Ontogen Medtech Achieves ISO 13485 Certification, Strengthening Contract Manufacturing Capabilities

Ontogen Medtech, a leading provider of design and manufacturing services for the medical device industry, is proud to announce that it has achieved ISO 13485:2016 certification, the internationally recognized standard for quality management systems in medical device manufacturing.

2025 Biomedical Innovation Scholarship award winner: Ruby Swafford

Ontogen + Lurie Children’s Advances Sterile Fluid Delivery Innovation with Multi-Disciplinary Collaboration

Medical innovation thrives on collaboration, and a recent partnership between Ontogen Medtech and Ann & Robert H. Lurie Children’s Hospital of Chicago exemplifies this. Working with Lurie Children’s Innovate2Impact (I2I) team, surgeon innovator Dr. Seth Goldstein, Dr. Justin Ryder, and a multidisciplinary group of healthcare professionals, the team is developing a new device to improve sterile fluid delivery in operating rooms.

5 Traits of a Startup-Friendly Contract Manufacturer

For early-stage medical device companies, selecting the right contract manufacturing (CM) partner is one of the most critical decisions in the path from prototype to commercialization. Yet, the needs of startups often differ substantially from those of established OEMs

Ontogen Medtech Announces New Contract Manufacturing Business Unit and State-of-the-Art Facility Expansion

Top MedTech Incubator Programs in the U.S.

The U.S. is home to some of the world’s most influential medtech incubators and accelerators, offering startups critical support across medical device development, regulatory strategy, clinical validation, and commercialization.For early-stage founders, choosing the right medtech incubator program can significantly accelerate timelines, reduce risk, and unlock access to investors and healthcare systems.