Improved capacity and faster lead time in R&D work through Kaizen

Situation

A medical device R&D pilot laboratory was not meeting the capacity and productivity needs for phase 2 of certain projects. The current process could only produce 30 units per slot per operator, far below the required 100 units. This gap necessitated a Kaizen event to scale up pilot batch sizes, increase productivity, and establish standard work to minimize variation and improve cross-project cooperation.

Approach

The Kaizen event used SW and SMED lean approaches and focused on several key areas:

• Current State Analysis: Reviewed the existing process, identified waste, and measured current performance.

• Future State Ideation: Developed a future state process with improved productivity and capacity.

• Implementation: Created standard work for the new process, performed dry runs, and developed training materials.

• Sustainability: Established a sustainability plan and metrics to ensure long-term adherence to the new process.

Key deliverables included:

1. Standard work for the pilot manufacturing process.

2. Scenarios for cross-project pilot manufacturing.

3. A traceability system for the new process.

4. Training materials and dry run completion.

Results

The Kaizen event successfully achieved its goals:

• Capacity and Productivity: Increased from 30 to 105 units per slot per operator, a 350% improvement.

• Process Efficiency: Reduced the lead time for pilot production batches from 32 hours to 8 hours.

• Standard Work Implementation: Created and documented standard work, enabling the production of two different products in the same slot.

• Sustainability: Established metrics to track adherence to the new process, with follow-up meetings to ensure continued success.

The new process was validated and training sessions were held to ensure all team members were proficient in the updated procedures. The Kaizen event also provided a clear baseline for future improvements in the pilot manufacturing process and showed the power of lean methods even in R&D operations.