In a race against time, startup takes advantage of Donatelle’s pure medical expertise and vertical integration for novel Class III device​

Challenge

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.

Adding to the challenge, the product already had launched on market in the European Union, and the company aimed to minimize or avoid the need for revalidation processes. Plus:

• The program had a complex supply chain requiring outsourced vendors for specialized parts and subassembly, which Donatelle would have to manage while designing components, and ensuring overall quality, final assembly and on-time delivery. 
• The device included some expensive components to be assembled, so the manufacturing yield had to maintain high levels in order to meet cost targets. 
• The final product and packaging also had to meet stringent cleanliness requirements, as a Class III device. 

 In total, the project entailed molding, validating and assembling 14 plastic parts with 25 purchased parts and blister tray medical packaging, along with sterilization management of the completed device. And, it all had to be done within months. 

Based on a long history of successfully developing and manufacturing complex medical devices, the Donatelle team – all under one roof – quickly guided the startup toward an absolute-quality solution. 

Action

 Testing the existing components revealed a portion did not meet the product specification criteria to be transferred, so Donatelle got to work building several new injection molds for production. In the process, the startup’s team required some scope changes for the program, resulting in several part geometry and material changes that required multiple iterations of product re-validation to occur in parallel with keeping the supply chain moving. 

At each stage, Donatelle’s vertically integrated capabilities enabled the team to rise to the challenges – in record time. End to end, the Donatelle team worked closely with the startup through design for manufacturability, tooling, injection molding, device assembly, testing, sterile tray packaging and sterilization management, all while managing and incorporating the outsourced components and subassembly. 

As an FDA-registered contract manufacturer adhering to Good Manufacturing Practices (GMP), Donatelle’s quality systems and documentation 

Result

 Donatelle met the Class III product requirements and the startup’s aggressive timeline. The improved device remained on market in the European Union, and gained investigational approval from the FDA. 

After the project was completed, the startup’s senior director of quality and operations noted that Donatelle met their program’s needs throughout the whole process, and was instrumental in helping mitigate and eliminate possible production issues. In her follow-up feedback she explained: The Donatelle team’s “persistence, knowledge, experience and strong quality system were key to our success. Donatelle’s technical abilities are far above the competition.” 

The cardiovascular company continues to rely on Donatelle to consistently and reliably manufacture the micro seal for this device, and has awarded similar product programs to the contract manufacturer’s roster.