A Race Against Time: Startup Partners With Donatelle For Novel Class III Device

To gain U.S. Food and Drug Administration (FDA) approval and be first to market in the United States, a startup with a novel Class III mitral valve repair therapy needed to first fine-tune some of the product’s delivery system components.

Behind schedule with deadlines and competitors looming, the startup turned to Donatelle’s deep engineering expertise and vertically integrated capabilities. The program involved a product transfer from another supplier that failed to consistently meet the intricate specifications.

The startup asked Donatelle to review and validate the existing tooling, and in parallel to redesign and build a portion of the fixtures and molds for manufacturability.

At each stage, Donatelle’s vertically integrated capabilities enabled the team to rise to the challenges – in record time.