INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based

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 Sleep apnea Ventilator & respirator Gas monitoring Pacemaker Kidney dialysis Heart monitor Coagulation Blood pressure Vital signs Infusion pump Glucose meter Pulse oximeter Bone density Body weight Pharmaceuticals Models, Analysis, & Simulations Healthcare Facilities and Equipment Standards & Regulations IT Systems / Medical Records Technologies 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 Biomedical-Healthcare 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 – – – – – 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 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 24

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 26

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

Drug Model

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 Biomedical-Healthcare 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 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