Cook Medical - smart manufacturing
Medulla is pleased to announce a partnership with Cook Medical, a global company that combines medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently.
The partnership includes a 12 month pilot trial of the Medulla Smart Factory platform, to be integrated within one of Cook's established manufacturing lines in Brisbane, Australia. The primary objectives of the trial is to quantify operational efficiency improvements and the cost of integration, with a focus to:
Demonstrate a proof of concept transition to paperless production lines
Convert legacy factory equipment into IIoT enabled equipment.
Display real-time dashboards providing intelligent manufacturing analytics and insights.
Enable autonomous quality control monitoring
Medulla's digital webforms used to log batch traceability @ Cook Medical
Quality
Implementation will be compliant with ISO13485 and FDA's 21 CRF Part 11 guidelines
Once operational, the system will closely monitor select stages of the assembly process to ensure product has advanced through each stage successfully.
IIoT Enabling
The pilot includes development of digital interfaces for direct communication with equipment in use on the manufacturing line. This includes; ovens, flow meters, sterile pack sealers, among a few others.
Performance of assembled product will be tracked against the manufacturing metadata captured from each machine. This information will be used to develop relationship models and help Cook engineers gain better insight into the assembly process.
Timeline
Commencing in June 2019, and running a total of 12 months.
Integration will roll out progressively, over a 3-4 month window to minimise disruptions, followed by 8 months of ongoing performance monitoring and quantification of efficiency improvements from the current baseline.
