M4D

What M4D does

M4D LLC (Manufacturing for Design) is a privately held, bootstrapped medical device contract design, development, and manufacturing organization founded in 2015 and headquartered in a 12,000 sq ft facility in Lake Forest, California, including 4,000 sq ft of ISO Class 8 cleanroom space across three dedicated rooms. The company specializes in neurovascular and peripheral vascular devices — principally microcatheters, balloon catheters, aspiration catheters, access devices, coils, and stents — with precision micro-assembly capabilities including balloon blowing, Steeger braiding (24/32/48 bobbins), 10-chamber reflow, micro laser welding (joints as small as 0.001 inches), micro soldering, and hydrophilic coating. All production operates under an ISO 13485:2016-certified and FDA-registered quality management system (compliant with 21 CFR Part 820), and M4D also offers pre-validated EtO sterilization adoption plus Gamma and E-beam validation services.

The business model is a B2B services CDMO: customers engage through a website quote-request funnel and direct enterprise sales, with revenue generated across three streams — contract manufacturing services (hardware, project-based), design and development services (SolidWorks 3D modeling, prototyping, engineering, professional services), and quality/regulatory plus sterilization services (professional services). Pricing is quote-based and project-specific rather than published; no transactional pricing tiers are disclosed. Target customers are vertically segmented into neurovascular OEMs, peripheral vascular OEMs, and medical device innovators/startups needing end-to-end support from concept through commercialization.

M4D is led by founder and President/CEO Dawson Le (ex-Microvention, ex-Blockade) and VP of Engineering & Business Development Hung Nguyen (ex-Integral Neurosciences, Abbott, Medtronic; 10+ US patents). The company employs 51-100 people and is actively recruiting production technicians and senior engineering talent, indicating ongoing capacity build-out. No external funding, M&A, named customer relationships, or revenue figures are disclosed in available data.

Name

M4D

Legal name

M4D LLC

Website

https://m4dllc.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

M4D is a bootstrapped, ISO 13485-certified medical device CDMO in Lake Forest, CA, designing and manufacturing precision neurovascular and peripheral vascular catheters, balloons, and accessories for OEM and startup clients.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro industry

PRIMARYHLAHAFAJ

Thrombectomy, Embolic Protection & Stroke Intervention Devices

Healthcare & Life Sciences/Medical Devices & Diagnostics/Cardiovascular Devices (Stents, Valves, Rhythm Management)

Keywords

• Medical device manufacturing
• Contract manufacturing services
• Catheter manufacturing
• Neurovascular devices
• Medical device design

Headquarters

HQ city

Lake Forest

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services: Manufacturing services for medical device components, subassemblies, and finished assemblies including catheter and balloon products. Revenue generated through project-based manufacturing engagements with clients.
2. Design and Development Services: Design and development services from concept through commercialization including 3D modeling, engineering drawings, prototyping, and product development support.
3. Quality and Regulatory Services: Quality system support, verification and validation testing, biocompatibility testing, and sterilization validation services.
4. Sterilization Services: Sterilization adoption and validation services including EtO, Gamma, and E-beam sterilization for medical devices.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels2 records

Core offering

M4D designs, develops, prototypes, and manufactures neurovascular and peripheral vascular medical devices for medical device OEMs and innovators. Services span catheter and balloon catheter manufacturing, precision micro-assembly (welding, soldering, braiding, reflow, cutting), design and development (SolidWorks 3D modeling, engineering, prototyping), quality and regulatory compliance (ISO 13485:2016, FDA QSR), and sterilization validation (EtO, Gamma, E-Beam), all delivered from an FDA-registered ISO Class 8 cleanroom facility in Lake Forest, CA.

Product overview

M4D (Manufacturing for Design) is a medical device contract manufacturer and design developer specializing in neurovascular medical device technologies. The company operates a single integrated platform providing end-to-end services from concept to commercialization. The core portfolio consists of catheter manufacturing services (neurovascular and peripheral vascular), balloon catheter manufacturing capabilities, design and development services, contract manufacturing, quality and regulatory services, sterilization services (EtO, Gamma, E-Beam), and precision manufacturing capabilities including welding, soldering, heat setting, gluing, assembly, heat shrinking, cutting, and braiding. All services are delivered through an ISO Class 8 cleanroom facility in Lake Forest, CA, supporting clients from prototype through commercial production.

Differentiator

Problem solved

Functional benefit

Products and services

• Catheter Manufacturing Services Endovascular catheter manufacturing services for neurovascular and peripheral vascular applications, including over the shaft winding (closed and large pitch), hydrophilic coating, trimming, hub selection and bonding, and marker band placement and bonding. Delivered in ISO Class 8 cleanrooms for medical device OEMs.
• Balloon Catheter Manufacturing Services Balloon catheter manufacturing services including balloon blowing (non-compliant, semi-compliant, and compliant materials), braiding (24/32/48 Steeger bobbins), 10-chamber reflow, heat folding (3 and 6 fold up to 200mm), bonding, tip shaping, segment fusing, marker band swaging, and trimming for medical device OEMs.
• Design and Development Services Full-service design and development for medical devices from concept to commercialization, including napkin-sketch to engineering-model support, SolidWorks 3D modeling and drafting, and prototype development for neurovascular and peripheral vascular devices.
• Contract Manufacturing Services Subassembly and finished-good contract manufacturing services including final packaging, labeling, label design, finished-good storage, and material tracking. Includes incoming, manufacturing, and in-process inspection; document control; equipment, fixtures, and tooling control; personnel training; and returned-goods analysis.
• Quality and Regulatory Services Quality management (Quality Collaboration By Design) compliant with EN ISO 13485:2016 and FDA 21 CFR Part 820. Testing services include biocompatibility, sterilization validation, radial force, tensile, micro-device tensile, bench, torque, feasibility, competitor, compatibility, and burst testing for medical device manufacturers.
• Sterilization Services Sterilization adoption and validation services for medical devices, including Ethylene Oxide (EtO) — with a pre-validated expedited cycle per ANSI/AAMI/ISO11135 2014 — and Gamma and E-Beam radiation validation per ANSI/AAMI/ISO11137 2016 (sterility assurance level 10^-6).
• Engineering Services Engineering support services including anatomical model testing and evaluation using neurovascular or cardiovascular models, SolidWorks 3D modeling and drafting, and verification and validation (V&V) testing services for medical device programs.

Quantifiable outcome

• Expedited EtO sterilization adoption saves significant time and product cost compared to standard validation (24 units vs 68 units, 2 weeks vs 7.5 weeks)
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature12 records

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Cirtec Medical: Contract manufacturer specializing in interventional and neurovascular devices, including catheter and minimally invasive device assembly. Directly comparable as a similarly sized CDMO focused on the same end customers and capabilities (catheter assembly, micro-machined components, full design-to-manufacturing).
• Tegra Medical: Medical device contract manufacturer offering precision machining, catheter and tube fabrication, and finished device assembly. Comparable to M4D in serving interventional and minimally invasive device OEMs with integrated manufacturing and finishing services.
• Resonetics: Specializes in laser micro-manufacturing and catheter-based device production for neurovascular, peripheral vascular, and structural heart customers. Highly comparable in the laser welding, nitinol processing, and catheter finishing capabilities that overlap directly with M4D's offerings.
• SMC Ltd. Medical device contract manufacturer providing design, engineering, and assembly services including catheter and balloon production. Comparable to M4D as an integrated CDMO serving interventional medical device OEMs.
• J-Pac Medical: Medical device and diagnostics contract manufacturer offering packaging, assembly, and contract manufacturing for catheters and combination products. Comparable to M4D in serving as a niche CDMO partner to medical device OEMs.

Broad incumbents

• Phillips-Medisize (Molex): Large-scale medical device CDMO offering drug delivery, diagnostics, and device manufacturing at global scale. Competes with M4D for catheter and interventional device programs but operates at significantly larger scale with broader capabilities.
• Integer Holdings: Major medical device outsource manufacturer serving cardiovascular, neurovascular, and other interventional markets. Comparable in serving the same neurovascular/peripheral vascular OEMs but at substantially greater scale and balance-sheet capacity.
• Cretex Medical: Medical device contract manufacturing division of Cretex Companies, offering precision machining, assembly, and sterile packaging for interventional devices. Comparable in serving catheter and interventional device customers with a broader manufacturing footprint.
• Viant Medical: Full-service medical device contract manufacturer focused on implantables, instruments, and catheter-based devices. Comparable to M4D in serving interventional device OEMs but at significantly larger scale and broader service offering.
• Helix Medical (Freudenberg Medical): Global medical device and catheter CDMO with specialty in silicone and thermoplastic components and finished device assembly. Competes with M4D for interventional and catheter programs but offers broader global manufacturing footprint.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

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 M4D