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
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

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

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

Decreasing Risk
Needle
Bending:
Incorrect
Insulin Dose
Vision
Problems
lead to
incorrect
type of
insulin
Company
does not
provide
proper use
instructions
Needle
Breaking:
Personal
Injury
Risk of
Liability
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

Market Information contd
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.


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
FDA Regulation
TITLE 21--FOOD AND DRUGS
CHAPTER IFOOD 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
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
Design Version 1
Design Version 2
Slimmer, more compact
Reduced base diameter
Stoppers added to
prevent components of
device from separating
Tracks modified to
ensure proper
movement
Design Version 3
Base widened to
allow fingers to hold
in place
Outer sleeve
lengthened to
ensure adequate
clearance for
needles
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

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

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
Future Modification
Needle loading mount
Needle modification
Injection assist
Injectease
Ability to work with Syringes
Manufacture two separate models
Success?
Stabilization of
needle decreases
amount of
bending,
ensuring correct
dose
Color coded
product allows
those with vision
problems
to determine
correct type
Proper use
directions
included with
product
Guide stabilizes
needle nearly
removing all
risk of
breaking
Decreased
Risk of
Liability
Distribution of Responsibilities
Summer Ryan Justin Mike
Market Analysis
Design
Manufacturing
Testing
Liability
Clinical Liaison
PDS
FMEA/Fault Tree
Business Plan
Human Factors

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

Thank You