SITES Medical offers a full-service manufacturing capability, using state-of-the-art equipment and our deep experience to drive out cost and ensure delivery of the highest quality product, whether the destination is the inpatient hospital or the more price-sensitive ASC environment. We are ASC-Ready™.

Our manufacturing engineering team has extensive experience with the complete range of equipment that is used to manufacture implants and instruments and with the complete range of products that are manufactured. Naturally, we are ISO 13485 certified.

Sample Manufacturing Projects

Laser cutting implementation

This project was undertaken by SITES in an effort to reduce cost on several of the products that we manufacture for our customers. The laser cutting equipment we installed greatly reduces processing time while increasing precision and handles simple to complex forms with its 5 axis cutting and laser welding capabilities. We use it often to cut OsteoSync Ti to shape, but it is also available as a service to others for titanium thin sheet cutting applications.

Specific activities performed:

  • Identified the appropriate technical solution
  • Conducted IQ/OQ/PQ for the laser cutting machine and processes
  • Completed programming
  • Developed tooling
  • Performed validations for specific products
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CoCr Stabilization Process

Critical component dimensional movement that occurs during standard manufacturing steps involving CoCr components requires manufacturers to inspect after every critical step and physically alter the product if necessary to restore dimensions to an appropriate range before moving to the next operational step. SITES Medical has developed a stabilization process that is applied to CoCr components to reduce dimensional movement without exposing the components to atypical manufacturing elements or temperatures. This process can enable meaningful improvements in inspection time, processing steps, rework and scrap rate. It also enables High Velocity Single-Piece flow manufacturing, a technology developed by SITES Medical and sister company Mach Medical.

Activities Involved:

  • Process parameter determination
  • Testing
  • Validation

Tool & Die design

In order to manufacture the PEEK/OsteoSync™ Ti interbody fusion devices, we needed to come up with insert molding tooling that featured very tight tolerances and tight fits between the inserts and the molds. We can offer up our experience with tool and die design to others.

Specific activities performed:

  • Insert Mold Tool Design
  • Prototyping
  • Manufacturing
  • Validation

Diffusion bonding process development

Bonding porous surfaces to solid substrates can be a challenge, especially with dissimilar metals. We developed a diffusion bonding method for the attachment of our OsteoSync™ Ti porous ingrowth material to a variety of solid titanium and cobalt-chromium substrates (eg. cast, wrought, forged) to ensure sufficient bonding strength while avoiding corrosion. The work formed part of our FDA Master File which multiple products reference.

Specific activities performed:

  • Process parameter determination
  • Fixturing
  • Tooling
  • Testing
  • Validation

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