Ontogen Medtech

Ontogen Medtech was hired by Hubly Surgical, a company focusing on the creation and sales of an advanced, auto-stopping cranial drill. The goal was to develop, test, and receive FDA clearance for the Hubly Drill, as well as establish and maintain its manufacturing and quality system. With a team of 2-5 employees, Ontogen Medtech successfully developed the Hubly Drill, created and maintained a Quality Management System, and achieved FDA clearance for the drill. The client appreciated Ontogen Medtech's location, budget-friendly pricing, and company culture.

In a separate project with Hubly Surgical, Ontogen Medtech was tasked with the design and early production development of surgical drills. The project also involved the establishment of a quality system and the development of line extensions. The scope of work included developing product architectures, design/development, testing, FDA submittal support, and the establishment and execution of a quality system. The client chose Ontogen Medtech for their geographic location, great culture fit, and good value for cost.

Ontogen Medtech also worked with Madison Scientific, a startup developing an advanced hydrocephalus shunt. The objectives of this project were to carry out early R&D, define project requirements, and establish a baseline design. Ontogen Medtech was able to research and define the requirements for the advanced medical device, perform early R&D ideation, trade studies, and baseline concepts, and identify development risks and mitigations. The client appreciated Ontogen Medtech's high ratings, proximity, budget-friendly pricing, and company culture.