Transcript Final Presentation - University of Pittsburgh

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
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 selfadminister, 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
Breaking:
Personal
Injury
Needle
Bending:
Incorrect
Insulin Dose
Risk of
Liability
Vision
Problems
lead to
incorrect
type of
insulin
Company
does not
provide
proper use
instructions
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 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.
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 preset dosage guide
• Only good for syringes
• $11.25
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 springloaded 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?
Guide stabilizes
needle nearly
removing all
risk of
breaking
Stabilization of
needle decreases
amount of
bending,
ensuring correct
dose
Decreased
Risk of
Liability
Color coded
product allows
those with vision
problems
to determine
correct type
Proper use
directions
included with
product
Distribution of Responsibilities
Summer
Ryan
Justin
Market Analysis
•
•
Design
•
Manufacturing
•
•
Testing
Liability
•
•
Clinical Liaison
•
PDS
•
FMEA/Fault Tree
Business Plan
Human Factors
Mike
•
•
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