Switchback Medical

What Switchback Medical does

Switchback Medical is a U.S.-based medical device contract development and manufacturing organization (CDMO) founded in 2018 and headquartered in Brooklyn Park, Minnesota. The company designs, develops, and manufactures highly precise catheters, delivery systems, and components for minimally invasive medical devices, serving medical device OEMs across neurovascular, structural heart, cardiovascular, peripheral vascular, and electrophysiology applications. Core manufacturing capabilities include thermoplastic and FEP extrusions, etched PTFE liners, balloon catheter forming (compliant, non-compliant, neurovascular, and high-pressure braided), reinforced composite shaft construction with wire coil and braid, steerable catheter development using 3D-printed handle prototyping, Nitinol shape setting, complex delivery system assembly, and precision laser processing.

The company operates a 120,000 sq. ft. purpose-built facility with approximately 13,500 sq. ft. of ISO Class 7 cleanroom, certified to ISO 13485:2016 and registered with the FDA under 21 CFR Part 820. Following an October 2025 strategic investment from TJC, L.P., Switchback merged with LightningCath (extrusion components) and Proto Lase (precision laser processing) into a single integrated platform providing single-source solutions from concept and prototyping through finished device packaging and sterilization. Geographic operations include Brooklyn Park, Minnesota, plus Costa Rica facilities in Coyol Free Trade Zone (leased April 2026, 18,000 sq. ft.) and Evolution Free Zone (planned 2027), establishing nearshore manufacturing for thermoplastic extrusion and top-level assembly.

Switchback generates revenue through project-based CDMO contracts covering design services, prototyping, component manufacturing, finished device assembly, testing, packaging, and sterilization, with pricing structured on a quote-based model tied to device complexity, volume, and development stage. Go-to-market is exclusively direct enterprise field sales to medical device OEMs, with customers invited onsite for collaborative development. The company is privately held under TJC sponsorship, with founders Brady Hatcher (CEO) and Randy Beyreis (CTO) retaining significant ownership, and a senior team that includes COO Jim Moran (appointed January 2026), CFO Joe Kwiatkowski, and VPs across program management, operations, business development, R&D, and quality.

Name

Switchback Medical

Legal name

Switchback Medical, LLC

Website

https://www.switchbackmedical.com/

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Switchback Medical is a U.S.-based medical device CDMO that designs, develops, and manufactures minimally invasive catheters, delivery systems, and components for medical device OEMs across neurovascular, structural heart, and cardiovascular applications. It provides single-source solutions from concept through sterilization.

Ownership category

akta.pro rank

Product category

Contract Medical Device Manufacturing (CDMO)

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Process Development & Tech Transfer Services (CDMO) (HLAGABAL)

Keywords

• Contract medical device manufacturing
• Catheter design services
• Minimally invasive devices
• Medical device prototyping
• FDA registered contract manufacturing

Headquarters

HQ city

Maple Grove

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

1. Contract Design and Manufacturing Services: Switchback Medical operates as a contract development and manufacturing organization (CDMO) providing end-to-end services from concept development through commercialization. Revenue is generated through project-based contracts for design services, prototyping, manufacturing, assembly, testing, and packaging/sterilization of medical devices. The company serves as a single-source provider allowing customers to engage at any stage of development.
2. Finished Device Manufacturing: Production of finished goods - manufacturing full assemblies or finished medical devices from component or assembly level into packaged and sterilized finished products. Focus on minimally invasive interventional devices including balloon catheters, delivery systems, and biomedical textile devices.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Switchback Medical is a contract development and manufacturing organization (CDMO) that designs, develops, and manufactures minimally invasive medical devices, with specialization in highly precise catheters, delivery systems, and components. The company offers single-source solutions spanning concept development, prototyping, testing, full-scale manufacturing, finished device assembly, packaging, and sterilization for medical device OEMs. Through its combined platform with LightningCath (thermoplastic extrusion) and Proto Lase (laser processing), Switchback delivers vertically integrated capabilities from component fabrication through finished, sterile-packaged devices.

Product overview

Switchback Medical operates as a unified platform combining three specialized brands: Switchback Medical (core CDMO), LightningCath (catheter component manufacturing), and Proto Lase (laser processing). The platform offers single-source solutions for contract design and manufacturing of minimally invasive medical devices, from concept development through finished device packaging and sterilization. Core products include balloon catheters, steerable catheters, reinforced catheters, delivery systems, and Nitinol components. The company serves therapeutic areas including structural heart, neurovascular, peripheral vascular, electrophysiology, and interventional cardiology.

Differentiator

Problem solved

Functional benefit

Brands

• LightningCath: Component-focused catheter manufacturer providing extrusion, design, and assembly solutions for interventional medical devices, including thermoplastic extrusions, FEP heat-shrink tubing, and etched PTFE liners for complex catheter shafts.
• Proto Lase

Products and services

• Switchback Medical Contract Design and Manufacturing Services (CDMO) Core CDMO offering providing single-source contract design, development, prototyping, manufacturing, assembly, packaging, and sterilization services for minimally invasive interventional medical devices (balloon catheters, steerable catheters, reinforced catheters, delivery systems, and Nitinol components), serving medical device OEMs across neurovascular, structural heart, peripheral vascular, electrophysiology, and interventional cardiology therapeutic areas.
• LightningCath Component Manufacturing Sub-brand offering component-focused catheter manufacturing services, including thermoplastic extrusions, FEP heat-shrink tubing, and etched PTFE liners used as critical components in complex catheter shafts, supporting early-stage prototyping and pilot production across structural heart, neurovascular, peripheral vascular, interventional cardiology, and electrophysiology.
• Proto Lase Precision Laser Processing Services Sub-brand offering precision laser processing services including laser cutting, ablation, marking, tube cutting, drilling, and wire stripping for medical devices, working with metals including Nitinol and various plastics to support catheter and delivery system manufacturing.

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Six partnerships are on record, tiered major, core and supporting.

• Coyol Free Trade ZonemajorStrategic or Co-development Partner · 13 April 2026Coyol Free Trade Zone is a prominent medical technology hub in Costa Rica. Switchback Medical signed a lease for an 18,000-square-foot facility including 3,500 sq. ft. cleanroom. The facility will support medical device component manufacturing with initial focus on thermoplastic extrusion and precision components. This represents the first phase of Switchback's Costa Rica strategy.
• LightningCath, Inc.coreStrategic or Co-development Partner · 1 October 2025LightningCath is a component-focused catheter manufacturer providing extrusion, design, and assembly solutions for interventional medical devices. Core capabilities include thermoplastic extrusions, FEP heat-shrink tubing, and etched PTFE liners. Combined with Switchback Medical to create a unified platform with comprehensive catheter manufacturing capabilities. Founded in 2022.
• Proto Lase, Inc.coreStrategic or Co-development Partner · 1 October 2025Proto Lase is a precision laser processing provider focused on medical device applications including laser ablation, tube cutting, welding, and marking. Capabilities support catheter and delivery system manufacturing with high-accuracy component fabrication for structural heart, neurovascular, and peripheral vascular therapies. Combined with Switchback Medical to create a unified platform. Founded in 2018.
• Evolution Free ZonemajorStrategic or Co-development Partner · 20 May 2025Evolution Free Zone, developed by CODE Development Group, is a high-tech business park in Costa Rica (Tacares de Grecia). Switchback Medical established operations as the seventh company to confirm arrival in the free trade zone, which projects to provide more than 20,000 quality jobs over 15 years. The free zone offers world-class infrastructure, skilled labor, and a solid business ecosystem for medical technology companies.
• PROCOMER (Costa Rican Foreign Trade Promotion Agency)supportingStrategic or Co-development PartnerPROCOMER is Costa Rica's foreign trade promotion agency. CEO Laura López welcomed Switchback Medical's investment, noting Costa Rica's position as a strategic destination for advanced medical manufacturing solutions with 29% year-over-year growth in medical technology exports in early 2025.
• Government of Costa Rica (Ministry of Foreign Trade)supportingStrategic or Co-development PartnerThe Minister of Foreign Trade, Manuel Tovar, welcomed Switchback Medical to Costa Rica, affirming the government's commitment to providing necessary conditions for successful operations. Costa Rica has become a global strategic hub for advanced manufacturing with a strong ecosystem for medical device production.

Scale indicators6 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Avalign Technologies: Avalign Technologies is a medical device manufacturer and outsourced services provider focused on implants, instruments, and delivery systems. Comparable mid-sized CDMO with similar specialization in complex medical device manufacturing for OEM customers.
• Viant Medical: Viant Medical is a medical device contract manufacturer offering design, engineering, and manufacturing services for minimally invasive and other medical devices. Closely comparable business model focused on OEM customers with vertically integrated capabilities.
• Cretex Medical: Cretex Medical is a medical device contract manufacturer providing design, prototyping, and production services including precision machined components and assemblies for interventional medical devices. Comparable mid-sized CDMO with similar OEM customer base and Minnesota-based presence.
• Tegra Medical: Tegra Medical is a medical device CDMO specializing in precision manufacturing of interventional devices, including catheters, delivery systems, and complex components. Highly comparable as a similarly-sized specialist serving overlapping therapeutic areas and customer profiles.
• Mach Medical (Hyperion Materials & Technologies subsidiary): Mach Medical is a precision medical device manufacturer focused on interventional catheters, components, and assemblies. Comparable as a specialist CDMO serving overlapping minimally invasive device OEMs.
• Donatelle: Donatelle is a medical device contract manufacturer specializing in interventional and complex medical devices including catheters and delivery systems. Directly comparable as a Minnesota-based mid-sized CDMO serving overlapping OEM customers in cardiovascular and other therapy areas.
• Medical Murray: Medical Murray is a medical device CDMO specializing in design, development, and manufacturing of minimally invasive devices including catheters and implant delivery systems. Closely comparable business model and therapeutic area focus.

Others

• JOTEC (part of Artivion): Artivion (formerly CryoLife) is a medical device company that, through its JOTEC subsidiary, develops and manufactures stent grafts and delivery systems. Adjacent as a vertically integrated device company that performs its own catheter design and manufacturing in overlapping therapeutic areas.

Broad incumbents

• Integer Holdings Corporation: Integer Holdings is one of the largest medical device outsource manufacturers globally, offering design, manufacturing, and assembly services for medical devices including catheters and delivery systems. Directly comparable as a large-scale CDMO competing for similar OEM customers across cardiovascular, neurovascular, and other therapy areas.
• Nordson Medical: Nordson Medical is a division of Nordson Corporation providing component and contract manufacturing services for medical devices, including catheter components, balloons, and delivery systems. Comparable as a large incumbent with overlapping capabilities serving similar interventional device OEMs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCg6Bj4UJ9N7qQd6yLJdV2jA
• Facebookfacebook.com/SwitchbackMedical
• LinkedInlinkedin.com/company/33316133/admin/dashboard
• Xx.com/Switchback_Med

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries2 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Switchback Medical