,” the spokesperson added. “Capital equipment costs for this expansion for the next two years will exceed $5 million.”
So how does the company continue to excel in such a demanding space where other medical material suppliers fear to tread: “The integrity of our quality systems,” is their answer. These include a large and growing database of preclinical biological and chemical testing and 26 years of clinical performance history so it can, in the words of the spokesperson, “meet ever increasing demands from customers and regulatory agencies.”