INCOSE BiomedicalHealthcare Working Group BHWG ModelBased Systems Engineering
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 – – – 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 Pharmaceuticals Models, Analysis, & Simulations Healthcare Facilities and Equipment Standards & Regulations IT Systems / Medical Records Technologies Translation of Elements of Clinical Care Health Systems 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 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 ? 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 Web. Ex 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 Biomedical. Healthcare System Engineering Generic Models: LIBRARY Standard Interfaces Reusable Elements Other Development Systems and Tools - Infusion Pump - ICE (ASTM F 2671) 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 (cornss@mst. edu) • Sandy Friedenthal (safriedenthal@gmail. com) • Jack Stein (jack. stein@me. com) • Ajay Thukral (ajay. thukral@cientivegroup. com) 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 – – – 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. ) 21
Vision – Enabling Excellence in Biomedical. Healthcare System Engineering Generic Models: LIBRARY Standard Interfaces Reusable Elements Other Development Systems and Tools - Infusion Pump - ICE (ASTM F 2671) 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 F 2671 Integrated Clinical Environment (ICE) Figure 1 from ASTM F 2671 – Conceptual functional model showing the elements of ICE 24
Bring Standards Directly Into the Design/Development Environment: Example – ASTM F 2671 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
Sys. ML Representation of the ASTM F 2671 Integrated Clinical Environment (ICE) Model 26
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
PCA Pump verification
Moving Forward
What do we want to accomplish this year?
Vision – Enabling Excellence in Biomedical. Healthcare System Engineering Generic Models: LIBRARY Standard Interfaces Reusable Elements Other Development Systems and Tools - Infusion Pump - ICE (ASTM F 2671) 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 38
From Document-Centric to Model-Centric 39
Object-Oriented (MBSE) SE Approach Traceability 40
Our OMG Wiki Page (Public) http: //www. omgwiki. org/MBSE/doku. php? id=mbse: drugdelivery 41
- Slides: 41