Mark Crawford, Contributing Writer06.04.20
The molding business is booming for medical devices. With continued advancements in manufacturing technologies and medical designs, molders are staying busy with a steady stream of new devices and diagnostic equipment entering the marketplace—which often require injection-molded components (often at the micro scale) and contract manufactured assemblies. In turn, medical molders must keep pace with new technologies, materials, shapes, tolerances, and applications—especially if they want to differentiate themselves in the crowded world of contract manufacturing.
Even with these technology demands for molding, it is still largely a cost-driven business, where a lower price might win out over skill or added capabilities.
“Medical molding is becoming a commodity market, where price is often considered a stronger driver for decisions,” said Jeff Lucash, vice president of industrial market group sales for Baraboo, Wis.-based Flambeau, an injection and blow molder of plastic parts and subsidiary of Flambeau Medical Markets Group in Phoenix, Ariz. “Therefore, cost savings and labor-reducing applications are in high demand.”
This has made medical molding a highly competitive business. Molders are constantly looking for ways to trim costs and still add value, as well as differentiate themselves from the competition.
“Molders have increasingly turned to automation to cope with the growing demand for parts, as well as to meet the rising quality requirements of these moldings,” said Emmanuel Achinivu, business development manager for Carclo Technical Plastics, a contract manufacturer that specializes in injection molding and assembly for the medical and optics markets. “Also, the imminent introduction of the Medical Device Regulation [MDR] and In Vitro Diagnostic Regulation [IVDR] regulations will surely intensify competition and molders will again be forced to innovate to remain competitive.”
COVID-19 has also increased demand for certain molded devices and equipment, personal protection equipment (PPE), and sanitation supplies to help fight the pandemic on the front lines.
“The battle against COVID-19 is leading some companies to introduce new products or to scale up,” said Mike Yurkewicz, engineering manager for C&J Industries, a Meadville, Pa.-based provider of plastic injection moldings. “For instance, one of our customers provides devices that help strengthen patients’ lungs and, of course, boosting lung function is especially beneficial for those with COVID-19.”
“Demand for test cartridges for COVID-19 and other respiratory illnesses has been rather steep, and we are running 24/7 to make as many as possible,” added Joe Szyperski, director of advanced design and development for Medbio, a Grand Rapids, Mich.-based contract manufacturer specializing in injection molding for the medical device and biotech industries.
Of course, it is uncertain how the COVID-19 pandemic will play out—it is likely, though, inventory for those essential medical devices and supplies critical to fighting COVID-19 will reach an all-time low; therefore OEMs will likely ramp up production of these products over the near future, rather than investing time and resources developing new products. This change in focus will be driven by the need for medical facilities and government agencies to stockpile critical supplies to prevent a similar shortage in the future (possibly as early as the second wave of COVID-19 predicted for fall-winter 2020).
What OEMs Want
OEMs are increasingly focused on precision and efficiency, especially for micro-molding (micron tolerances for small, high-precision parts), blow molding, high-volume parts, and disposables. They seek operational efficiencies that will reduce costs, speed time to market, and maintain price points. Increasingly, they expect very strong quality management systems from contract manufacturers (CMs) that will save them time and money, especially on validations. More medical device manufacturers (MDMs) are investing in design for manufacturability, finite element analysis, and even virtual reality and augmented reality to design the best possible product, thereby making validations and regulatory processes as smooth as possible—ultimately getting the product to market faster, with fewer problems or inefficiencies.
“Designs of experiments [DOEs] are becoming a necessity and a requirement from OEMs,” said Bryan Barrera, vice president of Trademark Plastics, a Riverside, Calif.-based custom injection molder. “DOEs assist customers with crucial data before jumping into validating operational qualifications and performance qualifications. DOEs allow us to assist medical device R&D groups and be part of highly visible projects at a corporate and, sometimes, executive level.”
OEMs are always looking for vertically integrated molders who can provide more services under one roof, shortening the supply chain. Shorter supply chains usually result in improved quality and continuity, streamlined processes, and regulatory knowledge and guidance—saving time and money and getting products to market faster.
“Medical device companies want a partner that can find the right balance between cost competitiveness and differentiation,” said Barrera. “It is important to maintain enough profits to pursue constant innovation. They want on-time delivery, Six Sigma-quality levels, robust process development, and an endless amount of traceability.”
“OEMs seek one-stop shops that can injection mold and blow mold, with secondary operations capability, and they want cleanroom molding, assembly, and packaging,” added Lucash. “Robotics and program management with secondary services such as sterilization are other important capabilities OEMs count on to generate efficiency and cost savings.”
This is especially true today—the large number of acquisitions taking place provide OEMs with more options for finding suppliers that can handle multiple key services and provide deep cross-discipline expertise.
“Our project teams are cross functional and comprised of multiple members across a variety of departments, and include a number of engineers from various disciplines,” said Yurkewicz. “This front-end strategy helps ensure a win-win as we prepare to become production-ready for our customers. We also strive to be a ‘one-stop shop’ by providing decorative, assembly, packaging, and distribution services as well.”
Another huge priority for OEMs is speed to market. OEMs are intent on getting their products to market faster, in order to get the return on investment to start work on their next products. They want suppliers that can take ownership of a project by providing engineering and design support that can handle all aspects of production, from development through product approval, which allows them to focus on their core business functions. MDMs are looking for fast-track turnaround time for product cycles, starting from concept through prototype, pilot run, validation, launch, and scale-up production. And, of course, on-time delivery is a top priority.
“OEMs look for speed and agility to support market introductions and potential upticks in demand,” said Thomas Caron, vice president of sales and marketing for Teamvantage, a Forest Lake, Minn.-based custom contract manufacturer and injection molder. “Speed to market is invariably a key factor in the medical device market.”
Recent Trends
Multi-shot injection molding is on the rise. Two or more colors and/or materials are injected simultaneously into a mold. The number of the additional injection units can be as high as six or more. This process is ideal for combining different material properties into a single component, such as molded seals, valves, soft-grip handle inserts, dashboard or instrumentation, flexible hinges, or movable components. Multi-shot injection molding can reduce the number of parts and provides engineers with more design options.
“We are seeing renewed interest in multi-shot injection molding, which involves multiple injection units involved in molding a single part geometry,” said Yurkewicz. “Benefits include reducing the number of assembly steps, with often superior results. Performance improvements are also gained through leveraging differing materials’ properties, such as varying hardness for tactile/ergonomic purposes, or different colors for enhanced aesthetics.”
OEMs are being more cautious, with more zero-risk and zero-defect expectations. This trend, especially by larger OEMs, is slowing down design and production. “What might have been commonly acceptable five years ago, seems to take an act of Congress to get approved now,” said Szyperski. “A simple drawing change requires review by all of the distribution managers around the world before it can be accepted. Even cost-saving measures are being eschewed because changes are so difficult to get through the system.”
The trend toward zero risk/zero defects is, in part, driven by tougher regulations, but also by wanting more predictable and reliable manufacturing processes, which OEMs realize are easier to achieve in the U.S. Shorter domestic supply chains, with easier communications and decision making, tend toward higher quality and repeatability. The current COVID-19 pandemic is especially driving this idea home.
“The medical device industry is witnessing an increased desire to manufacture domestically,” said Pete Scharber, vice president of direct sales and business development for Comar, a Voorhees, N.J.-based medical device and diagnostic contract manufacturer. “The recent trade war ramifications and the current COVID-19 situation have exposed some of the risks of foreign supply chains. The reality is that U.S.-based companies are often able to compete with low-cost labor-regions through the utilization of automation and press-side operations.”
“Due to the tariffs, more work is coming back to the U.S. in the form of mold-making and parts supply,” added Wayne Daniel, director of business development for Canon Virginia, a Newport News, Va.-based contract manufacturer for the medical device industry.
Szyperski noted an increased number of Medbio customers are reshoring to the U.S. from China. “Although medical was not as prone to sending its manufacturing overseas as much as some industries, the number of quotes we’re seeing is quite high, and we believe that companies are bringing business back to the U.S.,” he said.
Scientific Molding
Although scientific injection molding (SIM) is not a new technology, it is being used more than ever to produce the highest-quality injection-molded product with the best quality, tolerances, and repeatability. An increasing number of sophisticated tools are available to molders to predict product outcomes and monitor in-process melt variables. Conformal cooling in mold plates and cavity blocks expand the potential for reducing cycle times and address parts with non-uniform wall thicknesses. Sensor technologies and analytical software collect and analyze operational data from the injection molding equipment to document the specifications, settings, and steps needed to ensure reproducibility over time and across equipment. Scientific injection molding principles are applied across all phases of medical device component manufacturing, including product design, building and debugging the tool, material selection, and the injection-molding process. By analyzing factors such as injection speed, pressure, fill time, mold flow analysis, and gate-seal studies, engineers can determine the optimal mold parameters for a robust and repeatable process that delivers consistently defect-free components.
“The use of cavity-pressure sensors in the molds and the science-based process that SIM creates is incredibly valuable,” said Scharber. “SIM records actual outputs of the molding process in real time as the part is being created in the mold. We do not rely on the machine inputs, but rather the outputs and actual process happening within the mold, to determine high/low process limits and establish set points of alarm bands.”
Carclo Technical Plastics has installed RJG in-mold pressure transducers and e-Dart process monitoring software on its Fanuc injection molding machines. “Widespread use of these technologies is often made during the process development and validation phases of a project, supported by existing metrology and statistical analysis tools,” said Achinivu. “This process provides a complete visual insight of the conditions within each cavity during every single shot, ensuring comprehensive and accurate live and historical process monitoring. This allows us to guarantee the process inputs and outputs of every single shot, thereby ensuring that production parts are always within validated limits and guaranteed within specification, prior to shipping to the customer.”
FIMMTECH, which specializes in injection molding, is famous for its NAUTILUS mold qualification software, which is based on scientific molding and design of experiments. The program is designed to help molders validate and troubleshoot their molding processes, which reduces mold trial iterations, shortens cycle times, and speeds up process validations. Even just simple adjustments using NAUTILUS can achieve big gains (for example, reducing or eliminating inspection steps).
“FIMMTECH software is an incredible tool,” said Barrera. “It assists our team on a predictive level, before a process even runs. It is a highly beneficial tool for troubleshooting, process development, and factorial DOE implementation.”
Other Technology Trends
Use of automation and robotics to improve efficiency and address labor constraints is on the rise, as well as to improve inspection methods to detect potential issues early on and improve overall efficiency and quality. Automation reduces molding labor and part costs, part-to-part variations, and inconsistent cycle times, producing injection molded parts more quickly and efficiently.
Advancements in vision systems include solid-state 2D and 3D vision systems, which make it easier to assess parts quickly, or to establish virtual “gages” to fully measure a given feature during an MRB (material review board)-based sort. These systems are still only moderately effective with clear parts, but what might take several minutes with a touch-probe CMM takes only one-quarter of the time with a CT scanner.
CT scanners can be integrated with automation to accurately measure all features of a part, internal and external, and even detect voids or inclusions that would otherwise require sectioning of parts. “The cost of these devices is reaching the point of being feasible, and if they are as good as purported, we should be able to rely less on finicky CMM programs and the corresponding difficulty in holding parts in the required orientations without movement or flexing from the touch probe,” said Szyperski, who is considering acquiring a CT-scanner for Medbio. “Gage R&R should be easy or even unnecessary if the scanner proves reliably repeatable and accurate.”
Part cooling time is wasted time in the molding process; while the part cools, the molding machine remains idle, wasting production time. Canon recently launched its Shuttle Mold System, a new molding technology that increases production by utilizing part cooling time to mold another part. The system slides the mold out of the press so the cooling is done on the outside, allowing another part to be molded in another mold, effectively utilizing machine time. “In cases where there is enough available cooling time, the Shuttle Mold System can double the molding machine output,” said Daniel.
As MDMs focus more on quality management, efficiencies, and validations, they place increased emphasis on cleaning and zero residual contamination—both on the final part and the processing equipment.
Carclo Technical Plastics recently purchased an i3 MicroClean dry ice blasting machine from Cold Jet to clean tooling. This non-abrasive tool-cleaning method utilizes compressed air and fine ice particles to remove gas build-up produced during the molding of optically transparent diagnostic cuvettes. “We are currently able to perform in-press cleaning on both the fixed and moving half of mold tools, and the cleaning process can be performed while the tool is still hot, with no detriment to polished surfaces of the cavity or tool,” said Achinivu.
Since implementing the ice cleaner, Carclo Technical Plastics has reduced in-press tool cleaning time, on average, from four hours to 45 minutes per tool, while also reducing preventative maintenance time in the tool rooms. “Consequently, we can now produce more parts than we were previously capable of since tool cleaning time and frequency have been significantly reduced, therefore increasing the available production up time for the respective tools,” added Achinivu.
Molders sometimes develop their own in-house, proprietary molding methods, often in response to challenging customer designs. For example, Medbio developed oxygen-free molding of cyclic olefin copolymer, with O2 sensors tied into the press. If the level of oxygen exceeds 200 ppm at the feed-throat or in the mold cavity, the press stops. “This was requested to reduce the oxidation and discoloration of the resin at elevated temperatures,” said Szyperski. “We even helped develop a resin drier that maintained the same, oxygen-free environment.” Medbio has also developed a number of other tools using injection compression, which allow for thin-walled sections that would otherwise not be moldable. Other benefits of this process are uniform stress across the part and the removal of knit lines around small holes that otherwise caused leaks.
Moving Forward
More creative methods using injection molding will continue to evolve, creating more design freedom for engineers—”for example, taking additive-manufactured metal parts, machining in more complex geometries, and then overmolding these components into medical products,” said Caron.
Metal injection molding (MIM) can produce parts for a wide range of medical devices. MIM is considered to be a hybrid process, where a metal powder is mixed with a thermoplastic binder and injected into a mold. Lasers are being used to carve textures into the sides of molds. 3D-printed steel molds and injection sequencing with multi-shot are technologies in development. The Internet of Things will catalyze the integration of operating systems and technology to better manage and optimize manufacturing processes in real time, improving relevant, objective decision-making. Continued advancements will be made in materials, collaborative technology for manufacturing and assembly processes, smarter automation systems, vision systems, and artificial intelligence (AI).
“The potential of AI for process monitoring and control, as well as learning, with smart equipment making on-the-fly adjustments within a molding cycle toward ensuring acceptable product quality and improved efficiencies, is fascinating,” said Yurkewicz.
As technologies advance, OEMs will always want a solutions provider—not just a molding supplier.
“OEMs are asking us to become involved in projects much further upstream, often in the development stage or shortly after their design concepts are finalized,” said Scharber. “They are seeking front-end design support including design for manufacturability. Basically, customers are seeking confidence that their component, assembly, or finished device is optimized for molding and assembly. When this happens up front, it reduces project lead times, mitigates projects delays, and ensures sustainable quality over the program life.”
The allure of re-shoring has an increasing number of MDMs considering a return to the U.S., especially after experiencing turbulent supply chains, the result of tariff battles and the COVID-19 pandemic.
“With COVID-19, and the shortages we saw materialize literally overnight, a focus has returned to the real cost of doing business abroad,” said Tom Star, president of injection molding for Molded Devices, a Tempe, Ariz.-based provider of plastics processing, including injection molding, blow molding, and extrusion. “We have been contacted by virtually all of our large customers about the cost of reshoring items from China. There may be some type of intervention or mandate that ‘essential’ supplies such as PPE, pharmaceuticals, and infrastructure-supporting items be manufactured here in the U.S. When we get through this and the after-action reports pile up, I think people will realize that it is a good thing to control their supply chains in a sovereign matter.”
The problem, he noted, will be trying to keep costs down and maintain a reasonable margin. Star has spoken with many colleagues who are engaging in the same cost-evaluation exercises with their MDMs.
Companies that come back to the U.S. will face some major hurdles—"the cost of insurance, the cost of revalidation of products, the capital cost of factories and machinery, and the higher tax rates all create giant headwind for these companies to overcome,” said Star.
Subsidies will likely be needed to keep them afloat, at least initially. “We are spending a lot of time these days running these cost scenarios for customers,” said Star. “If we are to make this investment in America, we must find ways to subsidize the return of manufacturing—I hope that we can make it happen.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
Even with these technology demands for molding, it is still largely a cost-driven business, where a lower price might win out over skill or added capabilities.
“Medical molding is becoming a commodity market, where price is often considered a stronger driver for decisions,” said Jeff Lucash, vice president of industrial market group sales for Baraboo, Wis.-based Flambeau, an injection and blow molder of plastic parts and subsidiary of Flambeau Medical Markets Group in Phoenix, Ariz. “Therefore, cost savings and labor-reducing applications are in high demand.”
This has made medical molding a highly competitive business. Molders are constantly looking for ways to trim costs and still add value, as well as differentiate themselves from the competition.
“Molders have increasingly turned to automation to cope with the growing demand for parts, as well as to meet the rising quality requirements of these moldings,” said Emmanuel Achinivu, business development manager for Carclo Technical Plastics, a contract manufacturer that specializes in injection molding and assembly for the medical and optics markets. “Also, the imminent introduction of the Medical Device Regulation [MDR] and In Vitro Diagnostic Regulation [IVDR] regulations will surely intensify competition and molders will again be forced to innovate to remain competitive.”
COVID-19 has also increased demand for certain molded devices and equipment, personal protection equipment (PPE), and sanitation supplies to help fight the pandemic on the front lines.
“The battle against COVID-19 is leading some companies to introduce new products or to scale up,” said Mike Yurkewicz, engineering manager for C&J Industries, a Meadville, Pa.-based provider of plastic injection moldings. “For instance, one of our customers provides devices that help strengthen patients’ lungs and, of course, boosting lung function is especially beneficial for those with COVID-19.”
“Demand for test cartridges for COVID-19 and other respiratory illnesses has been rather steep, and we are running 24/7 to make as many as possible,” added Joe Szyperski, director of advanced design and development for Medbio, a Grand Rapids, Mich.-based contract manufacturer specializing in injection molding for the medical device and biotech industries.
Of course, it is uncertain how the COVID-19 pandemic will play out—it is likely, though, inventory for those essential medical devices and supplies critical to fighting COVID-19 will reach an all-time low; therefore OEMs will likely ramp up production of these products over the near future, rather than investing time and resources developing new products. This change in focus will be driven by the need for medical facilities and government agencies to stockpile critical supplies to prevent a similar shortage in the future (possibly as early as the second wave of COVID-19 predicted for fall-winter 2020).
What OEMs Want
OEMs are increasingly focused on precision and efficiency, especially for micro-molding (micron tolerances for small, high-precision parts), blow molding, high-volume parts, and disposables. They seek operational efficiencies that will reduce costs, speed time to market, and maintain price points. Increasingly, they expect very strong quality management systems from contract manufacturers (CMs) that will save them time and money, especially on validations. More medical device manufacturers (MDMs) are investing in design for manufacturability, finite element analysis, and even virtual reality and augmented reality to design the best possible product, thereby making validations and regulatory processes as smooth as possible—ultimately getting the product to market faster, with fewer problems or inefficiencies.
“Designs of experiments [DOEs] are becoming a necessity and a requirement from OEMs,” said Bryan Barrera, vice president of Trademark Plastics, a Riverside, Calif.-based custom injection molder. “DOEs assist customers with crucial data before jumping into validating operational qualifications and performance qualifications. DOEs allow us to assist medical device R&D groups and be part of highly visible projects at a corporate and, sometimes, executive level.”
OEMs are always looking for vertically integrated molders who can provide more services under one roof, shortening the supply chain. Shorter supply chains usually result in improved quality and continuity, streamlined processes, and regulatory knowledge and guidance—saving time and money and getting products to market faster.
“Medical device companies want a partner that can find the right balance between cost competitiveness and differentiation,” said Barrera. “It is important to maintain enough profits to pursue constant innovation. They want on-time delivery, Six Sigma-quality levels, robust process development, and an endless amount of traceability.”
“OEMs seek one-stop shops that can injection mold and blow mold, with secondary operations capability, and they want cleanroom molding, assembly, and packaging,” added Lucash. “Robotics and program management with secondary services such as sterilization are other important capabilities OEMs count on to generate efficiency and cost savings.”
This is especially true today—the large number of acquisitions taking place provide OEMs with more options for finding suppliers that can handle multiple key services and provide deep cross-discipline expertise.
“Our project teams are cross functional and comprised of multiple members across a variety of departments, and include a number of engineers from various disciplines,” said Yurkewicz. “This front-end strategy helps ensure a win-win as we prepare to become production-ready for our customers. We also strive to be a ‘one-stop shop’ by providing decorative, assembly, packaging, and distribution services as well.”
Another huge priority for OEMs is speed to market. OEMs are intent on getting their products to market faster, in order to get the return on investment to start work on their next products. They want suppliers that can take ownership of a project by providing engineering and design support that can handle all aspects of production, from development through product approval, which allows them to focus on their core business functions. MDMs are looking for fast-track turnaround time for product cycles, starting from concept through prototype, pilot run, validation, launch, and scale-up production. And, of course, on-time delivery is a top priority.
“OEMs look for speed and agility to support market introductions and potential upticks in demand,” said Thomas Caron, vice president of sales and marketing for Teamvantage, a Forest Lake, Minn.-based custom contract manufacturer and injection molder. “Speed to market is invariably a key factor in the medical device market.”
Recent Trends
Multi-shot injection molding is on the rise. Two or more colors and/or materials are injected simultaneously into a mold. The number of the additional injection units can be as high as six or more. This process is ideal for combining different material properties into a single component, such as molded seals, valves, soft-grip handle inserts, dashboard or instrumentation, flexible hinges, or movable components. Multi-shot injection molding can reduce the number of parts and provides engineers with more design options.
“We are seeing renewed interest in multi-shot injection molding, which involves multiple injection units involved in molding a single part geometry,” said Yurkewicz. “Benefits include reducing the number of assembly steps, with often superior results. Performance improvements are also gained through leveraging differing materials’ properties, such as varying hardness for tactile/ergonomic purposes, or different colors for enhanced aesthetics.”
OEMs are being more cautious, with more zero-risk and zero-defect expectations. This trend, especially by larger OEMs, is slowing down design and production. “What might have been commonly acceptable five years ago, seems to take an act of Congress to get approved now,” said Szyperski. “A simple drawing change requires review by all of the distribution managers around the world before it can be accepted. Even cost-saving measures are being eschewed because changes are so difficult to get through the system.”
The trend toward zero risk/zero defects is, in part, driven by tougher regulations, but also by wanting more predictable and reliable manufacturing processes, which OEMs realize are easier to achieve in the U.S. Shorter domestic supply chains, with easier communications and decision making, tend toward higher quality and repeatability. The current COVID-19 pandemic is especially driving this idea home.
“The medical device industry is witnessing an increased desire to manufacture domestically,” said Pete Scharber, vice president of direct sales and business development for Comar, a Voorhees, N.J.-based medical device and diagnostic contract manufacturer. “The recent trade war ramifications and the current COVID-19 situation have exposed some of the risks of foreign supply chains. The reality is that U.S.-based companies are often able to compete with low-cost labor-regions through the utilization of automation and press-side operations.”
“Due to the tariffs, more work is coming back to the U.S. in the form of mold-making and parts supply,” added Wayne Daniel, director of business development for Canon Virginia, a Newport News, Va.-based contract manufacturer for the medical device industry.
Szyperski noted an increased number of Medbio customers are reshoring to the U.S. from China. “Although medical was not as prone to sending its manufacturing overseas as much as some industries, the number of quotes we’re seeing is quite high, and we believe that companies are bringing business back to the U.S.,” he said.
Scientific Molding
Although scientific injection molding (SIM) is not a new technology, it is being used more than ever to produce the highest-quality injection-molded product with the best quality, tolerances, and repeatability. An increasing number of sophisticated tools are available to molders to predict product outcomes and monitor in-process melt variables. Conformal cooling in mold plates and cavity blocks expand the potential for reducing cycle times and address parts with non-uniform wall thicknesses. Sensor technologies and analytical software collect and analyze operational data from the injection molding equipment to document the specifications, settings, and steps needed to ensure reproducibility over time and across equipment. Scientific injection molding principles are applied across all phases of medical device component manufacturing, including product design, building and debugging the tool, material selection, and the injection-molding process. By analyzing factors such as injection speed, pressure, fill time, mold flow analysis, and gate-seal studies, engineers can determine the optimal mold parameters for a robust and repeatable process that delivers consistently defect-free components.
“The use of cavity-pressure sensors in the molds and the science-based process that SIM creates is incredibly valuable,” said Scharber. “SIM records actual outputs of the molding process in real time as the part is being created in the mold. We do not rely on the machine inputs, but rather the outputs and actual process happening within the mold, to determine high/low process limits and establish set points of alarm bands.”
Carclo Technical Plastics has installed RJG in-mold pressure transducers and e-Dart process monitoring software on its Fanuc injection molding machines. “Widespread use of these technologies is often made during the process development and validation phases of a project, supported by existing metrology and statistical analysis tools,” said Achinivu. “This process provides a complete visual insight of the conditions within each cavity during every single shot, ensuring comprehensive and accurate live and historical process monitoring. This allows us to guarantee the process inputs and outputs of every single shot, thereby ensuring that production parts are always within validated limits and guaranteed within specification, prior to shipping to the customer.”
FIMMTECH, which specializes in injection molding, is famous for its NAUTILUS mold qualification software, which is based on scientific molding and design of experiments. The program is designed to help molders validate and troubleshoot their molding processes, which reduces mold trial iterations, shortens cycle times, and speeds up process validations. Even just simple adjustments using NAUTILUS can achieve big gains (for example, reducing or eliminating inspection steps).
“FIMMTECH software is an incredible tool,” said Barrera. “It assists our team on a predictive level, before a process even runs. It is a highly beneficial tool for troubleshooting, process development, and factorial DOE implementation.”
Other Technology Trends
Use of automation and robotics to improve efficiency and address labor constraints is on the rise, as well as to improve inspection methods to detect potential issues early on and improve overall efficiency and quality. Automation reduces molding labor and part costs, part-to-part variations, and inconsistent cycle times, producing injection molded parts more quickly and efficiently.
Advancements in vision systems include solid-state 2D and 3D vision systems, which make it easier to assess parts quickly, or to establish virtual “gages” to fully measure a given feature during an MRB (material review board)-based sort. These systems are still only moderately effective with clear parts, but what might take several minutes with a touch-probe CMM takes only one-quarter of the time with a CT scanner.
CT scanners can be integrated with automation to accurately measure all features of a part, internal and external, and even detect voids or inclusions that would otherwise require sectioning of parts. “The cost of these devices is reaching the point of being feasible, and if they are as good as purported, we should be able to rely less on finicky CMM programs and the corresponding difficulty in holding parts in the required orientations without movement or flexing from the touch probe,” said Szyperski, who is considering acquiring a CT-scanner for Medbio. “Gage R&R should be easy or even unnecessary if the scanner proves reliably repeatable and accurate.”
Part cooling time is wasted time in the molding process; while the part cools, the molding machine remains idle, wasting production time. Canon recently launched its Shuttle Mold System, a new molding technology that increases production by utilizing part cooling time to mold another part. The system slides the mold out of the press so the cooling is done on the outside, allowing another part to be molded in another mold, effectively utilizing machine time. “In cases where there is enough available cooling time, the Shuttle Mold System can double the molding machine output,” said Daniel.
As MDMs focus more on quality management, efficiencies, and validations, they place increased emphasis on cleaning and zero residual contamination—both on the final part and the processing equipment.
Carclo Technical Plastics recently purchased an i3 MicroClean dry ice blasting machine from Cold Jet to clean tooling. This non-abrasive tool-cleaning method utilizes compressed air and fine ice particles to remove gas build-up produced during the molding of optically transparent diagnostic cuvettes. “We are currently able to perform in-press cleaning on both the fixed and moving half of mold tools, and the cleaning process can be performed while the tool is still hot, with no detriment to polished surfaces of the cavity or tool,” said Achinivu.
Since implementing the ice cleaner, Carclo Technical Plastics has reduced in-press tool cleaning time, on average, from four hours to 45 minutes per tool, while also reducing preventative maintenance time in the tool rooms. “Consequently, we can now produce more parts than we were previously capable of since tool cleaning time and frequency have been significantly reduced, therefore increasing the available production up time for the respective tools,” added Achinivu.
Molders sometimes develop their own in-house, proprietary molding methods, often in response to challenging customer designs. For example, Medbio developed oxygen-free molding of cyclic olefin copolymer, with O2 sensors tied into the press. If the level of oxygen exceeds 200 ppm at the feed-throat or in the mold cavity, the press stops. “This was requested to reduce the oxidation and discoloration of the resin at elevated temperatures,” said Szyperski. “We even helped develop a resin drier that maintained the same, oxygen-free environment.” Medbio has also developed a number of other tools using injection compression, which allow for thin-walled sections that would otherwise not be moldable. Other benefits of this process are uniform stress across the part and the removal of knit lines around small holes that otherwise caused leaks.
Moving Forward
More creative methods using injection molding will continue to evolve, creating more design freedom for engineers—”for example, taking additive-manufactured metal parts, machining in more complex geometries, and then overmolding these components into medical products,” said Caron.
Metal injection molding (MIM) can produce parts for a wide range of medical devices. MIM is considered to be a hybrid process, where a metal powder is mixed with a thermoplastic binder and injected into a mold. Lasers are being used to carve textures into the sides of molds. 3D-printed steel molds and injection sequencing with multi-shot are technologies in development. The Internet of Things will catalyze the integration of operating systems and technology to better manage and optimize manufacturing processes in real time, improving relevant, objective decision-making. Continued advancements will be made in materials, collaborative technology for manufacturing and assembly processes, smarter automation systems, vision systems, and artificial intelligence (AI).
“The potential of AI for process monitoring and control, as well as learning, with smart equipment making on-the-fly adjustments within a molding cycle toward ensuring acceptable product quality and improved efficiencies, is fascinating,” said Yurkewicz.
As technologies advance, OEMs will always want a solutions provider—not just a molding supplier.
“OEMs are asking us to become involved in projects much further upstream, often in the development stage or shortly after their design concepts are finalized,” said Scharber. “They are seeking front-end design support including design for manufacturability. Basically, customers are seeking confidence that their component, assembly, or finished device is optimized for molding and assembly. When this happens up front, it reduces project lead times, mitigates projects delays, and ensures sustainable quality over the program life.”
The allure of re-shoring has an increasing number of MDMs considering a return to the U.S., especially after experiencing turbulent supply chains, the result of tariff battles and the COVID-19 pandemic.
“With COVID-19, and the shortages we saw materialize literally overnight, a focus has returned to the real cost of doing business abroad,” said Tom Star, president of injection molding for Molded Devices, a Tempe, Ariz.-based provider of plastics processing, including injection molding, blow molding, and extrusion. “We have been contacted by virtually all of our large customers about the cost of reshoring items from China. There may be some type of intervention or mandate that ‘essential’ supplies such as PPE, pharmaceuticals, and infrastructure-supporting items be manufactured here in the U.S. When we get through this and the after-action reports pile up, I think people will realize that it is a good thing to control their supply chains in a sovereign matter.”
The problem, he noted, will be trying to keep costs down and maintain a reasonable margin. Star has spoken with many colleagues who are engaging in the same cost-evaluation exercises with their MDMs.
Companies that come back to the U.S. will face some major hurdles—"the cost of insurance, the cost of revalidation of products, the capital cost of factories and machinery, and the higher tax rates all create giant headwind for these companies to overcome,” said Star.
Subsidies will likely be needed to keep them afloat, at least initially. “We are spending a lot of time these days running these cost scenarios for customers,” said Star. “If we are to make this investment in America, we must find ways to subsidize the return of manufacturing—I hope that we can make it happen.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
