Ontogen Medtech

Ontogen Medtech was hired by Hubly Surgical, a company that creates and sells advanced, auto-stopping cranial drills, to develop the Hubly Drill. The project involved validation and verification testing, obtaining FDA clearance, establishing and maintaining a manufacturing and quality system, and developing the second generation of the Hubly Drill. The executive from Hubly Surgical found Ontogen Medtech through a referral and chose them due to their proximity, budget-friendly pricing, and company culture. 2-5 employees from Ontogen Medtech were assigned to this project. The project was successful, with the Hubly Drill receiving FDA clearance.

Ontogen Medtech worked with Madison Scientific, a startup developing an advanced hydrocephalus shunt, on early R&D and establishing a baseline design. The CTO of Madison Scientific found Ontogen Medtech through a referral and chose them for their high ratings, location, pricing, culture fit, and value for cost. The project involved researching and defining requirements for the medical device, performing early R&D ideation, trade studies, and baseline concepts, and identifying development risks and mitigations. The deliverables included documentation, hardware prototypes, and test reports.

Ontogen Medtech was hired by Hubly Surgical to design and develop surgical drills through early production, establish a quality system, and develop line extensions. The COO of Hubly Surgical found Ontogen Medtech through a referral and a hiring site and chose them for their location, culture fit, value for cost, and company values. The project involved developing product architectures, design/development, testing, FDA submittal support, and establishing and executing a quality system. The project was successfully completed with the assistance of 2-5 employees from Ontogen Medtech.