INCOSEBiomedical-Healthcare Working Group (BHWG)

Model-Based Systems Engineering (MBSE)Challenge Team Meeting

Monday, January 27, 2014

Steven CornsAjay 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

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INTRODUCTIONS

BIOMEDICAL AND HEALTHCARE SYSTEM CHALLENGES

Biomedical-Healthcare Engineering and Application Environment

Sleep apnea

Gas monitoring

PacemakerKidney dialysis

Ventilator & respirator

Pulse oximeter

Vital signs

Body fat scale

Bone density

Body weight

Heart monitor

Blood pressure

Glucose meterInfusion pump

Coagulation

Medical Devices

Pharmaceuticals

Healthcare Facilities and Equipment

IT Systems / Medical Records https://www.i2b2.org/about/index.html

Models, Analysis, & Simulations

Standards & Regulations

Technologies

Health Systems

Collaborative Care System

Translation ofElements of Clinical Care

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Biomedical-Healthcare System Solutions

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

"If it can be measured, it can be managed [and improved]“ Jack Welch

TRADITIONAL PRESSURES

HEA

LTH

CARE

REF

ORM CM

S / PAYERS

ACCOUNTABLE CARE ORGS

“For full effectiveness, all the work needs to be integrated into a unified program for performance.” Peter Drucker

Hoshin Kanri

KPI’s Metrics

Balance Scorecard

PROCESS OPTIMIZATION

Lean & Six Sigma

…are we there?

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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 TEAMADDRESSING 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)

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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

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Vision – Enabling Excellence in Biomedical-Healthcare System Engineering

Infusion and Drug Delivery System

(IDDS) Model

Risk Assessment /Safety Assurance

Analysis Structures

Generic Models:- Infusion Pump- ICE (ASTM F2671)

StandardsRegulations

Other publications

LIBRARYStandard InterfacesReusable Elements

Other Development Systems and Tools

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

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MBSE CHALLENGE TEAMMODELING EFFORTS

Domain

Requirements

Device Description

System Procurement

Method for Addition of Parametrics

MBSE CHALLENGE TEAMINDUSTRY 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.)

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Vision – Enabling Excellence in Biomedical-Healthcare System Engineering

Infusion and Drug Delivery System

(IDDS) Model

Risk Assessment /Safety Assurance

Analysis Structures

Generic Models:- Infusion Pump- ICE (ASTM F2671)

StandardsRegulations

Other publications

LIBRARYStandard InterfacesReusable Elements

Other Development Systems and Tools

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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)

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

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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.

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

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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

Algo Smarts(Supervisor)

Couple of eqs.

DeviceCreate simple pulse

model

Patient treatment Management Requirements

RequirementsDevice operational

requirements

Device Operational Characteristics/Failure

modesPatient Model

Eq 1

Drug Infusion

EKG

Oximeter (SpO2)

Device Operational

Characteristics/Failure

Create linear model with

drift/offset/noise

Operator ModelCreate rules with time delays wrt to trigerred

events

Auto

Restart/Override/Manual

BP

Respiratory Rate

Model add noise and drift

Alerts/Alarms

MonitorSensor

RequirementsClinical

Guidelines/Protocol

Overall System Assurance

Assessment

Monitoring frequency

Risk mitigationDrug infusion limit

Drug refill frequencyDevice servicing frequencyRisk mitigation

Operational failure & corrective action

Drug side effect

Operator effectivenessNos of devices

FDA

Risk Analysis

PCA Pump verification

Develop(treatment

plan)

Stakeholder Requirements

Satisfied Requirements

Deploy(people,

process and device)

Operational System

(Clinic setting, patient and deployed treatment

service)

Conformance?

Treatment requirement (new/ineffective)

Deployment requirement (New/ineffective)

Operational requirement (New/inaccurate)

Moving Forward

What do we want to accomplish this year?

Vision – Enabling Excellence in Biomedical-Healthcare System Engineering

Infusion and Drug Delivery System

(IDDS) Model

Risk Assessment /Safety Assurance

Analysis Structures

Generic Models:- Infusion Pump- ICE (ASTM F2671)

StandardsRegulations

Other publications

LIBRARYStandard InterfacesReusable Elements

Other Development Systems and Tools

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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

Copied from Sandford Friedenthal presentation

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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

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