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Rapid Design to Commercial Manufacturing of a Specialty Balloon Catheter

Rapid Design to Commercial Manufacturing of a Specialty Balloon Catheter
The Challenge

A large, multinational, health technology company was soliciting proposals for the design, development, and manufacture of a specialty balloon catheter. The company hoped to develop a better system to compete with an industry leader in the market.

A key challenge in the design criteria was to offer a new design with novel IP. The company was also looking to get a product to market as quickly as possible and was seeking a vendor that could meet their aggressive timelines.

The Solution

Engineers at Freudenberg Medical’s Carrick-on-Shannon (Ireland) facility proposed a design leveraging their deep knowledge and proven success in precision extrusion, catheter balloon technology, molding, and device design and assembly. This design had many advantages over the existing technology and provided the novel solution the customer was looking for.

Freudenberg Medical’s vertically integrated competencies and capabilities estab-lished a single point of contact, effective collaboration, and rapid iterations during the design phase.  For example, during the design phase, iterations typically took two to three weeks to refine and present, unlike the eight to ten weeks they expe-rienced with other vendors.

Rapid Design to Commercial Manufacturing of a Specialty Balloon Catheter
Rapid Design to Commercial Manufacturing of a Specialty Balloon Catheter
The Result

The project was approved for commercialization based on the novel, easier to use solution developed through rapid design iterations. Freudenberg Medical was able to meet the customer’s needs, developing the product from design concept to market-ready product. The project team completed the project in just 18 months, which included regulatory approval and brought the customer to market as quickly as possible.

The customer rapidly acquired a commanding market position and considered this product the most successful specialty device that they’d ever launched. That initial success established the foundation of a strong partnership leading to the devel-opment of next-generation versions of the product with different performance criteria, as well as expanding our development and manufacturing relationship across a wider portfolio of products spanning five different business units in the U.S. and Europe.

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