The customer had previously developed a design for a steerable ERCP device with a 3rd party design firm. The customer engaged Freudenberg Medical Minimally Invasive Solutions to perform verification, validation and manufacturing transfer, while improving manufacturability. At the time of design transfer to Freudenberg Medical Minimally Invasive Solutions, the product had passed only 42% of design verification testing requirements due to design problems.
Freudenberg Medical Minimally Invasive Solutions identified and resolved 100% of the device functionality challenges and developed solutions for several significant design-for-manufacturability issues. Specific examples of challenges:
We poke-yoked handle assembly components such as the gear and knobs to prevent reverse device functionality. We also developed internal manufacturing processes for intricate distal 3D geometrical wire forming that the customer’s wire forming suppliers could not accomplish.
Within 12 months from the initial discussion, the market evaluation proved successful as Freudenberg Medical Minimally Invasive Solutions successfully designed, developed and transferred the steerable ERCP device into manufacturing at a price point that was 30% less than originally anticipated.