The customer was struggling internally to develop a hemostasis clip device that would allow for an expansion of their endosurgery strategy. The customer engaged Freudenberg Medical Minimally Invasive Solutions and raised design issues about their technology that they feared would be impossible to overcome. In their words, “This is a significant challenge and we are not sure if this is the technology that Freudenberg Medical Minimally Invasive Solutions wants to take on, as there is a high risk of failure.”
Freudenberg Medical Minimally Invasive Solutions 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 and concepts were developed, evaluated, chosen and prototyped. Because this was a new market for the customer, clinical functionality and design requirements changed numerous times. Freudenberg Medical Minimally Invasive Solutions 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 Minimally Invasive Solutions successfully designed, developed, and transferred the Endoscopic Hemostasis Clip device technology into manufacturing. The technology entered the market with our 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 United States. The enhanced features of the device alleviated poor perceptions of the predicating therapies and opened a new market in the United States. 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.