ADVANCED MATERIALS FOR HEALTHCARE

Products and systems in medical-grade silicone are part of Trelleborg's business within Life Sciences, which is generally regarded as a growth market.

"Life Sciences is a field of science and discovery," explains Jim Hederman, product manager at Trelleborg Sealing Solutions, Hudson, MA. "Just think of the changes in healthcare each of us has seen in the span of our own lifetime. Some people who were once wheel-chair bound now have artificial limbs that allow them to compete in a race." For Trelleborg, the Life Sciences market compr ises three main segments: medical devices, biotechnology and pharmaceutical.

The products include tubing, hoses, silicone sheeting and custom-molded components made from medicalgrade silicone.

"These are the base components in the design and development of our medical devices and systems," Hederman explains. "The company uses a variety of manufacturing processes that include extrusion and liquid injection molding (LIM)." By way of example, Hederman cites one Trelleborg customer who was seeking an innovative method for providing cardiac treatment. "In the past, they had been using multiple silicon tubes to deliver the necessary drug treatments to cardiac patients," he explains. "We were able to join three separate silicone tubes together at a junction using our LIM process and, subsequently, have all three fluid pathways flow through one silicone tube constructed of three separate multilumen channels."

The demands of Trel leborg's pharmaceutical and biotechnology customers are broad. "We have a complete line of medical-grade silicone hoses ranging in size from an inside diameter of 1mm to 100mm, with the capability to withstand pressures of up to 55 bar," Hederman says.

Overall, the most popular product in the Life Sciences market today is tubing. "It is all about fluid handling," Hederman continues, "whether it be fluids in the body, such as blood, waste products or gases; external fluids, or media used during research and drug production. Tubes and hoses are the lifeline of this market." As might be expected of a marketplace with so much activity and unique product concerns, Life Sciences presents the company with many challenges and opportunities.

According to Hederman, the greatest challenge at present is to lower the cost of healthcare. "We are always trying to assist our customers in making healthcare more affordable.

Within the Life Sciences market, it is understood that cost reduction can only be achieved through technology and innovation," Hederman states.

One of the principal opportunities for Life Sciences is the shift from hard, fixed systems to disposable systems.

"Process equipment was once entirely made from stainless steel, but nowadays, storage tanks and tubing are manufactured out of thermoset materials," Hederman states. "By moving to a disposable system, companies are able to make the transition from one media to another with minimal loss of time and money." With the global population continuing to rapidly expand and age, Hederman sees continued growth in the Life Sciences market. "Currently, only 3% to 8% of the world's population is over the age of 65," he points out.

"By the year 2030, this number is expected to increase to more than 13%, while the world population will grow to more than 8 billion. This aging population will be one of the main driving forces behind the Life Sciences market in the future." Considering the sensitive nature of Life Sciences' products, it is not surprising that the industry requires a great deal of regulation - both legislative and through its own regulations and codes. "There is a tremendous amount of responsibility associated with Life Sciences," Hederman explains. "The majority of products we provide are directly or indirectly related to the health of human beings." Trelleborg's manufacturing processes are audited according to industry and government standards, and products are tested and regulated for compliance with standards. In addition, customers conduct their own audits of the facility and processes.

Hederman estimates that there are two to three customer audits in an average month.

"When you have a product recall for a car, it can be expensive and unfortunate for the owner of the vehicle," Hederman says. "When you design, manufacture and sell within the Life Sciences sector, product failure holds the potential for catastrophic consequences."

Trelleborg Sealing Solutions
Hudson, MA
tss.trelleborg.com