Sam Brusco, Associate Editor02.03.23
Machining and laser processing are mainstay methods used to manufacture medical components. Manufacturing firms specializing in precision machining and laser processing services 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 minute features these products require.
Many machining operations feature computer numerical control (CNC) and laser equipment depending on part specifications. CNC machines excel for bulk material removal, and lasers are better to profile and drill fine features. CNC machine makers specialize their products even further with improved raw material processing control, IoT and cloud connectivity, and advanced software. Cutting-edge femtosecond lasers have astounding speed, precision, and ability to cut small features, without risking heat-affected zones (HAZ).
Medical device makers partnering with firms specializing in these areas seek out higher standards of quality, lower costs, and faster speed to market. They also look for a partner with 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:
Mark Allen, VP of engineering and operations at Viant.
Bob Baldino, director of strategic projects, Lightspeed Lab, at Resonetics.
Dan Buttermore, director of engineering at Viant.
Dave Douglass, operations manager at Hall Industries.
Preston Featherlin, mechanical engineer at Hall Industries.
Mark Hall, VP of sales and marketing at Hall Industries.
Matt Hanks, COO of Paragon Medical.
Tim Hoklas, senior director of technical solutions at Viant.
Ken Lisk, advanced surgical VP and GM at Paragon Medical .
Aaron McVaugh, biomedical engineer at Hall Industries.
Redi Nasto, Business Development Laser Engineer at OKAY Industries.
Massimo Pollono, sales manager EMEA at Lincotek Medical.
Stefano Rappo, R&D manager, Lincotek Medical.
Arturo Sabbioni, global operations director, Lincotek Medical.
Kirk Stewart, CSO and GM of sales, marketing, and life services at SW Machines.
Sam Brusco: What latest technological or operational advances have most impacted your machining/laser processing capabilities for medical device manufacturing?
Bob Baldino: The most significant technological advance that has impacted our capabilities is our understanding and application of ultrafast lasers. There are many advantages for medical devices, especially those made out of nitinol. The ultrafast laser pulses do not produce a melt zone, so there’s no recast layer or heat-affected zone. This reduces or eliminates the post-processing needed after other types of laser or mechanical processes. We’ve been able to take the femtosecond laser technology and develop our own proprietary equipment to 3D ablate metal parts. This MICRABLATE process allows us to produce parts and features with tighter tolerances and more defined feature geometry on a scale smaller than nano-Swiss technology.
Hanks & Lisk: In machining, Paragon Medical depends on technology partners like DMG Mori, who are constantly innovating to advance machine speed and precision. Due to these partnerships, Paragon is able to keep pace with technological advances, which translate to cycle time advantages. Operationally, our Centers of Excellence for precision grinding (Pierceton, Ind.) and screw manufacturing (Smithfield, Utah) are examples of our proprietary manufacturing methods and knowhow, which are the result of decades of applied experience.
Tim Hoklas: First, automated or robot-assisted machining, which frequently combines several operations into one machine and allows it to run unattended. Second, laser Swiss machining. Laser cutting technology is more accurate and operates at faster speeds than conventional Swiss machining. Both are examples of combining processes for better reliability, as well as cost and labor savings.
We have found investing in automation drives cost improvements, higher quality, tighter tolerances, improved efficiency, and makes us less dependent on a constrained labor market. For example, machines that automate process control, vision, inspection, and other systems deliver enhanced repeatability and reproducibility at greater speed and with less operator variability.
McVaugh: After successfully registering for ISO 13485 Quality Management System in 2022, Hall has made a significant capital investment in multiple precision Swiss screw machines, horizontal lathes, and vertical mills. We have also made a strategic investment in a state-of-the art programable laser engraving machine.
Redi Nasto: Our primary objective is to implement the latest innovative technologies to expand our capabilities and enhance the efficiency and finish quality of current processes. The ability to change laser parameters “on the fly” during the laser cutting process allows us to optimize cut quality and process speed. Furthermore, the implementation of Position Synchronized Output (PSO), has shown even greater process speeds and cut finishes can be achieved when integrated into our standard laser tube cutting platforms.
Adding a fully synchronized tilt to our laser head has made it possible for Okay to laser cut off-axis features along 3D geometries such as spherical or elliptical closed end tubes. This has given us expanded capabilities in processing increasingly complex geometries and access to market segments related to shavers for ear, nose, and throat (ENT) applications. The introduction of picosecond laser marking technology results in matte black laser marks with superior contrast abilities under different lighting conditions. This picosecond laser mark creates a ripple structure on the nano-micro scale on the surface, which is effective in trapping light and creating a high contrast finish from the base metal.
Stefano Rappo: Some recent advances both in terms of hardware include cutting-edge technologies like multi-laser AM, as well as the introduction of specific software aimed at improving processes, reducing errors, and guaranteeing product quality—without sacrificing productivity. This is not enough, however; the above has an impact if combined with experience and analytical mentality, which allows analyzing every single step of the process to maximize the effectiveness of what is added.
Kirk Stewart: SW’s machine tool solutions for the medical industry address legacy challenges of material types and quality demands, while also solving manpower shortcomings and volume increases in today’s market.
Brusco: Why do medical device OEMs come to you specifically for manufacturing partnerships?
Baldino: Medical device OEMs come to us for our front-end support during the development process and unique manufacturing capabilities. Our Lightspeed Lab is a network of engineers, technicians, and equipment solely focused on prototyping and process development. We understand how easy it is for development resources to be consumed by production programs, so we fully separated it from our production group. It’s a separate part of the business that reports directly to our CTO. We also understand the importance of focused expertise, so each of our 10 Lightspeed Labs has specific technologies they work with to master the technology. We also invest in advanced technology projects to push the limits of what the processes are capable of and develop new technologies.
Dan Buttermore: Customers are looking for a partner to manufacture quality parts quickly, at the right price, with the necessary capacity, and often with the ability to scale. They’re looking to simplify their supply chain with fewer partners that can offer a greater depth and breadth of services. We can handle nearly every process involved in medical device manufacturing—not only machining and laser processing but also design/DFM, molding, extrusion, assembly, packaging, and logistics.
We’re seeing increased demand for design for manufacturability (DFM). OEMs appreciate our expertise in coming up with the most efficient and effective way to manufacture their product, including reducing unnecessary geometry on a part that costs money.
We can also add value with expertise in project management, new product introduction (NPI), lean techniques such as 3P, and regulatory support. Customers appreciate our global network of manufacturing facilities to meet a wide range of needs, including sites in major markets around the world as well as low-cost geographies.
In today’s unpredictable supply chain environment, supply chain excellence is also critical. Viant has invested in Kinaxis, a leading supply chain planning software that enables concurrent planning through our vertically integrated network. Kinaxis provides on demand scenario modeling capabilities and exception management tools to act as our early warning system to proactively address issues.
Mark Hall: We have over 25 years of experience with strategic partners, including a variety of medical centers in the Pittsburgh, Pa., area. We have forged unique relationships with surgeons and biomedical engineers to collaborate and assist with manufacturing solutions. We have extensive experience and knowledge with machining exotic metals such as titanium, cobalt chrome, molybdenum, stainless, and medical grade polymers.
Hanks & Lisk: In today’s challenging healthcare environment, OEMs are looking for a contract manufacturer to help simplify the complexities of the supply chain and expedite commercialization. We serve as their strategic partner in medical device manufacturing, offering an end-to-end supply chain solution from initial concept and product development, to verification and validation testing, to final production, assembly, and ongoing strategic demand planning. Our breadth of capabilities and global scale allows OEMs to streamline their manufacturing partnerships.
Nasto: We have built a reputation as experts and leaders in our field; we’ve built customer relationships through collaboration, open communication, delivery, and results. The introduction of NexTech Labs, an R&D center within Okay with dedicated process experts and equipment, has given us the ability to support customers during the conceptual stage. Having our customers reach out directly to our dedicated R&D process experts has been invaluable in streamlining our quick-turn prototype services. This early involvement collaboration has been pivotal and provided the building blocks to customer partnerships.
Customers rely on our manufacturing process expertise to provide guidance on manufacturability of certain components and assemblies. As we go through the early supplier involvement phase, our goal is to share ideas and suggestions for potential design or process improvements that enhance a part’s manufacturability, streamline processes and methods, as well as improve process controls and optimize efficiencies, time to market, and cost reduction opportunities.
Massimo Pollono: Among the needs of OEMs, certainly being able to take advantage of a reliable supply chain is among the most important. The possibility of concentrating the entire process flow in a single external partner guarantees maximum efficiency in management of purchases, logistics and quality—and at the same time, reduces lead time and working capital to a minimum. In this way, OEMs can reduce risks and complexity and consolidate their supply base, concentrating on things that enable them to stay competitive in the market, such as regulatory deadlines and market development.
When entering into a relationship with a supplier who will help to support the development and manufacturing of an orthopedic implant, it is critical to make the right decision in order to ensure the correct balance between high quality of service, cost-efficient product-to-service ratio, and fast time to market. Getting that choice right, however, isn’t easy. It’s crucial to find a well-established partner with broad capabilities that brings together the core competencies of R&D, product design, regulatory affairs, and manufacturing—all under one roof.
The pandemic brought the importance of working with quality partners to the forefront. It is fundamental to find a company with a fully-integrated offering and multiple locations around the globe to support shifting manufacturing needs, reduce risks and complexity, and consolidate the supply base.
Stewart: The fundamental monoblock design of the SW machine frame ensures the stiffest construction of equipment in its class. The robust construction allows for the most aggressive kinematic responses and for fine surfaces finishes to be achieved in parallel. This precision is especially critical for machining of medical-grade materials used in surgical settings for either disposable devices or permanent implants.
Brusco: What steps do you take to ensure machine operators are properly trained and kept up to date on new manufacturing technologies?
Baldino: Every new program at Resonetics has to go through a Lightspeed Lab for prototyping and process development. When it’s time to transfer the program into production, we have a detailed process we follow to validate the process and train the production operators on how to make the parts. By having our Lightspeed team focused on learning and developing new manufacturing technologies, we can ensure they get included on new devices and those capabilities get moved into production.
Each Resonetics site is also under the same quality umbrella, following the same procedures when taking a prototype to production. During the launch process and well into production, it’s common for a process optimization update or customer drawing change. This automatically triggers an updated drawing, spec review, and engineering change notification if required. Any affected documents would then be updated, and we would automatically see all individuals that require an updated training on their profile. Once all trainings are complete, the part number is released from the update process and production can carry on.
Buttermore: Training is core to everything we do, and it’s fundamental to the development of our associates and our ability to manufacture the highest quality products. As new manufacturing technologies are implemented across Viant, we make sure our associates are properly trained by updating and following process and product-specific work instructions, setup sheets, and quality standards. Our associates go through operator certification programs that include training by designated trainers to ensure they’re qualified to operate the equipment and adhere to all safety, performance, and quality standards.
Dave Douglass: We encourage the further education of our employees—we keep up with competitors when it comes to purchasing state-of-the-art equipment. With new purchases of equipment, we ensure appropriate personnel are properly trained on how to operate the equipment and software. We also send lead personnel to trade shows periodically and provide them access to tooling representatives to help ensure we are using state-of-the-art tooling during our manufacturing process. Our quality manager provides the employees with pertinent quality information monthly in the form of toolbox talks. Also, routine quality audits are conducted to verify our quality systems are functioning and meet the standards of ISO 9001 and 13485.
Hanks & Lisk: We prioritize investment in the development and training of our associates. It all starts with local recruiting. We support area high schools and colleges that provide technical certificate programs. From there, we offer a robust apprenticeship and mentor program to bring in and train new talent. Finally, we adhere to the tenets of lean training company-wide from which we are graduating yellow, green, and blackbelts to attack waste in business and manufacturing processes.
Nasto: Our R&D teams have regular internal meetings and presentations with our process engineers, specialists, setup technicians, and machine operators where we discuss new ideas, methods, and technologies. The main areas for process improvement are primarily identified by team members on the floor who have direct, hands-on involvement with the manufacturing processes. Once that feedback is received, the R&D team explores different options, methods, and new technologies that can be implemented to further improve our manufacturing processes.
Once the R&D team has researched, introduced, and developed a new process method or technology, it’s reviewed by our process engineers, specialists, technicians, and machine operators. Special setup instructions and work instructions are then created and documented. Formal training of those documents is then completed and recorded in our ERP system. Articles, webinars, and symposiums are other tools we use to educate a broader group of our team on the latest industry technology.
Arturo Sabbioni: Training is a pillar for office and for factory workers; several thousand hours per year are dedicated to training. We ensure different kind of trainings for machine operators: internal trainings from engineering, quality, and safety departments that often are used to spread in-production information collected by employees during external courses. We also give several periodic training courses for our machine operators.
Another relevant pillar is the training within several facilities inside the group. We organize working experiences for our operators in other facilities, giving to several operators the opportunity to share best practices among Europe, U.S. and China. During the pandemic, we were able to set up training courses needed to transfer some know-how from one facility to another by organizing web-based practical meetings between groups of operators in different continents. We take care of what we call our “tribal knowledge,” inherent knowledge within the company, passed from person to person. We combine it by recruiting personnel from large companies that have an international vision of technology.
The group has recently had a strong expansion through acquisitions and the management of the medical sector is the first sponsor of the internal technology transfer. We also had the opportunity to take advantage of numerous, international seminars and trade fairs. We regularly send our core of engineers and technicians to participate.
Another form of the maintenance of skills arises from the use of targeted external consultancy, especially in methods of approach to manufacturing as Lean experts or as operational excellences.
Stewart: To address the post-COVID labor resource shortage, our core offerings of either 2- or 4-spindle horizontal machining centers allow for double or quadruple the output of parts in a fraction of the floor space required for comparable single-spindle machine solutions.
Brusco: Do you employ ‘Industry 4.0’ technologies in your manufacturing process? If so, which ones and how do they ensure manufacturing excellence?
Mark Allen: We are using “smart automation” on the manufacturing floor in both machining and molding, including tool builds, as well as for inspections. We have a number of unattended machines that have automation to move a part and create a feedback loop that involves measurement, data capture, and then an automatic adjustment in order to optimize the process.
Take, for example, a key component we manufacture for a minimally invasive surgical device. A robot is integrated into the machining process to ensure proper alignment during part loading as well as to automate inspection. Critical features such as length, thread dimensions, and surface finish are inspected. The process automatically rejects an out-of-spec part and isolates it for analysis while allowing the process to continue to run. If the automated process encounters out-of-spec parts at a predetermined limit, the line will stop and signal an alert. With this automated system, we gain improved product quality, increased output, and availability of operators to perform value-added functions instead of part loading/unloading and inspection.
Baldino: We are involved in many aspects of Industry 4.0 and we’re making significant investments to further expand it in our manufacturing processes. We use data collection and statistical process control to better manage our manufacturing process. Our newest processing machines, which are built by our in-house equipment team, are being built to be fully automated with 100% inspection. The process data can then be used to manage and adjust the process in real-time. We’ve also been moving most of our business systems to the cloud to make it easier to access and process the data.
Preston Featherlin: We are in the beginning stages of employing “Industry 4.0 technologies.” With the use of an ERP system, we monitor the daily work in progress and employees are able to see this, so they are aware of the real-time progress they are making and their current hourly performance. We also have each machine connected to our server in order to efficiently import and export programs. We utilize high-accuracy image dimension measurement systems in our quality process. We’re also looking at purchasing our first fully automated machining cell focused on machining of parts requiring a secondary operation, as well as looking for a machine monitoring system that best fits our diversified business.
Hanks & Lisk: We are deeply partnered with Machine Metrics and will deploy their technology to every machine across 14 manufacturing sites by the end of 2023. We depend on this technology to maximize equipment utilization day-to-day, and to analyze downtime reasons systemically to make improvements. Connected factory initiatives play an ever-increasing role in our manufacturing strategy.
Nasto: We are currently implementing process monitoring systems within our production equipment, which will communicate with our ERP system items such as machine up/down time, efficiency rates, down time reasons, and overall OEE. The data communicated will be used to predict issues before they can ever occur, minimizing extended periods of downtime.
Stewart: Medical manufacturers who have dozens of milling spindles dedicated to common families of parts come to us to resolve their manpower and floor space challenges to effectively do more with less, and maintain the high level of quality expected in the industry.
Sabbioni: Companies like ours that are based on "multiphase" production cycles are characterized by a remarkable level of complexity. The natural response is a rigorous passage to an elevated specialization of the single units that compose the phases of the aforementioned cycle. This provides an organizational change that can only happen if supported by a widespread digitalization of the process. In this context, the application and use of the principles of Industry 4.0 becomes mandatory.
We are extremely sensitive to concepts like productivity, competitiveness, and automatization. Twenty years ago we based our coating production on use of 6-axis robots and, for the medical final packaging process, use of sensors like RFID to guarantee maximum traceability.
Lincotek has been a pioneer in additive manufacturing since 2006. A relevant milestone for the Lincotek Additive division is implementation in 2019 of a direct communication channel between our ERP and MES system with our 3D-printing production floor.
Until that moment, through this channel over 15,000 3D files to be printed have been automatically uploaded in our LPBF equipment, avoiding the issues that sometimes occur with the manual uploading. Thanks to Industry 4.0, all the principal information about the machine’s status during work have been constantly monitored by our MES software, giving us the opportunity to monitor and optimize our OEE, up to more than 85%. The next step, which we are already working, is the big data analysis based on the high level of information we’re collecting during production.
We’re working to create a direct connection between all production systems and information systems. The link consists of an IoT platform that collects data and generates the main process KPI in real time. This direct application will allow us to “clean” the background noise due to the natural imperfection of data collected by conventional methods and will make data available that most represents the level of manufacturing excellence. The additional strength of wired data collection is making visible hidden causes that are slowdowns on the path of manufacturing excellence.
Lincotek Forging division oriented its production vision to industry 4.0 technology from day one. The multirobot forging line has been developed with the idea of full control of production and data analysis. From the control room, one single operator can supervise the entire process tracing pieces individually, and through the MES, engineers can verify the machine’s status and their output calculating efficiency, timing, and costs. In the next year, this approach will be implemented on activities like mold production and finishing process. All these actions will permit a full tracking of orthopedic implants from the point-of-view of process parameters, precise cost reports, and production scheduling.
Many machining operations feature computer numerical control (CNC) and laser equipment depending on part specifications. CNC machines excel for bulk material removal, and lasers are better to profile and drill fine features. CNC machine makers specialize their products even further with improved raw material processing control, IoT and cloud connectivity, and advanced software. Cutting-edge femtosecond lasers have astounding speed, precision, and ability to cut small features, without risking heat-affected zones (HAZ).
Medical device makers partnering with firms specializing in these areas seek out higher standards of quality, lower costs, and faster speed to market. They also look for a partner with 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:
Mark Allen, VP of engineering and operations at Viant.
Bob Baldino, director of strategic projects, Lightspeed Lab, at Resonetics.
Dan Buttermore, director of engineering at Viant.
Dave Douglass, operations manager at Hall Industries.
Preston Featherlin, mechanical engineer at Hall Industries.
Mark Hall, VP of sales and marketing at Hall Industries.
Matt Hanks, COO of Paragon Medical.
Tim Hoklas, senior director of technical solutions at Viant.
Ken Lisk, advanced surgical VP and GM at Paragon Medical .
Aaron McVaugh, biomedical engineer at Hall Industries.
Redi Nasto, Business Development Laser Engineer at OKAY Industries.
Massimo Pollono, sales manager EMEA at Lincotek Medical.
Stefano Rappo, R&D manager, Lincotek Medical.
Arturo Sabbioni, global operations director, Lincotek Medical.
Kirk Stewart, CSO and GM of sales, marketing, and life services at SW Machines.
Sam Brusco: What latest technological or operational advances have most impacted your machining/laser processing capabilities for medical device manufacturing?
Bob Baldino: The most significant technological advance that has impacted our capabilities is our understanding and application of ultrafast lasers. There are many advantages for medical devices, especially those made out of nitinol. The ultrafast laser pulses do not produce a melt zone, so there’s no recast layer or heat-affected zone. This reduces or eliminates the post-processing needed after other types of laser or mechanical processes. We’ve been able to take the femtosecond laser technology and develop our own proprietary equipment to 3D ablate metal parts. This MICRABLATE process allows us to produce parts and features with tighter tolerances and more defined feature geometry on a scale smaller than nano-Swiss technology.
Hanks & Lisk: In machining, Paragon Medical depends on technology partners like DMG Mori, who are constantly innovating to advance machine speed and precision. Due to these partnerships, Paragon is able to keep pace with technological advances, which translate to cycle time advantages. Operationally, our Centers of Excellence for precision grinding (Pierceton, Ind.) and screw manufacturing (Smithfield, Utah) are examples of our proprietary manufacturing methods and knowhow, which are the result of decades of applied experience.
Tim Hoklas: First, automated or robot-assisted machining, which frequently combines several operations into one machine and allows it to run unattended. Second, laser Swiss machining. Laser cutting technology is more accurate and operates at faster speeds than conventional Swiss machining. Both are examples of combining processes for better reliability, as well as cost and labor savings.
We have found investing in automation drives cost improvements, higher quality, tighter tolerances, improved efficiency, and makes us less dependent on a constrained labor market. For example, machines that automate process control, vision, inspection, and other systems deliver enhanced repeatability and reproducibility at greater speed and with less operator variability.
McVaugh: After successfully registering for ISO 13485 Quality Management System in 2022, Hall has made a significant capital investment in multiple precision Swiss screw machines, horizontal lathes, and vertical mills. We have also made a strategic investment in a state-of-the art programable laser engraving machine.
Redi Nasto: Our primary objective is to implement the latest innovative technologies to expand our capabilities and enhance the efficiency and finish quality of current processes. The ability to change laser parameters “on the fly” during the laser cutting process allows us to optimize cut quality and process speed. Furthermore, the implementation of Position Synchronized Output (PSO), has shown even greater process speeds and cut finishes can be achieved when integrated into our standard laser tube cutting platforms.
Adding a fully synchronized tilt to our laser head has made it possible for Okay to laser cut off-axis features along 3D geometries such as spherical or elliptical closed end tubes. This has given us expanded capabilities in processing increasingly complex geometries and access to market segments related to shavers for ear, nose, and throat (ENT) applications. The introduction of picosecond laser marking technology results in matte black laser marks with superior contrast abilities under different lighting conditions. This picosecond laser mark creates a ripple structure on the nano-micro scale on the surface, which is effective in trapping light and creating a high contrast finish from the base metal.
Stefano Rappo: Some recent advances both in terms of hardware include cutting-edge technologies like multi-laser AM, as well as the introduction of specific software aimed at improving processes, reducing errors, and guaranteeing product quality—without sacrificing productivity. This is not enough, however; the above has an impact if combined with experience and analytical mentality, which allows analyzing every single step of the process to maximize the effectiveness of what is added.
Kirk Stewart: SW’s machine tool solutions for the medical industry address legacy challenges of material types and quality demands, while also solving manpower shortcomings and volume increases in today’s market.
Brusco: Why do medical device OEMs come to you specifically for manufacturing partnerships?
Baldino: Medical device OEMs come to us for our front-end support during the development process and unique manufacturing capabilities. Our Lightspeed Lab is a network of engineers, technicians, and equipment solely focused on prototyping and process development. We understand how easy it is for development resources to be consumed by production programs, so we fully separated it from our production group. It’s a separate part of the business that reports directly to our CTO. We also understand the importance of focused expertise, so each of our 10 Lightspeed Labs has specific technologies they work with to master the technology. We also invest in advanced technology projects to push the limits of what the processes are capable of and develop new technologies.
Dan Buttermore: Customers are looking for a partner to manufacture quality parts quickly, at the right price, with the necessary capacity, and often with the ability to scale. They’re looking to simplify their supply chain with fewer partners that can offer a greater depth and breadth of services. We can handle nearly every process involved in medical device manufacturing—not only machining and laser processing but also design/DFM, molding, extrusion, assembly, packaging, and logistics.
We’re seeing increased demand for design for manufacturability (DFM). OEMs appreciate our expertise in coming up with the most efficient and effective way to manufacture their product, including reducing unnecessary geometry on a part that costs money.
We can also add value with expertise in project management, new product introduction (NPI), lean techniques such as 3P, and regulatory support. Customers appreciate our global network of manufacturing facilities to meet a wide range of needs, including sites in major markets around the world as well as low-cost geographies.
In today’s unpredictable supply chain environment, supply chain excellence is also critical. Viant has invested in Kinaxis, a leading supply chain planning software that enables concurrent planning through our vertically integrated network. Kinaxis provides on demand scenario modeling capabilities and exception management tools to act as our early warning system to proactively address issues.
Mark Hall: We have over 25 years of experience with strategic partners, including a variety of medical centers in the Pittsburgh, Pa., area. We have forged unique relationships with surgeons and biomedical engineers to collaborate and assist with manufacturing solutions. We have extensive experience and knowledge with machining exotic metals such as titanium, cobalt chrome, molybdenum, stainless, and medical grade polymers.
Hanks & Lisk: In today’s challenging healthcare environment, OEMs are looking for a contract manufacturer to help simplify the complexities of the supply chain and expedite commercialization. We serve as their strategic partner in medical device manufacturing, offering an end-to-end supply chain solution from initial concept and product development, to verification and validation testing, to final production, assembly, and ongoing strategic demand planning. Our breadth of capabilities and global scale allows OEMs to streamline their manufacturing partnerships.
Nasto: We have built a reputation as experts and leaders in our field; we’ve built customer relationships through collaboration, open communication, delivery, and results. The introduction of NexTech Labs, an R&D center within Okay with dedicated process experts and equipment, has given us the ability to support customers during the conceptual stage. Having our customers reach out directly to our dedicated R&D process experts has been invaluable in streamlining our quick-turn prototype services. This early involvement collaboration has been pivotal and provided the building blocks to customer partnerships.
Customers rely on our manufacturing process expertise to provide guidance on manufacturability of certain components and assemblies. As we go through the early supplier involvement phase, our goal is to share ideas and suggestions for potential design or process improvements that enhance a part’s manufacturability, streamline processes and methods, as well as improve process controls and optimize efficiencies, time to market, and cost reduction opportunities.
Massimo Pollono: Among the needs of OEMs, certainly being able to take advantage of a reliable supply chain is among the most important. The possibility of concentrating the entire process flow in a single external partner guarantees maximum efficiency in management of purchases, logistics and quality—and at the same time, reduces lead time and working capital to a minimum. In this way, OEMs can reduce risks and complexity and consolidate their supply base, concentrating on things that enable them to stay competitive in the market, such as regulatory deadlines and market development.
When entering into a relationship with a supplier who will help to support the development and manufacturing of an orthopedic implant, it is critical to make the right decision in order to ensure the correct balance between high quality of service, cost-efficient product-to-service ratio, and fast time to market. Getting that choice right, however, isn’t easy. It’s crucial to find a well-established partner with broad capabilities that brings together the core competencies of R&D, product design, regulatory affairs, and manufacturing—all under one roof.
The pandemic brought the importance of working with quality partners to the forefront. It is fundamental to find a company with a fully-integrated offering and multiple locations around the globe to support shifting manufacturing needs, reduce risks and complexity, and consolidate the supply base.
Stewart: The fundamental monoblock design of the SW machine frame ensures the stiffest construction of equipment in its class. The robust construction allows for the most aggressive kinematic responses and for fine surfaces finishes to be achieved in parallel. This precision is especially critical for machining of medical-grade materials used in surgical settings for either disposable devices or permanent implants.
Brusco: What steps do you take to ensure machine operators are properly trained and kept up to date on new manufacturing technologies?
Baldino: Every new program at Resonetics has to go through a Lightspeed Lab for prototyping and process development. When it’s time to transfer the program into production, we have a detailed process we follow to validate the process and train the production operators on how to make the parts. By having our Lightspeed team focused on learning and developing new manufacturing technologies, we can ensure they get included on new devices and those capabilities get moved into production.
Each Resonetics site is also under the same quality umbrella, following the same procedures when taking a prototype to production. During the launch process and well into production, it’s common for a process optimization update or customer drawing change. This automatically triggers an updated drawing, spec review, and engineering change notification if required. Any affected documents would then be updated, and we would automatically see all individuals that require an updated training on their profile. Once all trainings are complete, the part number is released from the update process and production can carry on.
Buttermore: Training is core to everything we do, and it’s fundamental to the development of our associates and our ability to manufacture the highest quality products. As new manufacturing technologies are implemented across Viant, we make sure our associates are properly trained by updating and following process and product-specific work instructions, setup sheets, and quality standards. Our associates go through operator certification programs that include training by designated trainers to ensure they’re qualified to operate the equipment and adhere to all safety, performance, and quality standards.
Dave Douglass: We encourage the further education of our employees—we keep up with competitors when it comes to purchasing state-of-the-art equipment. With new purchases of equipment, we ensure appropriate personnel are properly trained on how to operate the equipment and software. We also send lead personnel to trade shows periodically and provide them access to tooling representatives to help ensure we are using state-of-the-art tooling during our manufacturing process. Our quality manager provides the employees with pertinent quality information monthly in the form of toolbox talks. Also, routine quality audits are conducted to verify our quality systems are functioning and meet the standards of ISO 9001 and 13485.
Hanks & Lisk: We prioritize investment in the development and training of our associates. It all starts with local recruiting. We support area high schools and colleges that provide technical certificate programs. From there, we offer a robust apprenticeship and mentor program to bring in and train new talent. Finally, we adhere to the tenets of lean training company-wide from which we are graduating yellow, green, and blackbelts to attack waste in business and manufacturing processes.
Nasto: Our R&D teams have regular internal meetings and presentations with our process engineers, specialists, setup technicians, and machine operators where we discuss new ideas, methods, and technologies. The main areas for process improvement are primarily identified by team members on the floor who have direct, hands-on involvement with the manufacturing processes. Once that feedback is received, the R&D team explores different options, methods, and new technologies that can be implemented to further improve our manufacturing processes.
Once the R&D team has researched, introduced, and developed a new process method or technology, it’s reviewed by our process engineers, specialists, technicians, and machine operators. Special setup instructions and work instructions are then created and documented. Formal training of those documents is then completed and recorded in our ERP system. Articles, webinars, and symposiums are other tools we use to educate a broader group of our team on the latest industry technology.
Arturo Sabbioni: Training is a pillar for office and for factory workers; several thousand hours per year are dedicated to training. We ensure different kind of trainings for machine operators: internal trainings from engineering, quality, and safety departments that often are used to spread in-production information collected by employees during external courses. We also give several periodic training courses for our machine operators.
Another relevant pillar is the training within several facilities inside the group. We organize working experiences for our operators in other facilities, giving to several operators the opportunity to share best practices among Europe, U.S. and China. During the pandemic, we were able to set up training courses needed to transfer some know-how from one facility to another by organizing web-based practical meetings between groups of operators in different continents. We take care of what we call our “tribal knowledge,” inherent knowledge within the company, passed from person to person. We combine it by recruiting personnel from large companies that have an international vision of technology.
The group has recently had a strong expansion through acquisitions and the management of the medical sector is the first sponsor of the internal technology transfer. We also had the opportunity to take advantage of numerous, international seminars and trade fairs. We regularly send our core of engineers and technicians to participate.
Another form of the maintenance of skills arises from the use of targeted external consultancy, especially in methods of approach to manufacturing as Lean experts or as operational excellences.
Stewart: To address the post-COVID labor resource shortage, our core offerings of either 2- or 4-spindle horizontal machining centers allow for double or quadruple the output of parts in a fraction of the floor space required for comparable single-spindle machine solutions.
Brusco: Do you employ ‘Industry 4.0’ technologies in your manufacturing process? If so, which ones and how do they ensure manufacturing excellence?
Mark Allen: We are using “smart automation” on the manufacturing floor in both machining and molding, including tool builds, as well as for inspections. We have a number of unattended machines that have automation to move a part and create a feedback loop that involves measurement, data capture, and then an automatic adjustment in order to optimize the process.
Take, for example, a key component we manufacture for a minimally invasive surgical device. A robot is integrated into the machining process to ensure proper alignment during part loading as well as to automate inspection. Critical features such as length, thread dimensions, and surface finish are inspected. The process automatically rejects an out-of-spec part and isolates it for analysis while allowing the process to continue to run. If the automated process encounters out-of-spec parts at a predetermined limit, the line will stop and signal an alert. With this automated system, we gain improved product quality, increased output, and availability of operators to perform value-added functions instead of part loading/unloading and inspection.
Baldino: We are involved in many aspects of Industry 4.0 and we’re making significant investments to further expand it in our manufacturing processes. We use data collection and statistical process control to better manage our manufacturing process. Our newest processing machines, which are built by our in-house equipment team, are being built to be fully automated with 100% inspection. The process data can then be used to manage and adjust the process in real-time. We’ve also been moving most of our business systems to the cloud to make it easier to access and process the data.
Preston Featherlin: We are in the beginning stages of employing “Industry 4.0 technologies.” With the use of an ERP system, we monitor the daily work in progress and employees are able to see this, so they are aware of the real-time progress they are making and their current hourly performance. We also have each machine connected to our server in order to efficiently import and export programs. We utilize high-accuracy image dimension measurement systems in our quality process. We’re also looking at purchasing our first fully automated machining cell focused on machining of parts requiring a secondary operation, as well as looking for a machine monitoring system that best fits our diversified business.
Hanks & Lisk: We are deeply partnered with Machine Metrics and will deploy their technology to every machine across 14 manufacturing sites by the end of 2023. We depend on this technology to maximize equipment utilization day-to-day, and to analyze downtime reasons systemically to make improvements. Connected factory initiatives play an ever-increasing role in our manufacturing strategy.
Nasto: We are currently implementing process monitoring systems within our production equipment, which will communicate with our ERP system items such as machine up/down time, efficiency rates, down time reasons, and overall OEE. The data communicated will be used to predict issues before they can ever occur, minimizing extended periods of downtime.
Stewart: Medical manufacturers who have dozens of milling spindles dedicated to common families of parts come to us to resolve their manpower and floor space challenges to effectively do more with less, and maintain the high level of quality expected in the industry.
Sabbioni: Companies like ours that are based on "multiphase" production cycles are characterized by a remarkable level of complexity. The natural response is a rigorous passage to an elevated specialization of the single units that compose the phases of the aforementioned cycle. This provides an organizational change that can only happen if supported by a widespread digitalization of the process. In this context, the application and use of the principles of Industry 4.0 becomes mandatory.
We are extremely sensitive to concepts like productivity, competitiveness, and automatization. Twenty years ago we based our coating production on use of 6-axis robots and, for the medical final packaging process, use of sensors like RFID to guarantee maximum traceability.
Lincotek has been a pioneer in additive manufacturing since 2006. A relevant milestone for the Lincotek Additive division is implementation in 2019 of a direct communication channel between our ERP and MES system with our 3D-printing production floor.
Until that moment, through this channel over 15,000 3D files to be printed have been automatically uploaded in our LPBF equipment, avoiding the issues that sometimes occur with the manual uploading. Thanks to Industry 4.0, all the principal information about the machine’s status during work have been constantly monitored by our MES software, giving us the opportunity to monitor and optimize our OEE, up to more than 85%. The next step, which we are already working, is the big data analysis based on the high level of information we’re collecting during production.
We’re working to create a direct connection between all production systems and information systems. The link consists of an IoT platform that collects data and generates the main process KPI in real time. This direct application will allow us to “clean” the background noise due to the natural imperfection of data collected by conventional methods and will make data available that most represents the level of manufacturing excellence. The additional strength of wired data collection is making visible hidden causes that are slowdowns on the path of manufacturing excellence.
Lincotek Forging division oriented its production vision to industry 4.0 technology from day one. The multirobot forging line has been developed with the idea of full control of production and data analysis. From the control room, one single operator can supervise the entire process tracing pieces individually, and through the MES, engineers can verify the machine’s status and their output calculating efficiency, timing, and costs. In the next year, this approach will be implemented on activities like mold production and finishing process. All these actions will permit a full tracking of orthopedic implants from the point-of-view of process parameters, precise cost reports, and production scheduling.