06.12.12
Flowonix Receives a Further $25 Million in Capital
Flowonix Medical Inc., a Mount Olive, N.J.-based medical device company that produces implantable drug delivery solutions, has received $25 million in new capital.
The financing comes from a group led by RFT Investment Company LLC, an Atlanta, Ga.-based private investment institution. Joining RFT is new investor OmniCapital Fund LP, a New Jersey venture capital firm dedicated specifically to helping entrepreneurs build next-generation technology for rapidly growing markets. A number of prior investors also joined this round of financing, including Clarus Ventures LLC, a life sciences venture capital firm that creates value across multiple disciplines. Clarus Ventures led the previous financing round.
The capital is intended to fund the next generation of implantable drug delivery products for the United States market. Flowonix will kick off with the Prometra pump, a battery-operated, implantable, programmable infusion pump that delivers Infumorph (a preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9 percent saline solution into the fluid around the spinal cord (intrathecal space) through an implanted infusion catheter. Infusion systems such as these are used when more traditional systems prove ineffective or inappropriate. For instance, if oral, intravenous, or topical medicines fail to provide effective pain relief or cause uncomfortable side effects in patients with chronic pain, the device then would be used.
“The FDA [U.S. Food and Drug Administration] approval of our Prometra pump is a major milestone that enables us to be a significant contender in the implantable drug delivery space,” said Steve Adler, president and CEO of Flowoni. “A portion of this investment will advance ongoing research and development of our next generation products. We are pleased the investors endorse our positive outlook of the future.”
Flowonix was founded in 2005 as Medasys. The Prometra pump gained FDA approval this year.
After a Successful First Quarter, Greatbatch Moves Headquarters
Greatbatch Inc., currently based in Clarence, N.Y., will move its headquarters to Frisco, Texas, beginning this summer. The company will remain in the Clarence area where Wilson Greatbatch founded the medical device company in 1970, but its central operations will now be in the Lone Star State. Clarence R&D, manufacturing and corporate offices will remain intact, as well as all jobs.
For several years now, Greatbatch has been growing. The company has added more than 20 locations worldwide as part of its plan to enter into emerging markets in Asia, and has made a concerted effort to increase profitability in its core markets: cardiac, neurology, vascular and orthopedic. The move to Texas is a large step toward establishing itself as a medtech leader, according to company brass. In Frisco, Greatbatch will have access to the Dallas/Fort Worth International Airport—a large global access point—as well as a medical device community with a strong business climate.
The company had a good 1Q 2012. It reported 7 percent growth in sales that, at $159.1 million, was a record for Greatbatch. The main driver behind this growth was the company’s December 2011 purchase of Micro Power Electronics Inc., a Beaverton, Ore., company that specializes in battery packs for medical devices. Greatbatch integrated Micro Power into its Electrochem business. In February, Greatbatch completed the acquisition of Ann Arbor, Mich.-based NeuroNexus Technologies, a medical device design firm specializing in neural interface technology, components and systems for neuroscience and clinical markets. The company also recently received two 510(k) clearances from the U.S. Food and Drug Administration and one CE Mark for medical devices developed under the Greatbatch name.
“We are pleased to report that the integration of Micro Power into the Electrochem business is progressing ahead of our initial expectations and has been well received by our customers and associates,” said Greatbatch Chief Financial Officer Michael Dinkins. “Our integration is leveraging the core competencies of both companies with the combined organization truly being more valuable than the sum of the parts.”
“The Dallas-Ft. Worth metro area is a recognized medical device cluster surrounded by a business community that includes leading medical technology and electronics firms, as well as academic research institutions and industry opinion leaders,” said Thomas J. Hook, president and CEO of Greatbatch. “While we anticipate expanding our presence at the new headquarters location in the years ahead, we also remain firmly committed to our more than 700 associates in western New York, as well as the local community. The high-quality work of our western New York associates is vital to our future and our associates here will remain an integral part of Greatbatch’s success.”
This summer, the first phase of the move will begin, including the relocation of several executive team members. Greatbatch will continue to move operations over slowly as warranted by business.
IMDS Refinances Debt, Makes Changes to Board
Fort Worth, Texas-based medical device manufacturer IMDS (Innovative Medical Device Solutions) has refinanced its debt obligations and appointed new members to its board of directors.
“The refinancing of our debt facilities is an important milestone in supporting IMDS growth objectives,” said Brady Shirley, CEO. “As a result of this transaction, IMDS gains access to substantial incremental capital and a reduction in the cost of our debt obligations—with the result of having more
liquidity to support our growth.”
The company has appointed James R. (Ron) Lawson as chairman of the board. He has served on the board since 2010. Lawson has more than 35 years of experience in the orthopedic industry, with experience in sales, marketing and general management both in the United States and abroad.
In 1996, Lawson served as senior vice president of worldwide sales and customer service for Pfizer’s orthopedic division, Howmedica. When Stryker Corp. acquired Howmedica in 1998, Lawson went with the company and became senior vice president of sales, marketing and product development. In 2000, he led Stryker’s European business as president of operations for Europe, Middle East and Africa. Shortly afterward, in 2001, he was promoted to international group president and took leadership of all of Stryker’s international distribution businesses. In 2005, Stryker added global responsibility of its orthopedic division to Lawson’s duties with concentration and heavy focus on strengthening the Stryker orthopedic business worldwide. He retired from Stryker at the end of 2007.
IMDS also appointed Donald Deieso, Ph.D., to the board. Deieso is an operating partner at Arsenal Capital Partners Inc., where his areas of focus are healthcare and technology. He has an extensive background in medical device and drug regulatory matters. Prior to joining Arsenal in 2011, he served as CEO and chairman of PeriGen Inc. He has held executive level positions at Metcalf & Eddy Inc., AlphaNet Solutions Inc., EA Engineering, Science and Technology Inc., and Air & Water Technologies Corporation. He was the assistant Commissioner of the New Jersey Department of Environmental Protection and chief chemical engineer of Consolidated Edison of N.Y. He holds a Ph.D. and an M.S. degree in environmental science, both from Rutgers University in New Jersey, and a B.S. degree in medical engineering from Manhattan College in New York.
“I look forward to the opportunity to support Brady and the team at IMDS in realizing their growth agenda,” said Deieso. “Arsenal is committed to ensuring the realization of this extraordinary business plan.”
IMDS provides contract, full-service medical device development and manufacturing with focus in the orthopedic sector.
Agilent to Acquire Dako
Santa Clara, Calif.-based Agilent Technologies Inc. and Swedish private equity group EQT announced that Agilent will acquire Dako, a Danish cancer diagnostic company. The deal is valued at $2.2 billion in cash, and is the largest purchase in Agilent’s history.
Agilent is a measurement company with three businesses: Chemical Analysis, Life Sciences and Electronic Measurement. The company uses gas chromatography and gas chromatography/mass spectrometry, and liquid chromatography and liquid chromatography/mass spectrometry to
analyze the composition of air, water, food, drugs, industrial process streams and forensic evidence.
Dako provides diagnostic antibodies, reagents, scientific instruments and software primarily to customers in pathology laboratories. The company also collaborates with various pharmaceutical companies to develop potential new pharmacodiagnostics, also called companion diagnostics, which may be used to identify patients most likely to benefit from a specific targeted therapy. Dako’s products are sold in more than 100 countries, and in 2010 its annual revenue was approximately $340 million. The company employs more than 1,000 people globally, primarily in Denmark and Carpinteria, Calif.
According to materials accompanying a conference call on the acquisition, the rationale for the purchase is that it will build a solid foundation in two high growth diagnostics markets: anatomic pathology and molecular diagnostics, with a projected $2.2 billion and $4.5 billion growth factor respectively. The purchase will double Agilent’s reagents business. The acquisition also is hoped to provide recurring revenues and reduce volatility, and accelerate Dako’s penetration into emerging markets. Finally, Agilent officials see the acquisition as the best use of its overseas cash.
“In the diagnostics market, Dako’s products and capabilities are a strategic complement to Agilent’s existing offerings,” said Bill Sullivan, Agilent president and CEO. “Together we will be able to
develop a wider range of products that help in the fight against cancer. Agilent’s strategy in acquiring Dako is about strengthening the company’s presence in life sciences and about revenue growth.”
Lars Holmkvist, CEO of Dako, said, “Our combined companies will have complementary strengths. Like Agilent, Dako has a long history as a leader in scientific advancement and a culture that values
discovery and innovation.”
The acquisition is expected to close by the end of July, subject to the satisfaction of customary closing conditions.
Saint-Gobain Performance Plastics Introduces New Silicone Extrusion Technology
The healthcare division of Saint-Gobain Performance Plastics went back the drawing board—to make its silicone extrusion process even better. The Northboro, Mass.-based supplier of high-performance medical device components, recently unveiled its Compass Technology for silicone extrusion.
Combining expertise in custom material compounding with high-precision silicone extrusion and fluid modeling, the company can design application-specific formulations and products in cooperation with their OEM partners. The goal? According to company officials, best-in-class tolerances in both material properties and product dimensions resulting in a reduced level of overall system variability.
Compass Technology provides a closed-loop system that automatically adjusts the extrusion process to reduce variation from production run to production run, while constantly monitoring in-process manufacturing data. The in-process data is captured and available as part of a detailed data package to expedite product validation for medical device OEMs. Extruded tubing manufactured using the technology can be used for various of medical applications, including ophthalmic pumps, enteral feeding and IV therapy.
“OEMs don’t have the time to be extrusion experts. That’s where we come in,” Robert D. Schwenker, business manager of Saint-Gobain Performance Plastics’ HealthCare Markets Business, told Medical Product Outsourcing, adding the company developed Compass Technology with critical feedback from its medical device OEM clients. “They see us as experts in this field, but their input is important so we can determine how to provide the services they need most.”
Saint-Gobain Performance Plastics works with customers to translate critical needs of the application into key material properties that then can be formulated into a custom compound. The material formulations can be optimized for tear strength, compression set, elongation, modulus, and durometer. The company also can deliver extruded solutions that meet regulatory needs for purity and low extractables.
As part of Compass Technology, Saint-Gobain Performance Plastics also is developing an advanced modeling platform dedicated to pump and fluid handling systems to provide insight into the effect of key variables on overall system accuracy. From physical dimensions to dynamic properties of the material, the model can serve as a predictor for new designs.
Saint-Gobain provides silicone, thermoplastic elastomer and fluoropolymer extrusion; silicone and two-shot silicone-thermoplastic molding; rapid prototyping, tooling design and build; and custom
material development.
Specialty Silicone Fabricators Moves Into New Facility
Specialty Silicone Fabricators (SSF) has opened a new facility in Paso Robles, Calif. The 102,000-square-foot property will house all current Paso Robles departments, operations and administration under one roof, consolidating all old offices, which SSF no longer will be using. The company also has facilities in Tustin, Calif., and Elk Rapids, Mich. The company aims for more efficiency, with all operations in one location. According to SSF, the new facility will provide the flexible environment necessary for successful Lean manufacturing.
The new facility includes a 3,500- square-foot ISO 7 Class 10,000 clean room as well as 35,000 square feet of ISO 8 Class 100,000 clean room space.
“Specialty Silicone Fabricators’ new facility [will power] our expansion into new markets with combination products—the science of combining active pharmaceutical ingredients with medical devices, as well as new medical materials such as hybrid polyurethane-silicone,” said Kevin Meyer, president of SSF. “The larger facility was designed to support our growing medical device manufacturing so that we can maximize our progressive partnerships. Our experienced and talented engineers partner with our clients, from raw material choice, to design for manufacturability all the way through packaging, ensuring both high value and consistent high-quality output.”
In response to a growing global demand for medical silicone device components, SSF already has expanded into new markets—which, as Meyer said, is the current growth driver. SSF is experiencing more business not only in the United States but in China, India, Japan and Europe as well.
SSF provides silicone fabrication and medical device assembly for medical device companies. As well as silicone extrusion and thin film processing, the company performs micromolding, coating services and device assembly, final package design and validation, and high tolerance thermoplastic extrusions.
Foster Corp. Adds Plastics Extrusion Capabilities
Putnam, Conn.-based medical plastics manufacturer Foster Corporation has added extrusion compounding capacity for custom pre-colored polymers used in Class I medical applications. Classes are designated by the U.S. Food and Drug Administration according to how much control a device needs to be safe, with Class I requiring the least regulatory control. The new extrusion line is designed to optimize pigment dispersion of colors and polymers that are challenging to manipulate, and to reduce compounding costs. The equipment was designed to serve high-volume medical applications where color is critical and cost is important, such as custom colored polymers for bandage or packaging film.
The line includes twin-screw extrusion capable of volume output in excess of 1,000 pounds per hour (454 kilograms per hour). Traditional strand cutting and underwater pelletizing are available, the latter for low-durometer materials such as urethanes and thermoplastic elastomers.
Traditionally, polymers produced in high volume are colored by blending concentrates from a master-batch of pigment with natural polymers prior to manufacturing. Another method is pre-coloring polymers using high-throughput, single screw extrusion equipment. Both methods can work well, but in some Class I devices, pigment dispersion proves difficult because some of the polymers in question require high color saturation and/or have very thin walls. Such delicate components require small molding or extrusion equipment, and that inherently limits pigment dispersion capabilities.
“Foster has developed an expertise in the dispersion of additives in polymers for thin wall parts,” said Christine Howe, director of manufacturing for Foster Corporation. “We have designed this new larger line to provide the same quality and consistency for Class I devices with demanding color requirements. These applications generally consume higher volumes and are under increased pressure to reduce costs.”
Flowonix Medical Inc., a Mount Olive, N.J.-based medical device company that produces implantable drug delivery solutions, has received $25 million in new capital.
The financing comes from a group led by RFT Investment Company LLC, an Atlanta, Ga.-based private investment institution. Joining RFT is new investor OmniCapital Fund LP, a New Jersey venture capital firm dedicated specifically to helping entrepreneurs build next-generation technology for rapidly growing markets. A number of prior investors also joined this round of financing, including Clarus Ventures LLC, a life sciences venture capital firm that creates value across multiple disciplines. Clarus Ventures led the previous financing round.
The capital is intended to fund the next generation of implantable drug delivery products for the United States market. Flowonix will kick off with the Prometra pump, a battery-operated, implantable, programmable infusion pump that delivers Infumorph (a preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9 percent saline solution into the fluid around the spinal cord (intrathecal space) through an implanted infusion catheter. Infusion systems such as these are used when more traditional systems prove ineffective or inappropriate. For instance, if oral, intravenous, or topical medicines fail to provide effective pain relief or cause uncomfortable side effects in patients with chronic pain, the device then would be used.
“The FDA [U.S. Food and Drug Administration] approval of our Prometra pump is a major milestone that enables us to be a significant contender in the implantable drug delivery space,” said Steve Adler, president and CEO of Flowoni. “A portion of this investment will advance ongoing research and development of our next generation products. We are pleased the investors endorse our positive outlook of the future.”
Flowonix was founded in 2005 as Medasys. The Prometra pump gained FDA approval this year.
After a Successful First Quarter, Greatbatch Moves Headquarters
Greatbatch Inc., currently based in Clarence, N.Y., will move its headquarters to Frisco, Texas, beginning this summer. The company will remain in the Clarence area where Wilson Greatbatch founded the medical device company in 1970, but its central operations will now be in the Lone Star State. Clarence R&D, manufacturing and corporate offices will remain intact, as well as all jobs.
For several years now, Greatbatch has been growing. The company has added more than 20 locations worldwide as part of its plan to enter into emerging markets in Asia, and has made a concerted effort to increase profitability in its core markets: cardiac, neurology, vascular and orthopedic. The move to Texas is a large step toward establishing itself as a medtech leader, according to company brass. In Frisco, Greatbatch will have access to the Dallas/Fort Worth International Airport—a large global access point—as well as a medical device community with a strong business climate.
The company had a good 1Q 2012. It reported 7 percent growth in sales that, at $159.1 million, was a record for Greatbatch. The main driver behind this growth was the company’s December 2011 purchase of Micro Power Electronics Inc., a Beaverton, Ore., company that specializes in battery packs for medical devices. Greatbatch integrated Micro Power into its Electrochem business. In February, Greatbatch completed the acquisition of Ann Arbor, Mich.-based NeuroNexus Technologies, a medical device design firm specializing in neural interface technology, components and systems for neuroscience and clinical markets. The company also recently received two 510(k) clearances from the U.S. Food and Drug Administration and one CE Mark for medical devices developed under the Greatbatch name.
“We are pleased to report that the integration of Micro Power into the Electrochem business is progressing ahead of our initial expectations and has been well received by our customers and associates,” said Greatbatch Chief Financial Officer Michael Dinkins. “Our integration is leveraging the core competencies of both companies with the combined organization truly being more valuable than the sum of the parts.”
“The Dallas-Ft. Worth metro area is a recognized medical device cluster surrounded by a business community that includes leading medical technology and electronics firms, as well as academic research institutions and industry opinion leaders,” said Thomas J. Hook, president and CEO of Greatbatch. “While we anticipate expanding our presence at the new headquarters location in the years ahead, we also remain firmly committed to our more than 700 associates in western New York, as well as the local community. The high-quality work of our western New York associates is vital to our future and our associates here will remain an integral part of Greatbatch’s success.”
This summer, the first phase of the move will begin, including the relocation of several executive team members. Greatbatch will continue to move operations over slowly as warranted by business.
IMDS Refinances Debt, Makes Changes to Board
Fort Worth, Texas-based medical device manufacturer IMDS (Innovative Medical Device Solutions) has refinanced its debt obligations and appointed new members to its board of directors.
“The refinancing of our debt facilities is an important milestone in supporting IMDS growth objectives,” said Brady Shirley, CEO. “As a result of this transaction, IMDS gains access to substantial incremental capital and a reduction in the cost of our debt obligations—with the result of having more
liquidity to support our growth.”
The company has appointed James R. (Ron) Lawson as chairman of the board. He has served on the board since 2010. Lawson has more than 35 years of experience in the orthopedic industry, with experience in sales, marketing and general management both in the United States and abroad.
In 1996, Lawson served as senior vice president of worldwide sales and customer service for Pfizer’s orthopedic division, Howmedica. When Stryker Corp. acquired Howmedica in 1998, Lawson went with the company and became senior vice president of sales, marketing and product development. In 2000, he led Stryker’s European business as president of operations for Europe, Middle East and Africa. Shortly afterward, in 2001, he was promoted to international group president and took leadership of all of Stryker’s international distribution businesses. In 2005, Stryker added global responsibility of its orthopedic division to Lawson’s duties with concentration and heavy focus on strengthening the Stryker orthopedic business worldwide. He retired from Stryker at the end of 2007.
IMDS also appointed Donald Deieso, Ph.D., to the board. Deieso is an operating partner at Arsenal Capital Partners Inc., where his areas of focus are healthcare and technology. He has an extensive background in medical device and drug regulatory matters. Prior to joining Arsenal in 2011, he served as CEO and chairman of PeriGen Inc. He has held executive level positions at Metcalf & Eddy Inc., AlphaNet Solutions Inc., EA Engineering, Science and Technology Inc., and Air & Water Technologies Corporation. He was the assistant Commissioner of the New Jersey Department of Environmental Protection and chief chemical engineer of Consolidated Edison of N.Y. He holds a Ph.D. and an M.S. degree in environmental science, both from Rutgers University in New Jersey, and a B.S. degree in medical engineering from Manhattan College in New York.
“I look forward to the opportunity to support Brady and the team at IMDS in realizing their growth agenda,” said Deieso. “Arsenal is committed to ensuring the realization of this extraordinary business plan.”
IMDS provides contract, full-service medical device development and manufacturing with focus in the orthopedic sector.
Agilent to Acquire Dako
Santa Clara, Calif.-based Agilent Technologies Inc. and Swedish private equity group EQT announced that Agilent will acquire Dako, a Danish cancer diagnostic company. The deal is valued at $2.2 billion in cash, and is the largest purchase in Agilent’s history.
Agilent is a measurement company with three businesses: Chemical Analysis, Life Sciences and Electronic Measurement. The company uses gas chromatography and gas chromatography/mass spectrometry, and liquid chromatography and liquid chromatography/mass spectrometry to
analyze the composition of air, water, food, drugs, industrial process streams and forensic evidence.
Dako provides diagnostic antibodies, reagents, scientific instruments and software primarily to customers in pathology laboratories. The company also collaborates with various pharmaceutical companies to develop potential new pharmacodiagnostics, also called companion diagnostics, which may be used to identify patients most likely to benefit from a specific targeted therapy. Dako’s products are sold in more than 100 countries, and in 2010 its annual revenue was approximately $340 million. The company employs more than 1,000 people globally, primarily in Denmark and Carpinteria, Calif.
According to materials accompanying a conference call on the acquisition, the rationale for the purchase is that it will build a solid foundation in two high growth diagnostics markets: anatomic pathology and molecular diagnostics, with a projected $2.2 billion and $4.5 billion growth factor respectively. The purchase will double Agilent’s reagents business. The acquisition also is hoped to provide recurring revenues and reduce volatility, and accelerate Dako’s penetration into emerging markets. Finally, Agilent officials see the acquisition as the best use of its overseas cash.
“In the diagnostics market, Dako’s products and capabilities are a strategic complement to Agilent’s existing offerings,” said Bill Sullivan, Agilent president and CEO. “Together we will be able to
develop a wider range of products that help in the fight against cancer. Agilent’s strategy in acquiring Dako is about strengthening the company’s presence in life sciences and about revenue growth.”
Lars Holmkvist, CEO of Dako, said, “Our combined companies will have complementary strengths. Like Agilent, Dako has a long history as a leader in scientific advancement and a culture that values
discovery and innovation.”
The acquisition is expected to close by the end of July, subject to the satisfaction of customary closing conditions.
Saint-Gobain Performance Plastics Introduces New Silicone Extrusion Technology
The healthcare division of Saint-Gobain Performance Plastics went back the drawing board—to make its silicone extrusion process even better. The Northboro, Mass.-based supplier of high-performance medical device components, recently unveiled its Compass Technology for silicone extrusion.
Combining expertise in custom material compounding with high-precision silicone extrusion and fluid modeling, the company can design application-specific formulations and products in cooperation with their OEM partners. The goal? According to company officials, best-in-class tolerances in both material properties and product dimensions resulting in a reduced level of overall system variability.
Compass Technology provides a closed-loop system that automatically adjusts the extrusion process to reduce variation from production run to production run, while constantly monitoring in-process manufacturing data. The in-process data is captured and available as part of a detailed data package to expedite product validation for medical device OEMs. Extruded tubing manufactured using the technology can be used for various of medical applications, including ophthalmic pumps, enteral feeding and IV therapy.
“OEMs don’t have the time to be extrusion experts. That’s where we come in,” Robert D. Schwenker, business manager of Saint-Gobain Performance Plastics’ HealthCare Markets Business, told Medical Product Outsourcing, adding the company developed Compass Technology with critical feedback from its medical device OEM clients. “They see us as experts in this field, but their input is important so we can determine how to provide the services they need most.”
Saint-Gobain Performance Plastics works with customers to translate critical needs of the application into key material properties that then can be formulated into a custom compound. The material formulations can be optimized for tear strength, compression set, elongation, modulus, and durometer. The company also can deliver extruded solutions that meet regulatory needs for purity and low extractables.
As part of Compass Technology, Saint-Gobain Performance Plastics also is developing an advanced modeling platform dedicated to pump and fluid handling systems to provide insight into the effect of key variables on overall system accuracy. From physical dimensions to dynamic properties of the material, the model can serve as a predictor for new designs.
Saint-Gobain provides silicone, thermoplastic elastomer and fluoropolymer extrusion; silicone and two-shot silicone-thermoplastic molding; rapid prototyping, tooling design and build; and custom
material development.
Specialty Silicone Fabricators Moves Into New Facility
Specialty Silicone Fabricators (SSF) has opened a new facility in Paso Robles, Calif. The 102,000-square-foot property will house all current Paso Robles departments, operations and administration under one roof, consolidating all old offices, which SSF no longer will be using. The company also has facilities in Tustin, Calif., and Elk Rapids, Mich. The company aims for more efficiency, with all operations in one location. According to SSF, the new facility will provide the flexible environment necessary for successful Lean manufacturing.
Paso Robles, California SSF Facility |
“Specialty Silicone Fabricators’ new facility [will power] our expansion into new markets with combination products—the science of combining active pharmaceutical ingredients with medical devices, as well as new medical materials such as hybrid polyurethane-silicone,” said Kevin Meyer, president of SSF. “The larger facility was designed to support our growing medical device manufacturing so that we can maximize our progressive partnerships. Our experienced and talented engineers partner with our clients, from raw material choice, to design for manufacturability all the way through packaging, ensuring both high value and consistent high-quality output.”
In response to a growing global demand for medical silicone device components, SSF already has expanded into new markets—which, as Meyer said, is the current growth driver. SSF is experiencing more business not only in the United States but in China, India, Japan and Europe as well.
SSF provides silicone fabrication and medical device assembly for medical device companies. As well as silicone extrusion and thin film processing, the company performs micromolding, coating services and device assembly, final package design and validation, and high tolerance thermoplastic extrusions.
Foster Corp. Adds Plastics Extrusion Capabilities
Putnam, Conn.-based medical plastics manufacturer Foster Corporation has added extrusion compounding capacity for custom pre-colored polymers used in Class I medical applications. Classes are designated by the U.S. Food and Drug Administration according to how much control a device needs to be safe, with Class I requiring the least regulatory control. The new extrusion line is designed to optimize pigment dispersion of colors and polymers that are challenging to manipulate, and to reduce compounding costs. The equipment was designed to serve high-volume medical applications where color is critical and cost is important, such as custom colored polymers for bandage or packaging film.
The line includes twin-screw extrusion capable of volume output in excess of 1,000 pounds per hour (454 kilograms per hour). Traditional strand cutting and underwater pelletizing are available, the latter for low-durometer materials such as urethanes and thermoplastic elastomers.
Traditionally, polymers produced in high volume are colored by blending concentrates from a master-batch of pigment with natural polymers prior to manufacturing. Another method is pre-coloring polymers using high-throughput, single screw extrusion equipment. Both methods can work well, but in some Class I devices, pigment dispersion proves difficult because some of the polymers in question require high color saturation and/or have very thin walls. Such delicate components require small molding or extrusion equipment, and that inherently limits pigment dispersion capabilities.
“Foster has developed an expertise in the dispersion of additives in polymers for thin wall parts,” said Christine Howe, director of manufacturing for Foster Corporation. “We have designed this new larger line to provide the same quality and consistency for Class I devices with demanding color requirements. These applications generally consume higher volumes and are under increased pressure to reduce costs.”