Mean Machines for Medical Device Machining

Innovation is not always bred the same way.

Some ideas are carefully cultivated while others are sired from fiction, ambition, necessity, happenstance, mishap, or discontent. Every once in a while, though, innovation is born from an unlikely pairing.

Consider the origins of bronze—one of the ancient world’s great breakthroughs—contrived from a material combination that proved far more capable than anything societies had previously used. 

That combination is composed of copper and tin, two pure chemical elements that, respectively, on their own, are far inferior to their amalgamation. Copper is soft, malleable, and highly conductive while tin is soft and weak; but together they produce an alloy that is considerably harder, stronger, and more durable than either element alone. 

The copper-tin coupling was so transformative that it defined an entire chapter of human progress: the Bronze Age.

Like bronze before it, the printing press was engendered from an unconventional pairing and also changed the course of human progress. Its mastermind was German inventor/craftsman Johannes Gutenberg, who pioneered the idea of combining a coin punch with a wine press to create the world’s first movable-type printing press. That curious combination led to the production of books, which subsequently helped spread knowledge and ideas throughout the Western World.

Healthcare experienced a similar odd combination-driven fundamental shift with the pacemaker’s inception seven decades ago. While tinkering with an oscillator designed to record heart rhythms, American engineer Wilson Greatbatch reached into a box of parts for a resistor to complete the circuit—but grabbed the wrong size (a 1 MΩ rather than a 10 MΩ). To his surprise, the smaller circuit emitted intermittent electrical pulses, just like a human heart. 

“I stared at the thing in disbelief,” Greatbatch reportedly said. He quickly realized that his device—technically conceived by accident, yet born from the improbable pairing of two items that otherwise would never have been put together—could drive a human heart. The battery-making company Greatbatch eventually founded (Greatbatch Inc., now Integer Holdings Corporation) is currently a leading power-component supplier for the medical device industry.

“When you combine two ideas to make a third, then two plus two can equal five,” Paul Sloane, author of “The Leader’s Guide to Lateral Thinking Skills” and “The Innovative Leader,” wrote in a post on InnovationManagement.se. “Nearly every new idea is a synthesis of other ideas.”

And that synthesis of (often unlikely) ideas can produce some pretty imaginative creations. In manufacturing, such ingenuity has emerged from the unexpected marriage of two traditionally feuding forces: additive and subtractive processes.

Hybrid manufacturing combines 3D printing (additive) and CNC machining (subtractive) to produce superior precision medical components. By combining both processes, medtech manufacturers can build intricate internal structures with 3D printing, and then use CNC machining to refine them into precise shapes with exacting surface finishes.

While additive and subtractive manufacturing each have their advantages, together they can enable design freedom and improve production timelines without sacrificing precision.

Hybrid manufacturing also speeds time to market because its agile methodology significantly shortens medical device development cycles. The process enables manufacturers to frequently produce prototypes throughout development, thus enabling early verification through unit tests and manual validation.

“The convergence of additive and traditional manufacturing signals a strategic evolution rather than a replacement,” specialized product development and contract manufacturer GSE Biomedical wrote in a LinkedIn post last fall. “Future hybrid systems will feature AI-driven process control, automated quality verification, and digital twins to predict performance in real time. As medtech continues moving toward customization and faster market cycles, hybrid manufacturing offers the blueprint: flexibility without compromise.”

To learn more about that blueprint and other aspects of medical device machining, MPO spoke with several experts over the last few weeks to gain insights on the overall market. Participants in this discussion included:

• Jeff Haag, vice president of technical solutions at Precera Medical
• Ryan Poff, vice president of sales and marketing at John Evans’ Sons LLC
• Scott Reese, director of business development at Vantedge Medical
• Zane Wyatt, NPI engineering manager at Lighteum Medical

Michael Barbella: Please discuss the industry trends and challenges currently impacting medical device machining. Have these trends/challenges changed in recent years? 

Jeff Haag: There continue to be two fundamental challenges in the medical device industry impacting machining suppliers. The first is the desire for faster responses for prototyping and NPI launches. The second is the continued trend towards smaller and smaller devices for interventional and minimally invasive procedures. These drive the need for more creative solutions and more technical problem-solvers to be available for DFM and rapid response to customer needs. These pressures have intensified in recent years: NPI timelines that once ran 12–18 months now often compress to a few months, and minimally invasive designs are pushing tolerances into single-digit micron ranges, forcing fixturing, tooling, and inspection strategy to be rethought together rather than in sequence.

Ryan Poff: Medical device manufacturers will always ask for tighter tolerances, more complex parts, better quality and traceability, and shorter lead times, while still wanting to control costs. One of the biggest changes we’ve seen in recent years is the increased focus on the supply chain. Customers want to know that their suppliers have the material, capacity, quality systems, and ability to deliver when needed. Certification to ISO 9001:2015, AS9100D, and ISO 13485:2016 gives customers documented evidence rather than assurances, which is what the supply chain conversation now demands. The real shift we see is the need for more support with lower-volume development and prototypes that can move into production quickly. Flexibility on the front end cannot come at the cost of consistency on the back end. Holding both is the actual requirement.

Scott Reese: Expectations have definitely changed. It used to be enough to make a good component and deliver it on time. Today, OEMs expect quality, speed, cost control, supply stability, and the ability to scale, all at the same time. Devices are also getting more complex, which puts more pressure on the entire process. It’s not just whether you can make the component once. You have to be able to repeat it, inspect it, document it, and continue producing it reliably as demand changes. The labor shortage is another major challenge. A lot of highly skilled machinists, toolmakers, and engineers are reaching retirement age, and there aren’t enough experienced people coming in behind them. Automation has helped, but only if it’s applied the right way. Putting a robot next to a machine doesn’t automatically create a better process. You have to understand how the equipment, inspection, data, quality systems, maintenance, and people all work together. A machine may solve one production challenge, but if it’s not connected to the larger manufacturing process, its value is limited.

Zane Wyatt: Historically, the primary focus was maintaining tight tolerances on a single machined component. Today, the challenge is maintaining those tolerances across ultra-complex, multi-material micro-assemblies (e.g., bonding a precious group metal electrode with specialty PVD coating onto a nitinol spine). Furthermore, OEMs now demand vertically integrated contract manufacturing organizations (CMOs) that can provide concurrent engineering, automated micro-machining, specialty coatings, and complex sub-assemblies under one roof.

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Barbella: How has demand for precision machining evolved over the past several years?

Haag: More companies are developing RAS systems, and these systems have shifted some focus toward larger parts than most medical machining companies are used to dealing with to support the construction of the robots themselves. The parts in these systems can be as large as 30+ inches with a blank weight of several hundred pounds. Having the right resources and approach to help OEMs with these types of parts while still serving the micro-component needs presents both challenges and opportunities. This bimodal demand—large structural RAS components on one end, micron-tolerance implants and instruments on the other—is pushing some CDMOs to build two distinct capability sets under one roof rather than specializing in just one.

Additionally, as demand has increased for smaller parts with tighter tolerances, in higher volumes, the industry has turned to higher-throughput machines such as rotary transfer and multi-spindle machines seen traditionally in the automotive industry, along with a high deployment of robots and other automation techniques to reduce labor costs.

Poff: Demand for precision components has grown steadily as devices get smaller and more complex. On the spring and wire form side, we’re seeing the same pressure the machining world is. There is a huge focus on tighter tolerances, tighter consistency, and far more process control than a print alone would suggest. We’re also getting involved earlier in the development process. Customers are looking for our engineering input on the design, materials, manufacturability, and overall performance of the part, not just asking us to build to a print. Customers want a supplier that can help solve problems, not just make the part.

Reese: Precision machining is no longer just about making the components. It is about creating a process that can carry that component from development through scale. The growth of minimally invasive and robotic-assisted procedures has increased the need for highly precise components, from surgical staplers and laparoscopic tools to orthopedic implants and bone screws. These components are often smaller, more complex, and harder to make consistently. Holding a tight tolerance once is one thing. Repeating it, verifying it, and keeping the process stable as volumes change is the bigger challenge. That is especially true in robotic-assisted surgery, minimally invasive surgery, surgical instrumentation, and orthopedics. Many programs start with a prototype or a low-volume build, but the process still has to be designed with validation and full production in mind.

Wyatt: The continued adoption of minimally invasive therapies has turned micro-machining into a standard requirement rather than a niche capability. The desire to fit more capability into devices that cannot be increased in size due to anatomical constraints has led medical device companies to push CNC machining to its tolerance and feature-size limits. We are seeing a drastic uptick in demand for parts featuring single-digit micron tolerances, zero heat-affected zones (HAZ), and complex geometric arrays that enable both diagnostic and therapeutic capabilities.

Barbella: How is AI being used in machining, inspection, predictive maintenance, or process optimization?

Haag: Beyond inspection, we’re applying AI to predictive maintenance—using spindle load, vibration, and tool-wear sensor data to flag machine or tooling issues before they cause scrap or downtime. In-process, AI-assisted metrology is also emerging, catching dimensional drift in real time rather than waiting on post-process CMM results, which shortens feedback loops on high-mix, low-volume medical work.

Reese: AI is helping manufacturers make better use of the data they already have. In machining, it can look at things like cycle times, downtime, machine alarms, tool life, and capacity. That can help teams identify trends, understand where they are losing time, and see where a process may be starting to drift. In inspection, for example, AI can help identify patterns across a larger set of quality data, giving teams a chance to respond earlier, before a small issue becomes a bigger one. Predictive maintenance is another practical use. If the equipment is showing signs that something is changing, the goal is to address it before the machine goes down unexpectedly. At the same time, as we look toward Industry 5.0, we are seeing a shift to bringing people back into the center of the equation. Where Industry 4.0 is about connecting machines and data, Industry 5.0 is about reconnecting that data with the people on the floor and the years of hands-on experience and knowledge they bring. The question is not just how much technology we can add. It is how to make a highly connected, automated system work better through human input, experience, and critical thinking. AI can help surface patterns and provide better information, but you still need people who understand the equipment and the process well enough to interpret what the data is saying and decide what to do next. Industry 5.0 is not just a technology upgrade. It is a business strategy that brings automation, human expertise, and sustainability together to create more resilient, flexible, and higher-value operations.

Wyatt: Inspection: Vision systems driven by AI deep-learning algorithms can now detect micro-burrs, micro-cracks, and coating anomalies on complex 3D geometries that human inspectors or traditional vision systems might miss.

Predictive maintenance: Acoustic and vibration sensors on high-speed Swiss spindles feed data into machine learning models to predict tool breakdown or spindle wear before a failure occurs, preventing scrap on expensive materials like Platinum-Iridium.

Barbella: In what ways are advancements in automation, materials, digital technology, and additive manufacturing driving innovation in CNC machining (and/or laser processing equipment)?

Haag: Camera technology combined with AI integration will continue to play a significant role going forward to detect and segregate parts that do not meet the dimensional or functional intent of the product. Detecting minute surface imperfections has historically been done with human visual inspection. There is no reliable way to calibrate and correlate one human eye to the next. Advanced camera technology coupled with a trainable AI agent removes this obstacle, resulting in a more robust quality output.

On the laser side, femtosecond (“cold ablation”) lasers are becoming more central to this trend. Because they cut with virtually no heat-affected zone or recast material, they leave burr-free edges without secondary deburring—a real advantage for bioresorbable magnesium and zinc alloys, which are reactive and prone to yield loss when post-processed after conventional fiber-laser cutting.

Wyatt: Automation and laser: We are seeing the integration of laser machining with custom automation in a single machine envelope to automate material feeding and part handling, maximizing efficiency. Additionally, femtosecond laser machining has evolved from primarily through-cutting and etching into more complex blind laser ablation, with the ability to perform turning and edge-profiling operations traditionally limited to Swiss machining. This allows a component to be turned, have features cut, and be parted off in a single setup without imparting thermal damage.

Materials: The proliferation of delicate, ultra-thin-walled PGM tubing has forced manufacturers to develop innovative material-handling tooling and laser-cutting algorithms that enable automated material loading while achieving perfect cut quality without damaging the material.

Digital technology and additive: While additive manufacturing is widely used for orthopedic implants, in micro-machining, it is heavily used for rapid DFM prototyping and creating custom, highly geometric work-holding fixtures for CNC machines.

Barbella: What are customers looking for in machining solutions/services?

Haag: Cost reductions continue to be at the forefront of most OEMs’ list of objectives. Partnering with an innovative supplier who desires to work with OEMs in the early design cycles of a new product is critical to driving as much cost out as possible. Customers continue to look for these suppliers to support them through the entire cycle. They are beginning to understand that once a design passes certain gates in the prototyping stage, they can miss out on opportunities for an optimized overall product cost if they are only working with prototype shops or services during development. Total cost of ownership is increasingly the real conversation—customers weigh scrap rates, inspection burden, logistics, and supply continuity alongside piece price, not just the quoted unit cost.

Poff: Everyone says customers want more than price. What they actually want is to stop worrying about you. A medical device program runs for years after launch. The purchasing conversation is about this quote. The real conversation is whether the supplier will still be here, still holding the same process, still producing the same part in year eight, when requalifying would mean opening a validated supply chain back up. That is what customers are buying when they screen for quality systems and documentation. They are buying the absence of a future problem. Traceability and documentation matter for the same reason. They are not paperwork. They are the evidence that what we did last year is what we will do next year. That is where being certified to ISO 9001:2015, AS9100D, and ISO 13485:2016 does its work.

Wyatt: OEMs are looking for operational velocity, scale, and technical depth. They do not want a supplier that simply executes a print; they want an engineering partner who can evaluate an early-stage PFA electrode array and apply DFM principles to make it scalable. Beyond technical capabilities, they require absolute regulatory data transparency, end-to-end component traceability, and an airtight quality management system (QMS).

Barbella: What advice would you give OEMs selecting a machining partner?

Haag:  Seek out true partners to engage with early that can help with DFM and early-stage prototyping.  The knowledge gained by both the OEM and supplier, who collaborate early and often, is the best pathway to a robust and cost-effective design.  Select a supplier with redundant technology resources that have a track record of delivering results from the early design through volume production, with robust systems to support the entire product life cycle. One good litmus test: ask a candidate partner how they have addressed technical challenges on similar products, along with examples of how they have been able to scale and support the entire life cycle of medical products.

Poff: I would look beyond just price and lead time. Those are important, but you also need to look at the supplier’s engineering capabilities, quality systems, capacity, and ability to manage the supply chain. It’s important to find a supplier that will get involved early and give you honest feedback on the design and manufacturability. This will help prevent problems later. Most importantly, choose a supplier that you can grow with. You want a partner that can support you from development and prototypes through production, and keep supporting the program for as long as the device is on the market.

Reese: Do not make the decision on piece price alone. A low quote can become very expensive if it leads to quality problems, redesigns, missed timelines, or a difficult production launch. Start by looking at the quality system and the people behind it. Ask how the supplier controls the process, manages changes, handles traceability, and responds when something goes wrong. You should take a close look at the technical team. Owning the right equipment is important, but experience matters just as much. You want people who understand the material, the geometry, the tooling, the inspection requirements, and how the device will eventually scale. Communication is another big one. You learn a lot about a supplier by how they handle a difficult conversation. The right partner will be honest about the issue, take ownership, and bring you a clear path forward.

Wyatt: Do not select a partner based on its machine list; select one based on its vertical capabilities and material expertise. Anyone can buy a Swiss machine or a laser, but handling Nitinol without damaging its shape-memory properties—or machining Platinum-Iridium without astronomical scrap costs—requires deep, specialized metallurgical knowledge. Ensure your partner owns the post-processing and surface-treatment steps (such as electropolishing, passivating, and PVD coating), as these steps dictate the ultimate biocompatibility and performance of the device.