Manufacturing Capabilities
Expansive Knowledge
Switchback Medical offers a single-source solution for your contract design and manufacturing needs. From component design and manufacturing to full device packaging & sterilization, we simplify your supply chain to reduce development costs and overall time to market.
Process Knowledge
Our tenured team has decades of collective experience in process development and validation including, but not limited to specializing in:
- Injection Molding
- Fixtures, Tooling and 3D Modeling
- Final Assembly
- Composite Shaft Construction
- Balloon Forming
- Sterile Packaging
- Nitinol Shape Setting
- Equipment Optimization
- Thermal Bonding
- (Laser, RF, Heated Die)
Equipment Capabilities
Switchback has a comprehensive inventory of equipment that can be used for catheter and device manufacturing. In addition, we are happy to add new equipment that suits your project needs.
- Braiding
- Coiling
- Reflow
- Balloon Forming
- Nitinol Shape Setting
- Silicone Application
- Sterile Packaging
- Thermal Bonding
- Soldering
- Laser Welding
- 3D Printing
- RF Tipping
Braider
Coiler
Balloon Forming Machine
Facility
Switchback is located in Brooklyn Park, MN where we relocated in 2022 into a beautiful 120,000 sq. ft. facility. We currently operate in about 75% of the facility and have room for expansion. This one facility has everything needed to service your project from a machine shop and 3D printing to a test lab and commercial manufacturing.
Cleanroom
Switchback has approximately 13,500 sq. ft. of ISO Class 7 Clean Room operations space where we build and package several finished medical devices.
Final Packaging Room
We have a room designed just for final packaging purposes where we box and label finished sealed devices coming out of the clean room. We can build palletized sterile loads in this room and move directly to the truck and ship to our sterilizer.
R&D Space
We have an R&D prototype area where each program has a dedicated space to work on design iterations and prototypes. Additionally, we have ample cleanroom space for R&D programs as they progress into more consistent manufacturing and enter the verification and validation stages.
Silicone Room
Switchback has a dedicated ISO Class 8 silicone process clean room where we can apply silicone to a device and keep it segregated from the rest of the clean room manufacturing area.
Design Assurance Lab
Our Design Assurance Lab is where we perform all of our design verification testing. This lab is used to develop test methods for evaluating device performance early on. The lab has several equipment capabilities for measuring tensile, leak, burst, simulated use in anatomical models, and your standard visual and dimensional characteristics.
Machine Shop
Switchback has an onsite machine shop where our Machinist, Technicians, and Engineers can quickly build or modify fixtures, tooling or anything needed to move your project along.
Infrastructure
Switchback has the infrastructure in place to take your product to commercialization.
- Manufacturing Certifications
- ISO
- FDA
- ERP System
- DFM Focus
- Supply Chain Management
External Resources
Switchback has built relationships with key suppliers and processors that compliment our internal capabilities.
- EO Sterilizer
- Laser Processing
- 3D Printing
- Molding
- Extrusion
- Tissue Processing
- Hydrophilic Coating
- Electronic Assemblies