Finnish firm Bioretec’s next-generation, patented bioresorbable material, RemeOs, is based on magnesium, zinc, and calcium, which are all essential elements for new bone formation in the human body.

The material retains the metallic properties of high strength, rigidity, and hardness without needing implant removal. The company claims the strength retention of RemeOs implants is tailored to match bone healing, combining the handling and feel of traditional metal implants with absorbable properties.

RemeOs implants are resorbed and replaced by bone, eliminating the need for removal surgery while facilitating healing of fractures. The company believes the material could make titanium implants redundant and help clinics reach value-based healthcare targets.

The first product made using this material, the RemeOs trauma screw, earned U.S. Food and Drug Administration (FDA) market authorization in 2023 for use on ankle fractures. In achieving this approval, the RemeOs trauma screw won the title of the first and only bioabsorbable metal implant approved by the FDA.

In June 2023, Bioretec announced that it acquired a new CNC machining center to increase the production of its RemeOs and Activa products in its Tampere, Finland, facility. The company said the acquired machine is optimized to produce magnesium-based implants, especially for the RemeOs screw.

This reported optimization likely includes the safety features necessary when machining magnesium alloys. Though prized for its lightweight and machinable properties, magnesium holds the inherent risk of its extreme flammability. It can ignite when exposed to air, particularly under high temperatures or when ground into fine particles.

As such, maintaining CNC machine integrity is crucial when machining magnesium. Over time, regular wear and tear can compromise safety, particularly if magnesium residues accumulate in the machine parts. These residues might become ignition sources if they are contacted by sparks or high temperatures.

Machines designed for magnesium may have features that reduce fire risks, like integrated fire suppression systems and designs that minimize the accumulation of magnesium chips. They may also have optimized cutting parameters that lower heat generation.

Of course, the machine is only half the risk—operators must also be properly trained to safely machine magnesium. Training must cover handling magnesium chips, detecting hazards, and taking quick action during fires. Beyond preventing fires, understanding proper machining techniques and learning to avoid tight clearance angles is paramount.

Advanced materials like magnesium, titanium alloys, and cobalt-chromium alloys are just one challenge that machinists face in making orthopedic devices and components. There is a constant drive for precision in orthopedic device manufacturing to create smaller features, tighter tolerances, and more complex geometries. Some devices also demand functional surfaces to promote bone growth.

Machining is a complicated process that needs expensive, high-precision tools and materials, as well as the skilled machinists to operate the equipment. In order to explore this topic further, ODT spoke to several experts in machining technologies and services for orthopedic device manufacturing:

• David Cabral, president and CEO of Five Star Companies, a New Bedford, Mass.-based provider of surgical instrument maintenance, repair, and manufacturing services to hospital organizations, OEM instrument manufacturers, and surgeons.
• Tanya DiSalvo, president and CEO of Criterion, a Brook Park, Ohio-based provider of precision machining for the medical device, aerospace, defense, and photonics industries.
• Matthias Dreher, head of global key account management at Schwäbische Werkzeugmaschinen (SW Machines), a Waldmössingen, Germany-based supplier of single and multi-spindle CNC machining centers.
• Jobi Ellison, strategic account manager at Rösler Metal Finishing USA, a Battle Creek, Mich.-based provider of machines and integrated systems for mass finishing and shot blasting, as well as development and production of dedicated consumables.
• Nick Martin, North American business development manager at GF Machining Solutions, a Lincolnshire, Ill.-based provider of milling, electrical discharge machining, laser micromachining, and metal additive manufacturing services for the medical device industry.
• Karin McQuillian, business development manager, medical industry at Tyrolit Group, a Schwaz, Austria-based manufacturer of grinding and dressing tools, as well as a system provider for the construction industry.
• Trisha Mowry, CEO of Metal Craft and Riverside Machine & Engineering, an Elk River, Mass. and Eau Claire, Wis.-based full-service machining provider.
• Eric Ostini, business development manager at GF Machining Solutions.
• Duncan Thompson, special projects manager at ANCA, a Melbourne, Australia-based manufacturer of CNC grinding machines, motion controls, and manufacturing solutions.

Sam Brusco: What steps does your company take to attract skilled machinists and support their ongoing education?

David Cabral: We attract skilled machinists—and all our associates—through a high-caliber package (health and dental insurance, life insurance, 401k w/match, holidays, vacations) and other generous benefits that make them feel appreciated and valued. We also work with local vocational schools, a community college, and UMASS Dartmouth to provide co-ops, internships, summer, and permanent employment after graduation and apprenticeship programs for those staying in our company.

We have a vast array of job opportunities and offer growth from within based on newly-learned skills, as well as promotional growth as a result of excellent performance. Our associates are truly our most critical asset and we make sure they know it.

Tanya DiSalvo: We cover our bases with what are now basic requirements: Ongoing education, competitive compensation packages, apprenticeship and mentorship programs, tuition reimbursement, investment in technology and equipment, recognition, awards, and company lunches.

I believe what’s most important is having individuals on the team know they have a voice and we value their opinion. We just conducted “stay interviews,” which are the opposite of an exit interview. We take an hour with each employee to find out their morale and mindset and how can we help improve it if needed.

We would rather address small issues before they grow into a big problem that may cause us to lose a team member. I was thankful for everyone’s honesty in this endeavor, and the leadership group has bullet points we are working to address.

Matthias Dreher: We have a comprehensive program that works to attract new entrants through an apprenticeship model, which we run in Germany and across the world, including in the U.S. This way, we generate our own skilled technicians for assembling, applications, or services.

We find it’s important to teach the knowledge from scratch to help apprentices become more confident in the profession later on. Additionally, a very good internal academy and training department is critical to educate on current priorities, technology, and systems, as well as continuing education to improve the depth and breadth of knowledge.

We want to create curiosity among colleagues to understand the “why” behind our company and processes, and empower them to use their skills to make things better, faster, and easier.

Jobi Ellison: Any Rösler technicians that help to install and maintain our equipment across the U.S. must be highly skilled and familiar with the nuances of the machines and processes. Most of the technicians spend a lot of time in our CEC (Customer Experience Center) in Battle Creek, Michigan, and our headquarters in Untermerzbach, Germany.

Trisha Mowry: We are very active with local technical colleges, colleges, and universities. We also partner with smaller trade schools and high school technical programs.
It’s about educating what manufacturing talent is available, then furthering development in the organization. We support further training through tuition reimbursement and training programs on site within our facilities.

Eric Ostini: I hear the statement “I can’t find good people” from our medical customers all the time. We manufacturers also often struggle to find good people that will work in service and application support positions.

Our strategy is when we can’t attract skilled machinists, we create them through internal training and education. Then we provide them ample opportunities to grow within the company.

Duncan Thompson: Being based in Melbourne, Australia, ANCA faces a limited pool of skilled tradespeople and machine operators. This is why we run a four-year apprenticeship program in collaboration with a Melbourne-based professional trade school.

The opportunity to complete formal training while getting paid with hands-on learning is a big draw for new apprentices and provides a stream of new talent to take up roles in machine operating, assembly, commissioning, and more. These same apprentices also get involved in projects working with undergraduate engineers as they compete to build their own race cars as part of their undergraduate degrees. This not only allows them to apply their learnings in a practical and fun project, but also develops comradery in the working teams that we have in ANCA.

Our best and brightest apprentices get nominated for state and national awards for Apprentice of the Year, which is great recognition of their accomplishments. We are very much a vertically integrated company, maintaining skills and capabilities across all aspects of machine design and manufacture. This means graduating apprentices recognize diverse and exciting opportunities in their employment future with us, including opportunities to travel and be posted to our overseas branches.

Brusco: What are the major orthopedic device market forces at present and how are they affecting your business?

Cabral: I see a major force in using 3D technologies for implants and other orthopedic components and assemblies, as well as a continued focus on disposable instrumentation.

This affects my business because we don’t utilize 3D technologies, nor do we derive substantial sales from manufacturing disposable instruments. Although we’re not engaged in these areas, we provide some secondary operations to 3D-printed components and are initiating new opportunities with single/limited-use products.

DiSalvo: Many OEMs and device companies are pushing the envelope, driving more sophisticated devices. The engineers behind the scenes are younger and less experienced in the actual production of complex components. That pushes shops like ours to focus on our investment strategy in order to keep up with cutting-edge technology and continue to satisfy customer demands.

Regulatory standards also require extensive quality management systems. Compliance can be costly and time-consuming for small manufacturers like us.

Dreher: The major market requirements in the orthopedic device space vary widely. One force I see is better understanding and willingness from suppliers in terms of validation and quality, bringing more suppliers to the global field, and driving the cost pressure up. This mostly concerns the cost per part for end customers and has the potential to provide a larger selection.

The quality and machines used in lower-cost regions are also getting better, pushing long-term suppliers to generate savings in their existing production environment.

Most of the time, this means large changes in production and assembly methods after years of success. Therefore, it is necessary to see and understand the current situation, adapt to the challenges, and take a step toward new production technologies.

Ellison: This market is driven by a high incidence of orthopedic disorders, a growing aging population, and increasing degenerative bone disease. When these trends are on the rise, so is demand to increase production of parts like hip stems and femoral implants. High production demand calls for the use of equipment to finish them, rather than manual labor.

Nick Martin: The most dominant orthopedic market force is growth—according to several industry forecasts, the orthopedic market is expected to experience between 6% and 8% growth per fiscal year through to 2027. On top of that, the U.S. market makes up about 70% of the approximately $62 billion worth of worldwide orthopedic sales, with many industry experts expecting that amount to reach $70 billion by 2027.

To keep pace with that growth, the broad range of orthopedic OEMs are undergoing mergers and acquisitions and seeking to further innovate production operations.

McQuillian: An aging and growing population is leading to an increase in age-related degenerative diseases. There’s more access to and investment in healthcare as well, leading to a growing number of surgical volumes. This caused an increase in tools required to manufacture the larger demand for orthopedic implants.

Thanks to our expertise in grinding solutions, we can support continuous and rapid growth of additive manufacturing of hip and knee implants. Customers can achieve their surface requirements, while we supporting the process and help to optimize cost.

Mowry: Building on automation and complete manufacturing have been the largest focuses given our current and rising skilled labor shortage.

Thompson: The growth in orthopedic surgical procedures is driving growth of consumable surgical instruments and implants. This is forcing manufacturers to explore equipment that can help increase their output while still driving down production costs. Reliable, consistent production lines that can run unattended is a key driver for our customers.

Brusco: Which mainstay or newer machining technologies, tools, and/or systems are you finding most useful to support the manufacture of complex orthopedic devices?

Cabral: In recent years, we have been producing similar types of instruments in larger volumes and incorporated use of a pallet pool, a type of machining technology. With this system, our techs can load material blanks while the machine is running and change fixture and program configurations on the fly.

This system minimizes machine downtime and allows us to continue manufacturing in a Lean environment; shortening lead times, while making the product configuration that a customer requires. Because the different finished goods are loaded into the pallet pool, the need for additional setups, tooling, and changeovers are significantly reduced.

DiSalvo: In the realm of manufacturing complex orthopedic devices, we identified three machining technologies, tools, and systems to help us create the factory floor of the future to focus on the team, quality, precision, and efficiency:

• Computer-aided design (CAD) and computer-aided manufacturing (CAM) software are crucial for producing the intricate orthopedic implants and generating tool paths for machining.
• Multi-axis machining centers, such as 5-axis and even 7-axis machines, enable simultaneous machining from multiple angles, enhancing efficiency and accuracy when producing complex orthopedic components and allow us to be hands-off as much as possible. This allows for less human error.
• In-process inspection technologies, such as coordinate measuring machines (CMMs) and optical measurement systems ensure orthopedic devices meet stringent quality standards throughout the manufacturing process.

Dreher: It’s not a specific technology or system that is most useful to support manufacturing—it’s more important to find the right partner to integrate those technologies and systems to specific production needs. A great system or CNC machine will not be helpful if it doesn’t fit the manufacturer’s requirements which are different between companies—even in the same industry.

The most useful way to support the manufacturing of complex devices is a CNC machine and automation supplier that understands the unique issues, has flexibility in their processes, and is willing invest the time to find specific solutions that can help manufacturers build a specialized, sometimes one-of-a-kind, solution.

Ellison: We believe that our drag finishing and surf finishing equipment, along with our media selection and water treatment (on demand as well as fully automated), is necessary for OEMs and contract manufacturers to keep up with the demand and precision required for these parts.

Martin: We are tracking upticks in use of both our wire and sinker electrical discharge machine (EDM), milling machine, laser texturing, and laser micromachining technologies. In particular, we foresee in the next three years that use of our laser technology will increase dramatically in the medical sector, especially for production of implants and endoscopic components.

We also notice more smaller-size suppliers to the medical device industry incorporating automation, ranging from pallet systems to standalone robots to fully automated multiple-machine cells. We expect the demand for automation to continue into for the foreseeable future.

McQuillian: We focus on high-tech tools and customized system solutions for complex orthopedic devices.

With over 100 employees in research and development, we cover the entire spectrum of product development and continuously strive to be at the cutting-edge of innovation. In order to integrate our tools into production processes as efficiently and economically as possible, we rely on our experienced specialists who create application-specific concepts together with customers.

Mowry: Building on automation and complete manufacturing have been the largest focuses given our current and rising skilled labor shortage.  

Ostini: We conduct a lot of research on medical implant surface finishes and how manufacturers experiment with new and unique surface textures to promote osteointegration.

Beyond that, we strive to match the ISO VDI 3400-standard surface finish of an EDM process with our laser texturing technology. When we’ve accomplished this, medical manufacturers can achieve surface finish requirements and be able to impart intricate textures/patterns to those part surfaces.

Thompson: Femoral head implant production is an application where our machine and motor control technology has been key in successful production. Our LinX linear motors driven by our servo drive systems can automatically detect when a grinding wheel touches the part, then applies a programmed force during the grinding operation.
This removed the need for the addition of complex sensing and feedback systems that other companies employ.