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Our CNC product development manager Damian Zyjeski and engineering manager for Costa Rica Mario Chaves Jr. recently spoke with MPO magazine’s Mark Crawford, about Subtractive Solutions for Machining in the Medtech space. Read the content of the article below or on MPO’s website.
Computer numeric control (CNC) machines enable the creation of intricate and life-saving medical devices, with exceptional accuracy, repeatability, and reliability. Depending on the function of the medical device, a wide range of materials are available for machining, including certified material stock such as stainless steel and high-performance polymers such as polyether ether ketone (PEEK). Machining is also critical for secondary processing of molded, cast, or 3D-printed medical devices.
Modern machining methods and technologies for medical devices continue to revolutionize the healthcare industry. Advanced machining techniques, including laser cutting, have enabled the precision engineering of complex medical components and devices. These sophisticated methods ensure high accuracy and repeatability, especially for complex and miniaturized devices and instruments for minimally invasive procedures.
“The integration of automation and robotics further streamlines manufacturing processes, improving productivity and cost-effectiveness,” said Kevin Rebello, director of technical operations for Medical Component Specialists (MCS), a Bellingham, Mass.-based contract manufacturer of precision orthopedic and interventional grinding solutions, including Swiss turning, gun drilling, and tool grinding. “As a result, modern machining has not only elevated the quality and performance of medical devices, but also accelerated the pace of medical innovation, leading to improved patient outcomes and enhanced healthcare practices.”
Technology advancements have also contributed to rapid improvements in machining processes (especially at the micro scale), allowing design teams to produce complex components that meet ever-increasing customer demands for superior quality, accuracy, and performance.
“Manufacturers are always looking to leverage innovative techniques, tools, and technologies such as artificial intelligence [AI]-enabled computer-aided manufacturing, augmented reality, and robotics to achieve higher levels of productivity, without sacrificing quality,” said John Cross, machining technologist and director for MICRO, a Somerset, N.J.-based full-service contract manufacturer of precision medical devices and fabricated tube assemblies.
This abundance of machining prowess makes it possible for medical device manufacturers (MDMs) to design more complex and multi-functional products faster than ever. MDMs and their contract manufacturers (CMs) work together to quickly develop prototype parts for testing and feasibility studies from initial design concepts, with dedicated R&D labs and engineering support.
“This means that manufacturers must be extremely flexible and provide fast response times,” said Damian Zyjeski, CNC product development manager for the U.S. operations of AVNA, a New Britain, Conn.-based contract manufacturer of precision medical components and assemblies for the medical device industry. “We must maintain our in-house expertise and state-of-the-art equipment to meet these ongoing demands.”
Machining is the process of removing material to shape a workpiece as per a specific design. These machines transform raw material into a custom-made component by using cutting tools to remove material stock. Main categories include milling, turning, drilling, and grinding, conducted sometimes by hand but most commonly with CNC machines—essentially robots that simultaneously reposition the workpiece and a rotating cutting tool that enable high-precision cutting and meet sub-micron tolerances for medical devices and instruments. Other methods are portable cutting machines and electrochemical grinding.
“These are just some of the main categories of machining methods,” said Mario Chaves Jr., engineering manager for the Costa Rica operations of AVNA . “There are additional specialized processes and techniques available for specific applications. Depending on the desired outcome, various machining techniques can be used to meet the complex design or precision required on the final part.”
One of these techniques is laser processing, which is capable of both through-cutting and partial-depth cuts, “which opens up a dimension of design possibilities,” said Todd Dickson, president of Lumenous Device Technologies—a Santa Clara, Calif.-based provider of precision materials, laser processing, and premium finishing for medical device companies. “Surface engineering, partial-depth cutting, and through-cutting can all be done on the same workstation. Because there are various laser-cutting technologies with specific benefits and a certain amount of overlap, it is important to partner with a strategic supplier with skills in near-infrared fiber, ultrashort-pulse, Nd:YAG, CO2, and excimer lasers.”
Current machining trends are increased precision, better surface finishes, and higher complexity in machined components. Other trends include the use of AI-enabled toolpathing, generative design, and machining of ceramics and glass.
Miniaturization and micro machining continue to drive innovations within the healthcare industry. “CNC machines capable of micro machining and producing complex designs on a tiny scale have become essential to meet these increasing demands,” said Rebello.
Technologies rooted by the Internet of Things (IoT)—for example, automation, robotics, data analytics, and in-line quality monitoring—are all on the rise. These are essential for increased productivity, reduced downtime, and improved process control. Another big factor is that cutting tools also continue to advance, with steady introduction of new materials, coatings, and geometries. “Tools that offer improved durability, higher cutting speeds, and enhanced material removal rates contribute to higher productivity and cost efficiency in machining processes,” said Chaves Jr.
The demand for complex and intricate parts has also led to increased adoption of multi-axis machining. “CNC machines capable of simultaneous five-axis or even more axes of movement enable the production of geometrically complex parts in a single setup, reducing the need for multiple operations,” he added.
It never changes—faster, smaller, and cheaper are always at the top of an MDM’s list. Long lead times across the industry have been a major challenge for MDMs and CMs. Although supply chain disruptions have less impact than they did a few years ago, lead times for some components and materials are still unpredictable. MDMs, in an effort to meet aggressive timelines, are proactively listening to their customers and analyzing their market data to try and improve their forecasting to minimize the impacts of supply chain constraints.
The desire by MDMs to get to market quickly is driving innovation and new process development by equipment manufacturers. “For example, hybrid machines like the laser/Swiss, which combines the speed of laser cutting with the precision of Swiss machining, help with producing high volume of parts in shorter lead times. This also drives the need for automation and ‘lights out’ manufacturing,” said Zyjeski.
MDMs can save time, control cost, and get products to market faster by using CMs that are vertically integrated. This includes machining, which optimizes manufacturability and streamlines processes that result in cost savings, faster speed to market, and enhanced product performance. “Being vertically integrated with the latest technologies ensures the ultimate process control, while also cutting the fat from bloated lead times,” said Rebello. “This has become a major selling point in our value proposition with our customers.”
For example, the supply chain for pre-cannulated material is a nightmare for orthopedic drills. Pricing and lead times have surged in recent years and show no signs of relenting. Instead of passing on the cost and inflated lead times, “MCS elected to vertically integrate in-house gun drilling technology,” said Rebello. “Having purpose-built gun drilling equipment that is custom-designed to service our applications has been a game changer in allowing us to make our own pre-cannulated material/parts.”
OEMs are also increasingly demanding machining that is ISO 13485-compliant “and capable of creating digital twins and providing an auditable digital thread,” said Greg Paulsen, director of applications engineering and marketing for Xometry, a North Bethesda, Md.-based AI-powered digital marketplace for global manufacturing needs, including domestic supply chain solutions. “They also expect impeccable cleaning procedures, a reliable supply chain, and the ability to achieve more demanding shapes, tolerances, and materials.”
This is where laser machining especially comes into play—as products and components become smaller and more complex, with the need for extremely tight tolerances, manufacturers increasingly turn to femtosecond lasers for their micromachining needs. “Features can be as small as a few microns, with submicron tolerances,” said Blake Winkelmann, technical solutions manager for Spectrum Plastics Group, an Alpharetta, Ga.-based provider of critical polymer-based components and devices for medical and other demanding markets. “In fact, some features can only be cut with femtosecond lasers, expanding design options for engineers and designers. Femtosecond lasers cut incredibly fine features with submicron accuracy, eliminating heat-affected zones and reducing the need for secondary finishing.”
Also, because of their superior peak power, femtosecond lasers can process nearly any type of solid material, including layered, mixed, laminated, or coated materials. Lasers can be automated to run 24/7 for large-volume or high-priority parts, maximizing production efficiency and speed to market.
The high precision of laser machining, and its ability to be automated, make it a key tool for achieving zero-defect production—especially for smaller and more complex parts—a goal that MDMs often push for. To achieve this, “machining firms must invest in a production method—including Cpk, trending, and all the tools that drive reliability higher—to drive zero-defect production,” said Dickson.
Over the last few years, there have been numerous technological advancements in precision manufacturing. Swiss machines have raised the bar in terms of accuracy, “now capable of maintaining tolerances as tight as ±0.0002 inches,” said Paulsen. “Micromachining technology now has the capability to create holes as small as 0.0005 inches. Additionally, micro EDM [electrical discharge machining] technology has advanced to achieve dimensions as small as 0.0008 inches.”
Micromachining is increasingly required to make smaller, feature-rich components with extremely high precision—especially for robotics and minimally invasive procedures. These tiny components, with diameters as small as 0.007 inches and tolerances in the 0.001-inch range (roughly half the width of a human hair) look like tiny metal shavings to the naked eye but are actually complex, tightly toleranced device components.
“Another hybrid technology is the laser microjet system, which uses a water lens for precise, deep laser drilling, offering a new level of precision in laser machining,” said Paulsen. This process combines a laser with a “hair-thin” water jet that precisely guides the laser beam by means of total internal reflection. The water also continually cools the cutting zone and efficiently removes debris. The cooler temperature eliminates problems such as heat-affected zones, micro-cracks, and other thermal damage.
MICRO’s PEM (Precision Electrochemical Machining) process is another method for contactless and precise machining of metal parts. PEM is ideal for working with complex geometry, fragile materials, and heat-sensitive or hard materials. Achieving excellent dimensional control and surface finish, PEM achieves sub-micron tolerances and produces mirror-like surface finishes without the need for additional polishing or deburring.
The PEM process dissolves ionized material from the workpiece anodically by employing a negatively polarized tool-electrode (cathode) and a positively polarized workpiece (anode), with an electrically conductive saltwater-based electrolyte. Through synchronization of precise pulse current and an oscillating tool electrode, coupled with a small working gap, PEM achieves exceptional precision in machining complex shapes.
“As an advancement of electrochemical machining, PEM offers minimal cathode wear and enables the creation of workpieces with reproduction and reproducibility accuracy ranging from two to five micrometers,” said Cross. “Notably, this process is entirely contactless, eliminating all mechanical forces on the workpiece during machining. The combination of precise pulse current timing, oscillating electrode, minimum wear, no mechanical force, and a small processing gap contributes to high precision and cost-effectiveness.”
CNC, automation, and robotics are major drivers of accuracy, process repeatability, and efficiency. These technologies also have the ability to mitigate the skills gap in the industry while improving process capabilities as new devices become smaller and more complex. “Holding four or five decimal places on tapered neural wire with a 0.002-inch tip has become commonplace,” said Rebello. “Being able to inspect these instruments can be just as challenging as making them. Scanning and assessing these features with the latest vision or laser metrology ensures the best reliable outcomes.”
Closed-loop feedback for inspection and adjustments is also getting more sophisticated. “Inspection systems integrated into the machines provide controllers with feedback to adjust on the fly or advise when tooling is about to expire, greatly increasing quality and productivity,” said Zyjeski. “AVNA is currently using this technology on a CNC grinder which inspects the part, provides feedback to the controller, and adjusts or dresses a form wheel, all without operator intervention.”
IoT has made significant inroads in the field of machining and CNC machining, improving automation, data collection, analysis, and process optimization. Automation and robotics, especially, are increasingly vital tools for helping MDMs control costs and stay competitive. Integrating automation with continuous data feedback loops from manufacturing processes helps to maximize uptime by driving down unnecessary downtime and scrap. Machine uptime monitoring utilizes machine data collection (MDC) software for real-time tracking and analysis of any machine’s operational status. As an example, MICRO has constructed an ever-expanding digital twin subnet that now has over 100 machines streaming data monitoring uptime on the factory floor. By continuously monitoring uptime, operators can identify and address issues that may lead to downtime, quality issues, or decreased productivity. MDC software, in conjunction with IoT-enabled sensors, captures vital data such as start/stop times, cycle times, tool changes, and error messages. This data is then analyzed using AI-powered algorithms, providing insights into overall equipment effectiveness, machine utilization, and production performance. “Downtime is reduced through early detection of malfunctions, optimized machine utilization, streamlined processes, and data-driven maintenance strategies based on predictive analytics,” said Cross.
AVNA began building its Industry 4.0/IoT environment years ago. Automation and robotics are a large part of its processes, with dozens of robots and in-house, designed-and-built automated machines. “We integrate production data provided by the machines with our material requirements planning system for real-time monitoring of our manufacturing operation,” said Zyjeski. “This gives us the ability to laser-focus our resources on those areas that provide the biggest positive impact for our customers and employees.”
Augmented reality (AR) is gaining more traction in the manufacturing world. It can be utilized through special glasses like Apple’s new Vision headset or devices like a smartphone or tablet that display information and instructions that are virtually overlaid on a real-world machine. “Using AR, you can access step-by-step visual guides, 3D models, and interactive animations that help you understand and perform tasks on the machine,” said Cross. “It is like having an expert technician right beside you, guiding you through each step, providing real-time information visually and audibly.”
AR can highlight specific parts and components, show how they work and interact, and provide detailed instructions for maintenance, repairs, or even assembly. It can display measurements, safety information, and warnings directly in the field of view, ensuring the operator/viewer follows the correct procedures and stays safe. “This technology could even enable someone unfamiliar with a particular machine to work on it confidently and effectively,” said Cross.
AR will likely evolve to have the same advanced capabilities as a personal virtual assistant, such as real-time guidance, visual and audible instructions, and interactive information visually, live, right in front of the operator. “This could revolutionize the way we approach machinery servicing, repair, and eventually even use, making complex tasks accessible and efficient,” added Cross.
While additive manufacturing (AM) excels at producing complex geometries and customized parts, CNC machining remains unmatched for surface finish, precision, material versatility, and production speed for larger quantities. CNC machining can, however, complement AM, enabling a holistic approach to device fabrication.
“While advancements in AM show great promise, it is unlikely AM will completely take over CNC machining in the foreseeable future,” said Rebello. “Both AM and CNC machining have unique strengths and limitations, making them suitable for different applications. Instead of one technology replacing the other, they are more likely to coexist and complement each other.”
For example, AM is perfect for creating intricate prototypes and custom tooling. It builds up layers of material to form complex shapes. Afterwards, CNC machines can add the final touches and refine the product with precision. “This collaboration allows us to enjoy the benefits of both methods, such as the flexibility to design, the accuracy in production, and a wide range of material choices,” said Cross.
Equipment manufacturers are working hard to create hybrid AM/CNC machines. For example, machining is often needed as a secondary operation to finish AM-made products. A hybrid machine could feed in a semi-finished component and then perform both subtractive and additive manufacturing to create the final product.
Industry 4.0 technologies—especially IoT, automation, and additive manufacturing—are improving quality and efficiency in both machining and laser processing at a rapid rate. IoT-enabled machining equipment can collect a wealth of performance data, using algorithms that allow CNC machines to make adjustments in real time, as well as predict when future maintenance might be needed.
In addition, machining also plays a critical role in medical device manufacturing beyond simply making the part—in-depth machine data is increasingly used to provide all the necessary data the FDA and other regulatory bodies need to verify and validate manufacturing processes.
“An auditable trail, encompassing the part’s lifecycle from material sourcing through to manufacturing, cleaning or sterilization, and packaging is essential,” said Paulsen. “Utilizing robust digital systems accelerates this process, ensuring comprehensive traceability and aiding quick resolution of potential issues, thereby facilitating FDA green lights.”
As CNC technologies continue to merge with IoT, AI will take on an increasingly pivotal (and disruptive) role in optimizing machine systems and enabling technologies in new and creative ways that will greatly expand design capabilities and revolutionize manufacturing.
Chaves Jr. agrees that intelligent machining systems will continue to bring big impacts to medical device manufacturing in the near future. “Intelligent machining systems can already optimize tool paths, predict tool wear, optimize cutting parameters, and even detect anomalies in real time,” he said. “These and future advancements will continue to improve productivity, reduce costs, and enhance process control.”
