Medical Device Manufacturing
The medical industry requires a machining process of parts that provide high tolerances and precision measurements because the slightest error can lead to detrimental health complications. Of course, most ordinary metal parts must satisfy ISO 9001 quality management obligations, but medical devices and components are held to higher standards. The International Standards Organization states that any companies involved in the design, development, production, storage, distribution, installation, or servicing of medical parts must demonstrate an “ability to provide medical devices and related services services that consistently meet customer and applicable regulatory requirements.” AW Miller provides CNC machines that produce components meeting the following standards:
To receive medical parts approval for use, they must pass these standards:
- ISO 13485: This is the medical industry-specific qualification standard. It expands on finer details from the ISO 9001 standard related to the medical industry, emphasizing the regulation of production processes. It regulates production stages such as process validation, risk management, and quality control. In addition, compliance with this standard makes it easier for any company to bring its products to the international market.
Requirements for medical equipment production success
- Human lives depend on the success or failure of these components so the CNC machines need to perform at the highest levels of precision and accuracy possible. Many of these medical parts require extra tight tolerances (as tight as 0.0001” for some parts) due to their small intended size. This is especially important for parts meant for intrusion into the human body. The small size will help to minimize intrusion and help patients to heal faster.
- 4-axis and 5-axis machining for complex geometries for extra flexibility and extra-cutting maneuverability.
- Ultra-high level of cleanliness.
- A wide selection of materials including stainless steel, and medical grade plastics such as PEEK.
- High-level surface finishing capabilities.
The medical technology industry has made significant developments in the production of devices and equipment. As a result, we are seeing an influx of CNC manufacturing for medical applications that require high precision and accuracy. In addition, these components can be more detailed, and the process allows an exceptional level of consistency between parts as necessary.
CNC Manufacturing Applications Within The Medical Industry
CNC manufacturing has a great compatibility rate for applications within the medical industry. These applications have time constraints and incomparable precision, which is where other machining processes fail. Machinists have begun to harness the potential of CNC manufacturing these precision parts. Some of these medical devices include:
Machined Surgical Instruments
CNC machining can manufacture high-grade surgical instruments to be used during operations, such as:
- Surgical scissors
- Blade handles
- Biopsy tubes
- Implant holders
These surgical tools require scrupulousness, precision. Their applicable use is also subject to additional safety requirements such as ease of sterilisation. Some of these instruments must be manufactured in short production runs, or they may demand fabrication for individual patients. Therefore, CNC machining is ideal because of the reasonable production perks.
Micromachining is the production of exceedingly small medical parts. These are used primarily in implantable devices, drug-delivering technologies, exploratory surgical tools, and more.
Micromachining is used to produce these tools:
- Pacemaker components
- Drug delivery systems
- Miniature screws for
- implants and devices
- Ophthalmic devices
These devices have immense sophistication bundled into their small sizes, demanding high precision and expertise. Battery manufacturers deal with significant challenges for micro-implantable devices. Therefore, CNC medical machining is the ideal choice because it provides high precision levels, even for components under 50 microns.
Electronic Medical Equipment
Surgical instruments normally consist of one or two metal components. However, CNC machines can produce a wider range of complex medical equipment, such as heart rate monitors, X-ray machines, and MRI scanners.
The equipment for these applications is made up of thousands of individual parts, most of which can be fabricated using the CNC machines. For example, these individual parts include tiny components such as buttons, switches, and levers, or bigger items like monitor housings.
All these components must offer unparalleled precision to eliminate the risk of machine failure, especially since medical apparatus gets wheeled frequently across the hospital. However, unlike surgical tools or implants, these components do not have to be biocompatible since they might never come in direct contact with a patient.
Machining medical parts has had a significant impact on the production of bodily implants, such as spine and knee implants, and hip replacements. Typically, medical professionals only need these in limited quantities since each patient needs a specific size to fit into the joint.
CNC medical machining is a better option when compared to injection molding for these applications because machinists can utilise the tools repeatedly, which inhibits the escalation of production costs. CNC machining, combined with 3D printing, can enhance the durability and performance of artificial body parts and prosthetics for amputees.
Dentists need to recreate the exact shape and size of the spaces in the teeth to be crowned, veneered, or to receive another dental implant. Being small and delicate, CNC combined with modern 3D imaging techniques enables these designs to be accurately produced to a higher degree than previous production technology allowed, making life a lot easier for both the patient and dental practitioner.
The Future of CNC Manufacturing in the Medical Industry
There are many factors that need to be considered when implementing and enforcing any type of change in healthcare, especially in the United States where the policies are more complex, and slower to change. There are also environmental and technological factors that play major roles in these contributions. The need for changes is rooted from trends in illness, doctor demographics, and technology availability. As society continues to evolve, so will our requirements of healthcare.
CNC processes have already enabled several medical innovations to be produced that would not have been possible with other types of traditional manufacturing.
These parts rely on precision as they need to be machined according to the exact specifications and tolerances of the original design in order to be a success and to work smoothly within an entire system. These parts include:
- Components for laser equipment used for the cutting and removal of tissue.
- Automated systems components for laboratories.
- Parts used in robotic surgical systems.
- Remote patient monitoring system components.
We are expecting a strong continuation of the advancements and applications CNC manufacturing can bring to the medical industry. As this technology increases in precision, speed, accuracy, and reliability, the medical industry will be able to create anything they need to as their own research and technology develops.
Machine Repair Services
AW Miller is proud to offer a team of certified technical engineers that will assist you with service requests in a timely manner to decrease down time. We will also help you to avoid service requests with routine maintenance tips. Please click here for more information.
If your team needs assistance with learning how to use the CNC machinery and technology, Mazak offers a variety of training classes. These will ensure your medical manufacturing teams are up-to-date on how to use and maintain the machines effectively. Please contact us to learn more about these training classes.