Larry Acquarulo, CEO
The use of polymers in medical devices has grown exponentially over the years, due to higher flexibility, versatility, and durability when compared to glass, metal, or other conventional materials. However, in today’s tightly regulated medical device industry, polymer manufacturers often find it challenging to cope with the compliance requirements and the inherent risk of liability. Not to mention, procuring high-quality raw materials, in reasonable quantities, is yet another pressing issue for manufacturers.
Given this challenging background, Foster Corporation is moving the needle by providing medical device manufacturers with industry-leading technology and service in custom polymer compounding. “As a full-service developer, manufacturer, and supplier of polymers for medical devices, we have emerged as one of the few companies that is fully dedicated to the medical device industry. From minimally invasive surgical devices to orthopedic implants, we have the capability to provide biomedical polymers for a wide range of healthcare devices,” says Larry Acquarulo, CEO of Foster Corporation. He continued, “Foster Corporation offers comprehensive polymer solutions, from prototype material development, through validation and production.”
Acquarulo goes on to mention that high and consistent quality is a mandatory requirement for medical devices; once a material is specified, the manufacturing process, location, formulation, and raw ingredients, must not be altered. With a keen focus on these factors, Foster Corporation audits its suppliers to make sure that they conform to the requisite quality and regulatory standards, and performs incoming quality checks on the materials, ensuring they are validated with a Certificate of Analysis.
With more than 30 years of experience in serving the medical device manufacturing industry, Foster Corporation understands that effective biomedical polymers are the building blocks of advanced medical devices. To that end, the company specializes in adding ingredients to polymers in order to improve their overall performance; for example, radiopaque additives for minimally invasive surgical instruments or catheter-based devices. Foster Corporation’s radiopaque compounds include a diverse range of advanced radiopaque fillers, such as Bismuth Subcarbonate, Barium Sulfate, Bismuth Oxychloride, and more; as well as medical-grade polymers to create high quality compounds required for small, “low profile” designs. “These fillers are blended with polymers that have certain physical properties along with other ingredients, such as stabilizers, lubricants, and pigments, to impart specific characteristics and performance to catheter tubes,” says Acquarulo.
“As a full-service developer, manufacturer, and supplier of polymers for medical devices, we have emerged as one of the few companies that is fully dedicated to the medical device industry"
Additionally, due to the high risk of infection posed by medical plastic components that are inserted in the body, Foster Corporation is capable of including antimicrobial additives that are widely used in catheter tubes or “in-dwelling” catheters. This proves to be highly beneficial for applications targeted for premature babies, which are extremely susceptible to infection. Foster Corporation’s multidisciplinary team works closely with medical device manufacturers to help them custom formulate blends that are tailored to their specific application requirements. “We usually provide customers with a formulation, or range of formulations, which they can test to verify if it meets their complex requirements. Once we fine-tune the formulation to suit their needs, the material is locked down to perform validation runs,” said Acquarulo.
Through thorough testing services, Foster Corporation conducts online quality checks, viscosity tests, extraction tests, contamination analysis, and more. Having a dedicated focus on quality has helped the company acquire ISO 13485 certification. The company also performs elevated temperature and stability tests to guarantee the highest quality of polymers. Being a member of the Institute Of Material Science (University of Connecticut), Foster Corporation has access to all UConn’s robust analytical equipment, which allows the company to enhance its testing services. Over the years, the company’s compounding business has expanded to include clean room compounding for implantable applications, toll compounding for material suppliers that require processing expertise as well as dry blending and supply chain partnerships that serve the specific medical device market needs. Apart from its primary business of custom compounding, Foster Corporation delivers contract services that include material development, process development, analytical testing, and regulatory support for drug delivery (pharmaceutical) applications through Foster Delivery Science, Inc., a strategic business unit of Foster Corporation.
Recently, Foster Corporation invested $9 million in another site to produce higher volumes of polymer compounds for serving the disposable medical device market. Offering such a comprehensive range of services and capabilities, Foster Corporation has earned the trust of a diverse clientele in the medical device industry. “We stand behind every product we make while equipping clients with complete technical assistance to minimize their risks in the highly regulated market,” asserts Acquarulo. The company has manufacturing facilities in Nevada and Connecticut, engineering offices in India, and partners throughout Asia and Europe. All these avenues have given Foster Corporation worldwide exposure opening global markets from which Foster draws their customers.