Marcos Esterman, Associate ProfessorIndustrial and Systems Engineering DepartmentRochester Institute of Technologymarcos.esterman@rit.edu

Multidisciplinary Senior Design I

Problem Definition Review Preparation

Agenda

Questions to be Answered by the Problem Review

Goals of the Problem Definition Review Mechanics of the Review

An Example

Questions to be Answered What is the current state and why is it unacceptable? What does the desired state look like? Who are the stakeholders that benefit from the desired state? What are those benefits (can be qualitative or quantitative)? What stakeholders can be negatively impacted by the desired state? What are the limits of those negative impacts (can be qualitative or

quantitative)? How will your system be used by stakeholders? What are quantifiable responses (engineering requirements) that

your system must produce? Do you have a project plan (objectives, key milestones,

responsibilities) that your team, Guide, and Customer agree to? What are some systems that already do (or are similar to) what you

want to do? How do these (similar) systems compare to the desired state? What

can you learn/borrow from them? Where should they be improved?

Goals of the Problem Definition Review Demonstrate that your team can answer the questions

posed by: Clearly defined and agreed upon problem statement & project

deliverables Prioritized list of Customer requirements Engineering requirements Use scenarios Draft of project plan

Identify any gaps that exist between your ability to meet the above goal and your actual state Be honest (Don’t try to BS) Show your action plan to close gap by next review

MECHANICS OF THE REVIEW

Marcos Esterman, Associate ProfessorIndustrial and Systems Engineering DepartmentRochester Institute of Technologymarcos.esterman@rit.edu

Daniel FentonKennedy KongMarie RevekantDavid EngellEric Welch

P13026: Portable Ventilator

Derek ZielinskiChris FreemanMelissa HarrisonRyan MuckelRoberto Castilla Zavala

Agenda

Introduce Team Project Background Problem statement & project deliverables Use scenarios Prioritized list of needs (customer rqmts) Engineering requirements Draft of project plan

Team Introduction & Roles

Member Role

Daniel Fenton Team Lead

Kennedy Kong Computer Engineer

David Engell Industrial Designer

Marie Revekant Industrial & Systems

Engineer

Eric Welch Electrical Engineer

Derek Zielinski Electrical Engineer

Christopher Freeman Mechanical Engineer

Melissa Harrison Mechanical Engineer

Ryan Muckel Mechanical Engineer

Current Product- Mediresp III Provide positive pressure ventilation 3 modes:

CMV (constant mandatory ventilation) Assist CPR

Manual Large and heavy 2-4 hour battery life FDA approval Patented Contains BVM backup

What is a PEV?

A Portable Emergency Ventilator (PEV) is a device that can provide mechanical ventilation to a person who is incapable of breathing on their own Volume controlled Pressure controlled Spontaneously controlled Negative pressure controlled

PEV Theory of OperationPressure controlled cycling is based on an applied positive pressure that is set by the clinician. In pressure controlled modes the total volume is variable as the ventilator is using only the pressure as a measurement for cycling.

P13026 Problem Statement Current State

A prototype was developed in 1990 that is too heavy, consumes to much energy and is not easy to use.

Desired State The device should not interfere with first responders’ abilities to administer life-saving

measures. A functional prototype which can be marketed to companies and ultimately be

manufactured Project Goals

Analyze the current design and the patent database Identify opportunities

lighter more energy efficient easier to use more feedback and control to the user

Constraints Consistent with the intellectual property and FDA approvals

Additional Project Deliverables Functional prototype which can be marketed to

companies and can be the basis for a product that will ultimately be manufactured

Appropriate design, test, manufacturing and supply chain documentation to support transition to a manufactured product

Test data verifying correct operation Designs alternatives

Other possible configurations Other possible use environments

User’s guide for operation

P13026 Stakeholders

14

First Responders Hospitals

Doctor

Inventors

MSD Team

Use Scenarios Considered

Scenario 1: Unresponsive patient, heart beating but not breathing – PEV assist and transport to hospital

Scenario 2: Unresponsive patient, heart beating but not breathing – PEV assist and administer life-saving measure X

Scenario 3: Unresponsive patient, heart not beating and not breathing – PEV assist and CPR

Unresponsive patient, heart beating but not breathing

Unresponsive patient, heart beating but not breathing

By-S

tand

erPa

tient

Firs

t Re

spon

der

911

Hosp

ital

Phase

Stops Breathing

Notices Patient Calls 911

Checks PatientsAirway

Dispatches 1st Responder

Drives to Patient

Checks PatientsAirwayIs

Clear?

Yes

Clears AirwayNo

Is Breathing? Starts CPR

Preps PEV

Relieves By-

Stander

Stops CPR

Set Up PEV

Administer to Patient

Load Patient in

Ambulance

Transport Patient

Transfer Patient to Hospital

Treat Patient

Patient Goes Home

P13026 Needs ListNeed Priority

Have a modern look and feel  3Is Light weight  3Is Small  3Is Easy to Use  9Has Long-Lasting Portable Power  9Low Cost Functional Prototype  3Low UMC for Final Design  9Alert user of the following data: XXX  9Measure Oxygen Levels  3Measure CO2 Levels  3Transfer Data Wirelessly  9Assist Human to Breathe  9Integrates into CPR Process  9

Does not interfere with the following life-saving measures: XXX  9Improves air quality delivered to patient  9Is safe  9Is reliable  9

Needs to use principles in patents #5,211,170 and # 5,398,676  9Needs to be consistent with FDA 510K Approval  9

Need Priority Brea

thin

g Ra

te

Flow

Vol

ume

Rang

e

Peak

Flo

w R

ate

Flow

Vol

ume

Set P

oint

Acc

urac

y

Air A

ssist

Sen

sitivi

ty

Bloo

d O

xyge

n Le

vel

Ope

ratio

n Te

mpe

ratu

re R

ange

Syst

em V

olum

e En

velo

pe

Wei

ght

90%

of U

ser fi

nd V

isual

ly A

ppea

ling

Succ

essf

ully

Pas

ses U

sabi

lity

Testi

ng (T

BD)

Prot

otyp

e Co

st

Uni

t Man

ufac

turin

g Co

st

Indi

vidu

al li

st o

f dat

a to

be

Mea

sure

d

Data

Tra

nsfe

r Rel

iabi

lity

to X

XX d

evic

e(s)

Air C

onta

min

ants

Adhe

res t

o an

d Pa

sses

UL/

FDA

Testi

ng

Inte

grat

es P

aten

t Prin

cipl

es

Inte

grat

es F

DA A

ppro

val

Have a modern look and feel 3 xIs Light weight 3 x xIs Small 3 xIs Easy to Use 9 xHas Long-Lasting Portable Power 9Low Cost Functional Prototype 3 x xLow UMC for Final Design 9 xAlert user of the following data: XXX 9 xMeasure Oxygen Levels 3 xMeasure CO2 Levels 3Transfer Data Wirelessly 9 xAssist Human to Breathe 9 x x x x xIntegrates into CPR Process 9 xDoes not interfere with the following life-saving measures: XXX 9 xImproves air quality delivered to patient 9 xIs safe 9 xIs reliable 9 x xNeeds to use principles in patents #5,211,170 and # 5,398,676 9 xNeeds to be consistent with FDA 510K Approval 9 x

Mea

sure

Brea

ths/

Min

Lite

rs

Lite

rs/m

in

cm H

20

% B

lood

C cm3

kg

Bina

ry A

esth

etic

Test

Bina

ry o

r Mor

e Fo

rmal

$$ $$

Bina

ry

Bits

Los

t/To

tal B

its D

esire

d to

be

Tra

nsfe

rred

Part

s per

Mill

ion

Bina

ry

Bina

ry

Bina

ry

Engineering Requirements

Key Performance Metrics

P13026 Engineering Requirements

Engineering Requirement Measure Target Value Acceptable ValueBreathing Rate Breaths/MinFlow Volume Range LitersPeak Flow Rate Liters/minFlow Volume Set Point Accuracy % of desired valueAir Assist Sensitivity cm H20Blood Oxygen Level % Blood Operation Temperature Range CSystem Volume Envelope cm3Weight kg90% of User find Visually Appealing Binary Aesthetic TestSuccessfully Passes Usability Testing (TBD) Binary or More FormalPrototype Cost $$Unit Manufacturing Cost $$Individual list of data to be Measured BinaryData Transfer Reliability to XXX device(s) Bits Lost/Total Bits Desired to be TransferredAir Contaminants Parts per MillionAdheres to and Passes UL/FDA Testing BinaryIntegrates Patent Principles Binary

Binary

P13026 Preliminary Schedule

P13026 Preliminary Schedule

Issue & Corrective Actions

Please highlight any gaps Identify action plans to close them