4 Proficiency and Efficiency Gains in Orthopedic Manufacturing

Clinical advancements in orthopedics and the demands of world-class surgeons push suppliers to improve the methods they use to manufacture devices for OEMs. Executives from several suppliers recently shared how their companies meet the increasing demands of a challenging market and tap into innovative technologies to manufacture high-quality and cost-effective orthopedic implants and instruments that contribute to improved patient care and outcomes.

Of note, this is part one of a three-part series where we ask companies throughout the supply chain about how they’re helping orthopedic device makers optimize the manufacturing process. Part two focuses on materials science and part three covers R&D and operations.

Machining: 6-axis CNC Tool Grinding for Cutting Tools

Rollomatic with President Eric Schwarzenbach

Metal cutting knowledge has helped shape the different geometries for drill points and flute shapes that are suitable for drilling into bone. The main goals in engineering medical drills are minimizing thermal injury to the surrounding bone and reducing cortical penetration.

A grinding machine, which has six interpolating axes, offers the highest flexibility and is exactly what is needed for manufacturing a variety of surgical instruments designed for orthopedics. In particular, an inclination of the grinding spindle is indispensable for creating drill points with low point angles (down to 55 degrees) and long instruments. In terms of wheel packs, two-wheel packs are normally sufficient. The 6th axis of the grinding machine is used to flip one of the two-wheel packs into a grinding position within two seconds.

A wide variety of orthopedic bone-cutting instruments are available, including drills, trocar points, shavers, taps, burs and spherical burs, rasps, perforators and trepanning tools for skull surgeries. For the last year, our technology development for grinding surgical cutting tools has centered on solutions for longer orthopedic drills, reamers and pins. The Strausak brand of CNC grinding machines recently launched a new model called ONE with extended-length capabilities. With the ongoing evolution of robotic surgeries, there is a need for cutting tools to be longer in overall length.

Polishing with Animal-Derived Ingredient-free Alternatives to Wool

Spartan Felt with Director of Marketing Gary Groat

Wool felt is highly effective for the mechanical polishing of wheels, belts and bobs (mandrel-mounted rotary tools) on medical devices. FDA recommends that the manufacturing of medical devices involves the use of materials with no animal-derived ingredients (ADI) to prevent the spread of viral disease or encephalitis (e.g., mad cow disease).

Manufacturers should be aware that wool felt is an animal-derived material commonly found in polishing processes in the form of small rotary tools (bobs). Wool felt can hold materials in its structure, which allows it to apply an abrasive compound against surfaces being polished. However, this becomes problematic if the wool is contaminated by disease in the animals from which it is harvested. Contamination can occur during the polishing process when the wool tool comes in direct contact with cracks or crevasses on the surface of medical devices that could harbor viruses or other infections. Wool is cleaned after harvesting to remove contamination; however, wool fiber itself is a protein, as are viruses. COVID-19 has increased awareness of the unpredictability of viruses and the importance of reducing such outbreaks. Synthetic polishing materials eliminate the aspect of animal disease as a cause for contamination and significantly reduce the chance of diseases spreading to medical devices.

It is easy to replace wool felt tools for ADI-free versions in most applications. We developed patented synthetic fiber polishing products that do not contain ADI; these tools can replace wool felt products or fiber scrubbers that contain animal-derived stearic acid lubricants. We can customize products to a specific application through abrasive impregnation (such as diamond) and shaping tools to part profiles and improve polishing efficiency, which makes its use in automated processes easier to implement. With most of today’s wool felt polishing tools manufactured in China and India and sold through distributors, manufacturers might not realize they have animal-derived materials in their facilities.

Removing Difficult Adhesives Used in Manufacturing

Pioneer Metal Finishing with Chief Commercial Officer Corey Strege

There is an increased use of and reliance on aggressive adhesives in medical device manufacturing. Chemists are developing adhesives that adhere better to various substrates, cure in less rigorous conditions, resist higher temperatures, show longer pot lives and provide improved durability.

The use of adhesives requires securing the bonded components during the curing phase, usually under pressure. However, users face the challenge of removing excess cured adhesive from metal bonding or holding fixtures used to apply this pressure. This excess adhesive can limit fixture life and introduce potential variations in the bonding process. Removing excess adhesive helps to ensure optimal, consistent outcomes. Reliability is even more vital in performance-critical bonding scenarios, such as structural performance or regulated medical devices that require process validation.

Supporting production tooling with technology that easily removes adhesives is key to optimal efficiency and quality control. It provides a durable solution to the problem that is viable for many different metallic substrates.

Automating Polishing of Joint Replacement Implants

Rosler Metal Finishing with Chief Executive Officer Bernhard Kerschbaum

Drag finishing and robotic grinding and polishing were the predominant finishing processes for joint replacement implants over the last decade, and have replaced most manual finishing. Implant manufacturers are eager to reduce per-piece cost and labor and deliver absolute process repeatability.

Drag finishing technology has evolved as a surface finishing solution, significantly reducing processing time. Integration of robotics allows for targeted treatment of specific areas of an implant. Automation eliminates labor and delivers highly repeatable output. Intelligent process controls and monitoring systems track data, analyze process parameters and guide the operators and supervisors to act before the process or equipment fails.

The workforce shortage in all industries is a major concern and will persist in the future because of changes in our demographic. This will impact capacity as well as product quality. Manufacturers that invest in the automation of their production can stay ahead of the curve.

Medical device manufacturing can easily be automated. Automating the finishing processes of medical instruments and orthopedic implants used for joints, trauma and spine includes more than the parts handling. The processes can also be monitored and automated. In the past, an operator ensured that all process parameters were within the prescribed limits and often process consumables had to be replenished manually. With today’s control systems, data collection, process parameter monitoring and automatic processes, adjustments can be easily integrated into the finishing systems. This results in the system guiding the operators if manual intervention, such as replenishing materials or investigating a fault, is necessary.

PM

Patrick McGuire is a BONEZONE Contributor.

Join us!

The best of BONEZONE content delivered to your inbox, twice each month.

RELATED ARTICLES



CONTACT BONEZONE

 

CONTACT BONEZONE