1. Terumo Cardiovascular Systems: Oxygenator Production Improvement
University of Delaware’s Senior Design Team:
Tom Craig
Mike Giuliano
Ronit Lilu
Chase Ross
Kate Staley

2. Description of Project
Project Goals:
Improve the efficiency of Reservoir Assembly production line via reduction in downtime, change over time, and cycle time.
Employ lean manufacturing techniques from the ground up such as participation in a Kaizen event

3. Assembly Line Reservoir Inspection Lid Assembly VR Station CR Station
Leak Tester VR CR
Lid
Final Assembly
Lid Line
Jig

4. Current Floor Layout vs. Future Floor Layout
Reservoir Assembly Table CR VR
Lid Line Assembly Table
Product Flow

5. Lean Manufacturing Techniques
The Kaizen event:
Attended a meeting with representation from operators, manufacturing, production supervisors, engineering, and plant leadership to discuss improvements
Time study
Spaghetti diagrams
Value Stream Mapping (VSM)
Value Added, Non-Value Added Time

6. Customers & Wants
Customers: Terumo Management, Terumo’s Floor Staff, Surgeons, Hospitals, Patients

7. Metrics and Target Values
Accuracy of Manufacturing/Error Proof
100%
Harmful Factors
3 feet egress clearance, limit body rotation/twisting/reaching, adjustable table heights for ergonomics
Minimize Space
VR Table 3 ft or less, CR Table 2’ x 2’
Waste of Time
less than 20%, less than 1 mile/day walking
Cycle Time
reduce by 4 sec (from 42 sec to 38)
Productivity
Increase of 675 units of oxygenators/week
Risk
Score below 25 RPN (no mitigating action required)

8. Current Floor Layout vs. Future Floor Layout
Product Flow
Reservoir Assembly Table
1 Pass of 3 Steps
6 Passes of 3 Steps Each CR VR
Lid Line Assembly Table
VR walking distance/day ≈ 6.6 miles
CR walking distance/day ≈ 1.5 miles
VR walking distance/day ≈ .5 miles
CR walking distance/day ≈ 0.3 miles

9. VR: Current State vs. Future
Future State
Time Saved: mostly due to table redesign and offline production
Walking Time seconds

10. VR Concepts Rotate lid assembly table and align it with Chemical Table
Redesign Chemical Table and “L” it with the assembly line
Design and manufacture additional jig
Take wings off jigs on table
Sensors on bins to force order
Reduce the 6.6 miles operator walks per day to about ½ mile (ergonomics, waste of time)
Removes full rotation movements (ergonomics, harmful factors, waste of time)
Cuts down cycle time to 32 seconds from 42 seconds (productivity, cycle time)
Sensors to reduce/eliminate chance of error (accuracy, reliability)
Establishes a better flow (waste of time, accessibility)
Reduces change over time (waste of time, productivity)

11. CR: Current State vs. Future State
Time Saved: 9.9 seconds reduced time through elimination of walking (moving caps) and addition of the chemical sensor.
Note: Increased VA time due to addition of inspection tasks

12. CR Concepts Move caps down to reservoir inspection
Time sensor for chemical dipping
Move CR cart closer to operator
Increase inspection duties
Eliminates walking down the line to the caps (waste of time, productivity, cycle time)
Reduces chemical dip time via a sensor system (accuracy, waste of time, reliability)
Pulls CRs faster (waste of time)
Aids in line balancing (cycle time)

13. Reservoir Inspection: Current State vs. Future State
Decreases walking time for CR (productivity, waste of time)
Effectively utilizes line balancing concepts
Reduction in Inspection Duties
Line Balancing: Additional responsibilities (placement of 6 more caps)

14. Proposed Floor Layout
Table at CR Station
Table at VR Station

15. Final VR Table Tricots Drainage cages Fume hood Small tubes
Large tubes
Small tubes
Jig
Position forcing tray

16. Preparation before Implementing
Risk Analysis
Met with a team of Terumo associates including engineering, upper management, quality manager, and manufacturing associates to assess risk via a Terumo Risk Analysis template.
Given GREEN light to go ahead
Update Standard Operating Procedures
Drafted changes to the SOP via text and pictures which was then reviewed and approved by Terumo

17. Implementation/Testing
Off-line implementation
Operator at Terumo tested the new set-up of VR table on manufacturing floor to make sure everything easy to reach and functions well.
Jig fit the lid
Ergonomics were ideal – little walking and did not have to reach far
Table took up smaller space
Eliminated waste of time
Minimal complexity and high convenience of use (operators were pleased)
Acceptable risk from Risk Analysis

18. Implementation/Testing
Parts were loaded into bins to test how much they hold.
Improvements:
Tricot and drainage cage bin sizes increased to increase capacity
Positioning adjustments made
Parts in bins
Current
Future
Large Tubes 60
110
Small Tubes 80
160
Drainage Cages 45 28
Tricots
100

19. Performance Metrics Metrics Target Values Actual Value
Accuracy of Manufacturing/Error Proof
100%
Determined in Path Forward
Harmful Factors
3 feet egress clearance, limit body rotation/twisting/reaching
3 ft. egress clearance met, eliminated rotations/twisting/reaching
Minimize Space
VR Table 3 ft or less, CR Table 2’ x 2’
VR Table 3’x 2.5’,
CR Table 2’ x 2’
Waste of Time
less than 20%, less than 1 mile/day walking
VR = 0.5 miles/day
CR= 0.3 miles/day, less than 20% waste achieved
Cycle Time
reduce by 4 sec (from 42 sec to 38)
Cycle Time in Path Forward expected to meet 38 sec requirement
Productivity
Increase of 675 units of oxygenators/week
675 units of oxygenators/week expected to be met in Path Forward
Risk
Score below 25 RPN (no mitigating action required)
Risk slightly increased but significantly under 25

20. Path Forward
Terumo will manufacture the new bins for the increased capacity and new arrangement.
Design can then be implemented on the line.
Additional time studies and spaghetti diagrams are recommended once implemented on the line.
Sensors will be implemented at a later date by Terumo.
Time data
Wasted time
Cycle time
Productivity
New spaghetti diagrams
Record any body rotations/twisting, quality improvements

21. Project Cost Item/Material Cost
CR Table
$411
VR Table
$468
Jig (block of Delrin)
$262
Sensors (2 sets)
$2,000 (about $1,000 each)
Plexiglas (for VR Chemical Hood and VR bins – includes duplicates of bins)
$400
Machine Shop- stainless steel plate
$220
Total
$3761
Note: Terumo will use their own Machine Shop to manufacture the jig and VR Chemical Hood. Team will use UD Machine Shop to manufacture bins.

22. $11,238,480 net gain/year Revenue Analysis 15 additional units/hour
30,960 additional units/year
$12,384,000 additional revenue/year
$1,145,520 additional material cost/year
$11,238,480 net gain/year

23. Project Summary
Lean manufacturing techniques such as VSM used to increase efficiency of manufacturing process
Improved ergonomics for operators
Maximized space used
Decreased cycle time
$11.2 million net gain/year

24. Questions?