Much like the aerospace industry, the medical industry has strict standards for precision machined parts. And while the AS9100 certification we possess here at Focused on Machining is specific to the aerospace industry, the processes we developed to maintain our status as an AS9100 machine shop enable us to meet the demands of the medical industry, as well.
4 Reasons to Trust Focused on Machining for Precision Medical Machining
Whether you’re nearby in Colorado or across the country, here’s why you should consider Focused on Machining for precision medical machining.
1. Material traceability
Material traceability is vital for medical parts inserted in the human body or used during surgery; there must be complete certainty that the materials have the necessary properties.
Focused on Machining guarantees material traceability throughout the entire manufacturing process, working only with carefully selected material vendors who provide accurate information, material specifications, and certifications.
2. Precision machining expertise
Medical parts often have intricate features, angles that are difficult to reach, tight tolerances, and high-precision surface finish requirements. A deep level of precision machining expertise is required to successfully manufacture these parts to specification.
Focused on Machining specializes in machining parts with complex features and has developed a reputation for our close attention to detail and superior quality.
We regularly machine stainless steel and acetal—two common materials used in precision medical machining. We’ve even put in the work to master more challenging materials—like titanium, a popular material for medical implants due to its durability, biocompatibility, and excellent strength-to-weight ratio.
3. Well-vetted electropolishing vendors
Parts used in medical environments must meet extremely high standards for cleanliness, and one way to achieve these standards is with electropolishing. This finishing method uses an electrochemical process to smooth a part’s surface, reducing and removing microscopic cracks and crevices that, if left untouched, could enable bacterial growth.
We machine many medical parts from stainless steel (known for its corrosion-resistant and bacteria-resistant properties), achieving a 32 or 24 Ra surface roughness. We’ll then send those parts to a trusted electropolishing vendor, who takes the roughness down to 10 or 8 Ra, which is essentially a mirror-like finish.
Focused on Machining facilitates coordination with vendors, taking on project management responsibilities to alleviate our customers of this burden.
4. Rigorous inspection process
We worked hard to improve our inspection process as part of our journey to becoming an AS9100 machine shop.
Each part is subject to a First Article Inspection, which means as soon as we finish an operation for the first time, we inspect the part thoroughly to verify that it’s in spec before moving on to the next operation.
If any adjustments are necessary, we cut another part (or re-cut the first part) and then re-inspect it. We document each inspection and maintain that documentation in our ERP system for historical purposes should we need to reference it at a later date.
We proceed through the manufacturing process until the parts are complete and inspect the completed parts per Acceptance Quality Limit (AQL) sampling standards. Upon customer request, we’ll inspect specific features on all parts—simply let us know what you need, and we’ll happily accommodate your preferences.
If parts require a plating process, such as anodizing or passivation, we outsource the service to a certified vendor and obtain the necessary certification(s) from the vendor to include in our quality documentation.
Get Precision Medical Machining Services
One of our primary medical customers builds testing equipment for artificial heart valves, and we make many of the parts for this equipment. We’re excited to take on more precision medical machining projects, especially with the numerous medical companies here in Colorado.
If you’re interested in our services, we’d love to hear from you. Request a quote, and let us put our expertise to work for you.