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

Sleep apnea Gas monitoring Kidney dialysis Coagulation Vital signs Infusion pump Bone density Body weight

Biomedical-Healthcare Engineering and Application Environment

Ventilator & respirator Pacemaker Heart monitor Blood pressure Glucose meter Pulse oximeter Body fat scale

Medical Devices Pharmaceuticals Healthcare Facilities and Equipment IT Systems / Medical Records Models, Analysis, & Simulations Standards & Regulations Technologies 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….." TRADITIONAL PRESSURES ACCOUNTABLE CARE ORGS 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 KPI’s Metrics Balance Scorecard Hoshin Kanri Lean & Six Sigma

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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 ?

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Issues to be Addressed

• • • • • Time to adoption Ensure regulatory, compliance, and risk management requirements are met Cost reduction Consistency across device design Others?

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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 document centric to a model-centric systems engineering environment 11

Vision – Enabling Excellence in Biomedical Healthcare System Engineering

LIBRARY Standard Interfaces Reusable Elements Generic Models:

- Infusion Pump - ICE (ASTM F2671)

Other Development Systems and Tools Infusion and Drug Delivery System (IDDS) Model Risk Assessment / Safety Assurance Analysis Structures Standards Regulations Other publications

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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]

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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

LIBRARY Standard Interfaces Reusable Elements Generic Models:

- Infusion Pump - ICE (ASTM F2671)

Other Development Systems and Tools Infusion and Drug Delivery System (IDDS) Model Risk Assessment / Safety Assurance Analysis Structures Standards Regulations Other publications

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Integrated Clinical Environment (ICE)

Medical Device Plug-and-Play Interoperability

“Getting Connected for Safety”

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ASTM F2671 Integrated Clinical Environment (ICE) 24

Figure 1 from ASTM F2671 – Conceptual functional model showing the elements of ICE

Bring Standards Directly Into the Design/Development Environment: Example – ASTM F2671 ICE (Interoperability) 25 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.

SysML Representation of the ASTM F2671 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

• • 𝐶 1 𝐶 2 𝐶 3 = −(𝑘 12 + 𝑘 13 𝑘 12 𝑘 13 + 𝑘 10 ) 𝑘 21 −𝑘 12 0 𝑘 31 0 −𝑘 31 𝐶 1 𝐶 2 𝐶 3 + 1 𝑉 1 0 0 𝐼 𝑑𝑙 = 1 0 0 𝐶 1 𝐶 2 𝐶 3

Drug Model

• • 10 = 0.152𝑚𝑖𝑛 0.040𝑚𝑖𝑛 −1 −1 , 12 = 0.207𝑚𝑖𝑛 −1 , 13 = 21 = 0.092𝑚𝑖𝑛 12 𝑙𝑖𝑡𝑒𝑟𝑠 −1 , 31 = 0.048𝑚𝑖𝑛 −1 , 1 =

Model and Environment

Operator Model Monitor Sensor Create rules with time delays wrt to trigerred events Operator effectiveness Nos of devices Restart/Override/Manual Alerts/Alarms Risk mitigation Drug infusion limit Auto Monitoring frequency Risk mitigation Algo Smarts (Supervisor) Couple of eqs.

Operational failure & corrective action 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 Respiratory Rate Device Operational Characteristics/Fa ilure Create linear model with drift/offset/noise BP EKG Oximeter (SpO2) Model add noise and drift Patient treatment Management Requirements Requirements Device operational requirements Requirements Clinical Guidelines/Protocol FDA Overall System Assurance Assessment Risk Analysis

PCA Pump verification

Stakeholder Requirements Treatment requirement (new/ineffective) Deployment requirement (New/ineffective) Operational requirement (New/inaccurate) 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

LIBRARY Standard Interfaces Reusable Elements Generic Models:

- Infusion Pump - ICE (ASTM F2671)

Other Development Systems and Tools Infusion and Drug Delivery System (IDDS) Model Risk Assessment / Safety Assurance Analysis Structures Standards Regulations Other publications

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Goals

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

Discussion

38 Copied from Sandford Friedenthal presentation

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 41