1. Insulin Injection Guide University of Pittsburgh Senior Design – BioE 1160/1161 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: 1.Concealed danger created by the design 2.Needed safety devices have not been included in the design 3.Design involved materials of inadequate strength 4.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 Risk of Liability Needle Breaking: Personal Injury Company does not provide proper use instructions Vision Problems lead to incorrect type of insulin Needle Bending: Incorrect Insulin Dose

7. Market Information 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

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? Decreased Risk of Liability Guide stabilizes needle nearly removing all risk of breaking Proper use directions included with product Color coded product allows those with vision problems to determine correct type Stabilization of needle decreases amount of bending, ensuring correct dose

22. Distribution of Responsibilities SummerRyanJustinMike Market Analysis Design Manufacturing Testing Liability Clinical Liaison PDS FMEA/Fault Tree Business Plan Human Factors

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