How do you know if you are choosing the right CDMO for your Medical Device? Selecting the right Contract Development and Manufacturing Organization (CDMO) is one of the most critical decisions a medical device organization can make. Your partner will directly impact your product’s success, from early-stage development through commercialization. At Nextern, we go beyond traditional CDMO services to deliver vertically integrated, innovative, and scalable solutions designed for speed to market and long-term growth.

Key Factors in CDMO Selection 

1. Technical Expertise & Advanced Manufacturing

Your CDMO should possess deep knowledge of complex device development, from implantables, delivery systems, and single-use devices.

Nextern Advantage: Our expertise in precision engineering ensures your device is built to the highest standards.

2. Seamless Design Transfer & Development Support

Efficient design transfer minimizes costly delays and ensures manufacturability without compromising innovation.

Nextern Advantage: Our cross-functional teams of engineers, regulatory experts, and manufacturing specialists collaborate to optimize your design for scalability and compliance.

3. Regulatory & Quality Assurance

Your partner must have a strong track record in ISO 13485-certified manufacturing and regulatory compliance.

Nextern Advantage: Our FDA-registered facilities and robust quality management system (QMS) align with global regulatory requirements and FDA submissions.

4. Flexible & Scalable Production Capabilities

As your business grows, your CDMO should scale production while maintaining quality and cost efficiency.

Nextern Advantage: Keeping commercialization in mind at the very beginning, we support our partners from conception through commercial launch and beyond.

5. Speed to Market Without Sacrificing Quality

Timely delivery of clinical trial materials and commercial products is essential for success.

Nextern Advantage: Our lean manufacturing approach, in-house R&D, and vertically integrated solutions allow us to accelerate timelines without sacrificing quality.

6. Strong Supply Chain & Risk Management

A reliable CDMO should proactively mitigate supply chain risks and ensure material availability.

Nextern Advantage: Our strategic supplier partnerships, strategic global locations and inventory management solutions ensure continuity in manufacturing.

7. True Partnership & Transparent Communication

Beyond a vendor, your CDMO should act as an extension of your team, offering clear communication and collaborative problem-solving.

Nextern Advantage: We build long-term partnerships through dedicated project management, real-time reporting, and a collaborative approach that aligns with your strategic goals.

Why Choose Nextern as your CDMO Partner?

• Innovative & Customizable Solutions: We tailor our approach to meet your unique device requirements.
• Cost-Effective & Scalable Manufacturing: We align with your financial roadmap to optimize costs at every stage.
• Global Regulatory & Market Readiness: Our regulatory expertise ensures smooth global market entry.
• Agile & Responsive Team: We act as an extension of your business, committed to your success.
• End-to-End Development & Manufacturing: From concept to commercialization, Nextern supports your full product lifecycle.

Let’s Build the Future of Medtech Together. Partner with Nextern for a seamless, strategic, and scalable manufacturing solution. Contact us today to explore how we can bring your device to market faster and with greater impact.

Nextern Overview

Since 2000, Nextern has been a collaborative medical device company specializing in cutting-edge product design, development, and manufacturing. As a strategic partner, Nextern provides end-to-end services including concept development, design for manufacturability (DFM), technology transfer, and commercial-scale production of medical devices.

With a global footprint, Nextern operates facilities in Vietnam, Costa Rica, China, and the United States, offering vertically integrated solutions combining engineering expertise and advanced manufacturing capabilities. Nextern’s core competencies include electromechanical devices: Power Systems, Bioelectronic Devices, and Connected Devices, along with Single-Use Disposables (SUDs), and rapid prototyping services.

Our Minnesota-based development team includes a multidisciplinary staff covering mechanical, electrical, software, and systems engineering to adapt to project needs. Nextern’s global manufacturing operations feature a scalable, skilled labor force enabling efficient production and the ability to meet evolving customer demands. Operating under a unified electronic Quality Management System (QMS), Nextern is ISO 13485 certified, and BSI notified, ensuring compliance with global regulatory standards.