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INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday, January 27, 2014 Steven Corns Ajay Thukral Jack Stein
INCOSEBiomedical-Healthcare Working Group (BHWG)
Model-Based Systems Engineering (MBSE)Challenge Team Meeting
Monday, January 27, 2014
Steven CornsAjay Thukral
Jack Stein
Biomedical-Healthcare Model-Based Systems Engineering (MBSE) Challenge Team
• Agenda– Introductions – (5 min) – Modeling Efforts – (10 min)– Industry Standards, Compliance, Assurance – (15 min) – Integration of Dr. Insup Lee’s work – (15 min)– MBSE Position Paper – (15 min)– Presentation by Drew Pihera
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INTRODUCTIONS
BIOMEDICAL AND HEALTHCARE SYSTEM CHALLENGES
Biomedical-Healthcare Engineering and Application Environment
Sleep apnea
Gas monitoring
PacemakerKidney dialysis
Ventilator & respirator
Pulse oximeter
Vital signs
Body fat scale
Bone density
Body weight
Heart monitor
Blood pressure
Glucose meterInfusion pump
Coagulation
Medical Devices
Pharmaceuticals
Healthcare Facilities and Equipment
IT Systems / Medical Records https://www.i2b2.org/about/index.html
Models, Analysis, & Simulations
Standards & Regulations
Technologies
Health Systems
Collaborative Care System
Translation ofElements of Clinical Care
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Biomedical-Healthcare System Solutions
Each Biomedical-Healthcare System strives to be a preeminent leader in clinical care, education, research and service. These are measured by objective evidence and established best practices….."
Vision that guides Biomedical-Healthcare Systems
"If it can be measured, it can be managed [and improved]“ Jack Welch
TRADITIONAL PRESSURES
HEAL
THCA
RE R
EFO
RM CMS / PAYERS
ACCOUNTABLE CARE ORGS
“For full effectiveness, all the work needs to be integrated into a unified program for performance.” Peter Drucker
Hoshin Kanri
KPI’s Metrics
Balance Scorecard
PROCESS OPTIMIZATION
Lean & Six Sigma
…are we there?
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Systems Challenges in the Biomedical-Healthcare Sectors
• Examples .…– Healthcare Cost Reduction– Electronic Health Records– Mobile Medical Apps - Remote & Telemedicine– Medical Device Interoperability– Counter Bioterrorism Coordination– Universal Healthcare Coverage– Your system challenges ?
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Issues to be Addressed• Time to adoption
• Ensure regulatory, compliance, and risk management requirements are met
• Cost reduction
• Consistency across device design
• Others?
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MBSE CHALLENGE TEAMADDRESSING SYSTEM CHALLENGES
INCOSE Biomedical-Healthcare Working Group (BHWG) MBSE Challenge Team
• One of over a dozen INCOSE MBSE Challenge and Activity Teams / Formed in 2011
• Information is public domain (OMG MBSE Wiki Site) • Current Modeling Project:
– Infusion and Drug Delivery System (IDDS) Model• Meetings
– Regular teleconference WebEx meetings– Periodically face-to-face (Missouri S&T St. Louis Campus,
INCOSE Conferences, and International Workshop)
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Challenge Team Mission, Vision, Charter• Mission:
– Demonstrate the value and utility of MBSE for biomedical-healthcare related applications and programs
– Provide INCOSE BHWG members a reference design to adopt for their specific drug, device, and/or biological product development efforts
• Project Overview: – Involve BHWG members in the use of MBSE thus expanding the
application beyond defense and aerospace industry related projects.– Develop frameworks and templates that can be used to accelerate the
development and approval of biomedical devices.– Investigate the integration of risk management, safety assurance, and
other aspects related to the regulatory environment.– Provide a forum for learning how to make the shift from a document-
centric to a model-centric systems engineering environment
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Vision – Enabling Excellence in Biomedical-Healthcare System Engineering
Infusion and Drug Delivery System
(IDDS) Model
Risk Assessment /Safety Assurance
Analysis Structures
Generic Models:- Infusion Pump- ICE (ASTM F2671)
StandardsRegulations
Other publications
LIBRARYStandard InterfacesReusable Elements
Other Development Systems and Tools
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Project Status / Team Development
• Recent Activities: – MBSE short course for working group and MBSE team members– Preliminary framework created– Wiki site updated to share information on progress– Met with University of Pennsylvania
• Challenge Team– All members are welcome (General Interest, Modeler, Leadership/Admin Roles)– Willingness to meet with bi-weekly to review model / Complete actions items– Contact a MBSE initiative member in the BHWG
• Steven Corns ([email protected])• Sandy Friedenthal ([email protected])• Jack Stein ([email protected])• Ajay Thukral ([email protected])
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MBSE CHALLENGE TEAMMODELING EFFORTS
Domain
Requirements
Device Description
System Procurement
Method for Addition of Parametrics
MBSE CHALLENGE TEAMINDUSTRY STANDARDS, COMPLIANCE AND ASSURANCE
Addressing Risk Up Front• Risk tolerance typically lower in medical devices• Risk management a key element in device
clearance/approval. New Safety Assurance practices and documentation likely (Infusion Pumps).
• Device clearance/approval is tightly linked to compliance with standards and regulations– ISO 14971 (Risk Management)– IEC 62366 (Usability Engineering)– ISO 62304 (Software Life Cycle)– IEC 60601 (Electrical Safety)– FDA Design Controls (Needs, Requirements, V&V, etc.)
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Vision – Enabling Excellence in Biomedical-Healthcare System Engineering
Infusion and Drug Delivery System
(IDDS) Model
Risk Assessment /Safety Assurance
Analysis Structures
Generic Models:- Infusion Pump- ICE (ASTM F2671)
StandardsRegulations
Other publications
LIBRARYStandard InterfacesReusable Elements
Other Development Systems and Tools
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Integrated Clinical Environment (ICE)Medical Device Plug-and-Play Interoperability
“Getting Connected for Safety”
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ASTM F2671 Integrated Clinical Environment (ICE)
Figure 1 from ASTM F2671 – Conceptual functional model showing the elements of ICE
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Bring Standards Directly Into the Design/Development Environment: Example – ASTM F2671 ICE (Interoperability)
Transform information in standards into integrated model elements, configurations, and views which are directly traceable to use scenarios, requirements, architecture, verification, validation, risk management, safety assurance, and other information.
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SysML Representation of the ASTM F2671 Integrated Clinical Environment (ICE) Model
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Model-Driven Safety Analysis of Closed-Loop Medical Systems – Dr. Insup Lee
Overview
• Model of a patient controlled analgesia (PCA) pump
• Allows for model with a patient in the loop
• Create a model that incorporates this devices with higher level system
Patient Model
•
Drug Model
•
Model and Environment
Algo Smarts(Supervisor)
Couple of eqs.
DeviceCreate simple pulse
model
Patient treatment Management Requirements
RequirementsDevice operational
requirements
Device Operational Characteristics/Failure
modesPatient Model
Eq 1
Drug Infusion
EKG
Oximeter (SpO2)
Device Operational
Characteristics/Failure
Create linear model with
drift/offset/noise
Operator ModelCreate rules with time delays wrt to trigerred
events
Auto
Restart/Override/Manual
BP
Respiratory Rate
Model add noise and drift
Alerts/Alarms
MonitorSensor
RequirementsClinical
Guidelines/Protocol
Overall System Assurance
Assessment
Monitoring frequency
Risk mitigationDrug infusion limit
Drug refill frequencyDevice servicing frequencyRisk mitigation
Operational failure & corrective action
Drug side effect
Operator effectivenessNos of devices
FDA
Risk Analysis
PCA Pump verification
Develop(treatment
plan)
Stakeholder Requirements
Satisfied Requirements
Deploy(people,
process and device)
Operational System
(Clinic setting, patient and deployed treatment
service)
Conformance?
Treatment requirement (new/ineffective)
Deployment requirement (New/ineffective)
Operational requirement (New/inaccurate)
Moving Forward
What do we want to accomplish this year?
Vision – Enabling Excellence in Biomedical-Healthcare System Engineering
Infusion and Drug Delivery System
(IDDS) Model
Risk Assessment /Safety Assurance
Analysis Structures
Generic Models:- Infusion Pump- ICE (ASTM F2671)
StandardsRegulations
Other publications
LIBRARYStandard InterfacesReusable Elements
Other Development Systems and Tools
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Goals
• Guidelines for using the framework developed• Expansion of library of components and
methods• Continue integration of ISO/IEC standards and
compliance• Others?
Discussion
Copied from Sandford Friedenthal presentation
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From Document-Centric to Model-Centric
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Object-Oriented (MBSE) SE Approach
Traceability
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Our OMG Wiki Page (Public)
http://www.omgwiki.org/MBSE/doku.php?id=mbse:drugdelivery
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