Cultivating Confidence
Redesign of OEM Heated Gutta Percha System
Situation: OEM was experiencing a significant failure rate with Kevlar threaded heating element in their medical device, used by endodontists in root-canal procedures. This device requires accurate and consistent heating for proper function and patient comfort. Unreliable heating of the media could yield catastrophic results.
Solution: The OEM consulted General Assembly (GA) for their expertise in reengineering and customization. GA troubleshot the issues with the heating element sub-assembly, and successfully redesigned the components for production and assembly which decreased the failure rate to <5%, a 10% improvement.
Full Handoff: Eventually GA took over assembly of the entire device, comprising 80% inbound parts. GA also moved the production of other components to FDA registered partners, ensuring the OEM met and continued to meet all FDA requirements.
