CoVent-19 Challenge and Ximedica Overviewinfo.grabcad.com/rs/008-JLC-434/images/CoVent_Design_Brief...

CoVent-19ChallengeandXimedica

24MAR2020

Overview

30 MARCH 2020 2COVENT-19 + XIMEDICA

Goalandchallengeoverview

Immersion§ VentilatorWorkflowOverview§ COVENTSystemArchitecture§ Requirementstable§ Designguidelines

Overview

CONFIDENTIAL | 31 March 2020 3COVENT-19

CoVent-19GoalandOverview


GOAL

Solvefortheventilatorshortage:

• Atthepeaktherewillbeaneedfor800k+ventilators• Only170kventilatorsintheUS• Increasethecapacityofhospitalstoprovidemechanicalventilationaroundtheworld• Rapidlydeployablesolution• Striveforacompletemechanicalsystem

• Note:electronicsandsoftwareadddevelopmentandregulatoryrisk

CHALLENGEISFOCUSEDONNEEDSOFMASSCASUALTYANDCRISISMODES

CrisisNormal Emergency MassCasualty

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

VentilatorsAvailable(170,000)

Co-Vent19ChallengeSpace

URGENCYNEED(OVERTIME)

NUMBEROFVENTILATORS

Expected PeakNeed(800,000+)


COVENT| Goalandchallengeoverview

GoalsSurvivethepeakCCurve:let'sallaimtoflattenthecurvewithhygiene andsocialdistancing,butwealsoneedto survivethepeak.

Open:weneedtocommittoopenmindsandopenaccessinordertotakeonthisenormousefforttosurviveCOVID-19.

Ventilation:weallventilatetobreathe,butduringrespiratoryfailuresometimesweneedassistance.Thisprojectaimstogiveeveryoneaccesstolife-savingmechanicalventilationwhentheyneedit.

Innovation:wewillcountonthebestengineers,innovators,designersandmakerstobringinnovative,rapidlydeployabledesignstoreality.

Deploy:additivemanufacturingandrapidprototypingtoolshavemaderapiddeploymentpossible.

TheCoVent ProcessAVirtualCo-DevelopmentandInnovationChallengeFoundedbyresidentsatMassachusettsGeneralHospital,theCoVent-19ChallengeisacompletelyvirtualopenmoonshotchallengehostedonGrabCAD todeveloparapidlydeployablemechanicalventilationsolution


WeeksMar – 23 Mar – 30 Apr – 6 Apr – 13 Apr – 20 Apr – 27 May – 4 May – 11 May – 18 May – 25 Jun – 1 Jun – 8 Jun – 15 Jun - 22

KeyMilestones&Activities

ProjectOverview|EstimatedTimeline- BaselineWearehere

ChallengeLaunch

+solutionsforeachfunctionfortheminimallyviableventilatorarchitecture+passesproofofengineeringfeasibility(byXimedica)+passesproofofclinicalfeasibility(byMGHclinicians)+passessubsequentproofoftechnicalfeasibilitybyventilatorexperts

Round1(generaladmission)Round2(invited)

Winner(s)Selected

DHF&MFGTransfer

+performanceevaluatedandsystemcomplieswiththerequirements

+applicationofregulatorystandardstodesignwithindustryguidanceanddirection

+proofofengineeringandassemblyfeasibilitybymanufacturinganddesignpartners

DesignBriefKickoff

Round2(invitedfasttrack)

+systemsolutionscanbesubmittedpriortothepublishedRound2startdateifapplicable;don’tdelaysubmissions

DHF&MFGTransfer

CONFIDENTIAL | 31 March 2020 7COVENT-19

Immersion


Immersion|Ventilator Workflow Overview

Primaryfocusareas


Immersion|VentilatorArchitecture


Immersion|SystemRequirementsDescription Identifier Inputs(Requirements) ModuleAllocation

GeneralPerform-ance

ModesofOperation

SR-01 MandatoryVentilation(Primaryfunction/minimum) ControlModule

SR-02 SpontaneousVentilation(Secondaryfunction/designgoal) Control,MonitoringModule

Control

SR-03 Volume Control(Primaryfunction/minimum) ControlModule

SR-04 PressureControl(Secondaryfunction/designgoal)5-60+/- 5cmH2O ControlModule

SR-05 PressureSupport10-15+/-5cmH2O;maybe eitherflow- orpressure-triggered(Secondaryfunction/designgoal)

ControlModule

SR-06 Apneaback-upkicksinat30or60seconds(+/-5sec)(Secondaryfunction/designgoal) Control,MonitoringModule

FlowRate SR-07 >60liters perminute DriveModule

PEEP SR-08 Pressure:5-15cmH2Oinincrementsof5cmH20(+/-5cmH2O) ControlModule

Inspiratory:Expiratory(I:E)Ratio

SR-09 MandatoryVentilation:1:2, 1:3,and1:4optionsavailable(click-stop)ControlModule

RespiratoryRate SR-10 10-30 breathsperminuteinincrementsof2bpmControlModule

TidalVolume SR-11

Option#1:Inputheightandgenderfor6cc/kgTV(+/- 10%or10mL)

Option#2:350cc(foraveragewoman)and450cc(foraverageman)(+/- 10%or10mL)

Option#3:400cconly(+/- 10%or10mL)

Option#4:300-600cc adjustablein100ccincrements (+/- 10%or10mL)

ControlModule

Gas

GasConnectors SR-12 Compatiblewithhighpressure(~50psi)gassource(i.e.,pipelinesupply)ORlow-flowinlet Air-OxygenMixingModule

Oxygendelivery SR-13Option#1:FiO2(21%+10%,50%+/- 10%,100%-10%)

Option#2:adjustablebetweenroomair(21%)and100%(+/-10%)

ControlModule



InfectionControl

Reusability SR-15 Allcomponentscomingincontactwiththepatientsbreathmustbedisposable ORsterilizable(e.g.,autoclavable) BreathingCircuit

ViralFiltersSR-16 0.22umorsmallerfilteronpatientinspirationandexpirationpathway BreathingCircuit

SR-17 Ventilatorinletgastoallowfiltration Air-OxygenMixingModule

Cleanable SR-18 Allexternal surfacesmustnotdegradewithapplicationofstandardagentsfordisinfection(e.g.bleachsolution) Allreusabletouchpoints

Alarms&Monitoring

Critical

SR-19 InletGas(O2)orPowersupplyfailure Alarm,Air-OxygenMixing,andPowerSourceModules

SR-20

• Inspiratoryairwaypressureexceededlimits• Pplat<30-35cmH2O• PeakPnomorethan2cmH2OgreaterthanPplat• Fail-safevalveopensat60cmH2O(poweredorun-powered)

AlarmandMonitoringModules

SR-21 Apnea(i.e. patientnotbreathing)onspontaneousmode(secondary) AlarmandMonitoringModules

SR-22 InspiratoryandPEEPpressurenotachieved(i.e.disconnection) AlarmandMonitoringModules

SR-23 Tidalvolumenotachievedorexceeded(with~20%tolerance) AlarmandMonitoringModules

SR-24 O2disconnection AlarmandAir-OxygenMixingModules

SR-25 AlarmVolume60to80dBAatonemeter(+/- 5dBA) AlarmModule

Monitoring SR-26 ActualValue(TV,RR,PEEP,FiO2,FlowRate,PIP) MonitoringModule



VentilatorSpecificStandards/Misc.

VentilatorSpecific

SR-27 Ventperformancefor</=10,000ftAltitude, GuidanceprovidedinRound2

SR-28 Durability=2,000hours GuidanceprovidedinRound2

SR-29 Compatibilitywithreadilyavailablepatientcircuits,(ISO5356-1fittings) GuidanceprovidedinRound2

SR-30 ComplywithFDAVentilatorGuidanceStandards(i.e.ISO80601-2-12) GuidanceprovidedinRound2

MedicalDeviceGeneric SR-31 ComplywithgeneralMedicalDeviceGuidanceStandards(e.g.ISO13485,ISO14971,ISO62304,ISO62366) GuidanceprovidedinRound2

Electric(ifapplicable)

Power SR-32 120VAC PowerModule

ElectricalSafety SR-33 ComplywithIEC60601-1andIEC60601-1-2 GuidanceprovidedinRound2

BatteryBackupSR-34 Nonewithlabeling(primaryfunction) PowerModule

SR-35 1hour(secondaryfunction/designgoal) PowerModule


Immersion|DesignBrief

EngineeringanddesignformanufacturingStrategy– Theeffortispredicatedonspeed!Designsolutionstothegreatestextentpossibleshouldidentifyandleveragethefastestpossiblemethodsthatwillmaximizeeaseofassemblyandfunction

1) Additivemanufacturing(particularlyStratasys)ispreferred• ConsiderdifferentStratasysmaterialoptions

2) Tolerancesandmaterialfinish–• Designpartsandclearanceconsideringthisprocess

3) Postprocessing– Sanding/smoothing• Whilepostprocessingispossibleitshouldbeavoided

4) RAWMaterials–• Incorporatingcuttubingextrusionsassleevestoachievesmoothsurfaces• Diecutting2Dshapesfromflatstock

5) Assembly–• Snapfits– considermaterialproperties(%deflection)• Snapfits– requireovertraveltoengage• Bayonets– AgoodAMtechniquebutshouldbeavoidformultipleactuations• Threadformingscrews– Plastite• Avoid– adhesivesifpossible• Avoid- Ultrasonicweldingorheatstaking

CoVent-19 Challenge and Ximedica Overviewinfo.grabcad.com/rs/008-JLC-434/images/CoVent_Design_Brief...

Documents

Transcript of CoVent-19 Challenge and Ximedica Overviewinfo.grabcad.com/rs/008-JLC-434/images/CoVent_Design_Brief...