1. Steven Corns Ajay Thukral Jack Stein
INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday, January 27, 2014
Steven Corns
Ajay Thukral
Jack Stein

2. 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

3. introductions

4. Biomedical and Healthcare System challenges

5. Biomedical-Healthcare Engineering and Application Environment
Medical Devices
Pharmaceuticals
Healthcare Facilities and Equipment
IT Systems / Medical Records
Models, Analysis, & Simulations
Standards & Regulations
Technologies
Translation of
Elements of
Clinical Care
Health
Systems

6. Biomedical-Healthcare System Solutions
…are we there?
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
TRADITIONAL PRESSURES
PROCESS OPTIMIZATION
“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
HEALTHCARE REFORM
CMS / PAYERS
KPI’s Metrics
Balance Scorecard
Hoshin Kanri
ACCOUNTABLE CARE ORGS
Lean & Six Sigma 6

7. 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 ?

8. Issues to be Addressed Time to adoption
Ensure regulatory, compliance, and risk management requirements are met
Cost reduction
Consistency across device design
Others?

9. Mbse challenge team Addressing System challenges

10. 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)

11. Challenge Team Mission, Vision, Charter
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

12. Vision – Enabling Excellence in Biomedical-Healthcare System Engineering
Generic Models:
Infusion Pump
ICE (ASTM F2671)
LIBRARY
Standard Interfaces
Reusable Elements
Infusion and Drug Delivery System (IDDS) Model
Other Development Systems and Tools
Risk Assessment /
Safety Assurance Analysis Structures
Standards
Regulations
Other publications

13. 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
Sandy Friedenthal
Jack Stein
Ajay Thukral

14. Mbse challenge team Modeling Efforts

15. Domain

16. Requirements

17. Device Description

18. System Procurement

19. Method for Addition of Parametrics

20. Mbse challenge team Industry standards, compliance and assurance

21. 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 (Risk Management)
IEC (Usability Engineering)
ISO (Software Life Cycle)
IEC (Electrical Safety)
FDA Design Controls (Needs, Requirements, V&V, etc.)

22. Vision – Enabling Excellence in Biomedical-Healthcare System Engineering
Generic Models:
Infusion Pump
ICE (ASTM F2671)
LIBRARY
Standard Interfaces
Reusable Elements
Infusion and Drug Delivery System (IDDS) Model
Other Development Systems and Tools
Risk Assessment /
Safety Assurance Analysis Structures
Standards
Regulations
Other publications

23. Integrated Clinical Environment (ICE) Medical Device Plug-and-Play Interoperability
“Getting Connected for Safety”

24. ASTM F2671 Integrated Clinical Environment (ICE)
Figure 1 from ASTM F2671 – Conceptual functional model showing the elements of ICE

25. 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.

26. SysML Representation of the ASTM F2671 Integrated Clinical Environment (ICE) Model

27. Model-Driven Safety Analysis of Closed-Loop Medical Systems – Dr
Model-Driven Safety Analysis of Closed-Loop Medical Systems – Dr. Insup Lee

28. 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

29. Patient Model
𝐶 𝐶 𝐶 3 = −( 𝑘 12 + 𝑘 13 + 𝑘 10 ) 𝑘 21 𝑘 31 𝑘 12 −𝑘 𝑘 −𝑘 𝐶 1 𝐶 2 𝐶 𝑉 𝐼
𝑑𝑙= 𝐶 1 𝐶 2 𝐶 3

30. Drug Model
𝑘 10 =0.152 𝑚𝑖𝑛 −1 , 𝑘 12 =0.207 𝑚𝑖𝑛 −1 , 𝑘 13 =0.040 𝑚𝑖𝑛 −1
𝑘 21 =0.092 𝑚𝑖𝑛 −1 , 𝑘 31 =0.048 𝑚𝑖𝑛 −1 , 𝑉 1 =12 𝑙𝑖𝑡𝑒𝑟𝑠

31. Model and Environment

32. PCA Pump verification

33. Moving Forward

34. What do we want to accomplish this year?

35. Vision – Enabling Excellence in Biomedical-Healthcare System Engineering
Generic Models:
Infusion Pump
ICE (ASTM F2671)
LIBRARY
Standard Interfaces
Reusable Elements
Infusion and Drug Delivery System (IDDS) Model
Other Development Systems and Tools
Risk Assessment /
Safety Assurance Analysis Structures
Standards
Regulations
Other publications

36. Goals Guidelines for using the framework developed
Expansion of library of components and methods
Continue integration of ISO/IEC standards and compliance
Others?

37. Discussion

38. Copied from Sandford Friedenthal presentation

39. From Document-Centric to Model-Centric

40. Object-Oriented (MBSE) SE Approach
Traceability

41. Our OMG Wiki Page (Public)