Erik Swain02.04.13
The world of medical device machining and laser processing is rapidly changing. Luckily for device OEMs, there are numerous outsourcing partners that have been adapting every step of the way.
There are a number of ways in which this change is happening. Obviously, there are changes in technology, which continues to improve in many ways each year. But there also are changes in how outsourcing partners are structuring their business models and offerings in order to better meet clients’ needs. And they have made changes in the ways in which they are interacting with their customers, in order to serve them faster and more accurately.
Changes in Technology
The capabilities of firms that provide machining and laser processing services are rapidly evolving, often in response to demands from medical device customers brought on by new product designs.
“We see trends on the medical device product side to devices that are smaller and require more robust controls of the manufacturing process,” said Kiernan Shannon, manufacturing manager at Cirtec Medical Systems, a full-service contract manufacturing and engineering firm based in East Longmeadow, Mass. “In response to this, we see the laser processing industry responding with lasers that can provide smaller spot sizes and lower energies for processing smaller parts and thinner materials. One of the primary trends we see is the move away from rod-based lasers to fiber-based lasers, in which the lasing medium is actually a fiber rather than a rod. This creates a smaller laser spot and allows a near perfect laser mode, or more efficient and predictable transmission of laser energy. The move towards fiber lasers provides tremendous capability in terms of processing small parts, but it also means that there is a greater need for good fit up between the components to be processed; this in turn requires tighter tolerances on machined parts.”
Richard W. Hurst, business development director for XL Precision Technologies, a manufacturer of precision microcomponents whose U.S. operations are in Kutztown, Pa., agreed.
“As new technology and manufacturing applications are developed, it naturally pushes device designers to exploit and push the boundaries of available solutions,” said Hurst. “The primary, and continuous, trend is still towards further miniaturization. This leads to more demanding requirements on machining tolerances. We are regularly supplying parts, fitting inside a 0.04-inch cube, with dimensions held to plus or minus 0.0002 inches.”
Another example of a new technology being put to good use is ultra-fast pulse lasers.
“Clearly ultra-fast pulsed laser solutions are growing for both medical and commercial applications,” said Dan Kapp, vice president of sales development for Laserage Technology Corp., a laser company based in Waukegan, Ill. “Ultra-fast pulsed lasers offer cold ablation material removal technology. Most standard laser processing is done with thermo processing, utilizing the laser to create a liquid and either ejecting the liquid from the substrate creating a cut or controlling the liquid flow/cooling to create a weld.”
Glenn Ogura, executive vice president for business development for Resonetics LLC, a Nashua, N.H.-based polymer laser micromachining company, sees the same sort of progression.
“From a laser perspective, traditionally we used CO2, excimer, and fiber lasers. But now the trend is to use ultrasoft lasers, femtosecond lasers (10-15 pulse) and picosecond lasers (10-12 pulse). Those are up to six orders of magnitude swifter than previous technologies,” he said. “For metals, the holy grail is to eliminate slag or recast. The longer you cut a metal surface, the more slag you have on a cut, and then you have to use a secondary process like grinding or electropolishing. These can be costly, and you use up more materials that way. So, if you can use lasers to cut swiftly without debris or recasting, that can make things much more efficient. For some materials like nitinol, secondary processes are still required, but it is better. Our perspective, on the polymer side, is that there are a lot of polymers used in medical device manufacturing, such as polylactic acid, ethylene tetrafluoroethylene, and polytetrafluoroethylene that have low melting temperatures. If we use lasers to cut them, they cut them well, but we have to go very slow so that they do not totally melt them. So when we look at using lasers on polymers with low melting temperatures, we have to figure out how to cut them faster and be more cost effective. “
“We are working a lot on 3-D devices, not just tubes or flat sheets,” noted Ogura. “We developed a nine-axis technology that can manipulate a part on nine axes of motion, to resemble true 3-D devices. There is also a lot of activity in surface texturing. We use lasers to modulate a surface to improve bonding or create more surface area.”
As these advanced technologies have matured, the cost of employing them has come down, which is good news for industry.
“Over the years, prototyping technology has gotten relatively less expensive,” said Kenneth Santiago, senior mechanical design engineer for Pro-Dex Inc., a contract development and manufacturing firm based in Irvine, Calif. “Printers that can make three dimensional solid plastic objects from a digital model (3-D printers) and machines that employ a high-powered fiber-optic laser to create a nearly complete, complex metal part in hours without any tooling (direct metal laser sintering, DMLS) are increasingly making their way into many medical device design and manufacturing companies. Three-dimensional printers and DMLS machines take prototyping to another level. Most prototypes are first created by the design engineer, sent to the CAD model, and then the machinists will have to figure out tooling from looking at the model on the computer screen. Whereas 3-D printers and DMLS machines allow the machinist to hold and feel the device so they will have a better understanding of what the device needs with regard to tooling, fixturing, etc. It helps them resolve potential problems early on that can delay the project and add cost.”
Suppliers also are adapting their capabilities in response to new and different materials being incorporated into medical device designs.
“Tungsten has increasing application in medical devices, due primarily to radio-shielding properties and to electrical wear resistance capability,” said Hurst. “It is a difficult material to machine but recent developments in electrical discharge machining (EDM) sink technology, combined with conventional EDM wiring and laser techniques, have provided medical device manufacturers with new opportunities to utilize this material. We have been at the forefront of this new machining technology.”
However, medical device OEMs should not simply take claims of suppliers at face value. As rapidly as the technology is evolving, it may still have limitations for certain applications. Therefore, OEMs need to review capability claims carefully, and ask many questions to potential suppliers.
“There has been lots of buzz over athermal or cold laser processing and its lesser heat-affected zone and improved dross conditions. But it is beyond me to tell if this is simply hype or reality,” said Patrick Pickerell, president of Peridot Corp., a Pleasanton, Calif.-based precision manufacturer. “Customers are repeatedly asking for excimer laser processing capability, but high machine and maintenance costs are a significant barrier to entry. Laser manufacturers are continuing to tout fiber lasers, disc lasers, infrared, green, etc., but do not seem to understand that job shops do not buy lasers, job shops buy workstations. Customer expectations are driven to a certain extent by hype from various laser manufacturers. Despite significant demand, cost-effective 3-D laser machining is beginning to see the light of day but is far from mature. In the burgeoning world of nanotechnology and microelectromechanical systems, feature size and complexity of detail continue to tax the limits of laser processing.”
Changes in Structure
Also evolving are the ways in which machining and laser processing firms have structured themselves. Some of them have branched out in recent years to offer additional services that complement their core offerings, often in response to interest from clients.
“In addition to lasers, we are using a broader range of machinery that complements the laser machinery that we use. In the past, we only had lasers, and we might not be able to help out a customer with a job that required more than that,” said Mike Adelstein, president and CEO of Potomac Photonics, a provider of laser and other services based in Lanham, Md. “Now, we have integrated lasers with technologies such as 3-D printing, micro CNC (computer numerical control), and hot embossing. They easily complement laser machining, and we can offer a much broader range of solutions. For example, we had a medical device customer with a small fluidic device. Some parts of it were very small and needed to be made with a laser. Other parts were larger, and laser was not the best way to make them. We were able to 3-D print the device, and then we took that part and used the laser to put smaller features on it. It is a matter of combining technologies.”
This trend also has led firms to hire people with different skill sets and focus their efforts in new directions.
“The cost pressures on device company outsourcing are definitely going to increase,” said Hurst, noting that some of this will be due to the 2.3 percent medical device excise tax contained in the Patient Protection and Affordable Care Act. “High technology companies like XL-PT need to find ways to give buyers the most economical solution for component supply. What we have done is develop our engineers into technology leaders, enabling them to produce the most effective fixtures and tools, and combine the best manufacturing processes with new ideas. Our growth and success has also been based on a unique business model—we have confidence in our ability to provide customers with the best answer and therefore never require an NRE (non-recurring engineering) fee. We will finance the process development and the component design support. As the device component design requirements become more challenging for outsourcing providers, there will be an increasing need for combined manufacturing technology solutions to provide economically viable supply to customers. We are already providing components and subassemblies utilizing a mix of conventional machining, EDM and laser processes to give their customers the best solution.”
Another way that firms have been adapting to stay on top of changes in the market is to focus on adapting their technologies to new sectors.
“There is an upswing in the in-vitro diagnostics (IVD) market, where there has been a big effort put into drilling holes smaller than a micron. This technology is adaptable to molecular diagnostics technologies like DNA sequencing,” said Ogura. “DNA fragments are so small, a matter of nanometers. That requires us to perform machining functions at the cellular level. We are putting a lot of effort into figuring out how to make those scalable. The rapid growth of the IVD market cannot be underemphasized. We are seeing big changes there. Technology from expensive large hospital equipment is now being transferred to smaller platforms at smaller hospitals and point-of-care devices. You can now perform cancer or flu diagnostics with small, handheld instruments. That development will drive the next growth phase.”
Changes in Customer Relations
Also contributing to how machining and laser processing suppliers have adapted their businesses are advances in communications. This has changed how they interact with customers and accelerated the timelines for projects.
“Medical device customers have a lot more information out there, especially via the Internet. They are coming to us much more informed and are looking to do things much faster,” said Adelstein. “In the past, they would call, and you would go back and forth with them about a design or about what would be the best manufacturing technology to use. Now, everything is software-based. They get a design to you electronically and want parts quickly. With 3-D printing, we can do that in 24 hours. They do not want to wait weeks for a part. They want you to get it done right away and then do iterations back and forth with them. So now, a lot of our business transactions are done right through our website. And we are focusing on building other Web sites, such as microfablab.com, where a customer can go on, quickly upload drawings, and get a part in 24-48 hours, especially if it is at the initial prototype stage where tolerances are not as important.”
Shannon agreed, noting that these interactions have resulted in improvements in the quality of products.
“Our customers tend to come to us now more educated on laser processing and the role of lasers in medical manufacturing,” he told Medical Product Outsourcing. “This is likely due to the wealth of information available on the internet as well as the growing presence of lasers in a wide variety of medical device manufacturing facilities. Overall, we have found this trend to be very favorable; it allows us to engage with customers in more productive discussions on design for manufacturability for laser processes than was previously possible.”
Another advantage is that not only can a project proceed more quickly, it can proceed at a lower cost, too.
“The ability to prototype in-house makes it faster, easier, and less costly for medical device designers and engineers to communicate their design intent to the customer,” said Santiago. “The ability to see what the design specifications produced and feel an early-stage device in their hands gives both the customer and designer a more accurate evaluation about whether or not the design is on track. And if changes need to be made, modifications can be incorporated and tested for fit, form, and function in hours instead of weeks. This allows for more rigorous testing of prototypes while decreasing the development time for new products.”
But this does not mean that OEMs and their partners can expend less effort. It is more important than ever that feedback be incorporated throughout the entire design and production process.
“A prototype machine (3-D printer or DMLS) may greatly reduce the number of iterations needed to meet customer requirements, but this does not mean that fewer prototypes should be made,” noted Santiago. “A common misjudgment is that it is sufficient to just print off only one 3-D model of the design to show to the customer, incorporate the revisions in the CAD drawing and then call it ‘good.’
Instead of relying on one prototype to serve as the model for all design refinements, an important step is to print off a physical prototype after each design iteration for the customer to review and approve. Another oversight made by some design engineers is that they do not show the prototype to the machinists or solicit their feedback. DMLS and 3-D printing have the ability to create almost any feature in a design, but it might not be realistic in terms of manufacturing—or in the manufacturing environment. To resolve this issue, it is critical for the designer to collaborate with the machinist. By working together, they can critique the device to determine its manufacturability and prevent redesigns later in the process that add cost and time to the project.”
A Decade of Evolution for Machining Firms
Ten years is a very long time in the business world, but even more so in the medical device industry, where innovation occurs at a rapid pace and outsourcing partners must adapt quickly to it.
In honor of MPO’s 10th anniversary, we asked some of the leading suppliers of machining and laser processing services about how their business has changed over the past 10 years. In many cases, the firms in the present day bear very little resemblance to what they were in 2003. This should not come as a shock, since the best outsourcing partners always are in tune with what their clients need, and in the medical device world, those needs are constantly changing.
The changes these firms cited mainly can be divided into three categories. First, some suppliers decided to focus more on the medical device industry, which has a more predictable revenue stream than most other sectors. In some cases, they were not serving the medical device industry at all in 2003, while in other cases, they were serving a variety of industries and streamlined themselves to focus more on medical devices.
“Ten years ago, we were not even in the medical space,” said Resonetics’ Ogura. “We were in the semiconductor and microelectronic spectrum. After the telecom bubble burst, we got tired of cyclic years, and switched our whole strategy to life sciences. We were 0 percent life-sciences, now we are 80 percent. That was definitely the right decision. No doubt about that.”
It is a similar story for XL Precision Technologies.
“XL-PT has changed from a general industry EDM subcontract services company into a component supplier dedicated to the medical device sector,” said Hurst. “We have invested $1.8 million over just the last three years in laser and EDM technology, and people, to ensure we have the most advanced and appropriate solutions for the successful device manufacturers. 98 percent of current production is now high-volume medical components. Our capability to provide high-precision microcomponents, to almost any design, is combined with a tremendous flexibility which customers truly appreciate.”
Second, a number of suppliers have evolved from having one area of expertise to offering a wider menu of complementary products and services. One example is Peridot.
“Peridot has evolved significantly from our humble beginnings as a metal stamping and wireforming specialist in our early days of the ’90s to a highly sophisticated CNC machining, laser processing and EDM provider,” said Pickerell. “With the addition of clean room assembly/packaging and contract manufacturing services in the past few years, Peridot continues to expand our capabilities as a one-stop shop for medical and surgical device companies.”
Cirtec has had a similar experience.
“The majority of our business was as a laser services provider —a customer would provide us with parts or a drawing, and we would weld an assembly for them,” said Shannon. “Today, our business has expanded to include a much broader range of manufacturing capabilities as well as a strong engineering team that can provide full product development services. Increasingly, our customers are looking for full-service outsourcing—design, development and manufacturing—and we have expanded our skill set to meet that need.”
Pro-Dex fits both categories, having expanded its reach and its capabilities.
“Pro-Dex has moved from dental into medical and we have increased our regulatory expertise to be in line with the FDA (U.S. Food and Drug Administration) to ensure that we are providing safe and highly effective solutions to our OEM partners,” said Santiago. “Many manufacturers have had a hard time keeping up with the regulatory demands, but we have made it our priority to stay ahead of the game by implementing exacting standards and processes that ensure compliance.”
Third, some firms have radically changed the way they do business over the past 10 years. This has to do with both the advancement in efficiency of certain processes, and the way in which suppliers interact with their customers.
“Ten years ago, a lot of our business was through calls and faxes. Now we get a significant amount of business activity via our website, email, and other electronic means,” said Potomac Photonics’ Adelstein. “We are doing things a lot faster and less expensively than we were 10 years ago because the technology has advanced so far ahead.”
The Road Ahead
Given the trends in medical device design and medical device OEM expectations, demand for machining and laser processing services will continue to increase, and more new applications for them will be tested.
“Laser processing is continuing to be adapted into more manufacturing arenas because of the smaller physical device size push and the less heat for better outcome results,” said Kapp. “Examples include very small hole drilling for controlled flow and filtering applications, and micro welding of implant and instrument assemblies.”
That means that outsourcing partners will need to continue to adapt their offerings to the new demands. Evidence suggests this will not be an issue.
“We are seeing laser processing expanding beyond the typical uses of cutting, ablation, and metal welding into new applications, particularly with ceramics and plastics,” said Shannon. “One of the great things about working with start-up companies is that it requires us to always be pushing the limits on what we can do with a laser.”
Erik Swain is a freelance writer based outside Philadelphia, Pa., in Barrington, N.J. He has covered the medical device industry for 14 years.
There are a number of ways in which this change is happening. Obviously, there are changes in technology, which continues to improve in many ways each year. But there also are changes in how outsourcing partners are structuring their business models and offerings in order to better meet clients’ needs. And they have made changes in the ways in which they are interacting with their customers, in order to serve them faster and more accurately.
Changes in Technology
The capabilities of firms that provide machining and laser processing services are rapidly evolving, often in response to demands from medical device customers brought on by new product designs.
“We see trends on the medical device product side to devices that are smaller and require more robust controls of the manufacturing process,” said Kiernan Shannon, manufacturing manager at Cirtec Medical Systems, a full-service contract manufacturing and engineering firm based in East Longmeadow, Mass. “In response to this, we see the laser processing industry responding with lasers that can provide smaller spot sizes and lower energies for processing smaller parts and thinner materials. One of the primary trends we see is the move away from rod-based lasers to fiber-based lasers, in which the lasing medium is actually a fiber rather than a rod. This creates a smaller laser spot and allows a near perfect laser mode, or more efficient and predictable transmission of laser energy. The move towards fiber lasers provides tremendous capability in terms of processing small parts, but it also means that there is a greater need for good fit up between the components to be processed; this in turn requires tighter tolerances on machined parts.”
Richard W. Hurst, business development director for XL Precision Technologies, a manufacturer of precision microcomponents whose U.S. operations are in Kutztown, Pa., agreed.
“As new technology and manufacturing applications are developed, it naturally pushes device designers to exploit and push the boundaries of available solutions,” said Hurst. “The primary, and continuous, trend is still towards further miniaturization. This leads to more demanding requirements on machining tolerances. We are regularly supplying parts, fitting inside a 0.04-inch cube, with dimensions held to plus or minus 0.0002 inches.”
Another example of a new technology being put to good use is ultra-fast pulse lasers.
“Clearly ultra-fast pulsed laser solutions are growing for both medical and commercial applications,” said Dan Kapp, vice president of sales development for Laserage Technology Corp., a laser company based in Waukegan, Ill. “Ultra-fast pulsed lasers offer cold ablation material removal technology. Most standard laser processing is done with thermo processing, utilizing the laser to create a liquid and either ejecting the liquid from the substrate creating a cut or controlling the liquid flow/cooling to create a weld.”
Glenn Ogura, executive vice president for business development for Resonetics LLC, a Nashua, N.H.-based polymer laser micromachining company, sees the same sort of progression.
“From a laser perspective, traditionally we used CO2, excimer, and fiber lasers. But now the trend is to use ultrasoft lasers, femtosecond lasers (10-15 pulse) and picosecond lasers (10-12 pulse). Those are up to six orders of magnitude swifter than previous technologies,” he said. “For metals, the holy grail is to eliminate slag or recast. The longer you cut a metal surface, the more slag you have on a cut, and then you have to use a secondary process like grinding or electropolishing. These can be costly, and you use up more materials that way. So, if you can use lasers to cut swiftly without debris or recasting, that can make things much more efficient. For some materials like nitinol, secondary processes are still required, but it is better. Our perspective, on the polymer side, is that there are a lot of polymers used in medical device manufacturing, such as polylactic acid, ethylene tetrafluoroethylene, and polytetrafluoroethylene that have low melting temperatures. If we use lasers to cut them, they cut them well, but we have to go very slow so that they do not totally melt them. So when we look at using lasers on polymers with low melting temperatures, we have to figure out how to cut them faster and be more cost effective. “
“We are working a lot on 3-D devices, not just tubes or flat sheets,” noted Ogura. “We developed a nine-axis technology that can manipulate a part on nine axes of motion, to resemble true 3-D devices. There is also a lot of activity in surface texturing. We use lasers to modulate a surface to improve bonding or create more surface area.”
As these advanced technologies have matured, the cost of employing them has come down, which is good news for industry.
“Over the years, prototyping technology has gotten relatively less expensive,” said Kenneth Santiago, senior mechanical design engineer for Pro-Dex Inc., a contract development and manufacturing firm based in Irvine, Calif. “Printers that can make three dimensional solid plastic objects from a digital model (3-D printers) and machines that employ a high-powered fiber-optic laser to create a nearly complete, complex metal part in hours without any tooling (direct metal laser sintering, DMLS) are increasingly making their way into many medical device design and manufacturing companies. Three-dimensional printers and DMLS machines take prototyping to another level. Most prototypes are first created by the design engineer, sent to the CAD model, and then the machinists will have to figure out tooling from looking at the model on the computer screen. Whereas 3-D printers and DMLS machines allow the machinist to hold and feel the device so they will have a better understanding of what the device needs with regard to tooling, fixturing, etc. It helps them resolve potential problems early on that can delay the project and add cost.”
Suppliers also are adapting their capabilities in response to new and different materials being incorporated into medical device designs.
“Tungsten has increasing application in medical devices, due primarily to radio-shielding properties and to electrical wear resistance capability,” said Hurst. “It is a difficult material to machine but recent developments in electrical discharge machining (EDM) sink technology, combined with conventional EDM wiring and laser techniques, have provided medical device manufacturers with new opportunities to utilize this material. We have been at the forefront of this new machining technology.”
However, medical device OEMs should not simply take claims of suppliers at face value. As rapidly as the technology is evolving, it may still have limitations for certain applications. Therefore, OEMs need to review capability claims carefully, and ask many questions to potential suppliers.
“There has been lots of buzz over athermal or cold laser processing and its lesser heat-affected zone and improved dross conditions. But it is beyond me to tell if this is simply hype or reality,” said Patrick Pickerell, president of Peridot Corp., a Pleasanton, Calif.-based precision manufacturer. “Customers are repeatedly asking for excimer laser processing capability, but high machine and maintenance costs are a significant barrier to entry. Laser manufacturers are continuing to tout fiber lasers, disc lasers, infrared, green, etc., but do not seem to understand that job shops do not buy lasers, job shops buy workstations. Customer expectations are driven to a certain extent by hype from various laser manufacturers. Despite significant demand, cost-effective 3-D laser machining is beginning to see the light of day but is far from mature. In the burgeoning world of nanotechnology and microelectromechanical systems, feature size and complexity of detail continue to tax the limits of laser processing.”
Changes in Structure
Also evolving are the ways in which machining and laser processing firms have structured themselves. Some of them have branched out in recent years to offer additional services that complement their core offerings, often in response to interest from clients.
“In addition to lasers, we are using a broader range of machinery that complements the laser machinery that we use. In the past, we only had lasers, and we might not be able to help out a customer with a job that required more than that,” said Mike Adelstein, president and CEO of Potomac Photonics, a provider of laser and other services based in Lanham, Md. “Now, we have integrated lasers with technologies such as 3-D printing, micro CNC (computer numerical control), and hot embossing. They easily complement laser machining, and we can offer a much broader range of solutions. For example, we had a medical device customer with a small fluidic device. Some parts of it were very small and needed to be made with a laser. Other parts were larger, and laser was not the best way to make them. We were able to 3-D print the device, and then we took that part and used the laser to put smaller features on it. It is a matter of combining technologies.”
This trend also has led firms to hire people with different skill sets and focus their efforts in new directions.
“The cost pressures on device company outsourcing are definitely going to increase,” said Hurst, noting that some of this will be due to the 2.3 percent medical device excise tax contained in the Patient Protection and Affordable Care Act. “High technology companies like XL-PT need to find ways to give buyers the most economical solution for component supply. What we have done is develop our engineers into technology leaders, enabling them to produce the most effective fixtures and tools, and combine the best manufacturing processes with new ideas. Our growth and success has also been based on a unique business model—we have confidence in our ability to provide customers with the best answer and therefore never require an NRE (non-recurring engineering) fee. We will finance the process development and the component design support. As the device component design requirements become more challenging for outsourcing providers, there will be an increasing need for combined manufacturing technology solutions to provide economically viable supply to customers. We are already providing components and subassemblies utilizing a mix of conventional machining, EDM and laser processes to give their customers the best solution.”
Another way that firms have been adapting to stay on top of changes in the market is to focus on adapting their technologies to new sectors.
“There is an upswing in the in-vitro diagnostics (IVD) market, where there has been a big effort put into drilling holes smaller than a micron. This technology is adaptable to molecular diagnostics technologies like DNA sequencing,” said Ogura. “DNA fragments are so small, a matter of nanometers. That requires us to perform machining functions at the cellular level. We are putting a lot of effort into figuring out how to make those scalable. The rapid growth of the IVD market cannot be underemphasized. We are seeing big changes there. Technology from expensive large hospital equipment is now being transferred to smaller platforms at smaller hospitals and point-of-care devices. You can now perform cancer or flu diagnostics with small, handheld instruments. That development will drive the next growth phase.”
Changes in Customer Relations
Also contributing to how machining and laser processing suppliers have adapted their businesses are advances in communications. This has changed how they interact with customers and accelerated the timelines for projects.
“Medical device customers have a lot more information out there, especially via the Internet. They are coming to us much more informed and are looking to do things much faster,” said Adelstein. “In the past, they would call, and you would go back and forth with them about a design or about what would be the best manufacturing technology to use. Now, everything is software-based. They get a design to you electronically and want parts quickly. With 3-D printing, we can do that in 24 hours. They do not want to wait weeks for a part. They want you to get it done right away and then do iterations back and forth with them. So now, a lot of our business transactions are done right through our website. And we are focusing on building other Web sites, such as microfablab.com, where a customer can go on, quickly upload drawings, and get a part in 24-48 hours, especially if it is at the initial prototype stage where tolerances are not as important.”
Shannon agreed, noting that these interactions have resulted in improvements in the quality of products.
“Our customers tend to come to us now more educated on laser processing and the role of lasers in medical manufacturing,” he told Medical Product Outsourcing. “This is likely due to the wealth of information available on the internet as well as the growing presence of lasers in a wide variety of medical device manufacturing facilities. Overall, we have found this trend to be very favorable; it allows us to engage with customers in more productive discussions on design for manufacturability for laser processes than was previously possible.”
Another advantage is that not only can a project proceed more quickly, it can proceed at a lower cost, too.
“The ability to prototype in-house makes it faster, easier, and less costly for medical device designers and engineers to communicate their design intent to the customer,” said Santiago. “The ability to see what the design specifications produced and feel an early-stage device in their hands gives both the customer and designer a more accurate evaluation about whether or not the design is on track. And if changes need to be made, modifications can be incorporated and tested for fit, form, and function in hours instead of weeks. This allows for more rigorous testing of prototypes while decreasing the development time for new products.”
But this does not mean that OEMs and their partners can expend less effort. It is more important than ever that feedback be incorporated throughout the entire design and production process.
“A prototype machine (3-D printer or DMLS) may greatly reduce the number of iterations needed to meet customer requirements, but this does not mean that fewer prototypes should be made,” noted Santiago. “A common misjudgment is that it is sufficient to just print off only one 3-D model of the design to show to the customer, incorporate the revisions in the CAD drawing and then call it ‘good.’
Instead of relying on one prototype to serve as the model for all design refinements, an important step is to print off a physical prototype after each design iteration for the customer to review and approve. Another oversight made by some design engineers is that they do not show the prototype to the machinists or solicit their feedback. DMLS and 3-D printing have the ability to create almost any feature in a design, but it might not be realistic in terms of manufacturing—or in the manufacturing environment. To resolve this issue, it is critical for the designer to collaborate with the machinist. By working together, they can critique the device to determine its manufacturability and prevent redesigns later in the process that add cost and time to the project.”
A Decade of Evolution for Machining Firms
Ten years is a very long time in the business world, but even more so in the medical device industry, where innovation occurs at a rapid pace and outsourcing partners must adapt quickly to it.
In honor of MPO’s 10th anniversary, we asked some of the leading suppliers of machining and laser processing services about how their business has changed over the past 10 years. In many cases, the firms in the present day bear very little resemblance to what they were in 2003. This should not come as a shock, since the best outsourcing partners always are in tune with what their clients need, and in the medical device world, those needs are constantly changing.
The changes these firms cited mainly can be divided into three categories. First, some suppliers decided to focus more on the medical device industry, which has a more predictable revenue stream than most other sectors. In some cases, they were not serving the medical device industry at all in 2003, while in other cases, they were serving a variety of industries and streamlined themselves to focus more on medical devices.
“Ten years ago, we were not even in the medical space,” said Resonetics’ Ogura. “We were in the semiconductor and microelectronic spectrum. After the telecom bubble burst, we got tired of cyclic years, and switched our whole strategy to life sciences. We were 0 percent life-sciences, now we are 80 percent. That was definitely the right decision. No doubt about that.”
It is a similar story for XL Precision Technologies.
“XL-PT has changed from a general industry EDM subcontract services company into a component supplier dedicated to the medical device sector,” said Hurst. “We have invested $1.8 million over just the last three years in laser and EDM technology, and people, to ensure we have the most advanced and appropriate solutions for the successful device manufacturers. 98 percent of current production is now high-volume medical components. Our capability to provide high-precision microcomponents, to almost any design, is combined with a tremendous flexibility which customers truly appreciate.”
Second, a number of suppliers have evolved from having one area of expertise to offering a wider menu of complementary products and services. One example is Peridot.
“Peridot has evolved significantly from our humble beginnings as a metal stamping and wireforming specialist in our early days of the ’90s to a highly sophisticated CNC machining, laser processing and EDM provider,” said Pickerell. “With the addition of clean room assembly/packaging and contract manufacturing services in the past few years, Peridot continues to expand our capabilities as a one-stop shop for medical and surgical device companies.”
Cirtec has had a similar experience.
“The majority of our business was as a laser services provider —a customer would provide us with parts or a drawing, and we would weld an assembly for them,” said Shannon. “Today, our business has expanded to include a much broader range of manufacturing capabilities as well as a strong engineering team that can provide full product development services. Increasingly, our customers are looking for full-service outsourcing—design, development and manufacturing—and we have expanded our skill set to meet that need.”
Pro-Dex fits both categories, having expanded its reach and its capabilities.
“Pro-Dex has moved from dental into medical and we have increased our regulatory expertise to be in line with the FDA (U.S. Food and Drug Administration) to ensure that we are providing safe and highly effective solutions to our OEM partners,” said Santiago. “Many manufacturers have had a hard time keeping up with the regulatory demands, but we have made it our priority to stay ahead of the game by implementing exacting standards and processes that ensure compliance.”
Third, some firms have radically changed the way they do business over the past 10 years. This has to do with both the advancement in efficiency of certain processes, and the way in which suppliers interact with their customers.
“Ten years ago, a lot of our business was through calls and faxes. Now we get a significant amount of business activity via our website, email, and other electronic means,” said Potomac Photonics’ Adelstein. “We are doing things a lot faster and less expensively than we were 10 years ago because the technology has advanced so far ahead.”
The Road Ahead
Given the trends in medical device design and medical device OEM expectations, demand for machining and laser processing services will continue to increase, and more new applications for them will be tested.
“Laser processing is continuing to be adapted into more manufacturing arenas because of the smaller physical device size push and the less heat for better outcome results,” said Kapp. “Examples include very small hole drilling for controlled flow and filtering applications, and micro welding of implant and instrument assemblies.”
That means that outsourcing partners will need to continue to adapt their offerings to the new demands. Evidence suggests this will not be an issue.
“We are seeing laser processing expanding beyond the typical uses of cutting, ablation, and metal welding into new applications, particularly with ceramics and plastics,” said Shannon. “One of the great things about working with start-up companies is that it requires us to always be pushing the limits on what we can do with a laser.”
Erik Swain is a freelance writer based outside Philadelphia, Pa., in Barrington, N.J. He has covered the medical device industry for 14 years.