CNC Precision Matters

In medical technology, device reliability is directly linked to patient health and safety. Surgical navigation systems, the "eyes" of modern precision medicine, require metal substrates, one of their core components, to meet stringent requirements for machining accuracy, biocompatibility, and surface cleanliness. This case study will delve into how WSRCNC successfully processed a batch of titanium alloy positioning plates for spinal surgical navigation systems for a leading global medical device OEM.

Project Background and Client Pain Points

Client: An international medical technology company specializing in neurosurgery and orthopedic surgical navigation systems.

Workpiece: Titanium alloy (Ti-6Al-4V, Grade 5) positioning plates for spinal surgical navigation systems.

Core Pain Points:

Precision Limits: The positional tolerances of multiple threaded and pin holes on the board must be within ±0.025mm. Any deviation will amplify the cumulative error of the navigation system, affecting surgical precision.

Strict Biocompatibility: The product will come into direct contact with human tissue, eliminating any sources of contamination and maintaining excellent surface integrity to prevent bacterial growth.

Complex Surface Treatment: Specific micro-arc oxidation and passivation treatments are required to enhance surface hardness, wear resistance, and corrosion resistance without compromising dimensional accuracy.

Regulations and Traceability: The entire production process must comply with ISO 13485 quality management system requirements, with complete material traceability and process records.

WSRCNC's Solution

Faced with this challenge, WSRCNC assembled a dedicated team of engineers, programmers, and quality experts to develop a comprehensive machining plan:

Design and Process Optimization (DFM):

Upon receiving the customer's CAD drawings, WSRCNC engineers immediately provided a DFM report. Addressing potential deformation issues associated with thin-walled structures during machining, they recommended optimized clamping solutions and cutting paths, which was highly praised by the customer.

High-end Equipment and Precision Machining:

Using a five-axis CNC machining center imported from Japan, all complex features were machined in a single setup, eliminating the cumulative errors associated with multiple setups and ensuring absolute hole accuracy.

Using ultra-fine-grain carbide tools and a high-speed milling (HSM) strategy, cutting at high speeds and shallow depths of cut effectively controlled cutting forces and heat, thereby suppressing the work hardening and deformation common in titanium alloy machining and achieving an exceptional surface finish (Ra < 0.4μm).

Full-Process Quality Control:

Incoming Material Inspection: The Material Certificate (MTC) of the titanium alloy is verified to ensure that the material composition and properties fully comply with the ASTM F136 standard.

In-Process Inspection: During processing, critical dimensions are 100% inspected online using a coordinate measuring machine (CMM), with real-time data monitoring to ensure all tolerances are within control.

Final Inspection: After the finished product is completed, in addition to the CMM full-dimensional report, surface roughness is verified using an optical profilometer.

Professional Post-Processing and Clean Packaging:

In a Class 10,000 dust-free room, the workpiece undergoes a passivation treatment to remove free iron ions on the surface and form a dense chromium oxide protective film.

Strict ultrasonic cleaning and vacuum packaging processes ensure that the products are delivered in an ultra-clean state, ready for direct shipment to the customer's sterilization facility.

Achievements and Value Creation

100% Quality Acceptance Rate: The first batch of 500 products all passed the customer's IQC inspection, with CPK values for critical dimensions exceeding 1.67, demonstrating extremely high process stability.

Cost Optimization: Through optimized machining strategies and tool management, WSRCNC reduced single-part machining time by 15%, effectively controlling costs for the client.

Speeding Product Launch: WSRCNC's reliable supply chain and efficient project management helped the client shorten the new product development cycle by several weeks.

Establishing a Long-Term Partnership: Based on this successful collaboration, the client has added WSRCNC to its global core supplier list and signed a long-term strategic cooperation agreement.

Conclusion

Manufacturing medical parts is more than just metal cutting; it is a deep integration of engineering, materials science, and quality management. Leveraging its technical expertise, rigorous quality systems, and deep understanding of medical industry compliance, WSRCNC successfully transformed a challenging engineering drawing into a reliable, high-performance medical product, providing a solid foundation for precision surgical procedures and ultimately earning the client's trust and long-term partnership.

Frequently Asked Questions (QA) About Medical CNC Machining

Q1: What are some common CNC machining materials in the medical industry?

A: The most common materials are titanium alloys (such as Ti-6Al-4V ELI) and medical-grade stainless steels (such as 316L VM and 440C) due to their excellent biocompatibility, high strength, and corrosion resistance. In addition, high-performance engineering plastics such as cobalt-chromium alloys and PEEK are also widely used.

Q2: Why is ISO 13485 certification required for medical CNC machining?

A: ISO 13485 is an international standard for quality management systems for medical devices. It emphasizes risk management and full process traceability, ensuring that every step, from raw material procurement to production, inspection, and packaging, is strictly controlled and documented. This is a fundamental requirement for medical device registration and marketing authorization in global markets.

Q3: What specific measures does WSRCNC take regarding the cleanliness of medical parts?

A: WSRCNC has a dedicated Class 10,000 cleanroom for post-processing and packaging. We perform a rigorous ultrasonic cleaning process and use pure water for a final rinse. After cleaning, parts are tested for particle contamination and bioburden and packaged in medical-grade vacuum packaging to ensure cleanliness upon delivery.

Q4: Can I only produce small batches of medical prototypes?

A: Absolutely. WSRCNC offers both rapid prototyping and low-volume production services. We understand the iterative nature of medical device R&D and can provide prototypes that meet medical standards, helping you accelerate design validation and clinical approval.

Q5: How do I get started with my medical CNC machining project?

A: Simply send us your 3D drawings (in STEP/IGS format) and technical requirements. WSRCNC's engineering team will immediately perform a design for manufacturability (DFM) analysis, provide a detailed quote, and provide a complete project execution plan.