High Precision CNC Turning Plastic Parts for Medical Devices

Product Specification

Service Progress of OEM High Precision Customized CNC Turning Plastic Parts for Medical Devices

1. Customer Inquiry & Project Evaluation

Requirements Communication: The client (usually a medical device manufacturer) communicates with the supplier (the CNC machining service provider) to provide detailed project requirements. This includes the part's 3D model (e.g., .STEP, .IGS files), 2D engineering drawings, material requirements (e.g., PEEK, UHMWPE, POM), tolerance specifications, and surface finish details.

Feasibility Analysis: The supplier's team performs a technical evaluation of the drawings and requirements. They analyze the part's machinability, the suitability of the chosen material, and determine the necessary equipment and technology for production.

Quotation and Lead Time: Based on the evaluation, the supplier provides a detailed quote, including per-part costs, tooling fees (if required), and an estimated production timeline.

2. Design & Engineering Validation

Design for Manufacturing (DFM) Optimization: The supplier's engineers optimize the client's design for "Design for Manufacturing" (DFM), taking into account the specifics of CNC machining. This may involve adjusting wall thickness, chamfer radii, or hole depths to ensure the part can be produced efficiently and consistently while meeting all functional requirements.

Prototype & Sample Testing: Before mass production, a few prototypes or first-article samples are typically made. These samples are sent to the client for rigorous testing and validation to ensure they meet all functional, dimensional, and material specifications.

PPAP (Production Part Approval Process): For some medical devices with stricter requirements, the supplier may need to provide a PPAP package. This includes detailed records of the entire production process and quality control data to demonstrate the stability and consistency of manufacturing.

3. Production & Quality Control

Once the prototypes are approved, the mass production phase can begin.

CNC Turning: High-precision multi-axis CNC lathes are used to precisely cut the plastic raw material. This is the core step, requiring highly skilled operators and advanced equipment.

In-Process Quality Inspection: During machining, precision measuring tools like calipers, micrometers, and Coordinate Measuring Machines (CMM) are used to perform real-time or sample inspections of critical dimensions, ensuring every part meets the specified tolerances.

Surface Finishing & Post-Processing: Depending on client requirements, parts undergo post-processing like deburring, polishing, and cleaning to achieve the desired surface finish. For medical devices, cleanroom cleaning and packaging are often required.

4. Cleaning, Packaging & Delivery

This is a critical step to ensure the final product meets the hygienic standards of the medical industry.

Cleanroom Cleaning: Parts are cleaned in a cleanroom environment using ultrasonic cleaning or special solvents to remove any residual cutting fluid and microscopic particles.

Sterile Packaging (Optional): For medical devices with extremely high cleanliness requirements, parts may undergo sterile packaging and be accompanied by relevant cleaning and sterilization certification reports.

Logistics Delivery: The parts are packaged and shipped securely with all necessary quality inspection reports and documentation, ensuring timely delivery to the client.

Common Materials for CNC Plastic Turning Parts and their Characteristics

1. PEEK :

Characteristics: PEEK is known as the "king" of high-performance thermoplastics. It has excellent biocompatibility and resistance to high temperatures and chemical corrosion. It can withstand repeated steam sterilization (autoclave), making it perfect for surgical instrument components that require repeated disinfection.

Applications: Handles for surgical instruments, endoscope components, and dental device parts.

2. UHMWPE (Ultra-High Molecular Weight Polyethylene):

Characteristics: This material has excellent wear resistance and a low coefficient of friction, along with superb biocompatibility. It is lightweight and tough, often used in applications requiring sliding or low friction.

Applications: Orthopedic implants (like liners for hip and knee joints) and arthroscopic instrument components.

3. POM (Polyoxymethylene):

Characteristics: POM is known for its high strength, rigidity, and excellent dimensional stability. It's easy to machine and is a more cost-effective option. While its temperature resistance isn't as high as PEEK's, it's sufficient for many non-implantable medical devices.

Applications: Diagnostic equipment housings, pump bodies, medical cart wheels, valves, and connectors.

4. Polycarbonate (PC):

Characteristics: PC is a transparent, strong, and impact-resistant material. It is often used in the medical industry for parts that need to be transparent. It can also withstand gamma and ethylene oxide sterilization.

Applications: Blood collection components, fluid dispensers, observation windows, and display screen housings.

Characteristics of CNC Turning

CNC turning is a subtractive manufacturing process where a cutting tool shapes a part by rotating and moving the material. For high-precision medical parts, the process has several key features:

1. High Precision and Repeatability: CNC lathes can machine parts with micron-level tolerances, ensuring that every produced part is identical to the design. This is critical in medical devices, where even minor dimensional deviations can affect a device's function and safety.

2. Surface Finish: With precise tools and optimized cutting parameters, CNC turning can create a very smooth surface. For medical parts, a smooth finish is not only aesthetically pleasing but, more importantly, it's easy to clean and less likely to harbor bacteria.

3. Complex Geometries: Although it's a turning process, modern multi-axis CNC lathes can handle complex geometries, including holes, threads, grooves, and different stepped diameters. This makes it ideal for manufacturing multi-functional, integrated parts.

4. Strong Material Versatility: CNC turning can handle various plastics with different hardnesses and properties, from soft UHMWPE to hard PEEK, with high efficiency.

5. No Molding Costs: Unlike injection molding, CNC turning does not require expensive molds. This is a huge advantage for small-batch production, prototyping, and customized designs, significantly reducing upfront costs, which is especially beneficial for innovative medical device projects.

Why choose Waltay to produce Customized CNC Plastic turning Parts?

1. High-Precision Capabilities and Equipment

Specialization in High Precision: The search results state that Waltay is a "professional CNC machining company" specializing in "precision machined parts." This focus is critical for medical devices, which often require extremely tight tolerances (micron-level accuracy) to ensure functionality and patient safety.

Comprehensive Equipment List: Waltay's listed equipment, including 25 CNC milling machines and 3 CNC turning machines, indicates a substantial capacity to handle various project sizes and complexities. The mention of having both milling and turning capabilities suggests we can produce a wide range of complex part geometries.

2. Experience and Material Expertise

Established Company: Waltay was established in 2005, giving them nearly two decades of experience in the CNC machining industry. This long-standing history suggests a proven track record and accumulated expertise.

Plastic Machining Experience: The search results explicitly mention Waltay's experience with plastic injection molding and CNC machining of plastic parts, including PEEK. This is crucial for medical devices, where specialized biocompatible plastics are often used. Their knowledge of these specific materials ensures they can handle the unique challenges of machining them.

3. Quality and Certifications

ISO 9001 Compliance: The search results state that Waltay "follow[s] ISO 9001 standards." While ISO 9001 is a general quality management standard, it is a foundational certification that demonstrates a commitment to consistent quality control. For the medical industry, a supplier would ideally also have ISO 13485 certification, which is specific to medical devices, and may also be asked to comply with FDA Quality System Regulation (QSR).

Quality as a "Core Value": The company's stated focus on "high end quality" as a core value, along with providing "smart designs" and "reasonable prices," aligns with the needs of medical device manufacturers who prioritize reliability and cost-effectiveness.

4. Service and Flexibility

(1) Rapid Prototyping and Fast Lead Times: Waltay offers "rapid prototyping services" . For R&D and product development in the medical field, quick turnaround for prototypes is essential for testing and design iterations.

(2) Low Volume and Customization: Our business model is well-suited for customized parts, which are common in the medical device industry. CNC machining, as a process, is ideal for low-to-medium volume production without the need for expensive molds, which is a major benefit for specialized medical components.

(3) Comprehensive Service Offering: Beyond just CNC turning, Waltay offers a full suite of services, including secondary machining (drilling, riveting), surface finishing (anodizing, powder coating), and custom packaging. This "all-inclusive package" approach allows clients to streamline their supply chain by getting multiple services from a single provider.

(4) Dedicated Support: The promise of a reply within 24 hours and the mention of providing design assistance from concept to drawing show a commitment to customer service, which is a key factor in complex OEM partnerships.

Waltay is specializing in custom CNC machined parts for over 15 years. We are good at making high precision metal and plastic components. We also provide one stop service such as part design, prototypes, mold making, plastic injection and part assembling to better meet customers’ needs. Beside aluminum CNC machined parts, we also provide stainless steel, ABS, PC, PA,PP and POM CNC machined parts which can be widely used in cables, sensors, motors,connectors, etc.