Sam Brusco, Associate Editor02.07.22
Machining and laser processing continue to be stalwart manufacturing methods employed for medical device manufacturing. Manufacturing firms that specialize in precision machining and laser processing services continue to thrive as component and device designs shrink and become more complex to accommodate healthcare trends like robotic and minimally invasive surgeries. As such, machinists need the technology, skill set, and education to forge the miniscule features these products need.
A significant amount of machining operations feature computer numerical control (CNC) and laser equipment depending on part specifications. CNC machines excel for material removal in bulk, and lasers are more effective to profile and drill fine features. CNC machine makers specialize their products even further with better raw material processing control, IoT and cloud connectivity, and advanced software. Cutting-edge femtosecond lasers exercise astounding speed, precision, and ability to cut small features, without running the risk of heat-affected zones (HAZ).
Medical device makers partnering with firms specializing in these areas generally seek out higher standards of quality, lower costs, and quicker speed to market. They also often desire a partner to have the skills necessary to handle complex components, some with multiple and/or delicate features and extremely tight tolerances. In order to examine the inner workings of this industry and gather more insight on the subject, MPO spoke to the following medical device and component machining and laser processing experts over the past few weeks:
Dan Buttermore, director of engineering at Viant, a Foxborough, Mass.-based full-service medical device manufacturer.
Nicholas Coburn, advanced development engineer at medical component and product manufacturer Paragon Medical ’s Southington, Conn., location, which specializes in medical project management and precision metal component manufacturing.
Joseph DeAngelo, director of new product development at Weiss-Aug Co. Inc.’s Surgical Product Division, a Fairfield, N.J.-based surgical instrument and surgical instrument assembly developer and manufacturer.
Tim Hoklas, senior director of technical solutions at Viant.
Frank Page, vice president of technical solutions at Viant.
Dharm Patel, business unit manager—CNC/manufacturing engineering leader at Wytech Industries, a Rahway, N.J.-based developer and manufacturer of wire and metal tube-based products for the medical device industry.
Greg Paulsen, director of application engineering at Xometry, a Derwood, Md.-based marketplace for on-demand manufacturing.
John Shegda, CEO of KMM Group, a Hatboro, Pa.-based manufacturer of medical device, aerospace, defense, and other advanced components.
Sam Brusco: What recent investments in machining/supporting equipment have been most valuable?
Nicholas Coburn: Laser welding and laser cutting equipment have been our most valuable recent technology investment. Being able to produce components, then join them together using welding technology simplifies the procurement process for our customers and allows us to take on more SKUs toward the final product device. Laser cutting technology puts us on the cutting edge of component feature design. This allows customer design engineers to reach outside normal manufacturing constraints to produce a better end product.
Joseph DeAngelo: We’ve invested in multiple laser machines and staffing to address prototype to production. Easily managing larger quantities and needs efficiently and effectively with maximum equipment utilization. We also invested in a femtosecond laser machining center, enabling feature size generations to the order of microns while allowing advanced engineering materials processing such as ceramics, glass, and even multi-material substrates.
Tim Hoklas: We invest continually in equipment and capabilities—from new technology to regular upgrades—to better serve our customers. Lights-out machining, which can run unattended both on and off shift and often combines multiple operations in one, is a major value driver. It optimizes labor, which is essential in today’s environment, while reducing variability and allowing greater process control to better deliver on the ever-critical quality, delivery, and cost parameters.
Laser Swiss is another example of combining processes for better reliability as well as cost and labor savings. Laser cutting technology provides strong value, as it is more accurate and operates at faster speeds. We have seen great value with Swiss lathes with low-frequency vibration technology. They eliminate chipwrap, which causes defects. They can also run unattended longer to better optimize labor and deliver increased tool life.
Consistently investing in process upgrades or expanding automation pays dividends in supporting reliable quality and delivery at speed. For example, we see investments in process control software, vision, and other systems delivering enhanced repeatability and reproducibility at greater speed and with less operator variability. Another example is expanding automation of secondary surface conditioning processes such as grit blasting, bead blasting, and mass finishing.
Dharm Patel: Wytech continuously invests in technology to support our customers as they push the boundaries of miniaturization. Wytech ensures that our complex manufacturing equipment includes remote monitoring systems that allow us to manage equipment on a 24-hour basis in our vertically integrated facility. We have invested in technology with control gaging that has feedback loops into the CNC controller for automatic tooling and machining offsets. Deploying and leveraging these systems allows our technical team to be aware of important tolerance and dimensional metrics during manufacturing. We combine these tools with service agreements with our customers, which has allowed us to create long-term visibility.
Greg Paulsen: Xometry offers a digital marketplace that connects medical device manufacturers with the best suppliers to make their innovations real. With medical devices, the machining equipment and tooling should hit multi-axis requirements, often with complex surfacing, while hitting a smooth surface finish. Most manufacturers use high-speed machining and live-tooling lathe services capable of materials like stainless steel, or engineered plastics like PEEK. We also implement non-marring inspection tools to maintain the part surface, such as soft tips on our profilometer to prevent scratching. During an inspection, we use a variety of measuring tools like CMM and gauges. With medical hardware, we also inspect for F.O.D. (foreign object debris), such as chips or internal burrs using borescopes.
John Shegda: Continued investments in guidewire grinding and automation through robotics were the most important in 2021. The interventional device market continues to grow, and issues with many of the larger contract manufacturers that specialize in guidewire/corewire grinding have created opportunity to help some OEMs.
Automation continues to be a focus for progressive companies to move forward. Labor shortages and pricing pressures in medical device markets continue to push to drive as much cost out as possible. Couple this with re-shoring initiatives, which impact off-shore production to some degree, and you have some factors that can impact the markets and advance the progressive companies for some time to come.
Brusco: Which services do you offer for medical device customers beyond machining? Why is it important to offer these services?
Coburn: Being able to join components by welding is a great business. We can weld components and manufacture the components themselves under the same roof, which is a major benefit for our customers. Paragon Medical - Southington offers a wide variety of component manufacturing processes including but not limited to; spring coiling, wireforming, fourslide stamping and forming, progressive die stamping, CNC machining, tubular manufacturing sharps and needles, heat treating, passivation, degreasing, cleanroom packaging, laser cutting and welding, program management, engineering, DFM review, automation, and rapid prototyping.
The full Paragon Medical organization offers even broader capabilities and services, with locations across North America, Europe, and Asia. Our team can provide everything from initial concept development and design for manufacturability support through full-scale manufacturing and demand planning. Our additional services and concept-to-supply business model enables our customers to tailor their relationship with us. They can work with us in just one phase of their project, or use us as a comprehensive partner that helps them consolidate suppliers and advance their outcomes.
DeAngelo: Weiss-Aug is not a “me too” supplier. The engineering talent, problem solving, and depth of abilities sets us apart. For our partners, Weiss-Aug embraces new technologies, partnerships, and workspace additions. The entire team is focused to further support the growth of technology and partnerships. This is done through a deliberate engineering focus on new problems working as a partner with new product development, innovation, and design for manufacturability.
Frank Page: We support customers across the full lifecycle from design and development (including DFM) to manufacturing a broad range of metal and plastic components to complex finished devices and packaging. A key service that underlies these capabilities is our ViaLaunch process for new product introductions and manufacturing transfers powered by experienced program managers to ensure successful product launches.
Customers are focused on optimizing cost and speed to market while ensuring consistent quality and service, and simplifying the supply chain is critical. The benefits are myriad—from local for local, to fewer points of contact, to having a full range of experts available to deploy for any problem.
Patel: Our broad portfolio of metal base capabilities sets us apart—beyond our various machining and laser processing capabilities, we also offer expedited straightened and cut medical wire and thin wall hypotubes from our FASTLANE online store, to complex machined, laser-cut, and precision ground needle pointed components and specialty core wires used in advanced guidewire systems. Our wide breadth of wire and metal tube capabilities in-house allow us to be a fast and flexible manufacturing partner that can scale. Wytech produces over 66 million parts annually.
Paulsen: Beyond making the shape, we must qualify a medical part through appropriate inspection and documentation. This is important because the end-use of the product can, and often does, affect patient health and outcomes. If there are any concerns, the ability to look back and examine the manufacturing record is an important part of discovery. Xometry’s platform makes it possible to request certifications for materials, conformance, and even hardware. Our digital tools build an auditable timeline from quoting to fulfillment, ensuring valuable information is recorded between production orders.
Shegda: Primarily for us, it is working with a client’s engineering group to ensure they understand the limiting factors in a design. Design for manufacturing (DFM) is becoming more and more important as supply chain issues continue, and cost-downs become more and more prevalent. Getting the design to a well thought out and highly manufacturable state near the outset of the project can pay big dividends to the OEM and the suppliers down the road. We continue to offer high-end consultation in DFM and rapid prototyping capabilities to help facilitate this important aspect of the client’s design. We are also strengthening our additive manufacturing partnerships, as this is a technology and capability 100 percent inside our strategic growth plan. Additive and subtractive processes in our market segments are converging at high speed. We will be leveraging both in the future.
Brusco: What do medical device OEMs look for in a manufacturing partner specializing in machining and/or laser processing services?
Dan Buttermore: At its core, all customers seek quality parts quickly, at the right price, with the necessary capacity, and often with the ability to scale. Like many successful endeavors, this requires a combination of capabilities and the expertise to power it. One of the most important elements is design for manufacturing support. Starting right can reap major benefits and eliminate costs and delays later in the process when they are especially painful. We helped a customer eliminate unneeded surface geometry and offered design options that allowed for machining with a more efficient form tool with the end result of double-digit cost savings, while also improving surface finish.
OEMs also look for a partner that can help them in more than one area to eliminate complexity. For instance, in the orthopedic market it’s important to offer solutions across implants, instruments, and cases/trays. Other elements for a successful machining or laser processing partner include statistical process capability, robust qualification and validation, and a range of technologies.
Coburn: In my experience, OEMs look for collaborative and innovative experts. Laser processing services are exponentially evolving and OEMs need support from manufacturing experts to design and generate a robust, cost-effective, manufacturable end product.
DeAngelo: To support the medical device OEMs Weiss-Aug is vertically integrated, addressing R&D, materials science, automation, tooling, machining, stamping, insert/injection molding, joining/secondary operations, assembly, and options for low-cost production opportunities.
Paulsen: Medical device development follows many industries in requiring a mix of commodity components and patient-specific customization. For machinists or craftsmen, this could mean the flexibility in their business to create and qualify a mix of needs. Xometry’s marketplace adds value as a single vendor with access to thousands of capabilities and suppliers.
Patel: OEMs typically look for a manufacturing partner with the technical knowledge and expertise to solve complex issues during development and a partner they can scale with as the product’s lifecycle evolves. OEMs want to work with a manufacturing partner that can retain this talent to avoid project timeline impacts on new product development projects and have the history that can carry over into the entire product lifecycle.
Shegda: Being a great vendor is all about instilling confidence while mitigating risk. It’s like working with your computer network—it is really working well when you don’t notice it. Vendors are the same way. The parts need to be right, on-time, packaged properly with paperwork dialed in, and proactive in communication. OEMs want to “not notice” their vendors until they need to lean on them to get them out of a jam.
Brusco: What will be expected of machinists/laser machinists/craftsmen in the coming years to ensure robust medical device part production?
Buttermore: As in other areas, the field is changing and this will likely accelerate. Today, many machine tool manufacturers build in what were once core components of apprentice programs. We believe machinists/craftsmen will need to combine a mastery of the basics in machining and toolmaking with the ability to use in parallel higher-end technology such as automation and programming.
Coburn: Like other manufacturing tradesmen, laser machinists/craftsmen need to be highly skilled, knowledgeable problem solvers that can support the development and process of medical device part production. We see that need today and can expect it to only intensify in the future. Medical device design and manufacturing is a demanding field that will require laser craftsmen to work closely with design engineers, process experts, and many other teams to create high-quality parts and finished devices that help advance healthcare.
Laser process knowledge and troubleshooting are vital for the continued use of this technology. We need to train our customers on the potential failure modes for this manufacturing process so the correct development and qualification is being performed upfront to create a robust process for future production.
DeAngelo: A can-do approach to problem solving with applied science, technology, engineering, and mathematics (STEM). Weiss-Aug is fully engaged with local schools and universities to share current needs for training and preparation of our future workforce. Internships and formal training exposure to relevant processes are shared and identified for the grooming of current and future candidates.
Patel: Equipment is becoming more sophisticated and product lines are becoming more complex. They will be expected to become more familiar with different software (programming) packages that will help them make adjustments and fully unlock the equipment’s potential. The use of CAD software will align with using CAM software packages like MasterCAM, FeatureCAM, etc. These software packages allow machinists to program machines in a fraction of the time and program much more complex geometries. There is also a push across the industry for cell-based manufacturing, and with that comes the need to understand and program different types of equipment. The ability to use and leverage various software packages and different equipment types is important today and will become mandatory in the near future.
Shegda: Many things, but the biggest will be adaptability. Changes in the manufacturing world are going to come hot and heavy over the next 10 years. As component manufacturers, we need to anticipate trends and technologies before they are mainstream. This will mean our employees must always be thinking about how to meet the challenges that we see, and understand they must continue to stretch themselves to meet personal goals. There is a huge opportunity for growth for the company and for employees going forward, and it will take a mindset that is open and accepting of change to participate.
Brusco: Is there anything else you’d like to say regarding machining for medical device manufacturing or any important topics in the machining/laser processing sector that you feel MPO readers should know?
Coburn: It is crucial for OEMs to get laser manufacturing companies involved early on in the part development process. Confirming manufacturability with the experts before finalizing design equals speed to market.
Page: Never forget that whether it’s machining, injection molding, or some other process, it is for a medical device that will touch someone’s life. It’s critical to have the robust systems and processes, but equally as important is a culture where quality is paramount. The fact that the components and finished devices we manufacture are used to save or enhance patients’ lives every day influences everything we do.
Paulsen: Cutting or turning parts is one step in manufacturing medical devices, but qualification and documentation are typical bottlenecks. Quality assurance of medical devices requires shop certifications like ISO 9001 or ISO 13485, material traceability, measurement and sampling, and the ability to access records as requested. Xometry’s online instant quoting allows for this level of configuration and connects the right supplier to meet these quality needs without restrictions like minimum quantities or capacity constraints.
Shegda: We are living history right now; the pandemic has changed the way the world works to a degree. We have an opportunity as individual companies and as an industry to think about how we approach the new paradigm and set the tone in a positive way for those that follow. We can try to squeeze the heck out of the advances that have been presented, or we can use the technologies to facilitate a forward-thinking and very human way of working together that will lead to advancement of the industry and society. It is a matter of being able to look beyond a grab for short-term profits and focus on long-term profitability, viability, and social impact.
A significant amount of machining operations feature computer numerical control (CNC) and laser equipment depending on part specifications. CNC machines excel for material removal in bulk, and lasers are more effective to profile and drill fine features. CNC machine makers specialize their products even further with better raw material processing control, IoT and cloud connectivity, and advanced software. Cutting-edge femtosecond lasers exercise astounding speed, precision, and ability to cut small features, without running the risk of heat-affected zones (HAZ).
Medical device makers partnering with firms specializing in these areas generally seek out higher standards of quality, lower costs, and quicker speed to market. They also often desire a partner to have the skills necessary to handle complex components, some with multiple and/or delicate features and extremely tight tolerances. In order to examine the inner workings of this industry and gather more insight on the subject, MPO spoke to the following medical device and component machining and laser processing experts over the past few weeks:
Dan Buttermore, director of engineering at Viant, a Foxborough, Mass.-based full-service medical device manufacturer.
Nicholas Coburn, advanced development engineer at medical component and product manufacturer Paragon Medical ’s Southington, Conn., location, which specializes in medical project management and precision metal component manufacturing.
Joseph DeAngelo, director of new product development at Weiss-Aug Co. Inc.’s Surgical Product Division, a Fairfield, N.J.-based surgical instrument and surgical instrument assembly developer and manufacturer.
Tim Hoklas, senior director of technical solutions at Viant.
Frank Page, vice president of technical solutions at Viant.
Dharm Patel, business unit manager—CNC/manufacturing engineering leader at Wytech Industries, a Rahway, N.J.-based developer and manufacturer of wire and metal tube-based products for the medical device industry.
Greg Paulsen, director of application engineering at Xometry, a Derwood, Md.-based marketplace for on-demand manufacturing.
John Shegda, CEO of KMM Group, a Hatboro, Pa.-based manufacturer of medical device, aerospace, defense, and other advanced components.
Sam Brusco: What recent investments in machining/supporting equipment have been most valuable?
Nicholas Coburn: Laser welding and laser cutting equipment have been our most valuable recent technology investment. Being able to produce components, then join them together using welding technology simplifies the procurement process for our customers and allows us to take on more SKUs toward the final product device. Laser cutting technology puts us on the cutting edge of component feature design. This allows customer design engineers to reach outside normal manufacturing constraints to produce a better end product.
Joseph DeAngelo: We’ve invested in multiple laser machines and staffing to address prototype to production. Easily managing larger quantities and needs efficiently and effectively with maximum equipment utilization. We also invested in a femtosecond laser machining center, enabling feature size generations to the order of microns while allowing advanced engineering materials processing such as ceramics, glass, and even multi-material substrates.
Tim Hoklas: We invest continually in equipment and capabilities—from new technology to regular upgrades—to better serve our customers. Lights-out machining, which can run unattended both on and off shift and often combines multiple operations in one, is a major value driver. It optimizes labor, which is essential in today’s environment, while reducing variability and allowing greater process control to better deliver on the ever-critical quality, delivery, and cost parameters.
Laser Swiss is another example of combining processes for better reliability as well as cost and labor savings. Laser cutting technology provides strong value, as it is more accurate and operates at faster speeds. We have seen great value with Swiss lathes with low-frequency vibration technology. They eliminate chipwrap, which causes defects. They can also run unattended longer to better optimize labor and deliver increased tool life.
Consistently investing in process upgrades or expanding automation pays dividends in supporting reliable quality and delivery at speed. For example, we see investments in process control software, vision, and other systems delivering enhanced repeatability and reproducibility at greater speed and with less operator variability. Another example is expanding automation of secondary surface conditioning processes such as grit blasting, bead blasting, and mass finishing.
Dharm Patel: Wytech continuously invests in technology to support our customers as they push the boundaries of miniaturization. Wytech ensures that our complex manufacturing equipment includes remote monitoring systems that allow us to manage equipment on a 24-hour basis in our vertically integrated facility. We have invested in technology with control gaging that has feedback loops into the CNC controller for automatic tooling and machining offsets. Deploying and leveraging these systems allows our technical team to be aware of important tolerance and dimensional metrics during manufacturing. We combine these tools with service agreements with our customers, which has allowed us to create long-term visibility.
Greg Paulsen: Xometry offers a digital marketplace that connects medical device manufacturers with the best suppliers to make their innovations real. With medical devices, the machining equipment and tooling should hit multi-axis requirements, often with complex surfacing, while hitting a smooth surface finish. Most manufacturers use high-speed machining and live-tooling lathe services capable of materials like stainless steel, or engineered plastics like PEEK. We also implement non-marring inspection tools to maintain the part surface, such as soft tips on our profilometer to prevent scratching. During an inspection, we use a variety of measuring tools like CMM and gauges. With medical hardware, we also inspect for F.O.D. (foreign object debris), such as chips or internal burrs using borescopes.
John Shegda: Continued investments in guidewire grinding and automation through robotics were the most important in 2021. The interventional device market continues to grow, and issues with many of the larger contract manufacturers that specialize in guidewire/corewire grinding have created opportunity to help some OEMs.
Automation continues to be a focus for progressive companies to move forward. Labor shortages and pricing pressures in medical device markets continue to push to drive as much cost out as possible. Couple this with re-shoring initiatives, which impact off-shore production to some degree, and you have some factors that can impact the markets and advance the progressive companies for some time to come.
Brusco: Which services do you offer for medical device customers beyond machining? Why is it important to offer these services?
Coburn: Being able to join components by welding is a great business. We can weld components and manufacture the components themselves under the same roof, which is a major benefit for our customers. Paragon Medical - Southington offers a wide variety of component manufacturing processes including but not limited to; spring coiling, wireforming, fourslide stamping and forming, progressive die stamping, CNC machining, tubular manufacturing sharps and needles, heat treating, passivation, degreasing, cleanroom packaging, laser cutting and welding, program management, engineering, DFM review, automation, and rapid prototyping.
The full Paragon Medical organization offers even broader capabilities and services, with locations across North America, Europe, and Asia. Our team can provide everything from initial concept development and design for manufacturability support through full-scale manufacturing and demand planning. Our additional services and concept-to-supply business model enables our customers to tailor their relationship with us. They can work with us in just one phase of their project, or use us as a comprehensive partner that helps them consolidate suppliers and advance their outcomes.
DeAngelo: Weiss-Aug is not a “me too” supplier. The engineering talent, problem solving, and depth of abilities sets us apart. For our partners, Weiss-Aug embraces new technologies, partnerships, and workspace additions. The entire team is focused to further support the growth of technology and partnerships. This is done through a deliberate engineering focus on new problems working as a partner with new product development, innovation, and design for manufacturability.
Frank Page: We support customers across the full lifecycle from design and development (including DFM) to manufacturing a broad range of metal and plastic components to complex finished devices and packaging. A key service that underlies these capabilities is our ViaLaunch process for new product introductions and manufacturing transfers powered by experienced program managers to ensure successful product launches.
Customers are focused on optimizing cost and speed to market while ensuring consistent quality and service, and simplifying the supply chain is critical. The benefits are myriad—from local for local, to fewer points of contact, to having a full range of experts available to deploy for any problem.
Patel: Our broad portfolio of metal base capabilities sets us apart—beyond our various machining and laser processing capabilities, we also offer expedited straightened and cut medical wire and thin wall hypotubes from our FASTLANE online store, to complex machined, laser-cut, and precision ground needle pointed components and specialty core wires used in advanced guidewire systems. Our wide breadth of wire and metal tube capabilities in-house allow us to be a fast and flexible manufacturing partner that can scale. Wytech produces over 66 million parts annually.
Paulsen: Beyond making the shape, we must qualify a medical part through appropriate inspection and documentation. This is important because the end-use of the product can, and often does, affect patient health and outcomes. If there are any concerns, the ability to look back and examine the manufacturing record is an important part of discovery. Xometry’s platform makes it possible to request certifications for materials, conformance, and even hardware. Our digital tools build an auditable timeline from quoting to fulfillment, ensuring valuable information is recorded between production orders.
Shegda: Primarily for us, it is working with a client’s engineering group to ensure they understand the limiting factors in a design. Design for manufacturing (DFM) is becoming more and more important as supply chain issues continue, and cost-downs become more and more prevalent. Getting the design to a well thought out and highly manufacturable state near the outset of the project can pay big dividends to the OEM and the suppliers down the road. We continue to offer high-end consultation in DFM and rapid prototyping capabilities to help facilitate this important aspect of the client’s design. We are also strengthening our additive manufacturing partnerships, as this is a technology and capability 100 percent inside our strategic growth plan. Additive and subtractive processes in our market segments are converging at high speed. We will be leveraging both in the future.
Brusco: What do medical device OEMs look for in a manufacturing partner specializing in machining and/or laser processing services?
Dan Buttermore: At its core, all customers seek quality parts quickly, at the right price, with the necessary capacity, and often with the ability to scale. Like many successful endeavors, this requires a combination of capabilities and the expertise to power it. One of the most important elements is design for manufacturing support. Starting right can reap major benefits and eliminate costs and delays later in the process when they are especially painful. We helped a customer eliminate unneeded surface geometry and offered design options that allowed for machining with a more efficient form tool with the end result of double-digit cost savings, while also improving surface finish.
OEMs also look for a partner that can help them in more than one area to eliminate complexity. For instance, in the orthopedic market it’s important to offer solutions across implants, instruments, and cases/trays. Other elements for a successful machining or laser processing partner include statistical process capability, robust qualification and validation, and a range of technologies.
Coburn: In my experience, OEMs look for collaborative and innovative experts. Laser processing services are exponentially evolving and OEMs need support from manufacturing experts to design and generate a robust, cost-effective, manufacturable end product.
DeAngelo: To support the medical device OEMs Weiss-Aug is vertically integrated, addressing R&D, materials science, automation, tooling, machining, stamping, insert/injection molding, joining/secondary operations, assembly, and options for low-cost production opportunities.
Paulsen: Medical device development follows many industries in requiring a mix of commodity components and patient-specific customization. For machinists or craftsmen, this could mean the flexibility in their business to create and qualify a mix of needs. Xometry’s marketplace adds value as a single vendor with access to thousands of capabilities and suppliers.
Patel: OEMs typically look for a manufacturing partner with the technical knowledge and expertise to solve complex issues during development and a partner they can scale with as the product’s lifecycle evolves. OEMs want to work with a manufacturing partner that can retain this talent to avoid project timeline impacts on new product development projects and have the history that can carry over into the entire product lifecycle.
Shegda: Being a great vendor is all about instilling confidence while mitigating risk. It’s like working with your computer network—it is really working well when you don’t notice it. Vendors are the same way. The parts need to be right, on-time, packaged properly with paperwork dialed in, and proactive in communication. OEMs want to “not notice” their vendors until they need to lean on them to get them out of a jam.
Brusco: What will be expected of machinists/laser machinists/craftsmen in the coming years to ensure robust medical device part production?
Buttermore: As in other areas, the field is changing and this will likely accelerate. Today, many machine tool manufacturers build in what were once core components of apprentice programs. We believe machinists/craftsmen will need to combine a mastery of the basics in machining and toolmaking with the ability to use in parallel higher-end technology such as automation and programming.
Coburn: Like other manufacturing tradesmen, laser machinists/craftsmen need to be highly skilled, knowledgeable problem solvers that can support the development and process of medical device part production. We see that need today and can expect it to only intensify in the future. Medical device design and manufacturing is a demanding field that will require laser craftsmen to work closely with design engineers, process experts, and many other teams to create high-quality parts and finished devices that help advance healthcare.
Laser process knowledge and troubleshooting are vital for the continued use of this technology. We need to train our customers on the potential failure modes for this manufacturing process so the correct development and qualification is being performed upfront to create a robust process for future production.
DeAngelo: A can-do approach to problem solving with applied science, technology, engineering, and mathematics (STEM). Weiss-Aug is fully engaged with local schools and universities to share current needs for training and preparation of our future workforce. Internships and formal training exposure to relevant processes are shared and identified for the grooming of current and future candidates.
Patel: Equipment is becoming more sophisticated and product lines are becoming more complex. They will be expected to become more familiar with different software (programming) packages that will help them make adjustments and fully unlock the equipment’s potential. The use of CAD software will align with using CAM software packages like MasterCAM, FeatureCAM, etc. These software packages allow machinists to program machines in a fraction of the time and program much more complex geometries. There is also a push across the industry for cell-based manufacturing, and with that comes the need to understand and program different types of equipment. The ability to use and leverage various software packages and different equipment types is important today and will become mandatory in the near future.
Shegda: Many things, but the biggest will be adaptability. Changes in the manufacturing world are going to come hot and heavy over the next 10 years. As component manufacturers, we need to anticipate trends and technologies before they are mainstream. This will mean our employees must always be thinking about how to meet the challenges that we see, and understand they must continue to stretch themselves to meet personal goals. There is a huge opportunity for growth for the company and for employees going forward, and it will take a mindset that is open and accepting of change to participate.
Brusco: Is there anything else you’d like to say regarding machining for medical device manufacturing or any important topics in the machining/laser processing sector that you feel MPO readers should know?
Coburn: It is crucial for OEMs to get laser manufacturing companies involved early on in the part development process. Confirming manufacturability with the experts before finalizing design equals speed to market.
Page: Never forget that whether it’s machining, injection molding, or some other process, it is for a medical device that will touch someone’s life. It’s critical to have the robust systems and processes, but equally as important is a culture where quality is paramount. The fact that the components and finished devices we manufacture are used to save or enhance patients’ lives every day influences everything we do.
Paulsen: Cutting or turning parts is one step in manufacturing medical devices, but qualification and documentation are typical bottlenecks. Quality assurance of medical devices requires shop certifications like ISO 9001 or ISO 13485, material traceability, measurement and sampling, and the ability to access records as requested. Xometry’s online instant quoting allows for this level of configuration and connects the right supplier to meet these quality needs without restrictions like minimum quantities or capacity constraints.
Shegda: We are living history right now; the pandemic has changed the way the world works to a degree. We have an opportunity as individual companies and as an industry to think about how we approach the new paradigm and set the tone in a positive way for those that follow. We can try to squeeze the heck out of the advances that have been presented, or we can use the technologies to facilitate a forward-thinking and very human way of working together that will lead to advancement of the industry and society. It is a matter of being able to look beyond a grab for short-term profits and focus on long-term profitability, viability, and social impact.