Life Sciences and Medical Devices

Non-conforming seal risks Phase 4 approval

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Material Used EPDM Ethylene propylene
Problem solved Technical

The Situation

The Director of Product Design at a manufacturer of Class 1 medical devices was experiencing seal failure which could derail Phase 4 approvals.

 

The Ask

We were tasked with supporting their root cause failure analysis and recommending a new design

 

The Solution

Our review showed the need for tighter tolerancing on ID and Cross Section, combined with a friction modified material.  Our unique solution solved the problem and scaled quickly from prototype to production volumes.

 

The Success

The customer met their production ramp and took the new product to market in time with a successful launch.

Ongoing predictable seal performance is assured regardless of influences inside and outside the supply chain by deploying Darcoid’s Seal Performance Creep controls

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EPDM Ethylene propylene
Technical