Presentation - Insulin Injection Guide

8/12/2019 Presentation - Insulin Injection Guide

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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

Documents

Presentation - Insulin Injection Guide