Development Services

Design for Manufacture Services

TE Connectivity (TE) is your fast and flexible partner for advanced catheter systems. Our experts work with your team from new product development through launch.

We have a complete set of in-house technologies for catheter and guidewire manufacture. We scale our production services to match your needs and grow with you from prototype to pilot manufacturing to high-volume manufacturing. Our manufacturing facilities are located in the Boston, Minneapolis and San Jose areas in the United States, and in a Costa Rica free-trade zone.

Design for Manufacture

Designing products that meet performance requirements at the lowest cost possible requires integrating your manufacturing partner early in the design process. Research has shown that up to 80 percent of the factors that determine final product cost are locked in before the product design is set. At TE, our engineers are a collaborative extension of your development team, providing expert Design for Manufacture (DFM) guidance. DFM ensures design specifications are within process capabilities which will reduce costs and streamline the transfer of designs into volume manufacturing.

Our experts support you with:

  • Material and process selection
  • Design, specification and tolerance stack analysis
  • Process FMEA
  • Process design & development and process capability analysis
  • Process validation

Prototype

Speed to market is critical, and TE's rapid prototyping capabilities help development teams reduce time to market. Our team includes an experienced development engineering group, a dedicated prototype lab and resident tool makers to provide prototypes, fixtures, special assembly machinery and tooling quickly and efficiently. Our engineers develop prototypes using equipment that is used for production, which helps minimize the time and effort needed to transfer designs from prototype into production processes.

TE provides rapid prototyping for medical technologies such as:

  • Extrusions
  • Catheter shafts
  • Medical balloons
  • Guidewires

TE creates an environment for collaboration between our customers and our engineering labs. This allows our customers to work alongside us and leverage our full breadth of capabilities, resulting in faster prototype fabrication. To learn more about our rapid prototyping capabilities, contact us today and we will be happy to assist you.

Pilot Manufacturing

The critical link between product development and volume manufacture is pilot manufacturing, where GLP studies, pre-clinical, clinical and low volume manufacture are produced under batch-released protocols. When you choose TE, your pilot manufacturing is supported with dedicated clean rooms, production resources and a quality system that ensures safety and allows flexibility. The pilot manufacturing stage brings together design engineering, process development and quality systems to refine production processes and inspection requirements for volume manufacture.

TE's pilot manufacturing services include:

• Process development
• Design and construction of assembly tools and fixtures
• Process FMEA
• Device master records
• Design transfer to manufacturing
• Process validation
• Manufacture of clinical and low volume commercial product

To learn more about TE's dedicated, professional engineers and how our high quality processes suit your pilot manufacturing needs, contact us today.

Volume Manufacturing

TE offers high quality and flexible manufacturing solutions for advanced catheter systems, including finished devices and components. Our manufacturing facilities are certified to ISO 13485:2003 and MDD:EC 93/42/EEC Annex II.3. Our Boston facility is registered both with the FDA as an approved finished device manufacturing facility and with the Japanese MHLW. Our wide range of manufacturing solutions are flexible enough to assist you in all phases of your product’s development from our three stateside locations in California, Minnesota and Massachusetts right through to high volume manufacturing in Costa Rica. TE has more than 90,000 square feet of manufacturing space in our four facilities, including 30,000 square feet of Class 100,000 ISO certified clean rooms.

TE provides the world’s largest medical device OEMs and many growing companies with:

  • Balloon catheters
  • Guidewires
  • Steerable and fixed curve catheter shafts
  • Braided and coiled catheter shafts
  • Finished sterile devices

TE's transfer to the manufacturing process works in parallel with product development. This ensures successful process validation and reduced time to high production volumes. Lean methodologies are designed into the product and our manufacturing engineers provide continuous process improvements through the product lifecycle. We want to help meet all of your volume manufacturing needs. To learn more about the services TE offers, contact us today.