Leveraging Lasers for Medical Device Manufacturing

Machining and laser processing in the medical device industry are evolving rapidly to meet growing demands for smaller, more complex, and highly functional next-generation devices. Manufacturers are adopting hybrid machining solutions, precision micromachining techniques, and multi-axis systems to achieve tighter tolerances, improved surface finishes, and extremely complex geometries. “The level of manufacturing accuracy that is required today also calls for state-of-the-art inspection tools,” said John Cross, director of advanced machining for MICRO, a Somerset, N.J.-based full-service contract manufacturer (CM) that specializes in medical assembly, precision metal stamping, insert and injection molding, machining, finishing, and assembly.

For example, automated coordinate measuring machines (CMMs) can be used to perform process inspections and produce first-article reports. In addition, digital multimeters have the capability to take thousands of data points during a scan of a complex curved surface, which is ideal for complex geometries. Advances in inspection technology such as machine vision-enabled systems continue to ensure quality measurements can still be taken as features get smaller with tighter tolerance requirements. 

“At Micro, we are also seeing a strong convergence of automation, robotics, and advanced materials, which is redefining what is possible in medical device design and manufacturing,” said Cross. 

One of these advanced machining technologies is grinding, which plays a crucial role in producing complex geometries and fine finishes for components such as surgical tools, orthopedic implants, and dental devices. Other solutions such as multi-axis CNC (computer numerical control) machining, automation, and hybrid processes are now considered standard for ensuring high-volume production with uncompromising quality. 

“CNC machines, known for their precision, flexibility, and automation, are pivotal in addressing the industry’s need for efficiency and repeatability, while artificial intelligence (AI)-driven process optimization and real-time monitoring help ensure regulatory compliance and process reliability,” said Zac Henninger, regional sales manager for ANCA, a Wixom, Mich.-based supplier of CNC tool and cutter grinders for a variety of industries. 

What OEMs Want

Top priorities for medical device manufacturers (MDMs) are quality, speed, and total engagement with their supply chain partners through a design for manufacturability team approach. MDMs seek partners that have quick turnaround knowledge about materials and manufacturing processes, as well as the ability to support production manufacturing, R&D, and quality control. Other key considerations are risk management and efficient operations utilizing the Internet of Things (IoT), AI, and cost controls. 

Requests from MDMs often include smaller and more complex components, which require intricate parts with tight tolerances to reduce overall device size, while still expecting an increase in functionality. “MDMs are continually raising the bar and asking manufacturers to step up in creativity and capability,” said Cross.

Cost-effective, high-volume production with fast speed-to-market is another top demand. MDMs also want scalable solutions that maintain quality and precision while reducing per-unit costs. “MICRO operates with the mentality that every process we develop in the prototype phase needs to be directly transferable to a highly effective production process so we accelerate product launches to production,” said Cross.

Rapid prototyping boosts speed and efficiency while also reducing lead time. MDMs seek machining and laser processing solutions that deliver high throughput without compromising quality. “Competitive pricing always remains a priority,” added Henninger. “MDMs want contract manufacturers that provide the best value by balancing quality, speed, and cost.”

When combined, these factors enhance customization and flexibility. This includes the ability to adapt processes for small batch sizes or unique designs, as well as flexibility in production schedules. Customization often calls for high precision and tight tolerances in machined components. “There is a growing need for machining capabilities that can handle a wide range of materials, including advanced composites, titanium, and high-strength alloys,” said Henninger. “MDMs are eager to find suppliers that can work with these materials effectively.”

Technology Trends 

Machining technologies continue to advance, pushing the limits of material science and machine capabilities to the limit. These technologies include:

• Micromachining—With the push for minimally invasive and robotically controlled surgical devices, there is a growing demand for high-precision micro-machined parts with extremely tight tolerances and highly complex geometries. 
• Hybrid manufacturing—The combination of traditional CNC machining with laser processing is becoming more common, especially for complex parts that require both subtractive and additive processes. 
• Laser micromachining—Lasers are increasingly used for ultra-fine cuts, drilling, and marking, especially for applications that require the highest precision. “We use precision laser cutting in place of traditional machining for thin-walled tubing to ensure a robust process and a high-quality product,” said Cross.
• Automation and AI—Automation in machining cells and the incorporation of AI for process control and quality inspection are gaining traction, improving efficiency and reducing lead times. “MICRO is considering partnerships with well-known web services to integrate AI into our document control systems, aiming to enhance workflow and streamline

Recordkeeping while ensuring strict adherence to guidelines. As an ISO-certified medical manufacturer, maintaining compliance and upholding the highest standards is paramount,” Cross added.

The hottest segments for machining include cardiovascular devices, orthopedic implants, and robotic-assisted surgical instruments, where high precision is mission-critical. Robotic-assist procedures are on the rise, thanks in part to an ever-expanding range of applications and the popularity of laser-cut hypo tubes, “which are a game-changer that translates the wishes of surgeons and developers into real surgical steps and sub-steps,” said Todd Dickson, president of Lumenous Device Technologies, a Santa Clara, Calif.-provider of precision components and assemblies for medical device companies, including nitinol semifinished materials production and component manufacturing. 

Laser-cut shafts enable robotic assistance in a variety of surgical procedures. For example, laser-cut shafts increase the inner diameter (ID) lumen or reduce the device profile, which can make devices more capable compared to braid-reinforced lumen. Other key features are:

• Diameter range—0.2 mm OD (outer diameter) to 26 mm OD
• Speed of development—Lead times within 24 hours 
• Cost of production—Taking over more applications that used to be the exclusive domain of braid-reinforced shafts
• Established, ubiquitous pattern families such as the interrupted spiral and circumferential brickwork
• Revolution of advanced patterns that radically optimizes medical performance by achieving previously incompatible combinations of mechanical properties, such as low bending stiffness for access and high axial stiffness for precise therapeutic targeting

Lumenous Device Technologies is pioneering laser-cut tube integration with liners and jackets that adhere to the shaft but are also hyper-lubricious for internal components and guidewires. “This knocks the quality struggle with delamination down to zero,” said Dickson. “It also opens up the design space for high-performance delivery, since old-school large-diameter laser-cut reflow windows and wide-gap slots all over the shaft are obsolete. Our Lumenous Everglide technology, which integrates laser-cut tube shafts with our family of Everglide extrusions, boosts the performance of traditional Pebax with a non-migrating lubricious additive. This delivers a quadruple-punch in performance, cost management, scalability, and health and safety.” 

Machining is also evolving rapidly to meet customer demands for high-precision, biocompatible components. Grinding is at the forefront of these advancements, “with an emphasis on achieving tighter tolerances, exceptional surface finishes, and the ability to handle intricate geometries required for surgical instruments and orthopedic implants,” said Henninger. “Automation and multi-tasking machines are streamlining production, reducing lead times, and improving consistency, which are critical in highly regulated fields like medical devices.”

CNC vs. Laser Processing

Micromachining and laser processing are processes that are more complementary than competitive; deciding which one to use often depends on the specific medical device application. For example, CNC machining is commonly used for producing devices such as orthopedic implants, which are larger, structurally complex medical devices. Lasers, however, are preferred for processing thin-wall, complex materials such as nitinol and other soft or hardened materials.

“Both lasers and traditional machining have their own specific applications,” said Troy Oberg, manager of laser technology and development for Laser Dynamics, a Hutchinson, Minn.-based contract laser materials processing company that specializes in laser marking, laser micromachining, and laser micro welding. “However, lasers have a slight advantage over CNC machining when it comes to feature size. Typical lasers can focus down to about 0.001 inches and even smaller for specialized laser systems and thinner materials.”

The ratio of standard CNC-type machining to laser processing in the medical device industry varies based on the application, but CNC machining remains the dominant process for a majority of components, especially for those requiring high precision, robust material removal, and complex 3D geometries. 

CNC machining capabilities are:

• Complex 3D geometries—CNC machining is essential for creating intricate shapes, such as surgical drills, orthopedic implants, and prosthetics, which require multi-axis grinding, milling, or turning.
• Material removal for hard metals—CNC machines excel at cutting through tough materials like titanium and cobalt-chromium used in implants.
• Threading and contouring—tasks such as screw threading for bone fixation plates or detailed contouring of implant surfaces rely on CNC processes.

Lasers are typically highly specialized and limited in what they can do in a manufacturing environment. They are most often used for marking, micromachining, welding, cutting, drilling, heat treatment, surface treatment, and more recently laser additive manufacturing, which uses laser beam technologies (stereolithography, selective laser sintering, and selective laser melting), creating new freedom for medical device designers.

Oberg often receives requests for laser-cut patterns that leave only a few thousandths of an inch of material between adjacent cut-out areas. These types of designs are not suitable for traditional laser cutting because a heat-affected zone (HAZ) often forms next to the laser cut that will warp or even melt away small areas of metal adjacent to the next cut area, impairing performance. Similar problems and challenges can be found when laser micromachining with a galvo-based beam delivery system.

“Femtosecond laser systems have improved some of these HAZ issues, as they can cut with less heat input to the adjacent material due to their extremely short pulse lengths,” said Oberg. “Many femtosecond laser systems can operate with a pulse length of a few hundred femtoseconds or less. To put that into perspective, one femtosecond is equal to one-millionth of one-billionth of a second, which can also be stated as one quadrillionth of a second.”

Innovation at the Forefront

Many new advances in machining rely on IoT, AI, and increasingly powerful software. For example, recent innovations in tool grinding software, such as those available in ANCA machines, enable greater precision and efficiency. These improvements allow for faster setups, simulation-based design validation, and optimized tool paths, thereby reducing cycle times and enhancing flexibility for producing intricate medical components.

Integration of automation features such as robotic tool handling, part probing, and in-machine measurement systems improve efficiency and reduce human error—streamlining production workflows for high-precision medical devices while maintaining repeatability. AI-powered machine monitoring platforms improve efficiency by predicting maintenance needs, optimizing tool life, and minimizing downtime. These systems ensure machines are running at peak performance, which is critical to meet the medical industry’s stringent quality standards.

As components become smaller and more complex, it is even more critical to be able to identify and measure the tiniest defects. In-machine measurement and laser scanning systems ensure every part meets specifications without the need for secondary inspections. These systems can detect deviations in real time, enhancing process reliability. For post-processing inspection, “high-resolution optical inspection systems can measure and validate features at sub-micron levels,” said Henninger. “This ensures compliance with the strict tolerances required for medical devices. Also, with closed-loop feedback, integrated inspection data can now be fed back into CNC systems to make real-time corrections, further ensuring quality and reducing waste in production.”

One of the most exciting aspects of IoT is being able to integrate machining and laser processing systems to create a connected, intelligent manufacturing environment. This allows for real-time monitoring, predictive analytics, and seamless communication between machines, operators, and production systems. As an example, ANCA’s AIMS Connect (ANCA Integrated Manufacturing System) optimizes connectivity, automation, and data management across ANCA’s CNC grinding machines and the broader manufacturing ecosystem. By enabling seamless integration between machines, automation systems, and monitoring tools, AIMS Connect provides:

• Tight controls control over manufacturing parameters, guaranteeing consistent production 
• Real-time data and predictive maintenance that reduces downtime and machine idle time
• Automated workflows streamline production, meeting the high demand for medical devices
• Centralized data management provides comprehensive documentation for audits, making it easier to comply with regulatory standards 
• Scalability for high-volume production, enabled through automated workflows and IoT-driven optimization

“Integration with in-machine and external inspection systems allows for real-time feedback and automatic adjustments, ensuring compliance with the stringent tolerances,” said Henninger. “Manufacturers can monitor and adjust production processes remotely, providing flexibility and reducing the need for on-site supervision.”

In the CNC world, five-axis machining is in high demand. Because it provides enhanced flexibility and precision by operating on five different axes simultaneously, this machining technology is preferred for creating high-precision medical devices with complex geometries and tight tolerances. Very challenging components can be completed in one setup, saving time by eliminating reorientations. Five-axis machining also enables rapid prototyping and can easily cut some of the most difficult materials, including titanium, cobalt-chromium alloys, and biocompatible plastics.

Moving Forward 

CNC machining and laser processing are both highly advanced processes that rely on high-precision equipment, new materials, surface-finishing technologies, inspection systems, and sophisticated software to meet the ever-evolving needs of MDMs 

As medical devices get smaller, machining will become more challenging—for example, creating more intricate features, maintaining tighter tolerances, and dealing with increasingly difficult quality/regulatory standards. Manufacturers must keep investing in advanced manufacturing and inspection technologies to meet these challenges. Some of these technology advancements include quantum computing, hybrid manufacturing, and femtosecond lasers. New cutting tools with better coatings, base materials, and geometries will also be needed. 

IoT will play a key role in this transformation by enabling smarter, more efficient, and highly precise manufacturing systems. “These IoT-enabled solutions will enhance quality control, improve throughput, and ensure full traceability, all of which are critical for the stringent requirements of the medical industry,” said Henninger.

Laser machining, in particular, is taking on a larger role in the production of intricate, small-scale components. Because lasers can create such high-precision features at the micron level, they are ideal for applications where miniaturization is critical (for example, ophthalmic devices, leadless pacemakers, and neurostimulation devices). 

More innovations are on the way, such as localized feature processing, burr-free machining via locally variable electrochemical removal, and surface modulated laser cleaning. Other emerging technologies include micro-precision half-micron processing, surface stress-free machining, deep-hole processing, and processing of pre-coated surfaces, which frees engineers from trying to manage the shrinking effect in curing and drying when coating machined components. 

Hybrid machine tools will be another key growth area for machining in the coming years. Setups that include CNC machining, laser cutting, and laser welding are already on shop floors. Some hybrid equipment can make small, high-precision cuts that cannot be achieved by conventional machining. AM can be added, as well as increasingly sophisticated micro-machining. Hybrid equipment drives costs down by shortening lead times for prototyping, increasing throughput, reducing scrap, and improving process capability, delivering a fairly quick return on investment. 

Finding the right combination of machine tools is essential for the efficient production of complex parts, which can be accomplished by turning, milling, and hole-making on a single hybrid machine. For example, LaserSwiss technology combines CNC machining and laser processing into a single step, increasing both efficiency and speed to market. These machines are also equipped with live tool stations that can produce complex features; small parts that do not require turning or drilling can be produced solely with live tooling. In the near future, hybrid machines will also be equipped with inspection capabilities, along with other IoT tools, to further increase process optimization.

“In manufacturing, everything is a trade-off,” said Oberg. “Having a broad knowledge of many machine tools and their capabilities—from wire electrical discharge machining to surface grinding to plastic injection molding and 3D printing, as well as multiple laser processes—give designers and engineers the insight to choose the correct path, saving time, energy, and money throughout the design process. It allows them to redesign their product with the limitations of each available machine tool in mind, allowing them to arrive at the point more quickly where they have a viable product.”

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.