INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday,

1. INCOSEBiomedical-Healthcare Working Group (BHWG)Model-Based Systems Engineering (MBSE)Challenge Team MeetingMonday, 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? PROCESS OPTIMIZATION TRADITIONAL PRESSURES “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 CMS / PAYERS HEALTHCARE REFORM KPI’s Metrics Vision that guides Biomedical-Healthcare Systems Balance Scorecard Each Biomedical-HealthcareSystem strives to be a preeminent leader in clinical care, education, research and service. These are measured by objective evidence and established best practices….." 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 teamAddressing 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 • 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

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 (cornss@mst.edu) • Sandy Friedenthal (safriedenthal@gmail.com) • Jack Stein (jack.stein@me.com) • Ajay Thukral (ajay.thukral@cientivegroup.com)

14. Mbse challenge teamModeling Efforts

15. Domain

16. Requirements

17. Device Description

18. System Procurement

19. Method for Addition of Parametrics

20. Mbse challenge teamIndustry 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 14971 (Risk Management) • IEC 62366 (Usability Engineering) • ISO 62304 (Software Life Cycle) • IEC 60601 (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. 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

30. Drug Model

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) http://www.omgwiki.org/MBSE/doku.php?id=mbse:drugdelivery