Medical Device Manufacturers
Switchback Medical
7625 Boone Ave N, Brooklyn Park, MN 55428, United States
- Contract manufacturer / job shop
- ISO 13485, ISO 14971:2019
About Switchback Medical
Switchback Medical is based in Brooklyn Park, Minnesota. The company was co-founded by Brady Hatcher, who serves as CEO, and Randy Beyreis, who serves as CTO. The leadership team also includes Jim Moran as COO, Jesse Jensen as VP of Global Integration and Quality, and several other vice presidents overseeing operations, quality, and business development. The company provides contract design and manufacturing services for medical devices, offering a single-source solution from concept through commercialization. Its capabilities include injection molding, balloon forming, nitinol shape setting, thermal bonding (laser, RF, and heated die), braiding, coiling, laser welding, 3D printing, and sterile packaging. Operations are housed in a 120,000-square-foot facility that includes approximately 13,500 square feet of ISO Class 7 cleanroom space, an ISO Class 8 silicone processing room, an on-site machine shop, and a design assurance lab equipped for tensile, leak, burst, and simulated-use testing. Switchback Medical serves the medical device industry, working with customers who need design verification, process development, and commercial-scale manufacturing of catheter-based and other interventional devices. The company’s external partners include suppliers for ethylene oxide sterilization, laser processing, extrusion, and hydrophilic coating. The company states its mission is to partner with customers to develop and commercialize medical devices with unmatched speed, responsiveness, and ingenuity. It emphasizes a single-source model intended to reduce development costs and time to market, backed by ISO 13485 certification, FDA registration, and ISO 14971:2019 risk management practices.
Manufacturing capabilities
Core processes
Finishing & coating
Inspection & quality
Industries served
- Medical Devices
Materials
Nitinol · Silicone · Hydrophilic Coating
Equipment
- Braider
- Coiler
- Balloon Forming Machine
- 3D Printing
- Laser Welding
- RF Tipping
Company details
- Location
- Brooklyn Park, Minnesota
- Company type
- Contract manufacturer / job shop
- Certifications
- ISO 13485, ISO 14971:2019, ISO Class 7 Cleanroom, ISO Class 8 Cleanroom
- Listed under
Frequently asked questions
Where is Switchback Medical located?
Switchback Medical is located at 7625 Boone Ave N, Brooklyn Park, MN 55428, United States.
What does Switchback Medical do?
Switchback Medical is listed under Medical Device Manufacturers, and its listed capabilities and products include Injection Molding, Fixtures, Tooling and 3D Modeling, Final Assembly, Composite Shaft Construction, Balloon Forming and Sterile Packaging.
What industries does Switchback Medical serve?
Switchback Medical lists Medical Devices among the industries it serves.
What certifications does Switchback Medical have?
Certifications on file for Switchback Medical: ISO 13485, ISO 14971:2019, ISO Class 7 Cleanroom and ISO Class 8 Cleanroom.
How do I request a quote from Switchback Medical?
Use the Request a quote button on this page to send Switchback Medical your requirements through FirmsLedger, or call (763) 401-1821 and visit switchbackmedical.com.
What companies are similar to Switchback Medical?
Other Medical Device Manufacturers in Minnesota listed on FirmsLedger include Cretex Medical, Minnesota Medical Technologies and Clarus Medical.