Manufacturing surgical instruments requires precision and reliability to ensure patient safety and effective surgery operations, providing accurate functionality, minimizing tissue damage, and preventing complications. CNC milling is a preferred method of CNC machining for medical tools, enabling safe, consistent, and innovative production. To fully understand the role of CNC milling in surgical instrument production, we will discuss how CNC milling works and the benefits of this process.
CNC milling is a precision machining process that utilizes computer-controlled toolpaths and multi-axis capabilities to remove material from a workpiece, creating a component from a 3D digital design. Its rotating cutting tool and separate workpiece axis deliver complex cuts, intricate features, and tight tolerances for high-quality solutions. Compared to more traditional machining methods, CNC milling offers:
The capabilities of CNC milling are integral to compliance with medical manufacturing standards. For ISO 13845 and FDA alignment, CNC milling enables the consistent production of high-precision, traceable, and validated medical components. Compliant processes built into production ensure that medical devices are manufactured to stringent quality and safety standards for patient use.
Known for its capabilities to achieve tight tolerances and intricate features, CNC milling can achieve tolerances within ±.0005. The micron-level accuracy provides high-quality solutions that reduce surgical risks and ensure consistent outcomes, minimizing mechanical failure and verifying that components perform as expected. CNC milling offers a high level of consistency, reducing human errors, while allowing manufacturers to produce critical components with repeatability and provide digital data to document every step of the production cycle.
With 5-axis CNC milling, a single setup can produce complex, intricate components. Through the simultaneous movement of both the cutting tool and the workpiece, CNC milling utilizes CAD/CAM software to program machine processes for controlled and precise material removal. It can access all surfaces of a part dynamically to produce intricate 3D surfaces, undercuts, and features. CNC milling offers high-accuracy solutions for surgical instruments used in minimally invasive and robotic surgery, enabling the creation of complex features and achieving the tight tolerances required for delicate procedures with enhanced dexterity.
Material choice is crucial for CNC milling of surgical components, as it significantly impacts performance, sterility, and ultimately, patient outcomes. Stainless steel is preferred for general instruments, while titanium offers strength and biocompatibility for specialized solutions, and hardened steel is used for precision cutting edges. Certain materials can experience work hardening during rigorous machining; however, CNC milling employs controlled cutting parameters, high-quality cutting tools, and lubrication and cooling to minimize heat transfer and prevent work hardening. Marver Med has the experience to work with stainless steel, titanium, Inconel, MP35N, and tungsten.
CNC machining operations produce smooth, defect-free surfaces for medical devices and surgical instruments, prioritizing patient safety and infection control. Tiny imperfections can cause critical complications or make sterilization challenging, making a superior surface finish essential for surgical instruments. Strengthening the chromium oxide layer through polishing, passivation, and electropolishing can provide additional corrosion resistance and sterility, resulting in smoother, cleaner surfaces.
For surgical instruments, CNC milling provides precision machining processes that can create complex and intricate geometries, as well as unique features, for components. This machining method is compatible with stainless steel, producing precise hinges and bevels, as well as ergonomic curves, machined flutes, teeth, and concentric geometry, offering benefits such as sharpness retention. CNC milling surgical instruments can deliver a variety of components and assemblies, including:
Highly flexible and scalable, CNC milling can be used for both custom one-offs and large-scale production runs. Its computer-based, software-driven operation minimizes the need for extensive physical retooling between projects, while providing a rapid, cost-effective solution. With a CAD-to-CNC digital workflow, CNC milling operations offer scalability to produce thousands of identical parts with repeatability and efficiency, delivering manufacturing capabilities that can meet your requirements for prototypes or high-volume runs.
CNC milling for surgical instruments offers unparalleled precision, achieving micro-level accuracy in component fabrication. With decades of experience in CNC processes, Marver Med is an expert fabricator that delivers consistency and repeatable quality, providing complex, reliable components designed to improve patient safety, optimize performance, and produce unique solutions with biocompatible materials. Learn more about our capabilities for surgical instruments or contact us for more information.
ISO 13485:2016 Certified and ITAR Compliant
| Certifications | ||
 |
 |
 |