TEAM LEADER : DANIEL FENTONKENNEDY KONGMARIE REVEKANTDAVID ENGELLERIC WELCHDEREK ZIELINSKICHRIS FREEMANMELISSA HARRISONRYAN MUCKELROBERTO CASTILLO ZAVALA

P13026: PORTABLE VENTILATOR

OVERVIEWProject SummaryCustomer SpecsEngineering Specs

• Market ComparisonHOQ/ QFD Relationship DiagramSystem Block DiagramFunctional DecompositionComponent BreakdownRisk AssessmentBenchmarking

• Market• EMT Products

Proposed Packaging Designs

PROJECT SUMMARY

PROJECT SCOPETeam Composition

3 Mechanical Engineers

2 Electrical Engineers

2 Computer Engineers

1 Industrial Engineer

1 Industrial Designer

1 Business Guru

CustomerJeff GuttermanRoman Press

Faculty MentorEdward Hanzlik

Project Objective: Redesign the Mediresp III update technical components and packaging to be contemporary.

Budget: $1000Market Release: 2015 (18 – 24 months)

Who:

What:

When: How much:

CURRENT PRODUCT- MEDIRESP III

Provide positive pressure ventilation4 modes:

• CMV (constant mandatory ventilation)

• Assist• CPR• Manual

Large and heavy2-4 hour battery lifeFDA approvalPatentedContains BVM backup

PROPOSED REDESIGNUpdates:

• Electronic controls (decrease size/more options)• Smaller pump• Reliable and smaller battery

Additions:• Ability to monitor and record vitals• Pulse oximeter feedback• Voice alerts/instructions• Carbon dioxide sensor

CUSTOMER SPECIFICATIONS

Customer Need #

Importance Description Comments/Status

CN1 3 Design SimilarlyThe design of an updated version of the PEV that remains "substantially equivalent" to the design which received FDA 510(k) approval to manufacture and market

CN2 3 Maintain PortabilityPortable based on digital electronics, preferably on microprocessor, minimize weight and size

CN3 3 Include Audio Feedback Gives non-visual, non-Braille instructions/feedbackCN4 3 Optimize Battery Life Operates for a minimum of 2 hours without rechargingCN5 3 Replaceable battery Battery is easily replacedCN6 3 Minimize Expenses Parts cost <1000$

CN7 3 Display Relevant DataShow information that will be necessary for customers to operate the ventillator on the front panel

CN8 2 Measure Oxygen Levels Add a pulse oximeterCN9 2 Measure CO2 Levels Measure CO2 levels on expirationCN10 1 Transfer Data Wirelessly Record and send data using bluetooth

Importance Weight: 3 = Must Have, 2 = Nice to Have, 1 = Preference Only

ENGINEERING SPECIFICATIONS

Portable Emergency Ventilator

Engineering Specifications - Revision 2 - 12/21/12

Specification Number Importance Source Function Specification (Metric) Unit of Measure Target Value Accuracy Comments / Status

S1 3 CN1 System Operation Volume Control Liters 0.2 - 1.2 Pending Market Analysis

S2 3 CN1 System Operation Breathing Rate BPM, Breaths per Minute 4 -15 Pending Market Analysis

S3 3 CN1 System Operation Peak Flow Liter/Min 15 - 60 Pending Market Analysis

S4 3 CN1 System Operation Air Assist Senitivity cm H20 0.5 - 1.5

S5 3 CN1 System Safety High Pressure Alarm cm H20 10 - 70

S6 3 CN1 System Operation DC Input Volts 6 - 16

S7 3 CN1 System Operation DC Internal Battery Volts 12 Pending Market Analysis

S8 3 CN4 System Operation Battery Operation Time Hours 2

S9 3 PRP System Safety Elasped Time Meter Hours 0 - 8000

S10 3 PRP System Longevity Pump Life Hours 8000

S11 3 PRP System Safety Secondary Pressure Relief cm H20 75

S12 3 PRP System Safety Timed Backup BPM

S13 2 CN8 System Operation Blood Oxygen Level % ±2

S14 2 CN9 System Operation Expiration CO2 %

S15 2 System Robustness Operational Temperature Degrees Fahrenheit

S16 2 CN2 System Portability Dimensions Inches Pending Market Analysis

S17 3 CN2 System Portability Weight Kg Pending Market Analysis

S18 2 System Robustness Drop Height Feet 4

Importance Weight: 3 = Must Have, 2 = Nice to Have, 1 = Preference Only

MARKET COMPARISONCurrent Market Comparison

Gas Operated Products

Compressor ProductsSpecification

Number Specification Unit of Measure Target Value

S1 Volume Control Liters 0.2 - 1.2 0.15 - 1.30 0.10 - 2.00S2 Breathing Rate BPM, Breaths per Minute 4 -15 8 -25 5 - 40S3 Peak Flow Liter/Min 15 - 60 8 - 35 5 - 60

S4 Air Assist Senitivity cm H20 0.5 - 1.5 - -

S5 High Pressure Alarm cm H20 10 - 70 60 up to 100S6 DC Input Volts 6 - 16 - S7 DC Internal Battery Volts 12 - 12S8 Battery Operation Time Hours 2 - 3 - 5S9 Elasped Time Meter Hours 0 - 8000 - -S10 Pump Life Hours 8000 - -

S11 Secondary Pressure Relief cm H20 75 - -S12 Timed Backup BPM Seconds - -S13 Blood Oxygen Level % - -S14 Expiration CO2 % - -S15 Operational Temperature Degrees Fahrenheit 0 -120 0 -120S16 Dimensions - -S17 Weight Kg ~ .5 4 - 8S18 Drop Height Feet 4 - -

HOQ/ QFD RELATIONSHIP DIAGRAM

SYSTEM BLOCK DIAGRAM

FUNCTIONAL DECOMPOSITION

TOP LEVEL FUNCTIONS

PROVIDE POWER FUNCTIONS

ASSIST USER FUNCTIONS

CIRCULATE AIR FUNCTIONS

MONITOR PHYSIOLOGICAL DATA FUNCTIONS

COMPONENT BREAKDOWNFunctions Solutions

Solar PanelsHand CrankFusionArc Reactor110 ACCar Battery3-phaseBattery (12V)Hamster WheelWind TurbineCapacitor (Big ones)AA Batteries ButtonsKnobsTouch ScreenVoice ActivationJARVIS (Iron Man)SwitchesClick Wheel

External Power

Internal Power

User Interface

Functions SolutionsLCDLEDE-InkChalkboardAnalog DialsParrotBeeps/BuzzesSpeech AlertsLightsSystem ShutdownVibration ResponseFanPumpCompressed TankBellow Mouth to Ventilator to MouthWind flowStraw

Displays Values

Alerts

Intake Air/Transport Air to

Patient

COMPONENT BREAKDOWN CONT’DFunctions Solutions

Coffee FilterOne Time useBio-FilterMagic One Way ValveCount particles SensorsBarometerCondensation Quality LevelSensorsManuallyPulse Oximeter Flame TestBlood Tests3.5 FloppiesUSBPaper/PenKeyboard InputVoice to TextMemory(Human)Internal System MemorySSD

Prevent Contamination

Monitor Air

Monitor Physiological Data

Recording Data

RISK ASSESSMENT

Severity Scale: 1 = Not Severe 2 = Moderately Severe 3 = Very SevereLikelihood Scale: 1 = Not Likely 2 = Conceivable 3 = Very LikelyImportance= likelihood* severity

Risk Item Effect Cause

Likelihood

Severity

Importance Action to Minimize Risk Owner

Date of Completion

1over heating

damaged components; total system failure

electronic components; environment; mis-use; upkeep

2 3 6 basic thermal analysis; provide safety cautions Dan week 9- MSD1

2Integration of hardware and software together

non-workable prototype

using devices from different companies that don't function together

2 2 4

plan and read specs on all technical components; test components compatability Derek week 9- MSD1

3inputs do not match outputs

failing to meet FDA requirements

programing and calibration errors

2 1 2quality testing of design

Chris/ Kennedy MSD2

4battery integration in system

underperforming; fire hazard

battery failure; not meeting engineering specs

1 2 2check with experts on how to manage battery functionality Eric MSD2

5 Durability failure

components breaking; failure of system

components malfunctioning during usage

2 3 6perform vibration testing; perform environmental testing Ryan MSD2

Tech Concerns

6

Over budget

cannot build a working prototype that looks like vision

necessary parts more expensive than budget leaving not enough money for aesthetics

3 3 9

perform cost analysis; utilize resourcefulness; properly plan so things can be done right the first time Marie week 9- MSD1

7uncoordinated team schedule

late completetion of deliverables; lack of team unity

conflicting schedules and desired meeting times

2 3 6

constant communication; survey of wekkly available time Dan

8 late delivery of parts

modification to design schedule; miss deadlines

lack of planning; problems with vendors

1 2 2order parts ahead of time; expedite when necessary Melissa week 5- MSD2

9

Remaining substantially equivalent with current design

design that is not capable with FDA approval

changing the current design drastically beyond the FDA approved design

1 3 3make sure any major changes to design are validated with client Chris week 9- MSD1

10conflicts with customer

more budget needed; change design schedule

change in market; change in design plans; change in prospective

2 2 4

team members should maintain open communication with client; relevant market research Dave week 5- MSD1

11product does not match consumer needs not profitable

not meeting FDA requirments; not meeting trends

2 3 6

benchmarking research Roberto

Project Concerns

BENCHMARKING

CUSTOMERSFirst Responders:

• EMT, FirefightersHospitalsHome Care

• Cancer and respiratory problem patientsNursing HomeIndividual Volunteers assisting in response activities

CUSTOMER PSYCHOGRAPHICSCustomers wants to transport a critical ill or injured patient in an array of situations in compliance with the ABCs of intensive care and collecting and sharing data efficiently.

The situations could be defined as:• Safe intra-hospital transport• From the hospital to home care• From an accident location the closest medical center

MARKET TRENDSMarket for portable ventilator:

• 2009: $1.2 billion• 2016: $2.5 billion

Categories of markets:• Alternate care• Critical care• Home Care• Transport

PORTABLE VENTILATOR MARKET LEADERS

OTHER PARTICIPANTS

Pneupac® paraPA by Smiths Medical CAREvent by O-Two Medical Technologies In.

Autovent 4000 W/CPAP by Progressive MEd

CURRENT VENTILATORS FOR EMT’S CONT’D

PROPOSED PACKAGING DESIGNS

QUESTIONS