Bidirectional ERCP Device

The customer had previously developed a design for a steerable ERCP device with a 3rd party design firm. However, lack of initial success lead them to engage Freudenberg Medical to perform verification, validation and manufacturing transfer, while improving manufacturability. At the time of design transfer to Freudenberg Medical, the product had passed only 42% of design verification testing requirements.

Freudenberg Medical identified and resolved 100% of the device functionality challenges and developed solutions for several significant design-for-manufacturability issues. Specific examples of challenges:

• The device would not steer in both planes in a tortuous path

• The device leaked at the contrast port

• The tip and handle parts were not moldable

• The cutting wire failed frequently

• The handle separated from the strain relief during load application

• The hydrophilic coating flaked off and was non-lubricious

• The working lumen was consistently damaged by the introduction of a guide wire

• The handle components, extrusions and packaging all had several tolerance stack-up problems

Freudenberg Medical poka-yoked the handle assembly components, including the gear and knobs, to prevent reverse device functionality. We also developed internal manufacturing processes for intricate distal 3D geometrical wire forming.  Within 12 months from the initial discussion, the market evaluation proved successful.  Freudenberg Medical successfully designed, developed and transferred the steerable ERCP device into manufacturing at a price point that was 30% less than originally anticipated.