Trusted Medical Device Manufacturing Partner

Kellyder specializes in precision CNC machining and metal casting solutions for medical OEMs and innovators. With over 10 years of experience serving the medical industry, we are your trusted manufacturing partner.

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Why Choose Kellyder

Our Medical Manufacturing Advantages

We stand out in medical device manufacturing with our expertise, capabilities, and commitment to quality.

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Our Process for Medical Device Manufacturing Support

We utilize a streamlined and collaborative 4 step process to deliver your custom medical components efficiently.

Design and Development
Development and Pilot Runs
Qualification and Certification
Volume Manufacturing and Supply

Product Design and Development

We help refine the product design through prototyping iterations and assist with materials selection, DFA optimization, tolerance stack-ups to streamline manufacturing.

Our engineering team supports with product renderings, 2D drawings, 3D CAD models, simulated analysis using Finite Element Analysis software to assess mechanical stresses and accelerate device optimization.

Development and Pilot Runs

The second phase develops and proves out specialized secondary processes like laser welding, sterile packaging in controlled environments, specialized coatings, laser marking etc. that are key to product functionality. Test runs validate capabilities at low rate initial production capability and quality.

Our technical staff fines tunes the specialized secondary processes involved through DOEs, gauge R&R, process capability analysis etc. to ensure repeatable techniques for seamless scale-up. Pilot runs of 10-100 parts validate quality.

Qualification and Certification

Prior to volume manufacturing, we assist with design verification and validation testing as needed, packaging qualification, and secure supply chain logistics for global regulatory submissions.

Our quality team supports design verification through environmental simulation testing and accelerated life tests using in-house equipment. We collaborate with select labs for further compliance testing like biocompatibility evaluations, EMC/EMI testing, sterilization validation etc. Our logistics specialist partners ensure seamless global delivery with packaging qualification as needed.

Volume Manufacturing and Supply

The manufacturing process and supply chain is locked down for volume production runs of 100-50,000 parts monthly supported by ongoing monitoring and continuous improvement initiatives.

Our automated cells, CNC machining centers, metal 3D printers and secondary process stations ensure consistent high quality output. Statistical process controls combined with continuous improvement projects enable us to manage key critical to quality characteristics. Our supply chain partnerships facilitate dependable delivery globally.

Medical Device Manufacturing Capability

Kellyder has integrated metalworking and 3D printing capabilities as well as finishing processes to provide complete medical device manufacturing solutions.

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Specialized Materials for Medical Device Manufacturing

Kellyder provides specialized medical device prototyping, machining and 3D printing for a range of high performance metals and biocompatible plastics.

  • Stainless Steel (316/304)

    We have extensive experience using the most common medical grade stainless steel options like 316 and 304 stainless steel. These exhibit excellent corrosion resistance and biocompatibility for long-term device performance.

    From tiny precision machined components to large weldments, our manufacturing expertise facilitates stainless parts with fine tolerances and surface finishes up to mirror polish. 

  • Bioresorbable Polymers

    Our technical expertise extends to controlled manufacturing using novel bioresorbable polymers like PLLA, PLGA, PGA blends which naturally dissociate preventing secondary surgical procedures. Especially useful forPatients with evolving anatomy like children, we precisely fabricate resorbable orthopedic screws and scaffolds by 3D printing, CNC machining, injection molding and extrusion to suit small batch R&D or commercialization.

Critical Device Surface Processing Techniques

Secondary finishing processes are vital for metal surface hardness, corrosion protection, wear performance, aesthetic appeal and biocompatibility.

Image Name Description
Passivation Required surface treatment to render stainless steel corrosion resistant for implants. Nitric acid removes free iron and enriches chromium oxide layer.
Electropolishing Electrolytic polishing process to smooth stainless steel and titanium surfaces for seamless insertion/extraction of devices. Produces consistent glossy mirror finish.
Anodizing Anodizing builds up a thick non-conductive oxide layer on titanium surface for electrical isolation needs like pacemaker casings and for color coding.
Parylene Conformal Coating Biocompatible transparent parylene coatings are applied via vapor deposition to add lubricity, electrical insulation and moisture/chemical barrier for printed circuit boards and other assemblies.
Gamma Sterilization Terminal gamma radiation sterilization services offered through partner facilities to achieve 10−6 sterility assurance levels for packaged components.

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NameDescription
PassivationRequired surface treatment to render stainless steel corrosion resistant for implants. Nitric acid removes free iron and enriches chromium oxide layer.
ElectropolishingElectrolytic polishing process to smooth stainless steel and titanium surfaces for seamless insertion/extraction of devices. Produces consistent glossy mirror finish.
AnodizingAnodizing builds up a thick non-conductive oxide layer on titanium surface for electrical isolation needs like pacemaker casings and for color coding.
Parylene Conformal CoatingBiocompatible transparent parylene coatings are applied via vapor deposition to add lubricity, electrical insulation and moisture/chemical barrier for printed circuit boards and other assemblies.
Gamma SterilizationTerminal gamma radiation sterilization services offered through partner facilities to achieve 10−6 sterility assurance levels for packaged components.

Trusted for Various Medical Device Projects

Kellyder leverages its manufacturing expertise to serve various medical OEMs and contract manufacturers.

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Our Product Cases

View a select sample of our manufacturing capabilities applied to medical device projects.

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Kellyder Supports Applications

Our CNC machining, metal printing, precision casting and finishing capabilities serve varied product development needs.

Guides on Manufacturing

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Our experts are online 24h, will respond quickly within two hours of receiving your demand, and immediately customize personalized one-stop solutions for you according to the information and drawings you provide.

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