A study in success: Custom procedure tray kitting
RRD’s customer is among the world’s leading suppliers of medical devices providing a wide range of standard and custom surgical trays used by hospitals and clinics. Their tray program is aimed at optimizing components for a specified procedure to complement the surgeon’s techniques, thereby improving efficiencies and reducing waste.
Sample tray development was taking up to 90 days. Lack of supplier control and visibility, combined with uncompetitive component pricing, exacerbated matters. Increased efficiency was needed to allow the customer to be competitive in the marketplace. The customer required rapid project implementation with no backlog and no impact to the end-customer.
Other additional challenges the supplier faced included:
- Inability to offer customization to end-users
- Inflexibility of scheduling for EO sterilization, compounded by the costs associated with testing
- Demand planning and inventory management
- Long lead times for product component sourcing and kitting
RRD developed a comprehensive solution to drive efficiencies, improve turnaround time and accomplish a rapid project implementation, while maintaining the highest standards of quality. Our centrally located facility is FDA registered, ISO 13485 accredited, cGMP/QSR compliant, and has an ISO 14644-1 Class 8 cleanroom.
A quality assurance management program ensures regulatory compliance, including maintenance of Device History Records and Device Master Records. The IT solution included the integration of RRD's ERP system with that of our client’s.
Along with centralized procurement and pharmaceuticals licensing, other key aspects of the solution included:
- Packaging and label requirement set-up design, and lot-level tracking and traceability
- Validation of a new sterilization provider, managed by RRD
- Managing the validations for sterilization, packaging and kitting process
- Rationalization of trays and Stock Keeping Units (SKU)
- Open bill of material pricing for increased transparency
- Print on demand for custom procedure tray contents and instructions
By developing and implementing this new solution, RRD demonstrated itself as an innovative and integrated provider. Rapid project implementation was achieved in 18 weeks, with no backlog or negative impact to the customer. The customer gained control over its relationship with sub-suppliers, allowing for improved payment terms.
Capital investment has been avoided and invoices are issued only when finished product is shipped from the sterilization provider, thereby greatly improving the customer’s cash flow. The customer now has a faster turnaround time for custom procedure trays all at a lower cost.
A cost savings of 5% was achieved in year one of the project and RRD was awarded the customer's Supplier of the Year in the second year of the contract.