Switchback Medical, LLC - Specialized CDMO for Minimally Invasive Medical Devices

📢 Key Milestones (2025–2026):
   In October 2025, Switchback Medical secured a strategic investment from TJC and combined with affiliates LightningCath and Proto Lase into a unified platform. In January 2026, Jim Moran was appointed Chief Operating Officer to oversee operational scale and global expansion. In April 2026, the company signed a lease for an 18,000-square-foot facility in the Coyol Free Trade Zone, Costa Rica, with a 3,500-square-foot cleanroom, to support medical device component manufacturing and ISO 13485 certification.

Company Profile (Updated April 2026)

Switchback Medical, LLC is a specialized contract development and manufacturing organization (CDMO) headquartered in Brooklyn Park, Minnesota, USA. Founded in 2018, the company partners with medical device innovators to develop and commercialize highly precise catheters, delivery systems, and components for minimally invasive interventional devices.

Switchback operates a vertically integrated model spanning concept development, Rapid prototyping, engineering, testing, full-device manufacturing, packaging, and sterilization. The company serves all minimally invasive interventional device markets with special expertise in neurovascular and structural heart applications, including microcatheters for stroke and brain aneurysm treatment.

Development History:

- 2018: Founded in Brooklyn Park, MN, as a specialized design and manufacturing partner for medical device companies

- 2020: Launched Switchback BioSim Innovations, a new division offering functional dynamic biosimulator model development, cell culture services, and physician training to accelerate preclinical device testing

- 2022: Affiliate LightningCath, Inc. founded in Brooklyn Park, MN, focusing on thermoplastic extrusions, FEP heat-shrink tubing, and etched PTFE liners for complex catheter shafts

- 2018: Affiliate Proto Lase, Inc. founded in Brooklyn Park, MN, providing precision laser processing including laser ablation, tube cutting, welding, and marking for medical device components

- 2025.10: Secured strategic investment from TJC (a private investment firm with $33.2 billion in assets under management); combined with LightningCath and Proto Lase into a single platform while maintaining founder ownership

- 2025: Announced plans to establish operations in Costa Rica's Evolution Free Trade Zone in Tacares de Grecia for high-volume manufacturing of complete medical device assemblies

- 2026.01: Jim Moran appointed Chief Operating Officer; brings over 30 years of medical device experience, most recently as CEO of Biocoat for more than seven years

- 2026.04: Signed lease for 18,000-square-foot facility in the Coyol Free Trade Zone, Costa Rica, with a 3,500-square-foot cleanroom; development and product transfers began immediately, with manufacturing and ISO 13485 certification targeted for later in 2026

Core Mission: To partner with customers to develop and commercialize medical devices with unmatched speed, responsiveness, and ingenuity to deliver the most advanced therapy to patients.

Core Capabilities & Services

Design & Development

- Concept Development: Early-stage ideation and feasibility assessment

- Rapid Prototyping: Quick-turn fabrication of R&D prototypes for clinical trials

- Engineering & Testing: Design verification, validation, biocompatibility, and sterilization qualifications

- Program Management: Full lifecycle support from concept through FDA submission and production manufacturing

Manufacturing & Assembly

- Balloon Catheters: Design and manufacturing of minimally invasive balloon catheter systems

- Complex Delivery Systems: Multi-component catheter shafts including braided shafts and extrusions

- Biomedical Textile Devices: Fabrication of textile-based interventional components

- Component Manufacturing: Thermoplastic extrusions, FEP heat-shrink tubing, etched PTFE liners (via LightningCath)

- Laser Processing: Precision laser ablation, tube cutting, welding, and marking (via Proto Lase)

Finishing & Commercialization

- Assembly: Full device assembly and integration

- Visual Inspection: Quality control and inspection services

- Packaging & Sterilization: Full device packaging and terminal sterilization services

- Supply Chain Management: End-to-end supply chain simplification to reduce development costs and time to market

BioSim Innovations (Preclinical Services)

- Functional Biosimulator Models: Animal and human tissue-based models providing both anatomy and physiology data (e.g., pumping heart with working valves, perfused tissues for neurovascular catheter evaluation)

- Cell Culture Services: Neuron cell cultures on biodegradAble scaffolding

- Physician Training: Clinical training platforms for complex device procedures

- PatHological Condition Simulation: Models simulating disease states for device efficacy and usability testing

Therapeutic Areas Served

- Structural Heart: Transcatheter valve repair and replacement delivery systems

- Neurovascular: Stroke treatment microcatheters, brain aneurysm devices, embolic protection systems

- Peripheral Vascular: Peripheral artery disease intervention devices

- Electrophysiology: Cardiac ablation and mapping catheters

- Interventional Cardiology: Coronary intervention and hemodynamic support devices

Corporate Information

Company Overview

Legal Name: Switchback Medical, LLC

Founded: 2018

Headquarters: Brooklyn Park, MN, USA

Company Type: Privately held LLC (PE-backed since October 2025)

Industry: Medical Device Contract Manufacturing / CDMO

Website: www.switchbackmedical.com

Leadership Team

CEO & Co-Founder: Brady Hatcher

- Seasoned executive in the MedTech CDMO space with deep industry relationships and a proven track record of driving business growth

Chief Operating Officer: Jim Moran (appointed January 20, 2026)

- Over 30 years of medical device experience spanning multinational corporations, private equity, and venture capital; most recently served as CEO of Biocoat for more than seven years, significantly expanding strategic growth and transacting the business twice during his tenure

Vice President of Operations: Jesse Jensen

- LeADINg global operations expansion including the Costa Rica facility launch

Vice President of R&D: Joe Moy

- Extensive experience in medical device project management, engineering, and product development

Vice President of Business Development: Joe Semanoff

HR Manager: Hanna Bounds

Global Operations & Expansion

United States (Minnesota)

- Brooklyn Park, MN: Primary headquarters and manufacturing facility for design, development, prototyping, and full-device production

Costa Rica (2025–2026 Expansion)

- Coyol Free Trade Zone (Alajuela): 18,000-square-foot facility with 3,500-square-foot cleanroom; component manufacturing and quick-turn development support; ISO 13485 certification targeted for 2026

- Evolution Free Trade Zone (Tacares de Grecia): Planned second, larger site expected to open in 2027; will serve as top-level assembly production site for high-volume manufacturing of complete medical device assemblies

- Strategic Rationale: Cost-effective manufacturing solution for existing and new customers; scalable production supporting thermoplastic extrusion and precision components

Strategic Partnerships & Customers

- Anteris Technologies: Executed amended Master Services Agreement in July 2025 for development and manufacture of structural heart devices; agreement expires March 31, 2028

- TJC: Strategic investment partner providing capital and operational resources for organic growth, acquisitions, and scaling

Competitive Advantages

- Single-Source Solution: End-to-end capabilities from component design to full device packaging and sterilization, simplifying customer supply chains

- Speed to Market: Rapid prototyping and agile development processes accelerate product commercialization timelines

- Vertical Integration: In-house extrusion (LightningCath), laser processing (Proto Lase), and preclinical testing (BioSim Innovations) reduce reliance on external suppliers

- Neurovascular & Structural Heart Expertise: Deep specialization in complex catheter and delivery system design for high-growth therapeutic areas

- Global Manufacturing Footprint: U.S. headquarters plus Costa Rica expansion enables cost-competitive, scalable production for global customers

2026 Strategic Outlook

- Costa Rica Ramp-Up: Complete Coyol facility commissioning and ISO 13485 certification; begin scaled component manufacturing and development support

- Evolution Facility: Advance planning and construction of the second Costa Rica site for top-level assembly and high-volume production

- Platform Integration: Leverage TJC investment to fully integrate LightningCath and Proto Lase capabilities under the Switchback brand

- Customer Expansion: Attract new OEM clients seeking cost-effective, high-quality CDMO partners in both the U.S. and Latin America

- Operational Excellence: Build strong company culture and talent retention in Costa Rica while maintaining U.S. engineering and development standards

Contact Information

Global Headquarters

Address: Brooklyn Park, MN, USA

Phone: +1 (763) 463-0843

Email: sales@switchbackmedical.com

Website: www.switchbackmedical.com

BioSim Innovations

Phone: +1 (763) 445-9607

Email: biosim.innovations@switchbackmedical.com

Website: www.biosiminnovations.com

Investor

TJC, L.P.

Website: www.tjclp.com

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