Endoscopic Hemostasis Clip Device
The customer was struggling internally to develop a hemostasis clip device that would allow for an expansion of their endosurgery strategy. When the customer engaged Freudenberg Medical they raised design issues about their technology that they feared would be impossible to overcome. In their words, “this is a significant challenge and we’re not sure if this is a technology that Freudenberg Medical wants to take on because there is a very high risk of failure.”
Freudenberg Medical accepted the challenge. Instead of trying to improve a less than successful design inherited from the customer, we quickly implemented our robust design for manufacturability process. Concepts were developed, evaluated, chosen and prototyped. Because this was a new market for the customer, the clinical functionality and design requirements changed numerous times. Freudenberg Medical tackled this ‘moving target’ by iterating designs, performing FEA analyses and building numerous prototypes. Animal labs and competitive comparisons efficiently and effectively proved out the correct design solution for commercialization. Within 18 months of the initial discussion, Freudenberg Medical successfully designed, developed, and transferred the Endoscopic Hemostasis Clip device technology into manufacturing. The technology entered the market with Freudenberg Medical-designed competitive advantages of clip actuation, unrelenting grip on tissue and clip positioning that was far superior to the competition.
When the customer’s new device hit the market, it was extremely well received and changed the perception of the therapy in the US. The enhanced features of the device alleviated poor perceptions of the predicating therapies and opened a new U.S. market. An industry ‘buzz’ surrounded the device and sales escalated. The customer’s forecast doubled before the launch and didn’t stop there. Current production volume is over 40 times the original year one forecast and is continuing to rise. Our customer now owns 80% of the market.