Operational Excellence in Endoscopic Device Manufacturing

A start-up company with superior endoscopic technology that improves tissue acquisition was struggling with its manufacturing partner. Product costs were challenging profitability targets, the component quality was not consistent, and a lack of transparency in engineering documentation was pushing the company to switch manufacturing partners early in the commercialization of their product.

Freudenberg Medical was engaged and quickly began leveraging lean principles and analyzing the issues at hand to identify bottlenecks, equipment needs, process requirements, and component specifications. Solutions included:

• Introduced significant innovation to the production line, including in-line injection molding, semi-automated fixturing, and in-process controls
   
•  Transitioned manufacturing from batch processing to continuous flow
   
• Updated and created documentation for technical drawings and production processes and leveraged an accessible information management system
   
• Rigorously analyzed components and where possible optimized tolerances for reduced manufacturing costs without loss of performance or quality
   
• Re-sourced over 90% of the components for assembly through our supply chain system and vast network of vendors which included vetting new vendors to ensure quality standards were consistently met

What began as a change in manufacturing partners for this start-up customer quickly evolved into an expanded engagement with Freudenberg Medical. Our forward-thinking project team was able to substantially lower costs by reducing waste, streamlining production, and reducing the physical footprint to 750 square feet from an original footprint that stretched across multiple buildings. This ensured that controls were in-line with production to better manage and improve quality, and re-engineer components and processes for better manufacturing integration.

Freudenberg Medical added significant value by ensuring that engineering documentation was well-organized, accessible, and updateable. This has increased trust and led to better production outcomes and more nimble problem solving. Utilizing lean enterprise processes, production capacity has increased from 15,000 devices per year up to 42,000 with the same equipment and processes originally designed. As a testament to the success of this original engagement which had minimal production disruption and transparency not achieved by previous vendors, we have built an enduring 10+ year partnership with this customer that has expanded to four product families, and 16 SKU’s.