precision medical CNC machining for medical device
The medical industry has had increased demands for high-quality and high-precision products over the past few years. These products must be produced within a short period and meet strict industry standards. While most ordinary metal parts must satisfy ISO 9001 quality management obligations, medical components and devices must comply with other standards. Product managers and designers now use medical CNC machining to meet these demands.
In an industry where even the slightest error can cause severe health complications, it is paramount that the machining process of medical parts provides high tolerances and precision measurements. Advancing CNC processing technologies have humanized the manufacturing of medical devices over the years.
CNC machining, the process by which machinists use code to automatically run a machine like a mill, router, or lathe, can help these manufacturers produce parts faster and more efficiently.
Custom Medical Machining Company，Manufacture in China
The product development of medical devices needs a process of product designing, prototype testing, and putting it into the market. Through medical device prototyping, you can create functional and customized prototypes. This needs a professional custom medical machining company， manufactured in China like us SAN-E Prototype. It is vital to verify the design and decide whether it’s necessary to change some parts of the design.
At SAN-E Prototype, there are skilled craftsmen and engineering staff here to offer you custom medical device prototyping, and custom medical precision parts solutions to support your product development. If you get any problems, our engineering team is always here to help you
Why Choose CNC Machining for Medical Industry?
CNC machining is a cost-effective and efficient method for producing highly accurate medical components, eliminating the need for specialized tooling. It does not involve expensive tooling, which saves both time and money, compared to other production methods.
Precision CNC machining offers faster turnaround times for small production runs or custom parts while mold tooling can take up to four weeks. In the medical area, quick and precise parts are frequently required in small quantities, and CNC machining has become the best ideal solution. It delivers accurate and high-quality results without specialized tools.
Material Flexibility
The easy transfer of digital CAD files is made possible by digital machining due to the use of portable CNC machines. Even portable CNC machines have limited capacity, they can help to manufacture simple medical parts. Apart from a few exceptions, standard CNC machines can work with the most common materials used for medical and surgical tools, appliances, and parts. There are stainless steel, aluminum, titanium, and production-grade plastics like PEEK.
No Minimum Order Volume
Unlike other manufacturing methods that require minimum order volumes, CNC machining does not, making it more suitable for smaller projects. CNC machining allows for the rapid generation of a cutting program from a digital CAD file.
This enables the high-precision production of one or more custom-machined medical parts with no minimum order requirement. CNC machining is, therefore, ideal for highly specialized medical devices, equipment, surgical products, prosthetics, and other products that frequently require one-off or single-use custom parts.
High Production Speed
Medical CNC machining can for the quick production of medical parts. You can produce finished parts within a few hours depending on their complexity. In medical emergencies, CNC production machining can quickly deliver high-quality parts in various quantities, when the types of parts or components required are difficult to predict.
Machined Parts with Tight Tolerances
CNC machining can easily achieve these service tolerances even though many sophisticated medical devices require very tight tolerances. This reduces the need for post-processing and minimizes the risk of errors. It saves time and money as well as ensures that medical components are fit for their intended purpose. It can have harmful consequences in the healthcare sector even small deviations in specifications. The precision and accuracy of medical CNC machining greatly reduce this risk and enable the production of high-precision parts.
Flexible Design Complexity
The ability to transfer digital programs quickly and easily between medical specialists, product designers, and manufacturing professionals is one key advantage of CNC machining. Regardless of where they are needed, this ability greatly enhances its effectiveness in creating high-quality and specialized CNC-machined medical equipment. This benefit is particularly valuable in situations where time is a critical factor. It can rapid creating and deliver essential medical components.
Materials for Medical CNC Machining
Medical components are typically designed with tolerances, ductility, and tension requirements in mind. Designers also consider disposal and sterilization requirements. Therefore, it is critical to select only the correct CNC machined material that meets the functional and quality requirements.
Most medical devices are made of stainless steel, with aluminum becoming increasingly popular. In some cases, plastic polymers and some composite materials are also desirable. The following table summarizes the applications of standard medical machining materials:
Metals
| Metal | Why Use It | Applications |
| Stainless Steel | Corrosion resistance, high strength, easy to clean, biocompatibility | Medical instruments, surgical instruments, surgical blades |
| Tungsten | High density, corrosion resistance, good high-temperature stability | Radiation therapy, nuclear medicine, electronic surgical instruments |
| Tungsten Alloy | High density, high strength, corrosion resistance, good high-temperature stability | Radiation therapy, nuclear medicine, electronic surgical instruments |
| Aluminum | Lightweight, corrosion resistant, easy to machine | Prosthetics, surgical instruments, medical devices |
| Copper | Good electrical and thermal conductivity, easy to machine | Medical instruments, micro-devices |
| Nickel | Corrosion resistance, good high-temperature stability, high strength | Medical instruments, implants, surgical instruments |
| Cobalt | High strength, corrosion resistance, biocompatibility | Implants, surgical instruments, pacemakers |
| Iron | High strength, easy to machine | Prosthetics, surgical instruments, medical devices |
Plastics
| Plastic | Why Use It | Applications |
| Acrylic | Transparency, impact resistance, scratch resistance | Medical equipment covers, surgical instruments |
| Polycarbonate | Impact resistance, transparency, biocompatibility | Medical equipment components, instrument bezels, optical lenses |
| Polyethylene | Chemical resistance, low friction, biocompatibility | Medical implants, prosthetics, packaging |
| Polypropylene | Chemical resistance, low density, low moisture absorption | Medical device components, lab equipment |
| Polystyrene | Clarity, stiffness, impact resistance | Medical device housings, lab equipment |
| Polyurethane | Flexibility, impact resistance, biocompatibility | Medical device seals, catheters, prosthetics |
| PVC (Polyvinyl chloride) | Chemical resistance, low cost, flexibility | Medical tubing, blood bags, IV bags |
| PEEK (Polyether ether ketone) | Biocompatibility, chemical resistance, high strength | Medical implants, surgical instruments, dental implants |
| Nylon | High strength, chemical resistance, low friction | Surgical sutures, medical device components, implantable devices |
| ABS (Acrylonitrile butadiene styrene) | Toughness, impact resistance, biocompatibility | Medical device components, enclosures, housings |
Considerations When Choosing Materials for Medical CNC Machining
Choosing suitable materials for machining medical parts needs careful consideration of many factors. It also needs a deep understanding of the specific needs and requirements of the medical applications.
The essential factors to keep in mind are as follows:
（1）If Long-Term Contact
Those semi-permanent or permanent implants on the body or inside the body are long-term contact CNC machined medical equipment. It includes pacemakers, prosthetics, artificial heart valves, hearing aids, artificial joints, etc. So, it must use strong and durable materials for these applications. Bio-compatibility is also a significant consideration in this situation.
In this case stainless steel and titanium and are the metals of choice because they are highly bio-compatible and non-toxic to the body. Thus, they can remain in contact with tissues without problems. Other good choices for such applications like plastic polymers like PE, PU, PET, and acrylic.
（2）If Chemical Resistance
Stainless steel known for its excellent chemical resistance can resist exposure to most acids, bases, and organic compounds. Titanium and aluminum also exhibit good resistance to corrosion by certain chemicals which are great choices for making such components. In this case, plastic resins like PC and PEEK are also valuable.
（3）If Radiation Resistance
X-rays, Magnetic resonance imaging, and chemotherapy can all be sources of radioactive contamination in medical parts. The effects of radiation accumulate over a product’s lifetime. So, it is important to choose medical machining materials that will not degrade from exposure to radiation. It is particularly crucial for X-ray machines, equipment used in surgical operations, and other diagnostic tools.
Of the metal materials discussed above, the most radiation-resistant is titanium. Because of its high density, making it less likely to absorb radiation. Manufacturers also use resins like PU, ABS, and PEEK for these applications.
（4）If Sterilization
Steam chemical vapor and radiation sterilization are the common types of sterilization in the medical industry. These methods expose the surfaces of medical materials to degrading agents, which include high temperatures, chemicals, and radiant energy. So, it is important choosing the right materials that can resist these agents.
CNC machined surgical tools Stainless steel is popular because of its corrosion-resistant and can withstand high temperatures and repeated sterilization cycles. Titanium with resistance to corrosion and wears upon sterilization is also a commonly used material. Plastics like PC, PU, PEEK, and ABS are also excellent options.
（5）If Drug Delivery
You must choose the correct material for tubes, vials, injectors, cans, and other drug delivery devices. Because drug dispensers delivering drug dosages must ensure aerosols and fine powders don’t stick to the surfaces of the material. This will affect the accuracy of the drug dosage, adversely affecting treatment outcomes.
Aluminum, stainless steel, copper, and titanium have excellent static-dissipation properties, making them suitable materials for drug dispensers. ABS, polypropylene, PC, and acrylic are all anti-static plastic polymers.
（6）If Artificial Joints
The choice of plastic for artificial joints depends on the specific joint being replaced and the individual patient’s needs. Joint replacement materials for semi-permanent or permanent use must be bio-compatible, wear-resistant, and strong.
Titanium, stainless steel, and cobalt-chromium alloys are the most commonly used metals for artificial joints. They are excellent choices because of their corrosion & wear resistance and high strength, and bio-compatibility. UHMWPE, PEEK, and PTFE are some of the most common plastic resins.
（7）If Prosthetics
The choice of material can depend on factors like the location of the prosthetic, its weight, and the level of durability needed. The prosthetic design ensures easy forming, strength, and ability to withstand high impact. This is important for artificial limbs and orthotics.
Titanium is a popular choice because it is strong, lightweight, corrosion-resistant, and bio-compatible. Aluminum and stainless steel are also excellent choices, with aluminum especially important for lightweight applications. ABS+PC, PMMA, PEEK, glass-filled nylon, and High-Impact Polystyrene (HIPS) are all plastic resins for these applications.
5 Tips for Designing CNC Machined Medical Parts
Even though CNC machining is an excellent option for manufacturing a wide range of medical components, it can get complex. So, it’s essential to put a few things in place to get the best result from medical CNC machining.
When designing your medical components, you can follow these CNC machining design guides.
(1). Simplify Design
Modifying the part design to enable easy and more efficient machining. Simplifying the design for CNC machining medical devices will improve efficiency, reduce costs, and ensure high-precision manufacturing.
- Minimizing material usage
- Designing for tool access
- Using standard features like chamfer, radii, and fillets
- Simplifying part geometry by removing unnecessary features
(2). Use Strong Colors
Strong colors help distinguish between different versions of a part, such as for prototypes or functional testing. This can also be a helpful way to improve the traceability and identification of parts, especially for those similar in size or shape.
When choosing colors for CNC machined medical parts, it is vital to consider the specific requirements of the component and its intended use. Some colors may impact the bio-compatibility of the part. Thus, it is important to ensure that the color does not negatively affect the part’s functionality or bio-compatibility. For example, some medical parts may require sterilization, and certain colors may not be able to withstand high temperatures or harsh chemicals.
(3). Have a Visual Appeal
A visually appealing design and strong colors can help differentiate a product in a crowded market. It brings a positive customer impression and makes the product easier to identify or use.
However, it is also vital to ensure that the design is functional and meets the specific requirements of the part as well as its intended use. When selecting colors, highlight the key features of the part, like ports and buttons. You should choose colors and textures that enhance the physical appearance of the component.
(4). Handy and Portable
Optimizing the design of medical parts for convenience and portability is crucial. This ensures easy transportation and uses in different clinical settings. Choosing lightweight materials like aluminum, designing easily detachable products, and choosing ergonomic designs. This will ensure improved patient outcomes, provide versatility, and reduce cost.
(5). Easy Maintenance
A simple design that is easy to access can make maintenance tasks more efficient and effective. So, designing CNC machined medical parts with easy maintenance in mind can help make sure that the parts continue to function properly and safely over time.
This can reduce maintenance frequency and increase the part’s lifespan using durable and easily cleanable materials. Incorporating monitoring systems into CNC machining medical devices can help detect any issues early on, good for timely maintenance and repairs.
Examples of CNC Machined Medical Products
Because of its significance in the medical industry, designers and machinists have harnessed the potential of medical precision machining to create high-quality medical prototypes and products.
Below are some examples of CNC-machined medical parts:
Medical Implants
A vital application of CNC machining medical parts is the fabrication of bodily implants, including spine implants, hip replacements, and knee implants. The medical field typically requires implants in small quantities. So, injection molding may need a high cost.
Therefore, medical CNC machining offers a cost-effective solution. This process utilizes reusable tools to reduce production costs. CNC machining’s compatibility with various materials makes it an ideal process for manufacturing medical implants. The materials include cobalt-chrome alloys, titanium, stainless steel, and plastics like PEEK. CNC machining also ensures precision and accuracy to provide medical practitioners with custom implants.
Electronic Medical Equipment
Surgical tools typically have simple designs and are composed of only a few metal parts. But, sophisticated medical equipment involves hundreds or even thousands of individual parts. Such as MRI scanners, X-ray machines, ultrasound equipment, CT scanners, heart rate monitors, and some diagnostic equipment.
CNC-machined medical equipment
CNC machines can produce intricate components for these advanced medical devices. The quality and precision of these components are crucial to prevent equipment malfunctions. These machined medical equipment parts must also meet rigorous standards for safety and reliability. CNC-machined parts for these devices may range from small buttons and switches to larger monitor housings. So, manufacturers can use a wider range of materials in their machining than surgical tools and implants.
Medical Surgical Instrument
CNC machining technology also helps in producing surgical instruments used in medical procedures. Such as blade handles, forceps, spacers, plate benders, biopsy tubes, surgical scissors, implant holders, saws, clamps, etc. It is crucial to create CNC-machined surgical instruments with precision and care to meet the strict safety and performance standards of the healthcare sector. The design of devices must make sure easy sterilization and undergo thorough testing before using them in medical procedures.
Due to the high level of precision required, CNC machining for the medical industry is also ideal for producing these surgical tools and instruments. This manufacturing technique offers an efficient and economical method for manufacturing these parts. In addition to precision, it also allows for comprehensive surface finishing treatments to make sure surgical instruments are without surface defects. This further enhances the quality and reliability of these essential medical parts.
ISO 13485 and 9001 Certified
ISO certification is an important consideration when looking for a reliable manufacturer of machined medical devices. An ISO-certified management system demonstrates that a company has met quality assurance and standardization standards. ISO 9001 is a widely recognized standard that defines management principles, and it is critical to consider whether a company using ISO 9001 meets the required standards.
ISO 13485 certification is the standard for quality management compliance in the medical device industry. Manufacturers who achieve this certification can easily demonstrate that their management systems meet international standards, making them the preferred choice for the production of medical components.
It is best to choose a company that is certified to ISO 13485 and 9001. This ensures that the manufacturer meets the required quality and safety standards in terms of management principles and medical device manufacturing. By considering these certifications, you can determine and select the manufacturer that will provide high-quality, compliant machined parts. SAN-E, for example, is a manufacturer that meets these standards.
Perks of CNC Machining
Following are some benefits and applications of employing CNC machining when manufacturing medical devices at any scale:
No Volume Restrictions
You can swiftly generate a coding program from it once you have created a CAD file. This coding program helps manufacture any number of parts just need a button’s push.
This is a significant advantage when producing single-use or one-off custom parts which is typically the case for specialized appliances, medical devices, equipment, prosthetics, and other medical components.
Portability
You can use a tabletop milling machine to manufacture fixtures, jigs, precise parts, and other urgently required medical or surgical components. Small portable CNC machines can easily fit on a desktop.
The miniature size and the modest power consumption for production are optimal for medical emergencies or isolated rural areas that might have limited access to full-service hospitals.
Fast and Seamless Production Pace
Proceeding from a digital CAD file to a finished product takes merely a couple of hours with CNC machining, depending upon the complexity of the medical component.
When it is challenging to anticipate the kinds of supplies and their quantities, swift manufacturing is exceptionally reliable in a medical emergency. This might be relevant for future patients within a brief window.
Tight Tolerances
Several sophisticated medical devices demand excessively tight tolerances that are easy to accomplish on decent CNC machines. CNC machining provides excellent surface finishes and needs minimal post-processing.
Any variation in specifications could lead to disasters in the medical domain while medical devices, products, and related equipment must be fit for all purposes. But, digital machining mitigates this risk to a bare minimum.
Conclusion
The medical industry requires high-quality and high-precision products that meet strict industry standards. CNC machining is an efficient and cost-effective method for producing high-precision medical components without minimum order requirements. CNC machining offers faster turnaround times, multiple tooling options, material flexibility, high production speeds, and machined parts with tight tolerances.
FAQ
Q: Why is precision important in medical machining?
A: Precision is important in medical machining because even the slightest error can have severe consequences for patients. Medical components and devices must meet strict industry standards to ensure their safety and efficacy. Precision machining helps to achieve these standards and ensure that medical products are fit for their intended purpose.
Q: What materials are commonly used in medical machining?
A: Common materials used in medical machining include stainless steel, aluminum, titanium, and production-grade plastics like PEEK. These materials are chosen for their biocompatibility, strength, and durability, and are frequently used in the production of medical devices and components.
