lean und smart medizin–produkte-entwicklung€¦ · • software-, electronics-and mechanics...
TRANSCRIPT
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LeanundSmartMedizin – Produkte - Entwicklung
BennoBieriIMTAG,19.Oktober 2017
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Abstract
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InterdisziplinäreSystemArchitekturfüreineerfolgreichesMedizingeräte-Projekt
«InterdisziplinäreSystemarchitektur»
«VermeidenunnötigerEntwicklungsschleifen»
«KonzentrierenaufdieUmsetzungderAnforderungendieDokumentationerstelltsichbeinahevonselbst»
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IMTAG…makingideaswork
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Erfolgreich inderEntwicklung vonMedizingeräten undEmbedded-Lösungenseit 1991
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IMTAG…makingideaswork
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Schwerzenbach (ZH) Buchs (SG)
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IMTAG…makingideaswork
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Singapur(SGP)
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IMTAG…makingideaswork
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SoftwareDevelopment
PCB MechanicalConstruction
ElectronicDevelopment
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Medizingeräte Entwicklung
• Software-,Electronics- andMechanicsDevelopment• RequirementsEngineering(ENISO13485)• RiskManagement(ISO14971)• Usability(EN62366)• System- undSoftware-Architektur (ENISO13485,EN62304)
• Prozesse einhalten (ENISO13485,EN62304)
• Verifikation undValidierung (ENISO13485,EN62304)
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V-Modell
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PerformforeachSubsystem
(PESS)
Software
Architecture
Software
Component
Design
MechanicsImplementation
SoftwareImplementation
ElectronicsImplementation
Software
Component
Tests
ValidationTest
StakeholderRequirements
FunctionalRequirementSpecification(FRS)
Software
Integration&
System
Tests
Software
Specification
SystemArchitecture
SubsystemTest
Electron
ics
Tests
Mecha
nics
Tests
UserRequirementSpecification(URS)
SubsystemArchitectur
SubsystemRequirements
System(Integration)Test
Mechanics
Specification
Mechanics
Specification
Mechanics
Design
Electronics
Specification
Electronics
Design
AnalysisandSpecification
Development
Definition
Integration,VerificationandValidation
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UserRequirementSpecification(URS)
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FunctionalRequirementSpecification(FRS)
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Geräte Entwicklung
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Subsystemarchitecture
«schematics»
port_pa0_LED0
«software»void setPowerLight(cmd myCmd ){Power_LED =myCmd;
}
è hohes Fehlerrisikoè nicht rück-verfolgbar
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FunctionalRequirementSpecification(FRS)
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Systemgrenzendefinieren
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SystemArchitektur
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Visualization Controller
CO2Sensor
Real Time Controller
Actors Sensors
Power Management
RS232_2 CANRS232_1
SpO2Sensor
BV-BusDevice
InternalBus
InternalBus
Microphone
Display
Touch
LoudSpeakers
AlarmLED’s
USB1USB StickTrending
USB StickSW Update
Ethernet
USB2
USB3
USB StickProfile
ON/OFFButton
GPIO
Solid State Disk
GPIO
NurseCall
InfoButton
KEY
Processor ExternalComponentElectronics
x y Communicationbetweenxandy
SystemBoundary
BatteryManager
Notinuse
Device Fan
EPC Fan
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SystemArchitektur mit Subsystemen
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MyDevice
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SubsystemRequirements
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SubsystemArchitektur
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PowermanagementSubsystem
Microcontroller Bus- Electronic
Battery Charger
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SubsystemArchitektur – wozu?
VermeidenvonRedesigns bevordieEntwicklerstarten!
SoläuftesoftinkomplexerenProjekten:zuwenigGPIO’s è EinI/OExpanderwirdzugefügtzuwenigADCEingänge èMUXoderexternerADCWorst Case:ProzessorwechselaufgrösseresGehäuseè komplettneuesLayout
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Mechanische Spezifikation
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Elektronik Spezifikation
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Elektronik Komponenten Design
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SoftwareSpecification
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SoftwareArchitecture
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SoftwareArchitektur für jedes PESS
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PESS:Powermanagement
Microcontroller Bus- Electronic
Battery Charger
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SoftwareArchitektur erste Ebene
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Powermanagement Mikrocontroller
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Voltage
SoftwareKomponentenDesign
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SoftwareKomponentenDesign
Konsistente Namensgebung
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SystemSpezifikation System Architektur SoftwareArchitektur
Subsystemarchitecture
Schema
PESS Architektur
SoftwarevoidsetPowerLight(cmdmyCmd ){Green_Power_LED =myCmd;
}
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IntegrationundTesten
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Zusammenfassung
• NahtloseIntegrationderverschiedenenDisziplinen• DiegraphischenKomponentensind die
Dokumentation• ReduktionvonKostenundÄrgerdurcheliminieren
vonFehlern• EinToolkannhelfenbeiKonsistenzundsogarCode
generieren
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Tool
• Arbeitshilfe• GarantiertVollständigkeit• VermeidetFehler• DurchgängigesRenaming• VerwendenderGrafikenin
beliebigenDokumenten• CodeGenerierungfürdie
SoftwareUnits
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Tool
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• CodeGenerierungfürden«Glue code»
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FragenDiskussion
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YourContact
09.03.2017 33
BennoBieriBusinessDevelopmentManagerMedicalDevices
Phone:+41817500631Mobile:+41799529296Email:[email protected]
Franz EgleBusinessDevelopmentManagerIndustrie Automatisation
Phone:+418175007 87Mobile:+41793074485Email: [email protected]
RolandWintelerBusinessDevelopmentManagerEmbeddedDevices
Phone:+41817506623Mobile:+417990663 31Email:[email protected]