While CNC machining has been around for decades serving many industries, the medical industry was among the slowest industries to adopt computer numerical control (CNC) technology.
Back in 1961, CNC machining was already gaining popularity in the aerospace and defense industry. Meanwhile, John Charnley (the father of hip replacement surgery) was still fabricating prostheses by himself using a manual lathe and bench tools. Thankfully, he made ground-breaking contributions to the medical field before anyone could question the precision and ergonomics of the artificial hips he was machining at the time.
Since that time, a lot has changed, and CNC machining is now at the forefront of machining technologies used in the medical industry. From machining medical parts to highly specialized lab automation components, the applications of CNC machines in the medical industry are near-endless.
This article covers 3 of the most common applications for CNC machining in the medical industry today.
3 Applications for CNC Medical Parts Manufacturing
#1 Medical Implants
Like with any other piece of machined medical hardware, bodily implants, such as knee implants and hip replacements, require a high level of precision and accuracy. A slight mistake during manufacturing, and the life and well-being of the patient could be affected significantly.
CNC Swiss machines are helping to accurately craft patient-specific parts while achieving tolerances as small as 4μm. After receiving a request from an orthopedist, a CNC machine center creates a CAD model and recreates the body part through reverse engineering and CNC technology.
The medical industry requires these implants to be made of biocompatible materials, such as PEEK and titanium. These materials are challenging to machine — they generate excessive heat during machining, and coolants are often prohibited due to fear of contamination. CNC machines are helping to solve this challenge as they boast compatibility with a wide array of materials.
#2 Medical Instrument Machining
The medical industry also heavily relies on CNC machining to manufacture surgical instruments, such as tubes, blades, surgical scissors, biopsy, spacers, and other minimally invasive surgical tools.
And the reason for this heavy reliance on CNC machines is easy to understand.
The U.S Food and Drug Administration (FDA) recently set out understandably strict requirements for the manufacture and use of surgical instruments and other medical devices. And CNC machining is among the most reliable machining technologies capable of meeting these standards.
While 3D printing also allows machine centers to meet these requirements, it’s not ideal for large production runs. CNC machines can create large volumes of identical medical instruments within hours, whereas 3D printing might take days (or even weeks) to complete.
#3 Electronic Medical Equipment
Many medical devices like MRI scanners, heart rate monitors, and X-ray machines feature thousands of CNC-machined electronic components. Examples include switches, buttons, and levers, as well as electronic housings and casings.
Unlike implants and surgical tools, these medical devices do not need to be biocompatible since they do not make direct contact with the patient’s internal systems. However, the manufacturing of these parts is still largely supervised and controlled by several regulatory bodies.
Non-compliance to the standards set by these regulatory bodies could attract hefty fines (or sometimes imprisonment) for the machine shop. There have also been cases where the medical professionals involved lost their medical licenses. As such, you must choose your medical device manufacturers wisely.
How to Choose a Machine Shop for Medical Precision Components
So, let’s say you’ve come up with the design of a medical implant, instrument, or device and are ready to outsource manufacturing to a third-party machine shop. Here are two essential things you should look out for in a third-party manufacturer.
ISO 9001 and ISO 13485 Certifications are Essential
You want to make sure you’re working with a machine shop that meets the requirements of ISO 9001 and ISO 13485.
An ISO 9001 certified machine shop adheres strictly to statutory and regulatory requirements by ensuring high-quality machining services. ISO 13485 is an international standard that provides specifications for a quality management system for manufacturers of medical devices or instruments.
Look for Highly Experienced Engineers and Quality Control Experts
The machining industry is flooded with inexperienced CNC operators and technicians. And to make things worse, many machining centers lack a quality management system to inspect the medical parts being machined by these technicians.
You want to make sure you’re working with a machine shop that has highly experienced engineers, as well as CNC quality control experts. This will save you from the hassle of going through the product development phase twice.
Gensun Precision Machining is a leading provider of medical CNC machining services around the world. Backed by nearly two decades of CNC experience, we have a reputation for creating high-quality medical components using state-of-the-art CNC technology.
We have a team of highly experienced CNC technicians and quality control experts, and our facility is ISO 9001 and ISO 13485 certified. Tell us about your project today, and let us help you create medical precision parts exactly to your specification.