In June of 2008, Klugē Design, Inc., was asked to participate in a Request for Quote for the manufacture of a blood platelet separator instrument. In August of 2008 we were awarded the business and began the transition process with the goal of shipping Klugē Design manufactured instruments by March of 2009.  Below are the steps in the transition process that demonstrate how we exceeded the customer’s expectations in meeting the assigned goal and achieved other significant milestones within the first year of producing their product.

• Contract awarded to Klugē Design Inc. – August 2008
• Designed and built a dedicated assembly room – completed Sept. 2008
• Converted 487 component specification and assembly drawings to the customer’s format – submitted for Document Change Order (DCO) – October 2008
• Loaded the instrument Bill of Material into Klugē’s ERP system – November 2008
• Relationships and accounts established with all vendors – November 2008.
• Operational, Safety and Functional Test automation designed by Klugē engineers
  • Developed a component and sub-assembly lot tracking data base to support Device History File (DHR) requirements
  • Developed an automated data collection and reporting system
  • Designed and built automation equipment
  • Validated all equipment and systems
• Created detailed, graphical work instructions
• Sourced a safe and consistent supply of bovine blood for product testing
• Conducted first engineering build – November 2008
• Validated Klugē production process – December 2008
• Shipped first production instrument – February 20, 2009
• Shipped 100th production instrument – June 2009

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