presentation - insulin injection guide
TRANSCRIPT
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Insulin Injection Guide
University of PittsburghSenior DesignBioE 1160/1161
Summer KostelnikRyan Pitman
Justin Redpath
Mike Strahota
April 18, 2006
Mentor: Monica DiNardo,
MSN CRNP CDE
UPMC
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Liability
Contract Relates to the
sale of a product
Tort Wrongful act or a
failure toexercise due
care resulting ininjury Suit in tort
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Product Liability Actions
Design Liabilities are based on:1.Concealed danger created by the design2.Needed safety devices have not been
included in the design3.Design involved materials of inadequate
strength4.Designer failed to consider possible unsafe
condition due to abuse or misuse of the
product which were reasonably foreseeable
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Application
MAUDE FDA database of adverse events
involving medical devices
14 broken needle cases in the pastyear Incorrect handling
Design Liabilities
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Problem Statement
Insulin injections can be difficult to self-administer, especially for elderly patients
Risks include tissue trauma, needlebending, and needle breakage
Design a device that will make injectionseasier, while reducing associated risks
http://www.diabetesmonitor.com/gifs/optipen.jpg -
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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
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Market Information
700,000 Type 1patients and 1.2million Type 2patients requireinsulin Injection sites
Costs due to diabetesaccount for 25% ofMedicare expenses(~$70 billion)
Diabetes deliverydevice market U.S. : $325 million in
1999, up from $208million in 1997
Europe: $409 million
in 2000
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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.
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Predicate Device
Inject-Assist By placing a needle and
bottle into this plastic mold,the bottle is securely heldin place, so no more
broken needles. The InjectAssist securesthe syringe in place leavingthe plunger free to set anaccurate dose with a pre-set dosage guide
Only good for syringes $11.25
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FDA Regulation
TITLE 21--FOOD AND DRUGSCHAPTER IFOOD AND DRUG ADMINISTRATION DEPARTMENT
OF HEALTH AND HUMAN SERVICESPART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICESSubpart G--General Hospital and Personal Use Miscellaneous DevicesSec. 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 apredetermined 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
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Design Requirements
Stabilize pen to limitneedle movement Not too bulky Fit on pen securely
Does not interferewith cap Does not obscure
dosage window
Allow adequateclearance and rangeof movement forinjection
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Design Version 1
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Design Version 2
Slimmer, more compact
Reduced base diameter
Stoppers added toprevent components ofdevice from separating
Tracks modified toensure propermovement
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Design Version 3
Base widened toallow fingers to holdin place
Outer sleevelengthened toensure adequate
clearance forneedles
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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
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Initial Feedback
Major Concerns
Who was the target user?
Is the device too bulky?
Can it be used with multiplepens/syringes?
Is there a need for the device?
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Surveys
Unable to perform due to IRB and HIPPAregulations
Met and discussed the device withnumerous nurses and diabetes educators
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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 combatingDiabetes
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Meetings with Clinicians
Issues remaining
Functionality of device
What else could it do?
Does the device only solve secondaryissues?
Needle loading, strength needed forinjection
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Future Modification
Needle loading mount
Needle modification
Injection assist
Injectease
Ability to work with Syringes
Manufacture two separate models
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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
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Distribution of ResponsibilitiesSummer Ryan Justin Mike
Market Analysis
Design
Manufacturing
Testing
Liability
Clinical Liaison
PDS
FMEA/Fault Tree
Business Plan
Human Factors
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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
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Thank You