11.20.12
The Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia’s national science agency, has opened a new titanium additive manufacturing facility that will be used for developing advanced titanium parts for various manufacturing applications, including medical.
The facility houses Swedish additive manufacturing company Arcam AB’s first additive manufacturing machine in the southern hemisphere. The machine uses electron beam melting to fuse metal powders into complex shapes layer by layer. The system creates 3-D parts from metals including titanium alloys, nickel and hard steel alloys.
CSIRO’s expertise in titanium manufacturing includes electron beam melting, coldspray, and thermally assisted machining. The new facility is part of CSIRO’s “future manufacturing flagship” (FMF), the aim of which is to “lead the development of cleaner advanced materials and manufacturing technologies to enable manufacturing companies to grow Australia’s future productivity and prosperity,” according to CSIRO’s website.
“Additive manufacturing is an emerging technology that is capable of changing the future of manufacturing in Australia and we are keen to facilitate the adoption of new technologies which will benefit Australian businesses,” noted Swee Mak, director of CSIRO’s FMF. “We have invested in a suite of technologies and research, which combined with our links with RMIT [Royal Melbourne Institute of Technology] and Monash University, provide industry an opportunity to explore and engage in forward-thinking design and production techniques.”
CSIRO has identified additive manufacturing as a key opportunity for the manufacturing sector in Australia due to its ability to support core technologies, including materials science, polymer science, and metal fabrication.
“Additive manufacturing has been used for rapid manufacture of prototypes where its speed of production is advantageous. It can also be used for manufacture of complex, high-value components for industrial applications, and is especially useful for short production,” said John Barnes, a titanium researcher for the FMF. “Companies that want to take on additive manufacturing face a number of practical challenges. We’ve been providing technical advice to solve problems and helping businesses to access these technologies for nearly 10 years now.”
Utah Claims Lead in Medical Manufacturing Concentration
The Economic Department Corporation of Utah (EDCUtah), a non profit organization that works with state and local government to drive economic growth, has reported research that shows Utah has the highest concentration of medical device manufacturing firms per total number of companies in the state.
About 17 percent of all life science companies in Utah are medical device companies (116 out of 600).
The state also leads the nation in the employment of medical device engineers and medical appliance technicians. Salt Lake City, the state’s capital, has the highest concentration of people working as biomedical engineers per total number of employed people, and the highest total number of medical appliance manufacturing technicians than any other city in the nation, according to EDCUtah.
“We beat Greensboro, N.C., and Boston, Mass. (second and third, respectively) with more than 30 percent higher employment, according to 2011 data from the U.S. Bureau of Labor Statistics,” said the EDCUtah researcher who compiled the data, Brigham Mellor.
He said the industry has “exploded” over the last few years in Utah. Since 2007, employment in medical device manufacturing has gone up in the United States 25.5 percent. In Utah, however, it has gone up a whopping 6,300 percent, according to EDCUtah’s figures.
“We don’t have the most medical device companies by number, we have the highest concentration,” Mellor explained to Orthopedic Design and Technology. “Think of it as though you were going to open a business. What is the likelihood that next door to your company you have a medical device manufacturer? In the state of Utah you are 400 percent more likely to have that happen than the U.S. average.”
Since 2007, companies leading the pack for most jobs created in Utah are Edwards Lifesciences Corp. with 1,272, Nelson Laboratories with 750, and Fresenius Medical Care with 700.
“I moved to Salt Lake City in 1973,” said Salt Lake City-based Medron Inc. President Ron Whortley. “At that time, the area was known to have more medical companies per population base than most states. Salt Lake City provides a good source of educated and motivated workers.”
Medron develops and manufactures disposable medical products, specializing in vascular access products and ancillary items for catheter placement.
MedPlast and United Plastics Group Align to Create Two Distinct Brands
MedPlast Inc., a Tempe, Ariz.-based manufacturing services company, has completed its structural alignment with United Plastics Group Inc. (UPG) after having bought the company in April this year.
UPG is focused on the manufacture of precision plastic products and various value-added services. The alignment now gives MedPlast 14 manufacturing locations globally, with MedPlast remaining the company brand for healthcare products, and UPG becoming its industrial brand.
“We remain committed to excellence, and continue to cultivate the strengths of each individual entity,” said Harold Faig, CEO of MedPlast. “It is an approach that allows customers to capitalize on our unique industry synergies and solutions that deliver superior return on investment. Each brand retains its focus, delivers industry-leading solutions to its individual customer base, and allows for growth from new business and organically. A recent example of how our strategy works to the benefit of all parties is the major on-shoring business win of the UPG Minneapolis plant.”
UPG’s Minneapolis, Minn., location “won” the business of a significant cell-phone accessory manufacturer from China, which bolsters MedPlast’s bottom line significantly. UPG, which post-merger also is headquartered in Tempe, has additional locations in Houston, Texas; Wales; and two in China.
UPG’s Houston facility is brand new—at 36,000 square feet, the facility has 15 molding presses that, in addition to injection molding, deliver capabilities including automated assembly, pad printing, sonic welding and custom fixture manufacturing.
MedPlast’s expertise includes injection molding, liquid injection molding, two-shot molding, over molding, insert molding, multi-component molding, extrusion, blow molding, injection blow molding, injection stretch blow molding, silicone extrusion, compression and transfer molding, and precision mold making.
Cretex Re-Brands Medical Companies
Cretex Companies Inc. has launched a new branding initiative for its newly named medical group, Cretex Medical. Cretex Medical is made up of RMS, RMS Surgical, Meier Tool and Engineering Inc., and JunoPacific. These companies provide a broad range of manufacturing services for implantable, non-implantable, durable, and disposable medical devices.
“We’ve had a strong presence in the medical device industry for many years, with each of our medical companies serving its own market niche,” noted Lynn Schuler, Cretex Companies president/CEO. “But most people don’t know that these companies are part of a larger group—Cretex Companies—with a portfolio of complimentary manufacturing capabilities. Under the umbrella name of Cretex Medical, we showcase the breadth of our services for medical contract manufacturing.”
The four companies making up Cretex Medical operate in seven locations throughout the United States with about 1,000 employees.
Minneapolis, Minn.-based RMS provides contract machining, molding and assembly services with a specialty in implantables for the cardio/neuro stimulation, vascular interventional, and orthopedic market segments. While the Minneapolis location is focused on medical implants, the company’s Memphis, Tenn., facility is focused on orthopedic instrument manufacturing.
RMS Surgical is an extension of RMS, and is a single-source provider of custom surgical instruments and sterilization cases and trays.
Based in Anoka, Minn., Meier Tool and Engineering manufactures precision stamped micro-sized metal-formed components and subassemblies.
JunoPacific—the result of a merger between companies Juno Inc. and Pacific Plastics and Engineering— also has locations in Soquel, Calif. (in Silicon Valley) and Anoka.
Cretex Companies is a manufacturing firm headquartered in Elk River, Minn.
GPI Expands Additive Manufacturing Capabilities
GPI Prototype and Manufacturing Services Inc. has installed a third direct metal laser sintering (DMLS) machine from Electro Optical Systems (EOS). This second EOSINT M270 machine joins an EOSINT M280 that also is being used at GPI to build metal parts additively. The overall addition of a third machine expands the company’s DMLS material capabilities to include aluminum.
DMLS often is preferred over traditional tooling due to its ability to manufacture complex geometries and shapes not possible with computer numerical control (CNC) machining. Conformal cooling channels also can be integrated into designs to dramatically reduce injection molding cycle/lead times and lower costs. GPI offers six material choices for DMLS including stainless steel, titanium, cobalt chrome, maraging steel, and nickel alloy. GPI is in the testing phase for aluminum and will begin using the EOSINT M280 machine exclusively for aluminum parts within the next month.
Additional services provided by GPI include stereolithography, selective laser sintering, 3-D printing, fused deposition modeling, room temperature vulcanization, investment casting, tooling, CNC machining, finishing, painting and laser scanning.
GPI specializes in rapid prototyping and additive manufacturing using additive technologies. The company is headquartered in Lake Bluff, Ill.
Off-Label Use of Bone Growth Proteins in Children Questioned
According to a recent study published in the Journal of the American Medical Association (JAMA), almost one-tenth of U.S. children undergoing arthrodesis, a type of spine fusion surgery, are injected with bone morphogenetic (bone growth) proteins (BMPs) that have not been approved for use by the U.S. Food and Drug Administration.
Off-label use of medical therapies is legal in the United States (although companies marketing their products for off-label uses is not), but researchers are concerned that “augmentation beyond instrumentation and autograft bone grafting in pediatric spinal arthrodesis” is unnecessary. BMPs are approved for limited use in adults when healing might not occur at an optimal rate. The use of BMPs, researchers reported, raises concerns about the possible onset of cancer, wound dehiscence (where the wound opens along the surgical suture), spinal stenosis (an abnormal narrowing of the spinal cord), and respiratory complications.
Last year, Medtronic Inc. faced a lawsuit over its bone growth device Infuse, also known as BMP-2. Physicians on the company payroll had failed to report serious complications arising from Infuse, which included carcinogenesis, sterility in men, infections, and bone dissolution.
Emily Dodwell, M.D., a lead researcher on the JAMA study, told Reuters Health that it is unclear whether children would suffer the same side effects, but the ways in which BMPs react with still-growing skeletons was concerning. Her study did not specify particular products by brand. There also is no reliable existing data on whether BMPs help children, who heal more quickly and effectively from spinal surgery than adults.
The researchers looked at approximately 4,100 hospitals in the national registry for their study. Out of 8,000 arthrodesis surgeries on patients under the age of 18, 9.2 percent involved BMPs. In cases where BMPs were used, patients’ hospital bills were an average of $47,136, compared to $43,126 when surgeons did not use the product.
There was no immediate difference between the recovery of children and the use of BMPs, but Dodwell and her colleagues stated that long-term effects were the main concern. She and her team will continue to monitor the progress of these children through a different registry once they leave the hospital.
Helium Shortage Prompts Response from MITA
The Medical Imaging and Technology Alliance (MITA) is urging federal lawmakers to keep the federal helium reserve operational to prevent a major shortage early next year. The group has closely been monitoring national helium supply levels since demand for the natural gas began exceeding U.S. government expectations in 2010.
Airborne balloons are not the only use helium sees: The element is crucial to the proper operation of medical imaging equipment. For instance, for a magnetic resonance imaging (MRI) scanner to work, the internal magnet needs to remain at a temperature of 452 degrees below zero. Helium is the only element that can remain at a sufficiently cold temperature to allow for the stable and uniform magnetic field the MRI scanners need to work. Helium also is critical in cryogenics, the study of materials under extremely low temperatures.
MITA has written a letter to Congress urging policy makers to keep the federal helium reserve operational. The York Daily Record (the helium shortage has just begun to affect York County, Pa.) claims the U.S. government has taken some risks when it comes to helium storage. The federal government began buying helium from natural gas miners in 1960, recognizing its value as a resource. By the mid-1970s, helium stores exceeded demand, so the purchasing program was ended.
Helium prices were set at a minimum needed to pay off the Federal Helium Program’s $1.3 billion debt, which kept helium prices artificially low. In 2010, the National Academy of Sciences (NAS) recommended the bureau start raising prices to reflect actual market value. However, current demand has exceeded the government’s expectations, according to the NAS, and a significant amount of the helium is being sold outside the United States.
The letter submitted by MITA warns that the U.S. Bureau of Land Management will be forced to shut down the reserve as early as April 2013—taking 30 percent of the world’s helium supply off the market—if Congress fails to act.
“Patients and an important manufacturing industry are facing a crisis due to helium shortages,” said Gail Rodriguez, executive director of MITA. “Ensuring reliable access to helium is critical in safeguarding patient access to life-saving medical imaging technologies and to the health of the U.S. economy.”
Since liquid helium is the only element that feasibly can cool MRI magnets to temperatures that are suitable for imaging, MRIs in hospitals must regularly be replenished with helium to maintain normal operating temperatures.
“Failure to preserve our domestic helium supply will have reverberating effects for the U.S. medical imaging sector and the entire health care industry,” said Rodriguez. “MRI manufacturing facilities will have no choice but to slow or shut down production, hospitals and physicians will have to turn away patients due to the insufficient helium supply, and, ultimately, patients will simply not have access to the care they need.”
So far, lawmakers have discussed the issue in the U.S. House of Representatives and U.S. Senate, and have introduced the Helium Stewardship Act of 2012, which aims to preserve the Federal Helium Reserve, a natural geologic gas storage formation about 15 miles north of Amarillo, Texas. The reserve provides 6 million cubic feet of helium a day and has been operating at full capacity for a year, said Samuel Burton, an assistant field manager for helium operations at the Bureau of Land Management. At that rate, the reserve would run out of helium by 2018. But under the proposed Stewardship Act, Burton said the reserve would continue to produce helium until 2029.
The facility houses Swedish additive manufacturing company Arcam AB’s first additive manufacturing machine in the southern hemisphere. The machine uses electron beam melting to fuse metal powders into complex shapes layer by layer. The system creates 3-D parts from metals including titanium alloys, nickel and hard steel alloys.
Titanium component of a hip prosthesis manufactured by an Arcam additive manufacturing machine. Photo courtesy of CSIRO. |
“Additive manufacturing is an emerging technology that is capable of changing the future of manufacturing in Australia and we are keen to facilitate the adoption of new technologies which will benefit Australian businesses,” noted Swee Mak, director of CSIRO’s FMF. “We have invested in a suite of technologies and research, which combined with our links with RMIT [Royal Melbourne Institute of Technology] and Monash University, provide industry an opportunity to explore and engage in forward-thinking design and production techniques.”
CSIRO has identified additive manufacturing as a key opportunity for the manufacturing sector in Australia due to its ability to support core technologies, including materials science, polymer science, and metal fabrication.
“Additive manufacturing has been used for rapid manufacture of prototypes where its speed of production is advantageous. It can also be used for manufacture of complex, high-value components for industrial applications, and is especially useful for short production,” said John Barnes, a titanium researcher for the FMF. “Companies that want to take on additive manufacturing face a number of practical challenges. We’ve been providing technical advice to solve problems and helping businesses to access these technologies for nearly 10 years now.”
Utah Claims Lead in Medical Manufacturing Concentration
The Economic Department Corporation of Utah (EDCUtah), a non profit organization that works with state and local government to drive economic growth, has reported research that shows Utah has the highest concentration of medical device manufacturing firms per total number of companies in the state.
About 17 percent of all life science companies in Utah are medical device companies (116 out of 600).
The state also leads the nation in the employment of medical device engineers and medical appliance technicians. Salt Lake City, the state’s capital, has the highest concentration of people working as biomedical engineers per total number of employed people, and the highest total number of medical appliance manufacturing technicians than any other city in the nation, according to EDCUtah.
“We beat Greensboro, N.C., and Boston, Mass. (second and third, respectively) with more than 30 percent higher employment, according to 2011 data from the U.S. Bureau of Labor Statistics,” said the EDCUtah researcher who compiled the data, Brigham Mellor.
He said the industry has “exploded” over the last few years in Utah. Since 2007, employment in medical device manufacturing has gone up in the United States 25.5 percent. In Utah, however, it has gone up a whopping 6,300 percent, according to EDCUtah’s figures.
“We don’t have the most medical device companies by number, we have the highest concentration,” Mellor explained to Orthopedic Design and Technology. “Think of it as though you were going to open a business. What is the likelihood that next door to your company you have a medical device manufacturer? In the state of Utah you are 400 percent more likely to have that happen than the U.S. average.”
Since 2007, companies leading the pack for most jobs created in Utah are Edwards Lifesciences Corp. with 1,272, Nelson Laboratories with 750, and Fresenius Medical Care with 700.
“I moved to Salt Lake City in 1973,” said Salt Lake City-based Medron Inc. President Ron Whortley. “At that time, the area was known to have more medical companies per population base than most states. Salt Lake City provides a good source of educated and motivated workers.”
Medron develops and manufactures disposable medical products, specializing in vascular access products and ancillary items for catheter placement.
MedPlast and United Plastics Group Align to Create Two Distinct Brands
MedPlast Inc., a Tempe, Ariz.-based manufacturing services company, has completed its structural alignment with United Plastics Group Inc. (UPG) after having bought the company in April this year.
UPG is focused on the manufacture of precision plastic products and various value-added services. The alignment now gives MedPlast 14 manufacturing locations globally, with MedPlast remaining the company brand for healthcare products, and UPG becoming its industrial brand.
“We remain committed to excellence, and continue to cultivate the strengths of each individual entity,” said Harold Faig, CEO of MedPlast. “It is an approach that allows customers to capitalize on our unique industry synergies and solutions that deliver superior return on investment. Each brand retains its focus, delivers industry-leading solutions to its individual customer base, and allows for growth from new business and organically. A recent example of how our strategy works to the benefit of all parties is the major on-shoring business win of the UPG Minneapolis plant.”
UPG’s Minneapolis, Minn., location “won” the business of a significant cell-phone accessory manufacturer from China, which bolsters MedPlast’s bottom line significantly. UPG, which post-merger also is headquartered in Tempe, has additional locations in Houston, Texas; Wales; and two in China.
UPG’s Houston facility is brand new—at 36,000 square feet, the facility has 15 molding presses that, in addition to injection molding, deliver capabilities including automated assembly, pad printing, sonic welding and custom fixture manufacturing.
MedPlast’s expertise includes injection molding, liquid injection molding, two-shot molding, over molding, insert molding, multi-component molding, extrusion, blow molding, injection blow molding, injection stretch blow molding, silicone extrusion, compression and transfer molding, and precision mold making.
Cretex Re-Brands Medical Companies
Cretex Companies Inc. has launched a new branding initiative for its newly named medical group, Cretex Medical. Cretex Medical is made up of RMS, RMS Surgical, Meier Tool and Engineering Inc., and JunoPacific. These companies provide a broad range of manufacturing services for implantable, non-implantable, durable, and disposable medical devices.
“We’ve had a strong presence in the medical device industry for many years, with each of our medical companies serving its own market niche,” noted Lynn Schuler, Cretex Companies president/CEO. “But most people don’t know that these companies are part of a larger group—Cretex Companies—with a portfolio of complimentary manufacturing capabilities. Under the umbrella name of Cretex Medical, we showcase the breadth of our services for medical contract manufacturing.”
The four companies making up Cretex Medical operate in seven locations throughout the United States with about 1,000 employees.
Minneapolis, Minn.-based RMS provides contract machining, molding and assembly services with a specialty in implantables for the cardio/neuro stimulation, vascular interventional, and orthopedic market segments. While the Minneapolis location is focused on medical implants, the company’s Memphis, Tenn., facility is focused on orthopedic instrument manufacturing.
RMS Surgical is an extension of RMS, and is a single-source provider of custom surgical instruments and sterilization cases and trays.
Based in Anoka, Minn., Meier Tool and Engineering manufactures precision stamped micro-sized metal-formed components and subassemblies.
JunoPacific—the result of a merger between companies Juno Inc. and Pacific Plastics and Engineering— also has locations in Soquel, Calif. (in Silicon Valley) and Anoka.
Cretex Companies is a manufacturing firm headquartered in Elk River, Minn.
GPI Expands Additive Manufacturing Capabilities
Three DMLS machines at GPI’s Lake Bluff facility. Photo courtesy of GPI Prototype and Manufacturing Services Inc. |
DMLS often is preferred over traditional tooling due to its ability to manufacture complex geometries and shapes not possible with computer numerical control (CNC) machining. Conformal cooling channels also can be integrated into designs to dramatically reduce injection molding cycle/lead times and lower costs. GPI offers six material choices for DMLS including stainless steel, titanium, cobalt chrome, maraging steel, and nickel alloy. GPI is in the testing phase for aluminum and will begin using the EOSINT M280 machine exclusively for aluminum parts within the next month.
Additional services provided by GPI include stereolithography, selective laser sintering, 3-D printing, fused deposition modeling, room temperature vulcanization, investment casting, tooling, CNC machining, finishing, painting and laser scanning.
GPI specializes in rapid prototyping and additive manufacturing using additive technologies. The company is headquartered in Lake Bluff, Ill.
Off-Label Use of Bone Growth Proteins in Children Questioned
According to a recent study published in the Journal of the American Medical Association (JAMA), almost one-tenth of U.S. children undergoing arthrodesis, a type of spine fusion surgery, are injected with bone morphogenetic (bone growth) proteins (BMPs) that have not been approved for use by the U.S. Food and Drug Administration.
Off-label use of medical therapies is legal in the United States (although companies marketing their products for off-label uses is not), but researchers are concerned that “augmentation beyond instrumentation and autograft bone grafting in pediatric spinal arthrodesis” is unnecessary. BMPs are approved for limited use in adults when healing might not occur at an optimal rate. The use of BMPs, researchers reported, raises concerns about the possible onset of cancer, wound dehiscence (where the wound opens along the surgical suture), spinal stenosis (an abnormal narrowing of the spinal cord), and respiratory complications.
Last year, Medtronic Inc. faced a lawsuit over its bone growth device Infuse, also known as BMP-2. Physicians on the company payroll had failed to report serious complications arising from Infuse, which included carcinogenesis, sterility in men, infections, and bone dissolution.
Emily Dodwell, M.D., a lead researcher on the JAMA study, told Reuters Health that it is unclear whether children would suffer the same side effects, but the ways in which BMPs react with still-growing skeletons was concerning. Her study did not specify particular products by brand. There also is no reliable existing data on whether BMPs help children, who heal more quickly and effectively from spinal surgery than adults.
The researchers looked at approximately 4,100 hospitals in the national registry for their study. Out of 8,000 arthrodesis surgeries on patients under the age of 18, 9.2 percent involved BMPs. In cases where BMPs were used, patients’ hospital bills were an average of $47,136, compared to $43,126 when surgeons did not use the product.
There was no immediate difference between the recovery of children and the use of BMPs, but Dodwell and her colleagues stated that long-term effects were the main concern. She and her team will continue to monitor the progress of these children through a different registry once they leave the hospital.
Helium Shortage Prompts Response from MITA
The Medical Imaging and Technology Alliance (MITA) is urging federal lawmakers to keep the federal helium reserve operational to prevent a major shortage early next year. The group has closely been monitoring national helium supply levels since demand for the natural gas began exceeding U.S. government expectations in 2010.
Airborne balloons are not the only use helium sees: The element is crucial to the proper operation of medical imaging equipment. For instance, for a magnetic resonance imaging (MRI) scanner to work, the internal magnet needs to remain at a temperature of 452 degrees below zero. Helium is the only element that can remain at a sufficiently cold temperature to allow for the stable and uniform magnetic field the MRI scanners need to work. Helium also is critical in cryogenics, the study of materials under extremely low temperatures.
MITA has written a letter to Congress urging policy makers to keep the federal helium reserve operational. The York Daily Record (the helium shortage has just begun to affect York County, Pa.) claims the U.S. government has taken some risks when it comes to helium storage. The federal government began buying helium from natural gas miners in 1960, recognizing its value as a resource. By the mid-1970s, helium stores exceeded demand, so the purchasing program was ended.
Helium prices were set at a minimum needed to pay off the Federal Helium Program’s $1.3 billion debt, which kept helium prices artificially low. In 2010, the National Academy of Sciences (NAS) recommended the bureau start raising prices to reflect actual market value. However, current demand has exceeded the government’s expectations, according to the NAS, and a significant amount of the helium is being sold outside the United States.
The letter submitted by MITA warns that the U.S. Bureau of Land Management will be forced to shut down the reserve as early as April 2013—taking 30 percent of the world’s helium supply off the market—if Congress fails to act.
“Patients and an important manufacturing industry are facing a crisis due to helium shortages,” said Gail Rodriguez, executive director of MITA. “Ensuring reliable access to helium is critical in safeguarding patient access to life-saving medical imaging technologies and to the health of the U.S. economy.”
Since liquid helium is the only element that feasibly can cool MRI magnets to temperatures that are suitable for imaging, MRIs in hospitals must regularly be replenished with helium to maintain normal operating temperatures.
“Failure to preserve our domestic helium supply will have reverberating effects for the U.S. medical imaging sector and the entire health care industry,” said Rodriguez. “MRI manufacturing facilities will have no choice but to slow or shut down production, hospitals and physicians will have to turn away patients due to the insufficient helium supply, and, ultimately, patients will simply not have access to the care they need.”
So far, lawmakers have discussed the issue in the U.S. House of Representatives and U.S. Senate, and have introduced the Helium Stewardship Act of 2012, which aims to preserve the Federal Helium Reserve, a natural geologic gas storage formation about 15 miles north of Amarillo, Texas. The reserve provides 6 million cubic feet of helium a day and has been operating at full capacity for a year, said Samuel Burton, an assistant field manager for helium operations at the Bureau of Land Management. At that rate, the reserve would run out of helium by 2018. But under the proposed Stewardship Act, Burton said the reserve would continue to produce helium until 2029.