Robling Medical

What Robling Medical does

Robling Medical is a US-based, full-service contract development and manufacturing organization (CDMO) serving medical device and life sciences OEMs. The company designs, develops, manufactures, packages, and sterilizes Class II and III medical devices from a 75,000 sq. ft. ISO 13485:2016 facility in Youngsville, North Carolina, comprising 12,000 sq. ft. of ISO Class 8 cleanroom space across four rooms. Robling is 100% dedicated to medical device and life sciences manufacturing and reports 30+ years of operating experience.

The service portfolio spans five integrated offerings: Design & Development Services (Design for Manufacturing, prototyping, V&V, regulatory filing support); Sterile Disposable Manufacturing (catheters, fluid management, urology, cardiovascular, orthopedic, and respiratory single-use devices) using bonding, RF tipping, heat sealing, and ultrasonic welding; Electro-Mechanical Assembly (cable/harness, PC board flashing, imaging, functional testing); Packaging & Kitting Services (form-fill-seal, sterile barrier systems, multi-component procedural kits); and Contract Sterilization Services (EtO, Gamma, E-Beam with validation and monitoring). Specialized manufacturing depth is claimed in fluid management and urology device categories.

Robling's business model is B2B contract manufacturing sold via direct enterprise sales and industry trade shows (MD&M West, Medical Technology Ireland), with custom multi-year project-based pricing and named customer relationships spanning large MedTech OEMs, mid-sized OEMs, and newly commercialized MedTech startups. The company maintains regulatory certifications across the US (FDA, 21 CFR Part 820), EU (MDR/MDD), Japan (PMDA #BG3040155), Brazil (ANVISA), Canada (Health Canada SOR/92-282), and Korea (GMP), enabling OEMs to commercialize devices internationally from a single supplier. Since June 2023, Robling has operated under controlling ownership of SV Health Investors, a Boston-based healthcare-specialist private investment firm, with founder Brent Robling continuing as CEO.

Name

Robling Medical

Legal name

Robling Medical, LLC

Website

https://roblingmedical.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

51–100 employees

Short description

Robling Medical is a US-based, full-service CDMO serving medical device OEMs with integrated design, manufacturing, packaging, and sterilization of Class II/III sterile disposables and electromechanical systems from its Youngsville, North Carolina facility.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industry

Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)

Keywords

• Medical device manufacturing
• Contract development manufacturing
• Sterile disposable devices
• Electromechanical assembly
• Medical packaging services

Headquarters

HQ city

Youngsville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services: Full-service outsourced manufacturing for medical devices including sterile single-use disposables, electromechanical systems, and complex assemblies. Revenue generated through project-based contracts and long-term manufacturing agreements with medical device OEMs.
2. Design and Development Services: Engineering and quality support including design for manufacturing, verification, validation, and regulatory filing support. Integrated into project contracts from early development through production.
3. Packaging and Kitting Services: Contract packaging including form-fill-seal operations, kitting for procedural applications, sterile barrier systems, and regulatory-compliant labeling services.
4. Sterilization Services: Contract sterilization management including EtO, Gamma, and E-Beam processing with validation and monitoring services.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

Robling Medical is a full-service Contract Development and Manufacturing Organization (CDMO) for the medical device and life sciences industries. The company provides integrated design, development, manufacturing, packaging, and sterilization services for sterile single-use Class II and III disposable devices (catheters, urology, cardiovascular, fluid management, etc.) and complex electromechanical medical systems. Services span from prototype through high-volume commercial production at its ISO 13485:2016 certified facility in Youngsville, NC.

Product overview

Robling Medical operates as a full-service contract development and manufacturing organization (CDMO) offering an integrated portfolio of medical device services. The company provides Design & Development Services (including Design for Manufacturing and validation support), Sterile Disposable Manufacturing (for Class II/III devices), Electro-Mechanical Assembly, Packaging & Kitting Services, and Contract Sterilization. Specialized manufacturing capabilities include Fluid Management Devices (collection reservoirs, tubing, connectors, IV sets, pump systems) and Urology Devices (catheters, cystoscopes, drainage systems). Quality & Regulatory Support rounds out the offering with FDA compliance, biocompatibility testing, and sterilization protocol management. The company maintains 30+ years of experience, a 75,000 sq. ft. ISO 13485:2016 certified facility with four ISO Class 8 cleanrooms in Youngsville, NC.

Differentiator

Problem solved

Functional benefit

Products and services

• Design & Development Services

Quantifiable outcome

• Hundreds of products successfully partnered through design, development, and commercialization process
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Integer Holdings: Integer is a large, publicly traded medical device outsource manufacturer serving similar cardio, vascular, and orthopedic OEM customers, with both sterile disposable and electromechanical capabilities — a much larger, scaled competitor.
• Phillips-Medisize: Phillips-Medisize (a Molex company) is a large medical device CDMO offering design, manufacturing, and drug-delivery device capabilities; significantly larger scale but operates in the same outsourced MedTech services space.
• Jabil Healthcare: Jabil's healthcare division provides design, manufacturing, packaging, and sterilization services for medical devices and diagnostics — overlapping with Robling's one-stop CDMO positioning but at vastly larger scale.
• West Pharmaceutical Services: West Pharmaceutical is a global leader in injectable drug delivery and packaging components, with significant medical device and combination product manufacturing — a much larger incumbent that competes for high-value CDMO programs.
• Nipro Medical: Nipro's medical device business manufactures injection, infusion, dialysis, and urology devices — directly overlapping with Robling's fluid management and urology specializations, though at much greater scale.

Direct peers

• Viant Medical: Viant is a pure-play medical device contract manufacturer offering design, engineering, precision components, and finished device assembly — closely aligned with Robling's integrated CDMO model and similar OEM customer base.
• Tegra Medical: Tegra Medical is a medical device CDMO focused on precision manufacturing, metal and plastic components, and finished device assembly, serving similar MedTech OEM customers with comparable capabilities.
• CMD MedTech (Cirtec Medical): Cirtec Medical is a medical device CDMO specializing in active implantable and minimally invasive devices, with design, manufacturing, and sterilization services targeting similar MedTech OEM customers.

Others

• Eurofins Medical Device Testing: Eurofins provides medical device testing, biocompatibility, and sterilization validation services — adjacent ecosystem partner where it overlaps with Robling's regulatory and sterilization support offerings.
• DuPont Medical Packaging: DuPont supplies Tyvek-based sterile barrier packaging materials used in medical device form-fill-seal operations — a critical material supplier that is adjacent but ecosystem-relevant to Robling's packaging services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/robling-medical-inc-

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Robling Medical