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Modern Plastics Adds Medical-Grade PEEK to its Offering
Modern Plastics has added a new medical-grade polymer to its line. The permanent implantable PEEK (polyetheretherketone), which the company calls MediPEEK-IM, is a “high-performance semi-crystalline thermoplastic designed for long-term body contact.”The resin, according to the firm, is produced to ASTM F2026 specifications and extensively has been tested to meet ISO 10993 requirements.
MediPEEK-IM can be used to manufacture spinal cage products, fixation rods, orthopedic implants, ophthalmic tools and surgical instruments as well as dental and diagnostic devices. A news release about the new natural-colored material claims it has various advantages over other plastics, including biocompatibility, mechanical strength and toughness, superior hydrolysis (reaction with water), chemical resistance and dimensional stability. In addition, the plastic is radio translucent and can be sterilized
The new polymer is manufactured by Westlake Plastics Company, a Lenni, Pa.-based firm that specializes in the extrusion and compression molding of high-performance thermoplastics. Modern Plastics distributes Westlake’s products.
Modern Plastics offers various sizes of extruded MediPEEK-IM in a 1-inch thick, 12-by-12-inch extruded plate. Thicknesses ranging from 0.250 inches to 4 inches, widths up to 18 inches and lengths up to 40 inches are available upon request, according to the company.
“This new capability to offer Medi-PEEK-IM in extruded plate allows flexibility in terms of yields, machinability and cost savings,” said Bing J. Carbone, Modern Plastics president. “Medi-PEEK-IM offers an alternative equivalent product to the marketplace with distinct advantages that include easier and faster access, better supply chain management and no contractual obligations. The value proposition we can offer now is truly exciting, and we think is a much-needed improvement in the way implantable PEEK has been presented in the past.”
Based in Bridgeport, Conn., Modern Plastics distributes medical grade plastic and high-performance engineering-grade plastic stock shapes.
New Bone Growth Formulations Available from PolyMedex
The custom compounds business unit of PolyMedex Discovery Group, which brings plastics processing, compounding and distribution under one roof, has expanded its range of services for implantable polymers to include a range of cleanroom blending of bone growth additives in polymers.
To enhance its custom compounding operation, the Putnam, Conn.-based company invested in a Leistritz twin-screw extruder, which allows for small-scale development batches that are scalable to full production. The smallest batch size ordered can be less than one kilogram, according to PolyMedex.
PolyMedex blends bioactive fillers such as tricalcium phosphate, hydroxyapatite, and biphasic calciumphosphate to make them osteoconductive, meaning that bone will grow on and bond to the plastic. Implantable plastics such as PEEK (polyetheretherketone) are used in permanent implants; bioresorbable polymers such as polycaprolactone, polylactic acid and polyglycolide are used in implants for temporary support while the body heals and ultimately replaces the implant with bone, according to the company. PolyMedex customizes bioresorbable polymers for resorption ranges from 1 to 36 months and flexural modulus from 30,000 psi (200 MPa) to more than 1 million psi (6,900 MPa).
The implantable polymers are available in various delivery forms. The material can be turned into components from specially-cut extruded film and fiber, or made into designs in the form of coextruded and multi-lumen tubing. For injection molding, PolyMedex’s custom formulations are available in a variety of pellet sizes for processing in standard or micromolding equipment.
PolyMedex is a privately held service provider to the medical industry, offering specialty polymers custom polymer blends, custom extrusions, and contract material blending for drug delivery. The company has more than 100,000 square feet of manufacturing among three plants—two in Connecticut and one in Nevada.
GAO Examining Cost of Implantable Devices
The medical device industry is back in the crosshairs of federal lawmakers as they attempt to control the escalating cost of healthcare.
Buoyed by their victory in the battle over a medical device excise tax, lawmakers have now shifted their focus to the cost and use of implantable devices. Leading this latest charge is U.S. Sen. Max Baucus, (D-Mont.), the Senate Finance Committee chairman who floated a $40 billion, 10-year tax proposal on devices before his colleagues cut that figure in half to appease medical manufacturing executives.
Baucus has asked the U.S. Government Accountability Office (GAO) to conduct an investigation into the pricing and use of implantable medical devices. As part of the investigation, the GAO will evaluate trends in the use of implantable products, the pricing of those devices for hospitals, and the effect of those prices on overall Medicare spending, according to a letter from James Cosgrove, a director in GAO’s healthcare office. Industry insiders speculate that Baucus may be targeting Medicare device payments to reduce healthcare spending.
The investigation into the pricing and use of implantable devices is expected to take about nine months.
Smith & Nephew Opens Overseas Plant for International Customers
Smith & Nephew plc has opened a manufacturing facility in China—its second in as many years—to better serve its international customers.
The 10,000-square-meter building in Beijing replaces a smaller structure that Smith & Nephew inherited when it purchased Plus Orthopedics Holding AG in 2007 for $889 million. At the time, the acquisition doubled Smith & Nephew’s share of the European orthopedic reconstruction market and increased its share of the global orthopedic market by 12 percent. Based in Rotkreuz, Switzerland, Plus Orthopedics was one of the largest suppliers of prosthetic hips in Germany, a country with the world’s third-largest orthopedic market. Founded in 1991, the firm made artificial knees, a shoulder product and small joints for the hands.
Smith & Nephew opened its new manufacturing plant in Beijing nearly a year after launching another facility in Suzhou, a city 645 miles to the southeast. That facility manufactures the company’s Allevyn adhesive dressings as well as other products for its Advanced Wound Management business. Products made at the Suzhou plant are exported to 65 countries worldwide, according to the company. Allevyn adhesive dressings are used to treat conditions such as geriatric and diabetic ulcers.
The Beijing manufacturing facility will produce surgical instruments and artificial hip and knee components. The opening of this plant, industry experts observed, reflects the importance Smith & Nephew’s leaders place on establishing a strong presence in China. Company executives have said they expect increasing demand both in China and internationally for orthopedic products and services.
Fears of counterfeit products are keeping Smith & Nephew from building high-tech instruments and artificial joint components at its Beijing manufacturing plant, according to ChinaBio Today. As Chinese demand grows for joint replacements, the company will begin developing parts designed specifically for China’s population.
If current trends continue, Smith & Nephew may design those patient population-specific parts sooner than executives expected. Recent estimates put the potential artificial joint market in China at 30 million patients and growth rates in the double digits. Experts attribute such a rapid market expansion to China’s aging society and its transformation from an agrarian culture to a machine-using civilization. The regular use of machines is expected to contribute to the rise in orthopedic procedures, as operators become more prone to serious injuries. According to Chinese Customs Data, between 70,000 and 80,000 joint replacements occurred in 2008, with two-thirds of those procedures being hip replacements (and one-third being knee replacements). China imported $140 million worth of orthopedic products in 2008, accounting for an in-market value of $420 million.
Study Shows Complex Spinal Surgeries on the Rise
The number of complex spinal surgeries in older adults surged 15-fold between 2002 and 2007, driving up medical costs as well as the risks of developing life-threatening complications, a study has found.
The surgery—complex spinal fusion—accounted for 14.6 percent of all back surgeries for Medicare patients in 2007, up significantly from the less than 1 percent the procedure represented in 2002, according to research in The Journal of the American Medical Association. Patients who had the surgery doubled their risk of developing life-threatening complications compared with a much simpler procedure known as decompression.
The research, according to lead investigator Richard Deyo, is the first to examine the rate of spinal surgery and its complications and cost in a large group of Medicare patients. Roughly 660,000 spinal surgeries, some of which used devices manufactured by Medtronic Inc. and Zimmer Holdings Inc., were performed in the United States last year, according to Millenium Research Group, a Toronto, Canada-based medical market research firm.
“All operations are not the same and some seem to be associated with higher complication rates than others,” Deyo told the Associated Press. “It’s not necessarily true that the more aggressive surgery is better, at least in terms of safety.”
More aggressive surgery certainly isn’t better, at least according to Deyo’s study results. The more complex procedure had a higher risk of mortality compared with the simpler surgery.
All 32,000 Medicare patients analyzed in Deyo’s research suffered from lower back stenosis, or a painful squeezing in the spine. The condition is most common in people older than the age of 50.
For purposes of the study, researchers grouped patients’ spinal surgeries into three categories: simple decompression (the most uncomplicated method), simple fusion and complex fusion. Surgeons using the simple decompression method cut away part of the spine that presses on nerves and causes pain. It can cost about $30,000 in hospital and surgeon fees, according to industry estimates. Fusion surgeries involve the binding of two or more vertebrae together using a bone graft with or without plates or screws. The researchers defined complex fusion as involving three or more vertebrae or more than one side of the spine. Fusions can cost between $60,000 and $90,000. The three surgeries’ cost to Medicare, strictly from hospital charges, amounts to roughly $1.65 billion annually, the researchers concluded.
The study did not address the success level of each procedure on pain relief. It did, however, reveal some surprising results about the risk of complications and death. Patients who underwent simple or complex fusions were more likely (five in 100) to suffer a major complication such as a stroke compared with those who opted for the decompression method (two in 100). Similarly, the risk of death was higher for the more complex procedures: six in 1,000 complex fusion patients had a higher risk of death within 30 days after surgery, compared with five in 1,000 simple fusion candidates and three in 1,000 decompression devotees.
In addition to the higher risks of complications and death, Deyo’s research found that more than half the patients who underwent complex fusions suffered from a simple stenosis, which usually is treated with decompression surgery. Experts claim there is little justification for performing a complex fusion procedure on a person suffering from simple stenosis.
“It certainly looks like there’s more complex surgery being done that we have very good evidence to support,” Eugene Carragee, M.D., of Stanford University Medical Center in Stanford, Calif., told the Associated Press. It certainly looks that way. But looks can be deceiving, and Ray Baker, a pain medicine specialist and president of the North American Spine Society, warned that Deyo’s research relied on “very coarse” data from patient records that are “not designed to answer therapeutic questions.” Though most doctors are not consciously making decisions to perform riskier, costlier surgeries, he admitted “a misalignment of incentives could be a problem.”
In 2008, the spine society adopted guidelines that declared decompression (the simplest of spinal operations) to be effective 80 percent of the time for patients who do not have serious spine defects or injuries. The guidelines say there is no evidence to support fusion surgeries in patients that do not suffer from spondylolisthesis (slippage of the spine) or spinal instability.
Tegra Medical Buys Facility in Latin America
Tegra Medical looked south of the border for its latest acquisition. The Franklin, Mass.-based device developer has purchased a 20,000-square-foot manufacturing facility in a tax-free trade zone in San Jose, Costa Rica.
The new operation, which was used for metal working and contained a range of manufacturing equipment, was bought from Penn United Technologies Inc., a Cabot, Pa.-based manufacturer of high-precision products for the medical, defense, energy, electronics and automotive markets. Neither company disclosed a purchase price for the manufacturing plant.
In a news release, Tegra Medical President and CEO Bob Roche said the new facility would enable his company to provide customers with a low cost alternative to help them better manage costs for mature products facing pricing pressures. “We’ve established our Genesis Tech Center, Quick Wire & Tube service and Lean Centers of Excellence in the United States to execute our new product launches efficiently,” he noted. “We will make additional investments in capabilities and infrastructure so our Costa Rican operation will have many of the same systems and capabilities as our other manufacturing plants.”
Over the next few months, Tegra will add Swiss machining and a Class-7 controlled manufacturing environment for assembly and packaging. The company also will pursue ISO 13485 and 9001 certifications for the Costa Rica facility, Roche said.
Formed in 2007, Tegra Medical manufactures wire and tubular components for the medical device industry.
Modern Plastics has added a new medical-grade polymer to its line. The permanent implantable PEEK (polyetheretherketone), which the company calls MediPEEK-IM, is a “high-performance semi-crystalline thermoplastic designed for long-term body contact.”The resin, according to the firm, is produced to ASTM F2026 specifications and extensively has been tested to meet ISO 10993 requirements.
MediPEEK-IM can be used to manufacture spinal cage products, fixation rods, orthopedic implants, ophthalmic tools and surgical instruments as well as dental and diagnostic devices. A news release about the new natural-colored material claims it has various advantages over other plastics, including biocompatibility, mechanical strength and toughness, superior hydrolysis (reaction with water), chemical resistance and dimensional stability. In addition, the plastic is radio translucent and can be sterilized
The new polymer is manufactured by Westlake Plastics Company, a Lenni, Pa.-based firm that specializes in the extrusion and compression molding of high-performance thermoplastics. Modern Plastics distributes Westlake’s products.
Modern Plastics offers various sizes of extruded MediPEEK-IM in a 1-inch thick, 12-by-12-inch extruded plate. Thicknesses ranging from 0.250 inches to 4 inches, widths up to 18 inches and lengths up to 40 inches are available upon request, according to the company.
“This new capability to offer Medi-PEEK-IM in extruded plate allows flexibility in terms of yields, machinability and cost savings,” said Bing J. Carbone, Modern Plastics president. “Medi-PEEK-IM offers an alternative equivalent product to the marketplace with distinct advantages that include easier and faster access, better supply chain management and no contractual obligations. The value proposition we can offer now is truly exciting, and we think is a much-needed improvement in the way implantable PEEK has been presented in the past.”
Based in Bridgeport, Conn., Modern Plastics distributes medical grade plastic and high-performance engineering-grade plastic stock shapes.
New Bone Growth Formulations Available from PolyMedex
The custom compounds business unit of PolyMedex Discovery Group, which brings plastics processing, compounding and distribution under one roof, has expanded its range of services for implantable polymers to include a range of cleanroom blending of bone growth additives in polymers.
To enhance its custom compounding operation, the Putnam, Conn.-based company invested in a Leistritz twin-screw extruder, which allows for small-scale development batches that are scalable to full production. The smallest batch size ordered can be less than one kilogram, according to PolyMedex.
PolyMedex blends bioactive fillers such as tricalcium phosphate, hydroxyapatite, and biphasic calciumphosphate to make them osteoconductive, meaning that bone will grow on and bond to the plastic. Implantable plastics such as PEEK (polyetheretherketone) are used in permanent implants; bioresorbable polymers such as polycaprolactone, polylactic acid and polyglycolide are used in implants for temporary support while the body heals and ultimately replaces the implant with bone, according to the company. PolyMedex customizes bioresorbable polymers for resorption ranges from 1 to 36 months and flexural modulus from 30,000 psi (200 MPa) to more than 1 million psi (6,900 MPa).
The implantable polymers are available in various delivery forms. The material can be turned into components from specially-cut extruded film and fiber, or made into designs in the form of coextruded and multi-lumen tubing. For injection molding, PolyMedex’s custom formulations are available in a variety of pellet sizes for processing in standard or micromolding equipment.
PolyMedex is a privately held service provider to the medical industry, offering specialty polymers custom polymer blends, custom extrusions, and contract material blending for drug delivery. The company has more than 100,000 square feet of manufacturing among three plants—two in Connecticut and one in Nevada.
GAO Examining Cost of Implantable Devices
The medical device industry is back in the crosshairs of federal lawmakers as they attempt to control the escalating cost of healthcare.
Buoyed by their victory in the battle over a medical device excise tax, lawmakers have now shifted their focus to the cost and use of implantable devices. Leading this latest charge is U.S. Sen. Max Baucus, (D-Mont.), the Senate Finance Committee chairman who floated a $40 billion, 10-year tax proposal on devices before his colleagues cut that figure in half to appease medical manufacturing executives.
Baucus has asked the U.S. Government Accountability Office (GAO) to conduct an investigation into the pricing and use of implantable medical devices. As part of the investigation, the GAO will evaluate trends in the use of implantable products, the pricing of those devices for hospitals, and the effect of those prices on overall Medicare spending, according to a letter from James Cosgrove, a director in GAO’s healthcare office. Industry insiders speculate that Baucus may be targeting Medicare device payments to reduce healthcare spending.
The investigation into the pricing and use of implantable devices is expected to take about nine months.
Smith & Nephew Opens Overseas Plant for International Customers
Smith & Nephew plc has opened a manufacturing facility in China—its second in as many years—to better serve its international customers.
The 10,000-square-meter building in Beijing replaces a smaller structure that Smith & Nephew inherited when it purchased Plus Orthopedics Holding AG in 2007 for $889 million. At the time, the acquisition doubled Smith & Nephew’s share of the European orthopedic reconstruction market and increased its share of the global orthopedic market by 12 percent. Based in Rotkreuz, Switzerland, Plus Orthopedics was one of the largest suppliers of prosthetic hips in Germany, a country with the world’s third-largest orthopedic market. Founded in 1991, the firm made artificial knees, a shoulder product and small joints for the hands.
Smith & Nephew opened its new manufacturing plant in Beijing nearly a year after launching another facility in Suzhou, a city 645 miles to the southeast. That facility manufactures the company’s Allevyn adhesive dressings as well as other products for its Advanced Wound Management business. Products made at the Suzhou plant are exported to 65 countries worldwide, according to the company. Allevyn adhesive dressings are used to treat conditions such as geriatric and diabetic ulcers.
The Beijing manufacturing facility will produce surgical instruments and artificial hip and knee components. The opening of this plant, industry experts observed, reflects the importance Smith & Nephew’s leaders place on establishing a strong presence in China. Company executives have said they expect increasing demand both in China and internationally for orthopedic products and services.
Fears of counterfeit products are keeping Smith & Nephew from building high-tech instruments and artificial joint components at its Beijing manufacturing plant, according to ChinaBio Today. As Chinese demand grows for joint replacements, the company will begin developing parts designed specifically for China’s population.
If current trends continue, Smith & Nephew may design those patient population-specific parts sooner than executives expected. Recent estimates put the potential artificial joint market in China at 30 million patients and growth rates in the double digits. Experts attribute such a rapid market expansion to China’s aging society and its transformation from an agrarian culture to a machine-using civilization. The regular use of machines is expected to contribute to the rise in orthopedic procedures, as operators become more prone to serious injuries. According to Chinese Customs Data, between 70,000 and 80,000 joint replacements occurred in 2008, with two-thirds of those procedures being hip replacements (and one-third being knee replacements). China imported $140 million worth of orthopedic products in 2008, accounting for an in-market value of $420 million.
Study Shows Complex Spinal Surgeries on the Rise
The number of complex spinal surgeries in older adults surged 15-fold between 2002 and 2007, driving up medical costs as well as the risks of developing life-threatening complications, a study has found.
The surgery—complex spinal fusion—accounted for 14.6 percent of all back surgeries for Medicare patients in 2007, up significantly from the less than 1 percent the procedure represented in 2002, according to research in The Journal of the American Medical Association. Patients who had the surgery doubled their risk of developing life-threatening complications compared with a much simpler procedure known as decompression.
The research, according to lead investigator Richard Deyo, is the first to examine the rate of spinal surgery and its complications and cost in a large group of Medicare patients. Roughly 660,000 spinal surgeries, some of which used devices manufactured by Medtronic Inc. and Zimmer Holdings Inc., were performed in the United States last year, according to Millenium Research Group, a Toronto, Canada-based medical market research firm.
“All operations are not the same and some seem to be associated with higher complication rates than others,” Deyo told the Associated Press. “It’s not necessarily true that the more aggressive surgery is better, at least in terms of safety.”
More aggressive surgery certainly isn’t better, at least according to Deyo’s study results. The more complex procedure had a higher risk of mortality compared with the simpler surgery.
All 32,000 Medicare patients analyzed in Deyo’s research suffered from lower back stenosis, or a painful squeezing in the spine. The condition is most common in people older than the age of 50.
For purposes of the study, researchers grouped patients’ spinal surgeries into three categories: simple decompression (the most uncomplicated method), simple fusion and complex fusion. Surgeons using the simple decompression method cut away part of the spine that presses on nerves and causes pain. It can cost about $30,000 in hospital and surgeon fees, according to industry estimates. Fusion surgeries involve the binding of two or more vertebrae together using a bone graft with or without plates or screws. The researchers defined complex fusion as involving three or more vertebrae or more than one side of the spine. Fusions can cost between $60,000 and $90,000. The three surgeries’ cost to Medicare, strictly from hospital charges, amounts to roughly $1.65 billion annually, the researchers concluded.
The study did not address the success level of each procedure on pain relief. It did, however, reveal some surprising results about the risk of complications and death. Patients who underwent simple or complex fusions were more likely (five in 100) to suffer a major complication such as a stroke compared with those who opted for the decompression method (two in 100). Similarly, the risk of death was higher for the more complex procedures: six in 1,000 complex fusion patients had a higher risk of death within 30 days after surgery, compared with five in 1,000 simple fusion candidates and three in 1,000 decompression devotees.
In addition to the higher risks of complications and death, Deyo’s research found that more than half the patients who underwent complex fusions suffered from a simple stenosis, which usually is treated with decompression surgery. Experts claim there is little justification for performing a complex fusion procedure on a person suffering from simple stenosis.
“It certainly looks like there’s more complex surgery being done that we have very good evidence to support,” Eugene Carragee, M.D., of Stanford University Medical Center in Stanford, Calif., told the Associated Press. It certainly looks that way. But looks can be deceiving, and Ray Baker, a pain medicine specialist and president of the North American Spine Society, warned that Deyo’s research relied on “very coarse” data from patient records that are “not designed to answer therapeutic questions.” Though most doctors are not consciously making decisions to perform riskier, costlier surgeries, he admitted “a misalignment of incentives could be a problem.”
In 2008, the spine society adopted guidelines that declared decompression (the simplest of spinal operations) to be effective 80 percent of the time for patients who do not have serious spine defects or injuries. The guidelines say there is no evidence to support fusion surgeries in patients that do not suffer from spondylolisthesis (slippage of the spine) or spinal instability.
Tegra Medical Buys Facility in Latin America
 Tegra Medical’s newest manufacturing facility in Costa Rica eventually will feature Swiss machining and a Class-7 controlled environment for assembly and packaging. Photo courtesy of Tegra Medical. |
The new operation, which was used for metal working and contained a range of manufacturing equipment, was bought from Penn United Technologies Inc., a Cabot, Pa.-based manufacturer of high-precision products for the medical, defense, energy, electronics and automotive markets. Neither company disclosed a purchase price for the manufacturing plant.
In a news release, Tegra Medical President and CEO Bob Roche said the new facility would enable his company to provide customers with a low cost alternative to help them better manage costs for mature products facing pricing pressures. “We’ve established our Genesis Tech Center, Quick Wire & Tube service and Lean Centers of Excellence in the United States to execute our new product launches efficiently,” he noted. “We will make additional investments in capabilities and infrastructure so our Costa Rican operation will have many of the same systems and capabilities as our other manufacturing plants.”
Over the next few months, Tegra will add Swiss machining and a Class-7 controlled manufacturing environment for assembly and packaging. The company also will pursue ISO 13485 and 9001 certifications for the Costa Rica facility, Roche said.
Formed in 2007, Tegra Medical manufactures wire and tubular components for the medical device industry.
