1. Team West Pharmaceutical Services Sponsors: Reginald Motley and Chris Evans Advisor: Dr. Singh BMEG: Ryan O’Boyle, Madison DeFrank, and Derek Hunter MEEG: Hayley Shaw and Kailey Nelson BMEG450/MEEG401 12/11/13

2. Background 1 Pharmaceutical Packaging Systems 2012 Revenue: $915million Market Leader Global Manufacturing Innovative and Proven Product Portfolio Pharmaceutical Delivery Systems 2012 Revenue: $352 million Proprietary Devices/ Delivery System Technologies Collaborative Development Contract Manufacturing DevelopmentPrimary PackageAdministrationPatient 12/11/13

3. Motivation West hopes to expand their product line to include a range of products that are reusable. This would reduce wastes and overall costs 2 To research and develop a novel drive mechanism that can be reset and move a piston in a 1 mL syringe for dispensing of liquid Scope 12/11/13

4. Product Line 3 Confidose Disposable Spring, motor, manually driven Easy to use At home use Not on market yet SmartDose SelfDose 12/11/13

5. Benchmarking Competing Products Unilife LISA Auto-injector System BD Pen II Reusable Pen Cambridge Consultants Flexi-Ject Auto-injector 4 12/11/13

6. Design Requirements 5 12/11/13

7. 6 FINAL CONCEPT: Shape Memory Alloy FINAL CONCEPT: Shape Memory Alloy Round 2 Neodymium Magnets Chemical Reaction Coil Wire/ Electromagnetic Force Round 2 Neodymium Magnets Chemical Reaction Coil Wire/ Electromagnetic Force Round 1 Shape Memory Alloy Soft Metal Alloy Flat Coil Spring Motor Driven Hydraulic Component Round 1 Shape Memory Alloy Soft Metal Alloy Flat Coil Spring Motor Driven Hydraulic Component Top 2 Concepts Shape Memory Alloy Neodymium Magnets Top 2 Concepts Shape Memory Alloy Neodymium Magnets Concept Generation 12/11/13

8. Shape Memory Alloy Deformable alloy material Returns to original shape when heated Nitinol = nickel + titanium Transition temperature is 70-80 o C Nitinol springs used as driving force 7 12/11/13

9. Nitinol Spring Video 8 12/11/13

10. Preliminary Testing 1 Spring tested Two different vendors Spring displacement held constant 9 Spring 2: Conclusion: Spring 2 provides a more cost effective solution. Spring 1: 12/11/13

11. 10 Final Prototype Syringe Toggle Switch Battery Pack Drive Mechanism 12/11/13

12. Design Overview Lined with heat shielding tape Fiberglass tape shields 260 o C Foil tape reflects 815 o C 8 stretchable Nitinol springs 11.1 V battery pack 3.5 A through each spring High-amp toggle switch 11 Top Platform Nitinol Springs Plunger Rod Bottom Platform Syringe Inner Assembly 12/11/13

13. Design Overview 12 Prefilled syringe inserted through bottom platform Locking platform secures syringe Springs supply up to 16.9 lb force Can be reset to prepare for new injection New syringe inserted after injection Top Casing Inner Assembly External Casing Locking Platform Syringe Outer Assembly 12/11/13

14. Validation Testing 13 Observational Testing 12/11/13

15. 14 Validation Testing Experimental Testing 12/11/13

16. Cost Analysis 15 Purchased Parts Prototype Cost (per unit) 46.6% of Budget Spent 12/11/13

17. Path Forward 16 Optimize force generated: use Nitinol springs of different composition Use ultra-capacitors in order to eliminate the need for a large battery Coating in heat shielding material during manufacturing stages Downsizing the system to maximize compactness Incorporate automatic shut off system o Increase safety o Decrease spring fatigue. 12/11/13

18. 17 Thank you! Questions? 12/11/13

19. 18 Delrin Polyoxymethylene (Acetel) Resin Melting point = 175 o C Can be injection molded Manufacturing Cost Per Unit (1000 units made) 56.1% Decrease! 12/11/13

20. Stress Analysis 19 Applied Force: 10 lbs Applied Force: 18 lbs

21. Viscosity Testing 20

22. Failure Testing 21 A trial was deemed a failure if a full dose of liquid was not dispensed or heat of the springs produced visible smoke.

23. Magnet Concept 22 Magnets were very difficult to work with Preliminary testing showed that concept was unable to displace plunger of an empty syringe

24. Magnet Testing 1 23

25. 24 Magnet Testing 2

26. Concept Generation Round 1 25 Shape Memory Alloy Soft Metal Alloy Motor Driven Flat Coil Spring Hydraulic Component

27. Concept Selection Round 1 26 Winning Concept = Shape Memory Alloy!

28. Concept Generation Round 2 27 Chemical Reactions o Potassium Chlorate + Sugar Magnet Gun Solenoid Coil Gun

29. Concept Selection Round 2 28 Winning Concept = Magnet Concept!

30. Current Optimization 29

31. Working Prototype 30