VERTICALLY INTEGRATED BUILT TO SCALE

As a vertically integrated, ISO 13485-certified contract manufacturer, we give orthopedic and medical device OEMs the confidence of one accountable partner — from design and development through injection molding, assembly, and sterile barrier packaging — all under one roof.

Quality and Manufacturing Expertise

As an ISO 13485-certified, FDA-registered contract manufacturer, Red Star holds every process—from plastic injection molding and Class 7/8 cleanroom assembly to precision machining and sterile barrier packaging—to the same rigorous quality standard. Our robotics and lights-out manufacturing capabilities give orthopedic and medical device OEMs the consistency and traceability their regulatory requirements demand, without sacrificing speed to scale.

Why Choose Red Star

More than 25 years of Medtech experience brings proven expertise to every program.

U.S. Manufacturing

U.S. Manufacturing

Built in Indiana for greater quality control and supply chain confidence.

Faster Production

Faster Production

In-house tooling and manufacturing help accelerate production timelines.

Engineering Expertise

Engineering Expertise

Engineering expertise that turns complex concepts into manufacturable solutions.

Capabilities That Take Your Device from Print to Patient

Product Development & Engineering

Turn innovative concepts into manufacturable products—faster, smarter, and with less risk.

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Tooling & Mold Manufacturing

From concept to production, our in-house mold design and build expertise delivers precision tooling engineered for performance.

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Injection Molding & Insert Over Molding

From validation through full-scale production, Red Star delivers precision-molded medical components with the consistency, quality, and control your program demands.

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Precision Machining

Red Star machines complex medical device components with the accuracy, consistency, and process control required for demanding applications

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Device Assembly & Secondary Operations

Red Star brings components together through controlled assembly processes designed to deliver consistent quality, reliable performance, and production-ready medical devices.

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Sterile Packaging & Kitting

Red Star provides controlled cleanroom packaging designed to protect product integrity and support your quality and regulatory requirements.

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POWERFUL PARTNERSHIP

A TRUE EXTENSION OF YOUR TEAM

We don’t just manufacture your product—we partner with you through every stage, from early design input to full-scale production. Our team stays close, communicates often, and treats your challenges as our own, so you always have a direct line to the people building your product.

ENGINEERING EXPERTISE

DESIGNED FOR MANUFACTURABILITY

We bring product design, development, and DFM expertise to every project, working with you early to optimize designs for manufacturability, cost, and quality before production begins. Our support extends through packaging development, so your product is engineered to perform and built to scale.

Advancing Medical Device Innovation
Across Critical Markets

Work with a medical device contract manufacturer built to turn innovative concepts into scalable, high-quality devices for specialized healthcare markets

Orthopedic Devices

Orthopedic Devices

Bring your orthopedic device designs to market with a manufacturing partner experienced in complex surgical instruments, implants, and single-use procedure solutions.

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Sports Medicine Devices

Sports Medicine Devices

Bring innovative sports medicine devices and instrumentation to market with a CDMO experienced in arthroscopy, soft-tissue repair, and single-use procedural solutions.

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Drug Delivery Devices

Drug Delivery Devices

Red Star manufactures critical components, subassemblies, and finished devices for a wide range of drug delivery applications.

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Diagnostic Devices

Diagnostic Devices

Red Star supports diagnostic OEMs with integrated manufacturing solutions for sample collection, fluid handling, point-of-care testing, and laboratory applications.

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Vascular Access Components

Vascular Access Components

Red Star manufactures critical components, subassemblies, and finished devices for vascular access applications.

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Women's Health

Women's Health

Red Star manufactures critical components, subassemblies, and finished products for diagnostic, biopsy, fertility, and gynecological applications.

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Tell Us About Your Device

Partner with Red Star to streamline your path from development through production.