Over the past few years, the COVID pandemic and recent world events have revealed deep supply chain vulnerabilities in the United States. For far too long, we have seen high-quality jobs shipped overseas in pursuit of ”cheaper” alternatives to American-made products. We saw instances where finished products could be purchased overseas for less than what the raw material would cost in the U.S. As a result, we developed a precarious reliance on foreign manufacturing.
When the pandemic hit in 2020, the country began to realize what those in the manufacturing industry have been screaming from the top of their lungs for years: “cheaper” comes at a cost! I have written several times in these blogs about the "true cost" of offshoring and thinking outside of the "purchase price." Factors such as environmental impact, sustainability, quality risks, supply chain risks, rising shipping costs, rising inventories, long lead times, and more impact the total cost indirectly, and now, directly.
At C&M, we care about our products' end users. It’s been part of our DNA since we opened our doors more than 40 years ago. Our roots are in the defense sector and stem from customers trusting us to do what it takes to ensure the devices in which our parts and assemblies are used fulfill their respective missions 100% of the time. In that same vein, we understand that our medical customers require the highest quality manufacturing standards for their parts and assemblies.
That required level of precision is no surprise. Supply chain partners like us, along with OEMs, are creating products that someone, somewhere in the world, will depend on for a diagnostic, a procedure, or a life-saving surgery. Therefore, it is critical that these parts do not fail.
So, how do companies like C&M meet these stringent standards? We must continue to invest in 4 key elements of our business: Talent (people), Equipment (machines), Facilities (cleanroom), and Processes (ISO 13485).
Talent
At C&M, we take pride in having manufactured more than 350 million parts and assemblies since our founding. To care about end-users as we do, we have to first care about our people.
At C&M, we invest in our team members. Our commitment to training and promoting from within is what ensures the sustainability of our organization. We partner with local technical high schools and colleges in conjunction with our in-house training programs to set our team members up for success.
Our team has a passion for excellence in manufacturing precision machined components and assemblies and takes pride in making products that can help save lives and improve the quality of life for end-users.
This attitude has allowed us to remain an industry leader for more than 40 years. It is an indispensable asset and the backbone of C&M.
Machines
In addition to having great people, it is highly advantageous for medical parts manufacturers to be able to work with almost any material, from plastic to copper to stainless steel to high-temperature alloys. The next time you are in a medical office, I encourage you to look around at all the instruments needed to diagnose and treat patients. It is truly astounding! The products we support can be found in operating rooms, surgical instruments, robotics, optics, MRI equipment, and more.
Our investment in state-of-the-art automated CNC machines makes us capable of manufacturing high-precision parts in large volumes. We’ve complemented our CNC machines by investing in EDM machines and other equipment to reduce costs and move up the value stream with our partners.
Some of our customers and supply chain partners have asked us to invest with them. They typically make complex assemblies from multiple machined parts that are welded together. We’re investing in production-capable additive manufacturing (AM) so we can replace multiple pieces with one assembly. The benefits of doing so include design flexibility, reduced costs, and positive environmental impact. We call it Engineered for AM Production.
As a result of this unwavering dedication to excellence, we delivered better than 6σ performance in one year to one of our largest customers by:
- Shipping More Than 5 Million Parts
- Experiencing Zero Returns
- Delivering 99.82% of Orders On-time with 2-Day Lead Times
Cleanroom
Cleanrooms are necessary for all services related to the production of medical assemblies. They are designed with considerations for structural, architectural, and application compliance in-mind, ensuring that medical devices are assembled in secure environments.
While the importance of cleanrooms for medical assemblies may be obvious, it is less well-known that many companies that advertise their quality management systems (QMSs) do not have a cleanroom. Customers must then rely on their cleanrooms or outsource the post-machining work, typically cleaning and assembly, to other companies that have cleanrooms.
At C&M, our cleanroom meets Class 8 standards. We have HEPA filtration to ensure a maximum particle count of 100,000 particles (≥0.5 µm) per cubic foot. This feature allows us to deliver foreign object debris (FOD)-free parts and assemblies that meet the most stringent specifications, making us the ideal partner for our medical industry customers.
ISO 13485 Certification
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Although most manufacturers meet ISO 9001 requirements, and possibly other quality management standards, there are extremely specific certification requirements for the medical device industry, which are encapsulated in ISO 13485. This certification is one of the highest standards to meet and hardest to attain.
As explained earlier, we started our business by supplying defense and optics customers that have stringent requirements, on par with those of medical equipment manufacturers. At the request of our customers, we applied for and received our ISO 13485:2016 certification.
Because our QMS has always been integral to our business, our ISO certifications are not just accomplishments that we hang on the wall. At C&M, our QMS is our business management system. What’s more, our team is highly trained, and every process is fully documented, as one would expect with this level of compliance.
Medical Machining Partner
C&M is one of the few manufacturers that has under one roof qualified and trained talent, a Class 8 cleanroom, state-of-the-art production equipment, and manufacturing processes focused continually on being your Partner for Complete Medical Machining Capabilities.
When selecting the right supplier, it’s often more than a matter of saving time or money. Those benefits help, but we have found that lasting relationships are built on value, trust, and partnerships. For machining and assembly solutions that will hold up against the critical use required of medical devices, look no further than C&M.
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