INCOSE Biomedical-Healthcare Working Group (BHWG)

Report
INCOSE
Biomedical-Healthcare Working Group (BHWG)
Model-Based Systems Engineering (MBSE)
Challenge Team Meeting
Monday, January 27, 2014
Steven Corns
Ajay Thukral
Jack Stein
Biomedical-Healthcare Model-Based Systems
Engineering (MBSE) Challenge Team
• Agenda
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–
–
–
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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
2
INTRODUCTIONS
BIOMEDICAL AND HEALTHCARE
SYSTEM CHALLENGES
Biomedical-Healthcare Engineering
and Application Environment
Medical Devices
Sleep apnea
Pharmaceuticals
Models, Analysis,
& Simulations
Healthcare Facilities
and Equipment
Standards &
Regulations
IT Systems / Medical
Records
Technologies
Ventilator & respirator
Gas monitoring
Pacemaker
Kidney dialysis
Heart monitor
Coagulation
Blood pressure
Vital signs
Infusion pump
Glucose meter
Pulse oximeter
Bone density
Body weight
Body fat scale
https://www.i2b2.org/about/index.html
Translation of
Elements of
Clinical Care
Health
Systems
Collaborative Care System
5
Biomedical-Healthcare System Solutions
…are we there?
Vision that guides Biomedical-Healthcare Systems
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….."
PROCESS OPTIMIZATION
TRADITIONAL PRESSURES
CMS / PAYERS
HEALTHCARE REFORM
“For full effectiveness, all the work needs to be
integrated into a unified program for
performance.”
Peter Drucker
"If it can be measured, it can be managed [and
improved]“
Jack Welch
KPI’s Metrics
Balance Scorecard
Hoshin Kanri
ACCOUNTABLE CARE ORGS
Lean & Six Sigma
6
Systems Challenges in the BiomedicalHealthcare 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 ?
7
Issues to be Addressed
• Time to adoption
• Ensure regulatory, compliance, and risk
management requirements are met
• Cost reduction
• Consistency across device design
• Others?
8
MBSE CHALLENGE TEAM
ADDRESSING 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)
10
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 documentcentric to a model-centric systems engineering environment
11
Vision – Enabling Excellence in BiomedicalHealthcare System Engineering
Generic Models:
LIBRARY
Standard Interfaces
Reusable Elements
Other Development
Systems and Tools
- Infusion Pump
- ICE (ASTM F2671)
Infusion and Drug
Delivery System
(IDDS) Model
Risk Assessment /
Safety Assurance
Analysis Structures
Standards
Regulations
Other
publications
12
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])
13
MBSE CHALLENGE TEAM
MODELING EFFORTS
Domain
Requirements
Device Description
System
Procurement
Method for Addition of Parametrics
MBSE CHALLENGE TEAM
INDUSTRY 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
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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 BiomedicalHealthcare System Engineering
Generic Models:
LIBRARY
Standard Interfaces
Reusable Elements
Other Development
Systems and Tools
- Infusion Pump
- ICE (ASTM F2671)
Infusion and Drug
Delivery System
(IDDS) Model
Risk Assessment /
Safety Assurance
Analysis Structures
Standards
Regulations
Other
publications
22
Integrated Clinical Environment (ICE)
Medical Device Plug-and-Play Interoperability
“Getting Connected for Safety”
23
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.
25
SysML Representation of the ASTM F2671
Integrated Clinical Environment (ICE) Model
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Model-Driven Safety Analysis of ClosedLoop 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
•
1
−(12 + 13 + 10 )
12
2 =
13
3
•  = 1 0
1
0 2
3
21
−12
0
31
0
−31
1
2 +
3
1
1
0
0

Drug Model
• 10 = 0.152−1 , 12 = 0.207−1 , 13 =
0.040−1
• 21 = 0.092−1 , 31 = 0.048−1 , 1 =
12 
Model and Environment
Operator Model
Create rules with time
delays wrt to trigerred
events
Operator effectiveness
Nos of devices
Monitor
Sensor
Alerts/Alarms
Algo Smarts
(Supervisor)
Couple of
eqs.
Auto
Monitoring frequency
Risk mitigation
Operational failure & corrective action
Respiratory Rate
Device
Operational
Characteristics/Fa
ilure
Create linear
model with
drift/offset/noise
Patient treatment
Management
Requirements
Restart/Override/Manual
Risk mitigation
Drug infusion limit
Device
Create simple pulse
model
Device Operational
Characteristics/Failure
modes
Drug refill frequency
Device servicing frequency
Drug Infusion
Drug side effect
Patient Model
Eq 1
Requirements
Device operational
requirements
Requirements
Clinical
Guidelines/Protocol
FDA
Overall System
Assurance
Assessment
BP
Risk Analysis
EKG
Oximeter (SpO2)
Model add noise and drift
PCA Pump verification
Treatment requirement (new/ineffective)
Deployment requirement (New/ineffective)
Operational requirement (New/inaccurate)
Stakeholder
Requirements
Develop
(treatment
plan)
Deploy
(people,
process and
device)
Operational
System
(Clinic setting,
patient and
deployed
treatment
service)
Satisfied
Requirements
Conformance?
Moving Forward
What do we want to accomplish
this year?
Vision – Enabling Excellence in BiomedicalHealthcare System Engineering
Generic Models:
LIBRARY
Standard Interfaces
Reusable Elements
Other Development
Systems and Tools
- Infusion Pump
- ICE (ASTM F2671)
Infusion and Drug
Delivery System
(IDDS) Model
Risk Assessment /
Safety Assurance
Analysis Structures
Standards
Regulations
Other
publications
35
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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