About Nextern Innovation, Inc

Nextern Innovation is a vertically integrated medical device contract design, development, and manufacturing organization (CDMO). The company collaborates with innovators and clinicians to design, develop, optimize, and manufacture medical devices across multiple therapeutic areas. Nextern operates four global manufacturing facilities totaling 250,000 square feet, including 20,000 square feet of cleanroom space, with a team of 600+ members worldwide. The company specializes in minimally invasive devices, single-use catheter and metal assemblies, Class III active implantable leads and delivery systems, power systems (catheter and generator development), bioelectronics, and connected care solutions. Nextern Liink, a subsidiary, develops custom, secure, and scalable software solutions for medical device connectivity. Core capabilities include device design and development (bio-simulation, pre-clinical testing, IP support), full-spectrum manufacturing with phased transition from development to commercialization, supply chain management, and life-cycle services including warranty and continuous improvement. The company operates virtual quality management systems and maintains presence in strategically located global manufacturing locations with localized supply chains. Nextern serves cardiology, neuromodulation, and other specialty device markets, with demonstrated expertise in brain-computer interfaces and platforms for labeling and graphical user interfaces.

Contact Information

nextern.com
regulatory@nextern.com
1-612-2032100-8208
10601 Fountains Drive — Maple Grove, MN

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