How to Use CNC Machining to Manufacture Medical Device Parts?

In today’s manufacturing world, precision and accuracy are paramount, and the development of CNC machining technology has made a crucial contribution to cutting-edge technology. CNC machine tool services demonstrate the complete unification of engineering design and automation technology. The impact on medical device production is almost unimaginable. In this blog, you will learn about the application of CNC machining technology in the medical field, how to choose the right materials for your project, and more.

Why is CNC machining technology suitable for manufacturing medical device parts?

While CNC machining has existed for decades, serving many industries, the medical industry is one of the latest to adopt Computer Numerical Control (CNC) technology. As early as 1961, CNC machining was already gaining popularity in the medical device manufacturing industry. Meanwhile, John Charnley (the father of hip replacement surgery) was still making his own prostheses using a hand lathe and benchtop tools. Fortunately, he made groundbreaking contributions to the medical field before anyone questioned the precision and ergonomics of the artificial hips he machined at the time. Since then, many things have changed. CNC machining is now one of the most commonly used machining technologies in manufacturing custom parts for medical devices. From custom medical device parts to highly specialized laboratory automation components, the applications of CNC machining technology in the medical industry are virtually endless.

The History and Development of Medical Device Manufacturing Technology

Tracing the history of medical device manufacturing, we witness a remarkable journey of industrial and manufacturing technological progress, from the earliest instruments to today’s complex CNC technology. In the early days of medical device manufacturing, small and medium-sized enterprises relied on manual labor to produce rudimentary medical products. Later, with the development of science and technology, before the invention of CNC technology, experienced craftsmen meticulously crafted musical instruments and implants by hand, but this could not meet the demands of increasingly complex medical devices, and the quality did not meet the required level. This manual method also contributed to the reduction in scale and variation, leading people to believe that medical devices were not safe enough. Moreover, the manual labor of production methods hindered innovation, but this further promoted the development of modern medical technology.

The Breakthrough of CNC Technology and the Development of Medical Device Manufacturing Technology

The advent of CNC machining ushered in an era of transformation in medical device manufacturing. This overcame the limitations of manual methods. CNC machine tools are computer-controlled components that enable manufacturers to lead the production process. This allows for the creation of highly refined components with unparalleled precision. Consequently, not only is the quality and reliability of medical devices improved, but complex and precise designs can also be accomplished.

Furthermore, advancements in CNC technology have improved manufacturing processes, facilitating the design of customized implants and high-precision medical devices to meet the personalized needs of the medical device market. Manufacturers can now combine CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing) software with advanced machining techniques, providing the ability to design customized devices that take into account the individual patient’s anatomy. This allows for optimal sealing and functionality.

What is CNC Machining for Medical Device Parts?

Medical CNC machining is a manufacturing process that utilizes a computer operating system to sculpt specific details of various medical components, such as tools and implants. Precision is critical for surgical instruments, as they are life-saving devices. At the heart of a CNC machine tool is a computer program that precisely controls the movement of cutting tools. These services encompass machining processes including milling, turning, drilling, and grinding. Each is customized to meet specific manufacturing requirements. CNC machining primarily involves removing material from a workpiece using a rotating cutting tool, making it ideal for creating complex shapes and contours.

CNC machining technology typically uses specially designed files to guide each cut, eliminating guesswork. This is crucial for components that will be implanted in the body. Therefore, there is no room for error. The medical industry therefore trusts CNC machining because they know accuracy is guaranteed. It can be used to manufacture the precision parts needed for bone screws, hip joints, dental implants, surgical scissors, and advanced scanning equipment, including dental and medical scanning devices. In the medical device manufacturing sector, CNC machining is essential for producing components with the precision and accuracy required to ensure patient safety and device effectiveness.

Common Materials for CNC Machining of Medical Device Parts

A key advantage of CNC machining is its ability to handle a wide variety of materials, most commonly found in the medical industry. These include metals, plastics, ceramics, and composites. The versatility of these materials allows manufacturers to experiment with new materials and further enhance their design capabilities. Different medical devices for different purposes require different materials. Material selection must be based on strength, flexibility, corrosion resistance, chemical resistance, and mechanical properties. When handling device components that come into contact with a patient’s body, biocompatibility must be considered. This ensures they do not cause adverse reactions in the body. Materials for critical components must possess the required tensile and compressive strength. The selected materials must not release any harmful elements, such as toxic, carcinogenic, or mutagenic substances.

Metals

MaterialsProperties
Stainless Steel 304Stainless steel 304 is a commonly used alloy in various applications, thanks to its excellent combination of corrosion resistance and machinability. However, it cannot be heat treated to enhance hardness. In cases where hardening is necessary, it’s advisable to opt for 18-8 stainless steel.
Stainless Steel 316/LDue to its exceptional corrosion resistance, stainless steel 316/L is widely favored in the medical device industry.
Stainless Steel 15-515-5 stainless steel provides corrosion resistance comparable to that of stainless 304, while also offering high corrosion resistance, improved hardness, and workability.
Stainless Steel 17-4Stainless steel 17-4 is a corrosion-resistant stainless alloy known for its high strength and heat-treatability. It is commonly utilized in medical equipment applications.
Titanium Grade 2Titanium grade 2 is a highly pure, non-alloy material known for its low weight, high strength, and thermal conductivity.
Titanium Grade 5Ti-6Al-4V, known for its excellent strength-to-weight ratio, owes its enhanced strength to a high aluminum content. This widely utilized titanium alloy offers favorable attributes such as high formability, corrosion resistance, and weldability.
AluminumAluminum is a lightweight and durable material with favorable corrosion resistance. It can also be conveniently anodized to enhance mechanical properties and corrosion resistance. While it may not be the most suitable option for devices that come into direct contact with the human body, it is ideal for support equipment such as orthopedic supports, IV stands, wheelchairs, and other similar applications.
CopperThis metal is known for its exceptional antibacterial and antiviral properties, making it well-suited for frequently touched surfaces such as monitor switches and buttons. It’s sometimes also utilized in certain dental implants.

Plastics and Composites

MaterialsProperties
AcrylicIt’s known for its impact resistance and optical clarity. It is commonly used for machining medical components such as protective shields, contact lenses, orthopedic implants, microscopes & lasers, and dental prosthetics.
NylonThis engineering-grade thermoplastic is highly versatile and commonly used in medical applications due to its durability, toughness, and strength, making it well-suited for making parts such as dental devices, implants, sutures, catheters, forceps, and clamps.
PEEKPEEK offers excellent tensile strength and can be used as a lightweight alternative to metal parts in extreme temperature and stress environments. It’s resistant to chemicals, wear, and moisture.
Delrin (Acetal)A resin with excellent moisture resistance, superior wear resistance, and low friction.
PTFE (Teflon)Teflon has superior chemical resistance and excellent performance in extreme temperatures compared to most plastics. It is highly resistant to solvents and is electrically insulated.
Polycarbonate (PC)PC has superior mechanical and structural properties with almost twice the tensile strength of ABS. Widely used in automotive, aerospace, medical, and other applications that require durability and stability, it is especially suited for solid infill parts that are fully dense.
Polypropylene (PP)PP is plastic with excellent electrical properties, low moisture absorption, the ability to carry light loads for extended periods in a variety of temperatures, and the capability to be machined into parts with chemical or corrosion resistance.
UHMW PEUHMWPE is a general-purpose material with high wear, chemical, corrosion resistance, and impact strength, low surface friction, and moisture absorption.
Garolite G-10Garolite G-10, also known as epoxy-grade industrial laminate and phenolic, is a material composed of epoxy resin, reinforced with fiberglass fabric. It has high strength and low moisture absorption and can be CNC machined to be used as an alternative to metal components when magnetic features cannot be achieved.

International Standards for CNC Machining of Medical Parts

To manufacture CNC machined parts, companies must meet the quality requirements of ISO 9001. If the company manufactures medical parts, it must meet other types of requirements, conforming to the standards of the International Organization for Standardization (ISO). According to ISO, companies involved in the design, production, development, distribution, or service of medical parts must demonstrate their ability to provide medical devices that consistently meet customer and regulatory requirements. The standard used for this is ISO 13485, accredited by the most important regulatory bodies. Another factor increasing the complexity of CNC machining is the high tolerance range. The materials, machining accuracy, and surface finish requirements for medical device components are extremely high, placing high demands on the reliability of the machining system. Therefore, extremely high demands are placed on machine tools, fixtures, cutting tools, and CAM software.

Key Advantages of CNC Machining for Medical Devices

The quality of equipment in the medical device industry is paramount, directly impacting patient safety. Therefore, medical devices demand high standards of quality and safety. CNC machining for medical devices offers unparalleled precision, enabling the fabrication of complex and intricate CNC medical parts. CNC-machined parts also ensure patient safety and device effectiveness. Its key advantages are as follows:

Accuracy and PrecisionLife is at stake, and medical equipment and instruments cannot afford to fail. Medical CNC machining provides unparalleled precision, enabling the creation of complex and detailed CNC medical parts. This level of precision is crucial, especially when developing components for surgical procedures and implants.
VersatilityMedical CNC machining services offer a wide range of applications. CNC milling, turning points, and precision stamping can be used to manufacture a variety of devices, from surgical instruments to diagnostic equipment. This versatility makes CNC machining indispensable in the medical industry.
Efficiency and ComfortIn the medical industry, time is of the essence, and CNC medical part manufacturing streamlines the production process. Prototypes can be produced in a short time without compromising quality, unlike other methods.
CustomizationCustomizing medical devices to individual needs is crucial. CNC machining of medical parts easily enables customization, allowing the creation of bespoke CNC medical devices to meet specific requirements.
Standard ComplianceMedical devices must comply with stringent regulatory standards. Precision machining of medical devices ensures adherence to these guidelines through rigorous quality control and certification processes.
Cost-EffectivenessWhile quality is paramount, medical CNC machining services also offer cost-effectiveness. By optimizing materials and reducing waste, CNC machining of medical devices provides an affordable solution without sacrificing quality.
Various Tooling OptionsA wide range of tooling options in medical CNC machining allows for exceptional flexibility and customization. From machining complex medical parts to CNC medical devices, choosing the right tools ensures perfection in every detail.

Key Applications of CNC Machining in Medical Devices

CNC machining has been discovered in the medical industry. As you know, it helps in manufacturing tools such as sensors, surgical instruments, and even machines used in hospitals because it ensures accuracy and precision. If you want to design medical devices that are high-precision, robust, and of the highest safety, then CNC machining is likely the best method for manufacturing such devices.

Surgical InstrumentsWith the invention of computers, the integration of computers with manufacturing processes, and the widespread application of computer technology, the production of surgical instruments has become more reliable and precise. Furthermore, CNC machining technology in medical applications makes the production of surgical instruments even more reliable and precise.
Orthopedic ImplantsOrthopedic implants are a complex example of machining medical components. These components are custom-made and extremely precise. This is important because they must withstand significant stress and strain.
Dental EquipmentCNC precision technology is a breakthrough in the field of dental medicine. These machines not only improve the efficiency and precision of dental clinics but also positively impact patient satisfaction.
ProsthesesThrough CNC machining, it has become easier to create prostheses for people who have lost limbs due to surgery because it allows for the precise fabrication of limbs and movable joints.
Diagnostic Equipment ComponentsThe precision and accuracy of instruments such as magnetic resonance imaging (MRI) and blood analysis instruments have benefited from CNC machining, further enhanced by modern scanning and phonon technologies. Furthermore, CNC machining of medical devices accelerates turnaround times and can be used to test diagnostic equipment prototypes.
Medical Device Housings and CoversCNC machining is also widely used for housings and enclosures of surgical robots, infusion pumps, and diagnostic monitors, all of which are manufactured using CNC technology.

Partnering with Elimold

Elimold manufactures a wide range of medical parts to date, including but not limited to: housings for velocity sensor probes, probe housings for medical sensors, rectal plugs for medical devices, valve parts for blood pressure monitors, and copper valve parts for medical devices.

Whatever type of medical part you need custom-made, we can help. Our team of experts can discuss your part design drawings with you and help you choose the most suitable process for your project. If you are looking for a CNC machining partner for the medical industry, you are the one to choose from. We offer precision CNC machining, providing a complete service—design support, rapid prototyping, production, and even final part inspection. From custom implants to complex surgical instruments, every detail at Elimold is medically certified. We have earned the industry’s trust with fast quotations, efficient communication, and rigorous quality control.

Conclusion

The emergence and development of precision CNC medical machining has revolutionized the way medical tools and devices are manufactured. The technology’s tight tolerances, speed, and reliability enable us to produce stronger, safer, and more precise parts. From custom implants to surgical instruments, CNC machining has significantly improved patient care. The future holds promise for enhanced, customized, and intuitive technologies. To reiterate, if you truly need precision CNC medical components for your application, Elimold is your trusted first choice. Contact Elimold now.

FAQ

What is Medical Device Manufacturing?

Medical device manufacturing refers to the process of producing devices, instruments, implants, and other apparatuses used in healthcare settings for the diagnosis, treatment, or monitoring of medical conditions.

What are the CNC machine tools used in the medical industry?

The medical industry uses 3-axis, 4-axis, and 5-axis CNC machine tools, Swiss-machined machine tools, CNC lathes, etc. They offer high precision and repeatability, ensuring medical devices meet stringent quality standards.

What are the components of CNC-machined medical devices?

Components: These devices include various parts such as bone screws, dental restorations, surgical blades, and prosthetic components. They are all manufactured with extremely high precision using CNC machine tools.

What are the three key components of a CNC machine tool?

The three key components of a CNC machine tool are the controller (the computer that runs the software), the machine tool (which cuts, shapes, or forms material), and the drive system (the motor that moves the tool).

What are the six essential elements of a CNC machine tool?

The six key elements of a CNC machine tool include the input device, machine control unit, machine tool, drive system, feedback system, and display unit.

What are the regulatory standards for CNC machining of medical devices?

Standards include biocompatibility standards ISO 10993 and ISO 13485, and other medical device regulations.

How does CNC machining improve the cost-effectiveness of medical device manufacturing?

CNC machining reduces overall costs by reducing material waste, enabling small-scale production, and minimizing errors.

What are the key stages of medical device manufacturing?

The key stages of medical device manufacturing typically include design and development, prototyping, testing and validation, regulatory approval, production, and post-market surveillance.

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