Magellan is a device that separates PRP (platelet rich plasma) from whole blood.
KDI provided DFM and manufacturing for these sub-assemblies:
- Custom centrifuge
- Syringe pumps – 2 sizes
- Auto – locking latch
- Guide for blood flow tubing
After one year, KDI took over production of the complete assembly:
- Fast and efficient technology transfer
- Designed and built test equipment
- 100% tested with bovine blood
Growing confidence in KDI’s abilities allowed this OEM to transfer the full production of the Magellan to KDI. The goal was to have the transfer complete and first production units shipped in 7 months.
Below are the steps in the transition process that demonstrate how KDI exceeded the customer’s expectations in meeting the assigned goal and achieved other significant milestones within the first year of producing their product.
- Designed and built a dedicated assembly room – completed in one month
- Converted 487 component specification and assembly drawings to the customer’s format – submitted for Document Change Order (DCO) – completed in two months
- Loaded the instrument Bill of Material into KDI’s ERP system – completed in three months
- Relationships and accounts established with all vendors – completed in four months
- Operational, Safety and Functional Test automation designed by KDI 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 – four months after contract awarded
- Validated KDI production process – one month later
- Shipped first production instrument – six months after contract awarded
- Shipped 100th production instrument – ten months after awarded
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