Mark Crawford , Contributing Writer02.03.16
Medical devices continue to get smaller and more complex. They are often made with newer advanced materials that present unique challenges, requiring in-depth know-how, such as highly precise process control. Machinists who want to be high on an OEM’s supplier list must be able to deliver very small features (<50 microns) with tolerances as tight as ±1.0 micron. These features must also be burr-free with no post-processing needs, which saves time and money and gets products into the marketplace faster. OEMs also expect their contract manufacturers to have the machining and laser-processing capabilities necessary to deliver accurate, dependable components and assemblies quickly, and still meet all validation and verification requirements—all while holding costs down.
“For the most part, from the customers’ perspective, it is up to the contract manufacturer to provide cost-effective, reliable solutions to meet their manufacturing requirements,” said Herb Bellucci, president and CEO of Pulse Systems, a Concord, Calif.-based contract manufacturer specializing in precision machining services for the medical device industry.
As their medical device designs become more intricate and the pace of business continues to increase, OEMs are less interested in doing their own processing work in-house. They want to focus on their own core strengths of engineering and design. Therefore, the trend is for OEMs to outsource their manufacturing and assembly needs. Contract manufacturers who can provide the machining, micro machining, and laser processing capabilities OEMs require will be in high demand.
“We see sustained double-digit growth in laser micro manufacturing as OEMs continue to globally outsource manufacturing and focus their attention on their core competencies,” indicated Kevin Hartke, chief technology officer for Resonetics, a Nashua, N.H.-based provider of laser micro manufacturing for the medical device and diagnostic industries.
Robert Roche, chief operating officer and director for Wytech Industries, a Rahway, N.J.-based manufacturer of precision wire and tubular components for the interventional, minimally invasive, and orthopedic markets, agreed.
“Given the continued trends of an aging population and the desire of medical device OEMs to outsource machined and laser-processed parts, contract manufacturers will continue to see the outsourcing market for these services grow anywhere from seven to nine percent compound annual growth rate over the next several years,” said Roche.
Contract manufacturers can get the machining and laser processing capabilities they need by integrating vertically to provide more services and be of more value in the supply chain. One way to add this capacity, or to simply control more market share, is to buy companies that offer these services. There is a current trend toward consolidation in this market, as mid-sized companies are being purchased by larger organizations.
“Many of these companies are endeavoring to broaden their service offerings through a combination of internal expansion, mergers, acquisitions, and strategic alliances,” said Bellucci. “Combined with continuing pressure from the medical device OEMs for year-over-year cost reductions, this industry expansion serves to cause a downward trend in pricing and profit margins. The bright spot in the industry is the continued development of innovative and cost-effective machining technologies.”
Innovation Leads the Way
Customers continue to push for technology advances—smaller parts, tighter tolerances, and better surface finishes and aesthetics. Contract manufacturers are under pressure to provide more value at lower cost, which means coming up with innovative ways to meet the product requirements and capabilities and still hold down costs. They can buy equipment, combine equipment to eliminate steps, or design their own in-house proprietary equipment. They also need to be responsive to evolving OEM demands and be able to look ahead to what their customers might need in the future.
Ongoing technological developments in the machining/laser processing world include smaller cutting tools for computer numerical control (CNC) machining (which enable the extension of existing CNC machine tools into micro machining), continual laser advancements, and hybrid machine tools, which combine lasers with conventional machining. Still, some companies—depending on client needs—come up with their own equipment designs.
Ultrashort Lasers
One of the biggest benefits of ultrashort femtosecond lasers is that the short pulses leave no thermal damage to the part. This is made possible by the small, sharply focused beam, which results in a high-quality cold ablation cutting process that delivers better quality and precision than the hotter, melt-ejection process of fiber lasers, which often require time-consuming secondary processing. The ultrashort laser beam can provide sharp edges and very fine feature sizes for a wide range of materials including plastic, metal, nitinol, and bioabsorbables.
Ultrashort femtosecond lasers provide complex geometric features in parts that conventional machining techniques cannot compete with from a capability, cycle time, and cost perspective. As a result, these lasers are being used more frequently in medical device manufacturing, especially for cardiac and peripheral stents and minimally invasive catheter components.
“Fiber laser technology continues to displace traditional lamp-pumped Nd:YAG tools and develop new applications in laser cutting and laser welding, with a wider range of wavelengths and improved beam quality,” said Glenn Ogura, senior vice president of market development for Resonetics.
Other applications include laser cutting of hypotubes, which is becoming an economic competitor to coiling for catheter applications. Laser ablation or laser machining continues to push down the feature scale fabricating production holes into the single micron range. Laser ablation and machining can also be used interchangeably, depending on the product, material, and depth of selective removal of material.
Perhaps the most promising use of ultrafast lasers will be on bioabsorbable materials—polymers that remain in the body for an extended period of time before breaking down and being absorbed. Cold-ablation laser processing of these materials results in very clean, microscale-machined features that are free of burrs and thermal defects—ideal for bioabsorbable stents and other polymer-based devices that are heat-sensitive.
Laser welding is also on the rise. In laser welding, a short pulse of light is aimed at a surface joint between components and melts both materials, forming a strong and clean bond between the two components when it cools. Laser welding minimizes thermal damage to the joined materials, making it an ideal process for bonding dissimilar metals together, such as platinum and stainless steel, heat-sensitive assemblies, and micro parts, resulting in neat, efficient welds.
“Laser welding continues to push down the feature scale and showing capability, with parts features down to 75 microns in production applications, especially for invasive catheter delivery components and micro cardiac implants,” said Hartke.
Validation for laser welding, however, can sometimes be a significant regulatory challenge. In general, specifications for depth of weld penetration are impractical to measure non-destructively and mechanical test limits (torque test, bend test, etc.) are usually destructive by design. For manufacturing components with significant cost and/or lead-time, the additional components required for process validation are often in direct conflict with components needed for customer internal qualification efforts.
“For a smoother transition into a validated process, consider functional test specifications that correlate to use/abuse tests, vendor alignment on test strategy and equipment, and early agreement on allotted time and parts for validation,” said Jeff Glass, senior project engineer for Cadence Inc., a Staunton, Va.-based high-tech contract manufacturer of medical, life science, and industrial specialty components. “We recommend against specifying the depth of weld penetration. Sectioning and other measurement methods are cumbersome and can be difficult to validate. But more importantly, correct weld depth alone does not necessarily indicate a well-formed weld joint where a functional test will show this clearly.”
Because fiber laser technology is becoming more popular in medical device manufacturing, machine tool suppliers have begun to “blend” innovations by integrating laser technology with either lathe or Swiss-turning know-how and principles, essentially creating “one-stop” machines.
“Although there are some limitations, clearly there are cost advantages with reduced set-up, cycle, handling, and queue times for the contract manufacturers, translating to lower prices for the OEMs,” said Roche.
Hybrid Equipment
Another way to reduce costs, especially with medical devices and products that are more complex to manufacture, is to not change the equipment, but find ways to save time by reducing steps. For example, advanced CNC equipment has the ability to produce a part’s final shape and contoured surface finish at nanometer resolution at that machine station. All the milling, turning, laser machining, and cladding is done on a single machine, eliminating the need to put the part through secondary operations such as grinding, deburring, and polishing. This saves time and money by decreasing cycle time and reducing the risk for errors or mistakes.
In the last few years, contract manufacturers and machine builders have been intent on integrating several manufacturing technologies, such as traditional metal cutting (milling, turning, grinding) with laser machining and additive manufacturing into a single machine tool platform. Lasers are being combined with other manufacturing technologies to increase functionality, including lasers combined with powder metal deposition and lasers combined with water jet cutting. This integration increases efficiency by eliminating the extra steps that would be needed to take that part or product to another machine, including refixturing. This reduces cycle time and produces more accurate medical parts in a single set-up. Lasers can be fully integrated with a six-axis precision CNC lathe, for example, with a fully enabled laser-cutting module—giving operators all the attributes of conventional Swiss turning and a laser cutter at their fingertips so they can choose the best technology for the part being machined, on a feature-by-feature basis.
A good example is the Tsugami S206-II, which combines six-axis Swiss machining with laser cutting on a single machine. To maximize productivity, the system includes an automatic bar feeder, which allows operators to run the machine unattended. “This system is especially beneficial for small part manufacturers,” said Michael Mugno, vice president at REM Sales LLC, a Hartford, Conn.-based provider of Tsugami CNC Swiss-type lathes and other machining equipment. “The laser isn’t just an attachment to the Tsugami—this is an entirely new system that completely integrates the laser with the machine tool. What makes this system so unique is that it can be used as a regular Swiss turning machine when that’s all that’s required, and used for laser cutting when that is preferred. It replaces two machines with one, eliminates the need for multiple part set-ups, and significantly reduces part production time.”
CNC machining equipment can be even faster and more efficient with robotic support, which can be easily connected over Ethernet, I/O Link, and FL Net. High-speed synchronization with the CNC allows faster part loading/unloading, flexible feeding, trays/pallets, or moving conveyors to take advantage of noncutting cycle time, thereby minimizing expensive fixtures. Integrated, highly sophisticated vision systems can be used to confirm barcodes for part identification to be sure the program is operating correctly. Also, while the machines are cutting, the robot can be utilized for other processes such as material removal, gaging, inspections, part cleaning, and assembly. The end result of robots integrated with machine tools is significant cost and time savings, greater throughput, and improved customer satisfaction.
Machining/laser-processing companies would like to see more combined features that would increase efficiency and reduce downtime. For example, Wytech’s Roche has asked machine tool suppliers to integrate more in-line inspection, metrology, and parts-cleaning technologies into their actual machine tools.
“Historically, each of these processes has been an independent, downstream process requiring extra personnel, programming, tooling, set-up, and changeover, which drives additional cost and lead time, which otherwise could be avoided,” he said.
Additive Manufacturing
Additive manufacturing (AM) technologies is becoming a dominant, disruptive force in the medical device industry. Once relegated to industrial design modeling and prototyping, AM is now beginning to move into the mainstream of production services. There is a steady supply of new materials for AM and 3-D printing. Other advances are tighter tolerances and the increased size range of parts (some of which, in limited cases, can be production ready—ideal for personalized devices and implants). Additive material processing continues to grow as a real alternative to heavy material removal by traditional machining. Depending on the material properties required, additive processed components can sometimes be used to replace hard-to-machine parts (material or shape), or even multiple components, in a more complicated device.
“There are additive materials available now that are true drop-in replacements of several traditional medical-grade plastics and stainless steels,” said Glass. “The processes applying them are mature and are even being combined with machining and lasers for some truly remarkable manufacturing capabilities.”
Unfortunately, there are still significant limitations that prevent broader usage of AM. For example, it is hard to beat the cost and rate of an injection-molded part, especially for companies that already own the die base. Some product designers are unfamiliar with how far these materials have come from the days of brittle plastics and rough surface finishes. Others are wary of the slow acceptance of new materials by regulatory committees. Vendors are worried about the real dangers of working with metallic powders while those that accept the risk might not be able to justify the high cost of processing equipment. Despite all of this, said Glass, “the technology is continuing to evolve so quickly that you almost need to check every month to see what new thing you can make.”
Moving Forward
Medical device companies are turning to their manufacturing partners to provide innovative solutions to design/manufacturing challenges. Suppliers with deep manufacturing know-how, combined with medical device experience, can provide much needed guidance to product developers. This trend is likely to accelerate as the gap between the product designers and the manufacturing technologists grows. OEMs will continue to outsource specialty manufacturing services, while staying closely involved with their proprietary product designs.
Nanotechnology has led to innovative laser and machining technologies that now produce smaller and tighter tolerance parts than ever before. Advanced, non-ablative techniques singulate devices, especially glass wafers, at much faster cutting rates. This is achieved by creating micro pressure gradients or fissures that initiate self-induced, controlled cracking. Additive manufacturing capabilities will continue to become more refined, especially at the micro scale.
Machining suppliers are committed to working with materials that are newer to the medical device industry, or new to the material additive/removal method being used. More expensive/exotic materials are typically used to create a specific physicial characteristic, such as ultra-high wear or high flexibility.
“The wide range of laser tools now available makes all materials capable of being processed,” added Ogura. “We have successfully processed everything from diamond to bone. The key is matching the right laser—pulse duration, wavelength, fluence—with the application. Excimer lasers are excellent for processing plastic components that require a large array of features created in parallel, such as embolic filters.”
To stay competitive, machining/laser processors must be ready to modify standard equipment as needed, to create new configurations or combined technologies that deliver what their clients expect. “Unless they are interested in commodity manufacturing, companies that want to be successful with these capabilities won’t just have off-the-shelf equipment and processes,” said Glass.
Most of all, the best gains, and the most successful projects, will result from early collaboration between the OEM and the machining provider—not only to bring in the wise counsel of the experienced vendor to help design and manufacture the best possible product, but also to tell the OEM what can’t be achieved. For example, sometimes OEM product developers have such faith in technology and their contract manufacturers that they think everything is possible; they design in a certain direction because they think the process is viable, when in fact it is not.
“3-D CAD [computer aided design] modeling has created a virtual product development environment that may exceed the ability of the machining industry to bring that product to life,” said Bellucci. “Just because it can be modeled doesn’t mean that it can be produced in the real world.”
Early supplier engagement, therefore, is critical. It typically involves a very important design for manufacturability discussion—either during the new product R&D phase or dual sourcing an existing part to a new supplier.
“For example, a design engineer may be thinking about machining a part in the product development phase, when it may lend itself more to being laser processed,” said Roche. “This engagement invariably provides the customer with valuable insight and knowledge on a process yielding a feature, tolerance, or material that the company previously thought was unachievable because it was either unaware or didn’t understand. When customers engage us late in the game, many of them remark, ‘I wish we did this months ago.’”
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. Contact him at mark.crawford@charter.net.
“For the most part, from the customers’ perspective, it is up to the contract manufacturer to provide cost-effective, reliable solutions to meet their manufacturing requirements,” said Herb Bellucci, president and CEO of Pulse Systems, a Concord, Calif.-based contract manufacturer specializing in precision machining services for the medical device industry.
As their medical device designs become more intricate and the pace of business continues to increase, OEMs are less interested in doing their own processing work in-house. They want to focus on their own core strengths of engineering and design. Therefore, the trend is for OEMs to outsource their manufacturing and assembly needs. Contract manufacturers who can provide the machining, micro machining, and laser processing capabilities OEMs require will be in high demand.
“We see sustained double-digit growth in laser micro manufacturing as OEMs continue to globally outsource manufacturing and focus their attention on their core competencies,” indicated Kevin Hartke, chief technology officer for Resonetics, a Nashua, N.H.-based provider of laser micro manufacturing for the medical device and diagnostic industries.
Robert Roche, chief operating officer and director for Wytech Industries, a Rahway, N.J.-based manufacturer of precision wire and tubular components for the interventional, minimally invasive, and orthopedic markets, agreed.
“Given the continued trends of an aging population and the desire of medical device OEMs to outsource machined and laser-processed parts, contract manufacturers will continue to see the outsourcing market for these services grow anywhere from seven to nine percent compound annual growth rate over the next several years,” said Roche.
Contract manufacturers can get the machining and laser processing capabilities they need by integrating vertically to provide more services and be of more value in the supply chain. One way to add this capacity, or to simply control more market share, is to buy companies that offer these services. There is a current trend toward consolidation in this market, as mid-sized companies are being purchased by larger organizations.
“Many of these companies are endeavoring to broaden their service offerings through a combination of internal expansion, mergers, acquisitions, and strategic alliances,” said Bellucci. “Combined with continuing pressure from the medical device OEMs for year-over-year cost reductions, this industry expansion serves to cause a downward trend in pricing and profit margins. The bright spot in the industry is the continued development of innovative and cost-effective machining technologies.”
Innovation Leads the Way
Customers continue to push for technology advances—smaller parts, tighter tolerances, and better surface finishes and aesthetics. Contract manufacturers are under pressure to provide more value at lower cost, which means coming up with innovative ways to meet the product requirements and capabilities and still hold down costs. They can buy equipment, combine equipment to eliminate steps, or design their own in-house proprietary equipment. They also need to be responsive to evolving OEM demands and be able to look ahead to what their customers might need in the future.
Ongoing technological developments in the machining/laser processing world include smaller cutting tools for computer numerical control (CNC) machining (which enable the extension of existing CNC machine tools into micro machining), continual laser advancements, and hybrid machine tools, which combine lasers with conventional machining. Still, some companies—depending on client needs—come up with their own equipment designs.
Ultrashort Lasers
One of the biggest benefits of ultrashort femtosecond lasers is that the short pulses leave no thermal damage to the part. This is made possible by the small, sharply focused beam, which results in a high-quality cold ablation cutting process that delivers better quality and precision than the hotter, melt-ejection process of fiber lasers, which often require time-consuming secondary processing. The ultrashort laser beam can provide sharp edges and very fine feature sizes for a wide range of materials including plastic, metal, nitinol, and bioabsorbables.
Ultrashort femtosecond lasers provide complex geometric features in parts that conventional machining techniques cannot compete with from a capability, cycle time, and cost perspective. As a result, these lasers are being used more frequently in medical device manufacturing, especially for cardiac and peripheral stents and minimally invasive catheter components.
“Fiber laser technology continues to displace traditional lamp-pumped Nd:YAG tools and develop new applications in laser cutting and laser welding, with a wider range of wavelengths and improved beam quality,” said Glenn Ogura, senior vice president of market development for Resonetics.
Other applications include laser cutting of hypotubes, which is becoming an economic competitor to coiling for catheter applications. Laser ablation or laser machining continues to push down the feature scale fabricating production holes into the single micron range. Laser ablation and machining can also be used interchangeably, depending on the product, material, and depth of selective removal of material.
Perhaps the most promising use of ultrafast lasers will be on bioabsorbable materials—polymers that remain in the body for an extended period of time before breaking down and being absorbed. Cold-ablation laser processing of these materials results in very clean, microscale-machined features that are free of burrs and thermal defects—ideal for bioabsorbable stents and other polymer-based devices that are heat-sensitive.
Laser welding is also on the rise. In laser welding, a short pulse of light is aimed at a surface joint between components and melts both materials, forming a strong and clean bond between the two components when it cools. Laser welding minimizes thermal damage to the joined materials, making it an ideal process for bonding dissimilar metals together, such as platinum and stainless steel, heat-sensitive assemblies, and micro parts, resulting in neat, efficient welds.
“Laser welding continues to push down the feature scale and showing capability, with parts features down to 75 microns in production applications, especially for invasive catheter delivery components and micro cardiac implants,” said Hartke.
Validation for laser welding, however, can sometimes be a significant regulatory challenge. In general, specifications for depth of weld penetration are impractical to measure non-destructively and mechanical test limits (torque test, bend test, etc.) are usually destructive by design. For manufacturing components with significant cost and/or lead-time, the additional components required for process validation are often in direct conflict with components needed for customer internal qualification efforts.
“For a smoother transition into a validated process, consider functional test specifications that correlate to use/abuse tests, vendor alignment on test strategy and equipment, and early agreement on allotted time and parts for validation,” said Jeff Glass, senior project engineer for Cadence Inc., a Staunton, Va.-based high-tech contract manufacturer of medical, life science, and industrial specialty components. “We recommend against specifying the depth of weld penetration. Sectioning and other measurement methods are cumbersome and can be difficult to validate. But more importantly, correct weld depth alone does not necessarily indicate a well-formed weld joint where a functional test will show this clearly.”
Because fiber laser technology is becoming more popular in medical device manufacturing, machine tool suppliers have begun to “blend” innovations by integrating laser technology with either lathe or Swiss-turning know-how and principles, essentially creating “one-stop” machines.
“Although there are some limitations, clearly there are cost advantages with reduced set-up, cycle, handling, and queue times for the contract manufacturers, translating to lower prices for the OEMs,” said Roche.
Hybrid Equipment
Another way to reduce costs, especially with medical devices and products that are more complex to manufacture, is to not change the equipment, but find ways to save time by reducing steps. For example, advanced CNC equipment has the ability to produce a part’s final shape and contoured surface finish at nanometer resolution at that machine station. All the milling, turning, laser machining, and cladding is done on a single machine, eliminating the need to put the part through secondary operations such as grinding, deburring, and polishing. This saves time and money by decreasing cycle time and reducing the risk for errors or mistakes.
In the last few years, contract manufacturers and machine builders have been intent on integrating several manufacturing technologies, such as traditional metal cutting (milling, turning, grinding) with laser machining and additive manufacturing into a single machine tool platform. Lasers are being combined with other manufacturing technologies to increase functionality, including lasers combined with powder metal deposition and lasers combined with water jet cutting. This integration increases efficiency by eliminating the extra steps that would be needed to take that part or product to another machine, including refixturing. This reduces cycle time and produces more accurate medical parts in a single set-up. Lasers can be fully integrated with a six-axis precision CNC lathe, for example, with a fully enabled laser-cutting module—giving operators all the attributes of conventional Swiss turning and a laser cutter at their fingertips so they can choose the best technology for the part being machined, on a feature-by-feature basis.
A good example is the Tsugami S206-II, which combines six-axis Swiss machining with laser cutting on a single machine. To maximize productivity, the system includes an automatic bar feeder, which allows operators to run the machine unattended. “This system is especially beneficial for small part manufacturers,” said Michael Mugno, vice president at REM Sales LLC, a Hartford, Conn.-based provider of Tsugami CNC Swiss-type lathes and other machining equipment. “The laser isn’t just an attachment to the Tsugami—this is an entirely new system that completely integrates the laser with the machine tool. What makes this system so unique is that it can be used as a regular Swiss turning machine when that’s all that’s required, and used for laser cutting when that is preferred. It replaces two machines with one, eliminates the need for multiple part set-ups, and significantly reduces part production time.”
CNC machining equipment can be even faster and more efficient with robotic support, which can be easily connected over Ethernet, I/O Link, and FL Net. High-speed synchronization with the CNC allows faster part loading/unloading, flexible feeding, trays/pallets, or moving conveyors to take advantage of noncutting cycle time, thereby minimizing expensive fixtures. Integrated, highly sophisticated vision systems can be used to confirm barcodes for part identification to be sure the program is operating correctly. Also, while the machines are cutting, the robot can be utilized for other processes such as material removal, gaging, inspections, part cleaning, and assembly. The end result of robots integrated with machine tools is significant cost and time savings, greater throughput, and improved customer satisfaction.
Machining/laser-processing companies would like to see more combined features that would increase efficiency and reduce downtime. For example, Wytech’s Roche has asked machine tool suppliers to integrate more in-line inspection, metrology, and parts-cleaning technologies into their actual machine tools.
“Historically, each of these processes has been an independent, downstream process requiring extra personnel, programming, tooling, set-up, and changeover, which drives additional cost and lead time, which otherwise could be avoided,” he said.
Additive Manufacturing
Additive manufacturing (AM) technologies is becoming a dominant, disruptive force in the medical device industry. Once relegated to industrial design modeling and prototyping, AM is now beginning to move into the mainstream of production services. There is a steady supply of new materials for AM and 3-D printing. Other advances are tighter tolerances and the increased size range of parts (some of which, in limited cases, can be production ready—ideal for personalized devices and implants). Additive material processing continues to grow as a real alternative to heavy material removal by traditional machining. Depending on the material properties required, additive processed components can sometimes be used to replace hard-to-machine parts (material or shape), or even multiple components, in a more complicated device.
“There are additive materials available now that are true drop-in replacements of several traditional medical-grade plastics and stainless steels,” said Glass. “The processes applying them are mature and are even being combined with machining and lasers for some truly remarkable manufacturing capabilities.”
Unfortunately, there are still significant limitations that prevent broader usage of AM. For example, it is hard to beat the cost and rate of an injection-molded part, especially for companies that already own the die base. Some product designers are unfamiliar with how far these materials have come from the days of brittle plastics and rough surface finishes. Others are wary of the slow acceptance of new materials by regulatory committees. Vendors are worried about the real dangers of working with metallic powders while those that accept the risk might not be able to justify the high cost of processing equipment. Despite all of this, said Glass, “the technology is continuing to evolve so quickly that you almost need to check every month to see what new thing you can make.”
Moving Forward
Medical device companies are turning to their manufacturing partners to provide innovative solutions to design/manufacturing challenges. Suppliers with deep manufacturing know-how, combined with medical device experience, can provide much needed guidance to product developers. This trend is likely to accelerate as the gap between the product designers and the manufacturing technologists grows. OEMs will continue to outsource specialty manufacturing services, while staying closely involved with their proprietary product designs.
Nanotechnology has led to innovative laser and machining technologies that now produce smaller and tighter tolerance parts than ever before. Advanced, non-ablative techniques singulate devices, especially glass wafers, at much faster cutting rates. This is achieved by creating micro pressure gradients or fissures that initiate self-induced, controlled cracking. Additive manufacturing capabilities will continue to become more refined, especially at the micro scale.
Machining suppliers are committed to working with materials that are newer to the medical device industry, or new to the material additive/removal method being used. More expensive/exotic materials are typically used to create a specific physicial characteristic, such as ultra-high wear or high flexibility.
“The wide range of laser tools now available makes all materials capable of being processed,” added Ogura. “We have successfully processed everything from diamond to bone. The key is matching the right laser—pulse duration, wavelength, fluence—with the application. Excimer lasers are excellent for processing plastic components that require a large array of features created in parallel, such as embolic filters.”
To stay competitive, machining/laser processors must be ready to modify standard equipment as needed, to create new configurations or combined technologies that deliver what their clients expect. “Unless they are interested in commodity manufacturing, companies that want to be successful with these capabilities won’t just have off-the-shelf equipment and processes,” said Glass.
Most of all, the best gains, and the most successful projects, will result from early collaboration between the OEM and the machining provider—not only to bring in the wise counsel of the experienced vendor to help design and manufacture the best possible product, but also to tell the OEM what can’t be achieved. For example, sometimes OEM product developers have such faith in technology and their contract manufacturers that they think everything is possible; they design in a certain direction because they think the process is viable, when in fact it is not.
“3-D CAD [computer aided design] modeling has created a virtual product development environment that may exceed the ability of the machining industry to bring that product to life,” said Bellucci. “Just because it can be modeled doesn’t mean that it can be produced in the real world.”
Early supplier engagement, therefore, is critical. It typically involves a very important design for manufacturability discussion—either during the new product R&D phase or dual sourcing an existing part to a new supplier.
“For example, a design engineer may be thinking about machining a part in the product development phase, when it may lend itself more to being laser processed,” said Roche. “This engagement invariably provides the customer with valuable insight and knowledge on a process yielding a feature, tolerance, or material that the company previously thought was unachievable because it was either unaware or didn’t understand. When customers engage us late in the game, many of them remark, ‘I wish we did this months ago.’”
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. Contact him at mark.crawford@charter.net.