Ontogen Manufacturing LLC

Ontogen Medtech is a full-service medical device development and contract manufacturing partner based in Lisle, Illinois. Founded in 2021, the company specializes in end-to-end product realization for Class I, II, and III medical devices and in-vitro diagnostics across multiple therapeutic areas including orthopedics, cardiovascular, neurosurgery, women's health, pediatrics, and airway management. Services encompass strategic product design, engineering, prototyping, verification and validation testing, regulatory management (FDA compliance, 510(k) support), design history file documentation, and contract manufacturing from pilot builds to large-scale production. Ontogen operates a state-of-the-art facility with Class 7 cleanroom capabilities and sterilization coordination expertise. The team brings over 45 years of combined experience in sensor-driven smart devices, minimally invasive catheters, drug preparation and infusion systems, and class III implants. The company serves entrepreneurs, startups, and established medical device organizations, with a track record supporting clients through SBIR grants, pitch competitions, patent filings, and FDA clearances.