What Gilero does

Gilero is a medical device contract development and manufacturing organization (CDMO) founded in 2002 and headquartered in Durham, North Carolina. The company provides end-to-end services spanning product design and engineering, clinical and small-batch manufacturing, electromechanical systems, human factors engineering, regulatory affairs, and contract manufacturing for medical devices, drug delivery systems, and combination products. Its service portfolio is organized around seven core areas: Design & Development, Clinical & Small Batch Builds, Electromechanical, Human Factors & Design, Regulatory Services, Contract Manufacturing, and a Global Manufacturing Network. The company serves medtech companies, pharmaceutical and drug delivery firms, and digital health/connected device companies requiring complex product development and scale-up support. Gilero is ISO 13485 certified, FDA registered, and operates in compliance with cGMPs, with manufacturing facilities totaling more than 300,000 square feet and ISO Class 7 and 8 cleanrooms across the U.S. (Durham, Pittsboro, Greensboro, Carlsbad, Chicago), Mexico (Tijuana), and Europe (Athlone, Ireland), with additional capacity accessed via its parent Sanner Group in Europe and Asia.

Gilero's revenue is generated primarily through professional services (engineering, design, regulatory consulting) and contract manufacturing (assembly, packaging, kitting, injection molding), with custom, project-based pricing typical of B2B CDMO engagements. The business operates exclusively through direct enterprise sales to medtech and pharmaceutical decision-makers, with no indirect channels or self-service model. The customer base includes named accounts such as Anutra Medical (buffered anesthetic delivery) and an ocular therapeutics company (intravitreal implant injection device), alongside unnamed Closed System Drug Transfer Device customers. The company is led by co-founder and CEO Ted Mosler and a management team with deep medical device and regulatory experience, including specialized VPs of Technical Operations, Manufacturing, Quality & Compliance, and Business Development.

On September 25, 2024, Gilero was acquired by Sanner Group, a German-headquartered global healthcare packaging and medical device CDMO backed by GHO Capital. The acquisition combined Sanner's 130-year market leadership and European/Asian manufacturing footprint with Gilero's North American design and manufacturing capabilities, positioning the combined business as a leading end-to-end provider across drug delivery, diagnostics, and medtech device sectors. Post-acquisition, Gilero continues to operate under its own brand, and in June 2025 launched a new 60,500-square-foot injection molding and pharmaceutical packaging facility in Greensboro, North Carolina—the first North American injection molding and pharma desiccant packaging site for Sanner Group.

Name

Gilero

Legal name

Gilero Group, LLC

Website

https://gilero.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

101–250 employees

Short description

Gilero is a medical device CDMO providing end-to-end design, engineering, regulatory, and contract manufacturing services for medtech and pharmaceutical companies, operating globally as a subsidiary of Sanner Group since September 2024.

Ownership category

akta.pro rank

Product category

Medical Device Contract Development and Manufacturing (CDMO)

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

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

akta.pro secondary industries

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Medical device CDMO
• Drug delivery systems
• Contract manufacturing
• Medical device design
• Combination products

Headquarters

HQ city

Morrisville

HQ country

United States

HQ region

North America

Offices8 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 Manufacturing Services: Gilero generates revenue through contract manufacturing services for medical devices, including assembly, packaging, kitting, and injection molding. Manufacturing services are provided from facilities in the US, Mexico, Europe, and Asia.
2. Design & Development Services: Engineering and design services including product development, prototyping, testing, human factors engineering, and regulatory consulting. These professional services support clients from concept through commercialization.
3. Combination Product Manufacturing: Manufacturing of drug delivery systems and combination products, including drug handling, kitting, and packaging services for pharmaceutical and medical device combination products.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Gilero is a medical device contract development and manufacturing organization (CDMO) that provides end-to-end services spanning design and development, clinical and small batch builds, electromechanical systems, human factors engineering, regulatory services, and contract manufacturing. The company partners with medtech and pharmaceutical companies to take medical devices and drug delivery systems from concept through commercialization, operating injection molding and cleanroom assembly facilities across North America, Europe, and Asia as part of the Sanner Group.

Product overview

Gilero is a medical device contract development and manufacturing organization (CDMO) offering end-to-end services from concept to global-scale production. The company operates as a single unified service offering that includes Design & Development, Clinical & Small Batch Builds, Electromechanical Systems, Human Factors & Design, Regulatory Services, Contract Manufacturing, and a Global Manufacturing Network. As part of the Sanner Group since September 2024, Gilero provides integrated design, development, assembly, packaging, and manufacturing services for medical devices, diagnostics, and drug delivery/combination products across facilities in North America, Europe, and Asia.

Differentiator

Problem solved

Functional benefit

Products and services

• Design & Development Comprehensive medical device design and development services spanning concept to production, with subject matter expertise across drug delivery and diagnostic systems to anticipate design risks early. Aimed at medtech and pharmaceutical companies that need external engineering support to bring new medical devices to market.
• Clinical & Small Batch Builds Tailored manufacturing services for companies developing products requiring clinical trials and small batch builds, with flexible manufacturing and specialized regulatory support for drug-led combination products. Designed for medtech and pharmaceutical clients moving from prototype to clinical-stage production.
• Electromechanical Systems Development Development of electromechanical systems for medical devices, including both subsystems and fully integrated solutions that perform reliably and meet regulatory requirements. Targeted at medical device OEMs needing electronics, mechanics, and software integration.
• Human Factors & Design Integration of human factors engineering into every stage of product development through robust risk analysis and usability testing, implementing design changes that mitigate context-dependent risks early in the design process. Targeted at medical device manufacturers needing FDA human factors compliance.
• Regulatory Services Expert regulatory guidance for devices at every stage of product development, managing regulatory communications, supporting submission processes, and maintaining long-term compliance for medical devices and combination products. Aimed at medtech and pharmaceutical companies navigating FDA, ISO 13485, and other regulatory pathways.
• Contract Manufacturing Efficient, cost-effective manufacturing solutions with assembly and manufacturing processes for complex products that scale for production, including design transfer, injection molding, complex assembly, packaging, and kitting. Targeted at medical device OEMs requiring manufacturing partners for clinical and commercial volumes.
• Global Manufacturing Network Scalable global manufacturing solutions with injection molding and cleanroom assembly facilities in the U.S., Mexico, Europe, and Asia to produce medical devices as finished goods. Designed for medtech and pharmaceutical companies needing multi-region manufacturing capacity and supply chain resilience.

Quantifiable outcome

• Reduced design-to-manufacturing friction through dedicated design transfer team
• +1 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 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.

• Sanner GroupcoreStrategic or Co-development Partner · 25 September 2024Sanner Group, a leading global healthcare packaging and medical device CDMO headquartered in Germany, acquired Gilero on September 25, 2024. The acquisition positions the combined business as a leading provider of end-to-end services across drug delivery, diagnostics, and medtech device sectors. Gilero's capabilities in design, development, assembly, packaging, and contract manufacturing enhance Sanner's integrated offering, while Gilero gains access to Sanner's 130 years of market leadership, European and Asian manufacturing footprint, and desiccant packaging solutions.

Scale indicators6 records

Recent moves12 records

Expansion highlights5 records

Direct peers

• Phillips-Medisize: One of the largest medical device CDMOs globally (Molex-owned), providing design, development, and contract manufacturing of drug delivery devices, combination products, and diagnostics. Highly comparable to Gilero across full device lifecycle services, injection molding, and combination product capability.
• West Pharmaceutical Services: Global leader in injectable drug containment and delivery, supplying elastomeric closures, pre-filled syringe components, and drug delivery devices. Directly comparable as a primary CDMO partner to pharma for combination products and injectable delivery systems — Gilero's stated core focus.
• Nelipak Corporation: Medical packaging CDMO specializing in thermoformed packaging, cleanroom manufacturing, and sterilization services for medical devices and pharma. Closely comparable in cleanroom-based contract manufacturing and packaging for medtech.

Broad incumbents

• Catalent: Large diversified pharma services platform covering drug development, biologics, and drug delivery/auto-injector manufacturing. Overlaps with Gilero in combination product development and clinical-stage device manufacturing, but operates at significantly greater scale across the full pharma services stack.
• Integer Holdings: Medical device outsource manufacturer offering design, development, and contract manufacturing of components and finished devices for cardiology, neurology, and surgical markets. Directly comparable business model to Gilero in medtech design-to-manufacturing outsourcing.
• Jabil Healthcare: Division of Jabil providing manufacturing, design, and supply chain services for medical devices, drug delivery, and diagnostics. Comparable end-to-end CDMO offering but with the resources of a Fortune 500 contract manufacturer.
• Variavilla (Gerresheimer): European-headquartered pharma and drug delivery packaging/CDMO with substantial plastic and glass primary packaging, autoinjector, and inhaler offerings. Overlaps with Gilero in drug delivery devices and combination product assembly.
• Recipharm: European CDMO providing contract development and manufacturing of pharmaceuticals and drug delivery devices. Comparable combination product and sterile manufacturing footprint, acquired by EQT-backed platform to scale pharma CDMO services.
• Nipro Corporation: Japanese-headquartered medical device and pharma CDMO with global manufacturing for drug delivery, dialysis, and injection-related products. Comparable in injection molding and drug delivery device manufacturing across multiple jurisdictions.

Emerging players

• Accumold: Specialist micro-injection molder for medical and micro-miniature parts serving medtech and drug delivery customers. Comparable to Gilero's electromechanical and injection molding capabilities at the component level, though narrower in scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/gilero
• Xx.com/GileroMed

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds1 record

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 Gilero