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Device locationDevice identity (FDA/UDI)Universal timeNetwork dependency mapsPerformance dashboardsPower monitor, mgt
Pre-acquisition specifications (ECRI), evidence databases, assessment, simulations, demos, standards, testing, certification
Design partnerships
Workforce training, labor negotiations, toolsSupply chain mgt., supplies, green sustainabilityStaging, provisioning, safety testsMD/FIRE contract requirementsITIL complianceAsset Mgt. (UNSPSC, UDI), deploy, retireService Mgt , Service Level AgreementsRemote device management, troubleshootingPlanned maintenance/PMsIncident mgt/corrective maintenanceProblem mgt, root-cause analysisPerformance metrics, analytics, reports
Move-add-change activityPatch, upgrade, updateSecurity updateAutomated inventoryVersion updates
Self-monitoring and self-reportingPredictive failure checksEvent logsData buffers, cachesBusiness continuity, disaster recovery statusing
Pt. identification, device pairingBarcode scannersProximity sensors, activatorsDisplays, Data VisualizationAlarms, Alerts, NotificationsPaging
Secure, high confidence network mgt.Clinical checklistsClinical practice guideline conformanceCarepath, workflow re-engineeringSafety interlocks Institutional researchClinical decision supportMulti-core processorsHypervisorsEMR transactionsEpisode of care log, billing, coding
Availability
Mgt
System Lifecycle Mgt
Model
Configuration
Mgt
Reliability, Risk
Management
Peripherals
Mgt
Network
Transaction
Mgt
Integrated Clinical
Environment(ICE) Mgt
Procedure
Health
InformaticsDrug
Vision, Strategy, Policy
*Sector, Enterprise *Clinical *Operations
Technology Assessment,
Planning, Budgets
Integration Planning, Testing,
Certification
Contracting,
ProcurementDeployment
Operations Support
Refresh, Recycle
Next-Generation Medical Devices and Systems will go well beyond Clinical functions to include
complex Network Transactions and System Lifecycle Management functions as well
Evolutionaryinter-dependencies
Fred Hosea, Ph.D.
Kaiser Permanente
Contact
• Program Manager, Clinical TechnologyResearch and Innovation
• 1795 Second St.
• Berkeley, California 94710
•[email protected] [email protected]
•510-559-4842 office 510-812-5086 cell
•510-684-6925 cell
B14Frameworks for addressing the increased complexity, networking and interoperability of medical devices
©Fred Hosea, Ph.D. - 2010
Systems-of-
Systems
Clinical Systems
MedicalDevice
RESEARCHREGULATION
BEST PRACTICESCOST STRUCTURE
WELLNESS, TELEHEALTH, TELEMEDICINE
Enterprise Architecture
Transition planning: IPv4 ->6 , HL7 v2->v3, ICD-9->10,
SNOMED, LOINC, UMLS etc.
Electronic Medical Record transactions,
data warehousing
Quality of Service Environments (deterministic
vs. probabilistic; wireless spectrum mgt.
life critical vs. business)
Data, messaging, imagestandards and updates (HL7,
CDL, XML, RIM, DICOM, syntactic, semantic
interoperability)
Connectivity, logon, session management,
security, confidentiality
Device, facility data cacheing
