Catheter Tube Assembly Process

1. Catheter Tube Assembly Process Team Members: Darren Brown Art Chandler Brian Tuchband

2. Project Introduction 3-Way Valve Assembled Catheter Tube Tube Mission Statement: Design a device to streamline the assembly process of the tube, TBV valve, and three-way valve. TBV Valve

3. Current Process

4. Current Process

5. Current Assembly Problems • Operators at multiple stations required for assembly • Incomplete assembly leads to product waste and loss of money • Repetitive motion injuries experienced by operators Carpal Tunnel Syndrome

6. Benefits of Automation • Cost Savings • Fewer operators are needed to assemble the product • Ergonomics • Repetitive motion injuries are significantly reduced through the use of automation • Productivity • Higher success rate leads to virtually no failed parts that need to be thrown away

7. Wants and Metrics Wants: Metrics:

8. Workstation Overview Cautionary Indicator Lights Hand Tie-Down Buttons Emergency Stop Buttons Tube Clamp Positioning Actuators Insertion Actuators Optical Sensors Pneumatic Valves 3-Way Jig Main Circuit Breaker TBV Jig 80/20 Frame

9. Process Description Step 4: Apply primer to both ends of the tube using a brush Step 11: Clamp opens to release the finished assembly Step 1: Insert the tube into the clamp Step 3: Insert the 3-way valve into its jig Step 13: Machine resets to the original position Step 2: Insert the TBV valve into its jig Step 8: Clamp closes on the tube Step 9: Insertion actuator inserts the TBV valve into the tube Step 7: Positioning actuator moves 3-way valve forward until sensor picks up the tube Step 6: Positioning actuator moves TBV valve forward until sensor picks up the tube Step 5: Place hands on hand tie-down buttons and press firmly to activate the machine Step 10: Insertion actuator inserts the 3-way valve into the tube Step 12: Remove the finished assembly

10. Machine Demonstration Success!

11. Prototype Development

12. Prototype Development

13. Level of Automation • Full Automation vs. Semi-Automation • High cost and intricacy of a fully automated system such as a robot would not be worth the minor advantages it offers over a semi-automated approach • With our semi-automated system, we can achieve ergonomic and productivity benefits at a much lower cost • Remaining non-automated tasks do not pose any risk to operator safety

14. System Validation

15. Setup Time Validation • Setup Time: The amount of time the operator interfaces with the machine before the automated process begins. • Using a stop watch, we measured the actual time needed to complete the following steps: • Procedure • Insert TBV valve and 3-way valve into their respective jigs. • Insert the tube into the tube clamp. • Apply primer to both ends of the tube using a brush. • Place both hands on hand tie-down buttons and press down.

16. Setup Time Validation Sample Size = 30 Average Setup Time = 11 seconds Exceeds Target Value

17. Cycle Time Validation • Cycle Time: The time required to make one unit of product. • Using a stop watch, we determined the cycle time of the machine assembly process.

18. Cycle Time Validation Sample Size = 30 Average Cycle Time = 23 seconds Time (Seconds) Exceeds Target Value

19. Success Rate Validation Success Rate: The percentage of assembled products that pass the specifications of Terumo Medical (within 1mm of valve socket) Using 40 samples, we determined how many products passed. FAIL PASS Buckling Point 2mm Gap Between Tube End and Socket Tube reached all the way to end of Socket

20. Success Rate Validation # of successful assemblies total # of assemblies Success Rate = x 100% Sample Size = 40 Mode of Failure: Tube Insertion Depth Not Sufficient Fails to meet Target Value: 98%

21. Price Validation • Price: The amount of money it takes to build a production machine. • Final cost is calculated from the actual cost of the prototype in addition to the estimated costs of the hand-off components: • Glue Dispenser • Air Blow-Off

22. Project Budget = Acquired from Terumo Medical Meets Target Value

23. Safeguards Validation • Safeguards: The number of devices incorporated into the design of the machine to protect the operator. • Safeguards Included: • 2 Locking Emergency Stop Buttons • 2 Hand Tie-Down Buttons • Cautionary Indicator Lights Exceeds Target Value

24. Path Forward • Success Rate Deficiency Correction • System Fabrication • Air Blow-Off • Glue Dispensing • In-House Qualification Testing • Installation Qualification • Operation Qualification • Process Qualification • Operator Training • Place System into Production

25. Success Rate Deficiency • Possible causes for failure: • Not enough insertion force • Clamp does not grip well enough • Insufficient primer application • Suggestions to improve success rate: • Use higher pressure air system • Optimize PLC code • Automate primer application process • Optimize flow control fittings • Redesign clamp (silicon coating, split-clamp design)

26. The Next Step • Air Blow-Off Process • Air will be sent into the three-way valve at a high velocity to remove excess primer • Implemented through the addition of small pneumatic hose and spring-return valve • Controlled by the PLC • Estimated cost: $80 • Glue Dispensing Process • Precision Dispensing System for Cyanoacrylate Adhesives • Developed and sold by EFD, Inc. • Precise material deposition improves bond strength by applying the correct amount of material to parts • Rejects are reduced and product appearance is improved • Controlled by the PLC • Estimated cost: $5,400

27. Questions