Key Manufacturing Competencies
Cirtec offers a full range of capabilities to meet the needs of leading companies who demand the highest quality and tightest tolerances. From design and development, to prototyping and support for long-term development processes, Cirtec provides expertise in material selection, tooling and design and flawless manufacturing.
Leads design and manufacturing
The delicate wires connecting a device to its target anatomy are critical to the safety and reliable performance of your product. Cirtec’s seamless materials, design and manufacturing expertise helps to ensure even high-density leads will not succumb to fatigue or poor insulation and sealing. We can even help you explore novel architectures such as leadless (i.e. wireless) pacing.
Hermetic welding and testing
Hermetically sealing electronics against body fluids is critical to the safety and reliability of your implantable medical device. Combining glove box technology, vacuum ovens, advanced materials science and decades of engineering expertise, Cirtec is today a leading fabricator of hermetically sealed implantable medical devices. Yet no seal remains hermetic forever. So, Cirtec further provides unique expertise in testing hermetic leak rates. With our help, you can target and ensure an optimized leak rate for even the most compact device architectures.
Micro machining and manufacturing
The medical device industry has been making medical device assemblies with micron dimensions for some time, but in the last few years the miniaturization of medical components and assemblies has expanded. To accommodate these requirements, we have developed miniaturized capabilities to support all micron requirements.
Standard and custom wire coil winding over mandrel or deflection winding are available in a wide range of wire coiling styles and sizes. We can supply all standard and custom materials including flat and shaped wire for coiled products. Our custom designed equipment allows us to manufacture with tight pitch control on straight, tapered or multi-pitched coils in all wire forms. All wire coilings for medical components and assemblies are manufactured in a Class 100,000 clean room for pristine wire coils. We have the ability to make medical device wire coils to the tightest tolerances required for the most stringent medical applications. Our tooling expertise allows us to consistently develop new methods to meet or exceed our customers’ tolerance requirements. We take extreme pride in our innovative abilities to create tooling and fixtures to support our proprietary wire coiling efforts.
Laser welding and cutting
Laser welding provides accurate, repeatable and reliable joining for medical devices and assemblies. Components are laser welded using a fixtured and automated system. Spot size achievable as small as .0007″ diameter with automated circumferential weld. Laser welding provides precision joining of coil wires and joining of metal components for finished assemblies and is a proven method for joining a wide variety of metals and metal alloys.
Laser cutting produces close tolerance, tubular medical components devices and assemblies. Cirtec’s system allows us to manufacture very complex, difficult components with an extremely accurate automated system. Our laser cutting process provides fast, flexible and cost-effective cutting of metals and non-metals.
Silicone molding, backfilling and adhesion
Both epoxy- and silicone-based polymers are instrumental to sealing and protecting sensitive electronics within active implantable devices fabricated under the ISO 10993 biocompatibility standard. However, both polymers have their benefits and drawbacks. Cirtec Medical’s expertise in the material science and implementation of either chemistry can help you determine which will best serve your device, and how best to apply it.
Sterilization is a critical process for many finished medical devices and sub-assemblies. From components to long term implantables, medical device companies trust Cirtec’s Sterilization Management program to care for their terminal sterilization requirements. Managed from our Enfield, Connecticut and Brooklyn Park Minnesota locations, Cirtec offers our partners full sterilization management services.
Cirtec’s in-house EO sterilization services are ideal for sterilizing smaller lots for research, clinical trials and functionality/compatibility testing. Whether utilizing our in-house EO sterilization capabilities, or a Cirtec managed third party for Gamma, E-beam, and other terminal sterilization methods, we take on every aspect of the process – from sterile pack design, process validations, to final sterile release. In addition, our team handles bioburden and endotoxin testing, sterile pack integrity, complete sterilization cycle documentation, and overall logistics.
Save time, manage costs, and mitigate risk in product development and production by leveraging Cirtec’s complete Sterilization Management.