1. University of Pittsburgh Senior Design – BioE 1160/1161 Insulin Injection Guide Summer Kostelnik Ryan Pitman Justin Redpath Mike Strahota April 18, 2006 Mentor: Monica DiNardo, MSN CRNP CDE UPMC

2. Liability • Contract • Relates to the sale of a product • Tort • Wrongful act or a failure to exercise due care resulting in injury • Suit in tort

3. Product Liability Actions • Design Liabilities are based on: • Concealed danger created by the design • Needed safety devices have not been included in the design • Design involved materials of inadequate strength • Designer failed to consider possible unsafe condition due to abuse or misuse of the product which were ‘reasonably foreseeable’

4. Application • MAUDE • FDA database of adverse events involving medical devices • 14 broken needle cases in the past year • Incorrect handling • Design Liabilities

5. Problem Statement • Insulin injections can be difficult to self-administer, especially for elderly patients • Risks include tissue trauma, needle bending, and needle breakage • Design a device that will make injections easier, while reducing associated risks

6. Decreasing Risk

7. 700,000 Type 1 patients and 1.2 million Type 2 patients require insulin Injection sites Costs due to diabetes account for 25% of Medicare expenses (~$70 billion) Diabetes delivery device market U.S. : $325 million in 1999, up from $208 million in 1997 Europe: $409 million in 2000 Market Information

8. Market Information cont’d • 3 delivery modes: syringe, pen, pump • Syringe: $10 for 100 • Pen: $60 for five • Pump: $5200 • Syringes and pumps dominate U.S. market • Pens and pumps dominate European market • Difference driven by respective nature of health care systems, familiarity of syringes in U.S.

9. Predicate Device • Inject-Assist • By placing a needle and bottle into this plastic mold, the bottle is securely held in place, so no more broken needles. • The InjectAssist secures the syringe in place leaving the plunger free to set an accurate dose with a pre-set dosage guide • Only good for syringes • $11.25

10. FDA Regulation TITLE 21--FOOD AND DRUGS CHAPTER I—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES Subpart G--General Hospital and Personal Use Miscellaneous Devices Sec. 880.6920 Syringe needle introducer (a) Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface. (b) Classification. Class II (performance standards). US Food and Drug Administration: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=870.2700

11. Design Requirements • Stabilize pen to limit needle movement • Not too bulky • Fit on pen securely • Does not interfere with cap • Does not obscure dosage window • Allow adequate clearance and range of movement for injection

12. Design Version 1

13. Design Version 2 • Slimmer, more compact • Reduced base diameter • Stoppers added to prevent components of device from separating • Tracks modified to ensure proper movement

14. Design Version 3 • Base widened to allow fingers to hold in place • Outer sleeve lengthened to ensure adequate clearance for needles

15. Manufacturing • Prototype Manufactured • Swanson Center for Product Innovation • Stereo lithography • Liquid DSM ® SOMOS 11120 WaterShed Polymer • Manufacturing • Injection Molded Polystyrene • Human Factors • Different colors • Different types of insulin

16. Initial Feedback • Major Concerns • Who was the target user? • Is the device too bulky? • Can it be used with multiple pens/syringes? • Is there a need for the device?

17. Surveys • Unable to perform due to IRB and HIPPA regulations • Met and discussed the device with numerous nurses and diabetes educators

18. Meetings with Clinicians Device was well-accepted • User - Peripheral neuropathy, stroke, amputees, arthritis… • Size - Secondary issue • Use - Pre-filled syringes • Need - Real • Had reports of patients bending the needles • Aggressive therapy is key for combating Diabetes

19. Meetings with Clinicians Issues remaining • Functionality of device • What else could it do? • Does the device only solve secondary issues? • Needle loading, strength needed for injection…

20. Future Modification • Needle loading mount • Needle modification • Injection assist • Injectease • Ability to work with Syringes • Manufacture two separate models

21. Success? Easier Injections

22. Distribution of Responsibilities

23. Acknowledgements • Monica DiNardo, MSN CRNP CDE • Swanson Center for Product Innovation • Bioengineering Department • Pittsburgh Life Sciences Greenhouse • A generous donation from Drs. Hal Wrigley and Linda Baker

24. Thank You