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“Electrosurgical ENT Instrument”

A medical device OEM that specializes in electromechanical instruments needed help in resolving distinct quality issues that surfaced throughout the life of their device in the field. These issues ranged from cosmetics to catastrophic functional failure and a long-term solution was needed. To start, TSE worked with the client to understand in full the failure modes, field complaints, and failure testing performed to verify field complaints. Isolating the issue to the cable assembly provided by their supplier, TSE helped define the requirements for the solution:

  • A cable assembly that was hard wired to the device but easily detachable from the capital system.
  • The cable assembly would transmit power and signals within the same cable and connectors.
  • The cable would be sealed to prevent fluid ingress.
  • The connectors would mate with the existing devices and system.
  • The cable would withstand specific tensile, bend, and torsion requirements through handling and sterilization cycles.
  • The cable assembly could withstand a minimum of 300 autoclave cycles with no functional or cosmetic failures.

The Process
TSE integrated into the client’s Quality and Engineering teams to collaborate in the development of the improved cable assembly. TSE provided its expertise in interconnect design and manufacturing to drive finalization of the root cause investigation, document the design inputs and requirements, and then develop a proposal to address each of the observed failures in their current design as well as streamline the manufacturing process to eliminate a 3rd party process being utilized. Using TSE’s 5-phase New Product Development process, TSE managed the project from concept to development and testing to ensure the design and process was optimized to meet the client’s requirements and expectations prior to moving into the validation phase. In collaboration with the customer, the design was frozen, and validation executed on schedule to move the product into commercial production.

The Solution
The TSE team delivered to the client an enterprise solution that required no device or capital equipment changes, by designing and manufacturing a cable with: Two customized connectors with near hermetic seals that exceed the sterilization and fluid ingress requirements threefold. A cable bundle design that addressed both the functional and cosmetic failures in the field. Component cost within the cost saving initiative for the project. Manufacturing processes engineered and validated to meet all critical to quality characteristics and cosmetics. With the ability to leverage significant economies of scale and materials sourcing, TSE was able to provide the customer with a higher quality cable at a lower price than the current, sub-optimal product offering.