Lucas Medical

What Lucas Medical does

Lucas Medical, Inc. is a privately held, US-based contract manufacturer specializing in custom silicone extrusion and assembly of medical devices for the global medical device industry. Founded in 1998 and headquartered in a single facility at 1554 N. Case Street, Orange, California, the company operates with 51-100 employees and focuses on Class 3 medical silicone devices intended for long-term human implantation. Its core technology is centered on tight-tolerance silicone extrusion, with patented processes covering catheter balloon manufacturing and wire-reinforced silicone catheter tubing with integrated flexible stylets that eliminate the vessel-perforation risk of loose removable stylets, plus a proprietary Smooth-Flo cable insertion process for kink-resistant tubing. Underlying capabilities include single-to-multi-lumen tubing transitions, tapered tubing, mandrel-based dip molding and coating, and full turnkey assembly with contract sterilization, pre-validated pouching, and tray sealing.

The product portfolio splits between proprietary finished devices — Embolectomy Catheters, Thrombectomy Catheters, Occlusion Catheters, Biliary Catheters, Bi-Lumen and Straight Irrigation Catheters, and Carotid Shunts (CESB and CSB variants) — and contract manufacturing services sold to medical device OEMs. Lucas Medical holds ISO 13485:2016 certification (GMED, valid 2024-2027), CE Mark approval for all existing products, FDA device establishment registration, and a California Department of Public Health Device Manufacturing License, positioning it as a qualified supplier for regulated OEM programs. Its certified quality management system and documented process engineering capabilities in material science, biochemistry, mechanical engineering, and process design form the basis of its supplier qualification.

The business operates a dual revenue model. Contract manufacturing revenue is generated through quote-based, project-specific engagements with medical device OEMs requiring custom silicone components and assembly, typically structured as multi-year engagements. Proprietary product revenue is generated through sales of branded catheters and shunts via direct sales and a network of regional distributors: Edwards Lifesciences (US, exclusive), Dahlhausen (Germany), Biomedica Italia (Italy), Orakci (Turkey), and Biomedical (Brazil). Pricing is opaque (quote-based only), no public pricing exists, and go-to-market relies on direct enterprise field sales, a request-a-quote website flow, and downloadable product brochures, with the company explicitly positioning itself as a high-precision, low-volume manufacturer rather than a commodity producer.

Name

Lucas Medical

Legal name

Lucas Medical, Inc.

Website

https://lucasmedicalinc.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

51–100 employees

Short description

Lucas Medical is a privately held Orange, California-based contract manufacturer of custom silicone extrusion and Class 3 medical devices, serving global medical device OEMs with proprietary silicone catheters, shunts, and full-service prototyping, assembly, and packaging capabilities.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (33911)

SIC

Surgical & Medical Instruments & Apparatus (3841), Plastics Products, Nec (3089), Fabricated Rubber Products, Nec (3060)

akta.pro primary industry

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

akta.pro secondary industries

Medical & Life Sciences Injection Molding (Devices, Diagnostics, Cleanroom) (IMANAFAC), Pharmaceutical & Medical Plastic Packaging Manufacturing (IMANAEAK)

Keywords

• Contract manufacturing services
• Medical device extrusion
• Silicone catheter manufacturing
• Catheter balloon fabrication
• Medical device prototyping

Headquarters

HQ city

Orange

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Custom silicone extrusion, prototyping, assembly, packaging, and dip coating services for medical device manufacturers. Revenue generated through project-based contracts with medical device companies requiring custom silicone components. Services include full turn-key options including assembly, sterilization, and packaging.
2. Proprietary Medical Device Products: Sale of proprietary silicone catheters and shunts including Embolectomy Catheters, Carotid Shunts, Bi-Lumen Irrigation Catheters, Occlusion Catheters, Thrombectomy Catheters, Biliary Catheters, and Straight Irrigation Catheters. Products are distributed through global distributor network.

Pricing tiers

Go-to-market motion1 record

Distribution channels6 records

Marketing channels2 records

Core offering

Lucas Medical is a contract manufacturer specializing in custom silicone extrusion and medical device fabrication for the global medical device industry. The company produces 100% silicone Class 3 implantable devices, including proprietary catheters and shunts (Embolectomy, Thrombectomy, Occlusion, Biliary, Irrigation Catheters, and Carotid Shunts), and offers turn-key contract manufacturing services covering extrusion, prototyping, dip molding/coating, assembly, sterilization, and packaging.

Product overview

Lucas Medical is a contract manufacturer specializing in 100% silicone medical devices for the global medical device industry. The company's core product portfolio centers on Class 3 implantable silicone catheters and shunts, including Embolectomy Catheters, Thrombectomy Catheters, Occlusion Catheters, Biliary Catheters, Irrigation Catheters (both Bi-Lumen and Straight), and Carotid Shunts (CESB and CSB variants). These finished devices are complemented by a suite of manufacturing services: Custom Silicone Extrusion (featuring patented catheter balloon technology, single-to-multi-lumen tubing, tapered tubing, and kink-resistant tubing), Prototyping Services, Silicone Dip Molding and Coating Services, and Medical Device Assembly and Packaging Services (including contract sterilization, pre-validated pouching, and tray sealing). The company leverages proprietary patented processes for wire-reinforced silicone catheter tubing and catheter balloon formation to deliver superior performance products distributed worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• Smooth-Flo™: Proprietary cable insertion process for kink resistant tubing

Products and services

• Custom Silicone Extrusion Services Custom silicone extrusion services including tight tolerance tubing, catheter balloons, kink-resistant tubing, and precision multi-lumen tubing, with post-processing such as curing, cutting, spooling, printing, drilling, and grinding. Targeted at medical device OEMs requiring Class 3 implantable silicone components.
• Prototyping Services Rapid prototyping services supporting medical device engineers from concept stages to refine design features, improve manufacturability, minimize variability, and ensure successful commercial launch. Targeted at medical device companies in early-stage product development.
• Silicone Dip Molding and Coating Services Mandrel-based dip molding process using silicone with adjustable wall thickness through varying number of dips or percent solids concentration, plus dip coating for thin silicone films on medical devices for biocompatible finishes. Targeted at medical device OEMs requiring cost-effective silicone molding alternatives.
• Medical Device Assembly and Packaging Services Full assembly and packaging services including secondary operations, contract sterilization, pre-validated pouching, and tray sealing. Engineers collaborate to design packaging appropriate for various sterilization methods. Targeted at medical device OEMs needing turn-key manufacturing support.
• Embolectomy Catheter A 100% silicone catheter designed for intra-operative removal of arterial emboli from arteries, featuring patented wire-reinforced tubing for precision and durability. Targeted at healthcare providers and surgical centers performing vascular procedures.
• Bi-Lumen Irrigation Catheters (Distal/Proximal) Dual-lumen irrigation catheters designed for fluid delivery and removal during surgical procedures. Targeted at healthcare providers performing surgical interventions requiring irrigation capabilities.
• Occlusion Catheters Silicone catheters designed for short-term occlusion of blood flow during surgical interventions. Targeted at healthcare providers performing vascular surgical procedures.
• Thrombectomy Catheters 100% silicone catheters designed for intra-operative removal of venous thromboli (blood clots) from veins. Targeted at healthcare providers and surgical centers performing thrombectomy procedures.
• Biliary Catheters Silicone catheters designed for removal of gall stones from the biliary duct. Targeted at healthcare providers performing biliary surgical procedures.
• Straight Irrigation Catheters Catheters for heparinizing the arterial tree and veins following embolectomy and thrombectomy procedures, as well as biliary tree after cholangiography. Targeted at healthcare providers performing vascular and biliary surgical procedures.
• Carotid Shunts (CESB and CSB) 100% silicone shunts for providing temporary blood flow to the cerebral area during carotid endarterectomy procedures, featuring proprietary wire-reinforced tubing with integrated flexible stylets. Targeted at healthcare providers performing carotid endarterectomy surgery.

Quantifiable outcome

• Elimination of significant costs associated with secondary operations and inspection through patented balloon extrusion process
• +1 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Edwards LifesciencescoreChannel Partner/ Reseller/ DistributorEdwards Lifesciences serves as the US distributor for Lucas Medical catheters and shunts. Located at One Edwards Way, Irvine, CA 92614. Edwards is a global leader in medical devices for the treatment of advanced cardiovascular disease, providing broad market access for Lucas Medical products in the United States.

Scale indicators2 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Spectrum Plastics Group: Specialty medical plastics and silicone CDMO serving medical device OEMs with extrusion, molding, and assembly. Closely comparable business model in tight-tolerance medical polymer processing for implantable and Class 2/3 devices.
• Confluent Medical Technologies: Medical device contract manufacturer focused on nitinol and polymer components, catheters, and finished devices for OEMs. Comparable as a specialty CDMO serving interventional and vascular medical device customers.
• Nordson MEDICAL: Medical device CDMO (formed from the merger of Vention Medical and Nordson Micromedics) specializing in precision tubing, catheter components, and assembly for OEMs. Direct overlap with Lucas's medical tubing extrusion, balloon forming, and device assembly offerings.
• Donatelle: US-based medical device contract manufacturer with capabilities in silicone molding, extrusion, and assembly for Class 2/3 devices. Most comparable as a similarly sized specialty medical CDMO serving OEM customers.
• Trelleborg Healthcare & Medical: Global silicone and polymer component manufacturer serving medical device OEMs, including silicone tubing, extruded and molded parts. Direct peer in silicone extrusion and Class 3 implantable silicone components.
• Biomerics: Specialty medical device contract manufacturer focused on interventional and catheter-based devices, with polymer and balloon forming capabilities. Overlaps with Lucas's vascular catheter and extrusion-balloon technology.
• Freudenberg Medical (Helix Medical): A leading silicone and specialty medical components CDMO offering molded and extruded silicone components, catheters, and assembly services to medical device OEMs globally. Highly comparable to Lucas Medical's combination of custom silicone extrusion and Class 3 device contract manufacturing.

Broad incumbents

• Edwards Lifesciences: Global cardiovascular medical device leader and Lucas Medical's exclusive US distributor. Comparable as a vascular intervention incumbent whose products overlap with carotid shunt and catheter end-markets Lucas serves.
• Integer Holdings: Large publicly traded medical device contract manufacturer serving OEMs across cardiovascular, neurology, and surgical franchises. Comparable as a medical device CDMO at greater scale and broader scope, including catheter and extrusion-adjacent capabilities.
• Teleflex: Diversified medical device OEM with a vascular and interventional franchise (including embolectomy and thrombectomy catheters historically competitive with Lucas's line). Comparable as an incumbent in vascular silicone-style catheter markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Lucas Medical