18% Throughput Gain at a Medical Device Assembly Facility
A Class II medical device assembler was running two shifts at full headcount but still missing customer delivery commitments. By redesigning the assembly cell around takt time and standard work, KAIZEN unlocked 18% more throughput — without adding a single operator.
The Challenge
The facility assembled a family of diagnostic devices with strict FDA documentation requirements. Despite running 16 hours per day with a full crew, on-time delivery was stuck at 81% — threatening a key distributor contract renewal. The operations team had added headcount twice in 18 months with no measurable throughput improvement.
The Diagnosis
A Gemba-based time study of the eight-station assembly cell revealed operator cycle times varying by 40% between the fastest and slowest at the same station — a standard work problem. Three stations were routinely waiting while two were consistently overloaded, capping the whole cell. The cell was balanced to headcount, not to takt time. Uncontrolled component placement was causing 14 seconds of search time per cycle.
The Lean Intervention
A cell-balance kaizen event over four days: calculate takt time based on actual demand, rebalance all eight stations to within ±5% of takt. Standard work instructions developed with photos and time elements. 5S deployed at every workstation with shadow boards. A visual pacing board installed for the cell leader. Batch size reduced from trays of 50 to trays of 10, tightening the feedback loop for defect detection.
The Results
Throughput increased by 18% within 10 weeks — without adding operators or extending shift hours. Defect rate fell from 2.4% to 0.8%. Assembly cycle time dropped from 8.4 to 5.9 minutes. On-time delivery reached 97% the following quarter, securing the distributor contract renewal. The operation absorbed a 22% volume increase in the subsequent year with existing headcount.
Engagement Details
- Client
- Class II Medical Device Manufacturer
- Industry
- Medical Devices
- Duration
- 16 weeks
Methods Used
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