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mbse:drugdelivery

Biomedical-Healthcare MBSE Challenge Team: Modeling for a Healthy Future

Purpose

The Biomedical-Healthcare Model-Based Systems Engineering (MBSE) Challenge Team was formed to develop SysML models which facilitate patient-centered development of medical/pharmaceutical devices and systems, with particular emphasis on assurance of safety, reliability, usability, interoperability, and compliance with standards and regulations. Currently, the team is developing a SysML model for use in the biomedical-healthcare community as a centralized information source user/stakeholder needs and expectations, standards and regulations, design requirements, physical and logical architecture, and behavior models describing infusion pumping and drug delivery technologies. Our mission is to demonstrate the value and utility of MBSE in biomedical programs, as well as provide INCOSE members including the Healthcare Working Group (HWG) members a reference design to adopt for their specific drug, device, and/or biological product development efforts.

Measure of Success

Develop a methodology and architectural framework that can be used in programs within the biomedical industry. Success of this architectural framework will be seen in it being capable of accelerating the development of biomedical systems and successful implementation of those designed systems. In addition, the adoption of the framework by members of the healthcare community for their biomedical system development efforts is also a success metric.

Topic Overview / Description

The team will create a SysML model for use as a reference architecture to guide the development of medical devices and the necessary associated documentation. This effort is intended to demonstrate a biomedical application of model-based systems engineering (MBSE) by creating a system model consisting of a medical device, pharmaceutical product, and a human physiological system. In addition, unique applications of MBSE to medical device and pharmaceutical development will be explored, including the management of safety risks, usability, and unique regulatory and compliance challenges.

Task List

MilestoneDue DateStatusPoint of Contact
Develop MBSE Team modeling guideline CompleteSteve Corns and Chad Gibson
Update Biomedical-Healthcare MBSE Challenge Team Charter CompleteSteve Corns / Melissa Masters / Ajay Thukral / Jack Stein
Organize the model to allow integration of additional focus areas15-APR-2014Preliminary completeSteve Corns
Create structure for Standards-Regulations section of model30-Mar-2014InitiatedJack Stein
Elaborate on Safety Assurance / Risk Management section of the model 30-APR-2014 Initiated Jack Stein
Review proposal for updated model structure with Sandy Friedenthal04-Sept-2014InitiatedSteve Corns / Jack Stein / Ajay Thukral
Develop library of standards and regulations31-May-2014InitiatedAjay Thukral
Write Paper for INCOSE 2014 IS20-Jan-2014accepted Steve Corns / Ajay & Vijay Thukral / Dustin Nottage / Jack Stein
Develop Use Cases for using the framework03-Jul-2014Initiated Group

Schedule (all times EST/EDT)

MilestoneDateNotes
Kick-off Meeting06-Mar-2011 Completed
Weekly MeetingsEvery Thu WebEx at 3:00 pm (Organizer - Ajay Thukral)

Team Members

NamePreferred Email AddressTeam Role(s)Affiliations
Campeau, Greg gregcampeau@Hotmail.com ModelerINCOSE HWG
Castex, Julien Julien.Castex@adn.fr General Interest
Celentano, Mike Mike.Celentano@roche.com General InterestINCOSE HWG
Collins, Patricia patricia.collins@bd.com General Interest
Corns, Steven cornss at mst.eduTeam Leader / Wiki PageINCOSE HWG / Missouri University of Science and Technology
Friedenthal, Sanford safriedenthal@gmail.comTeam and Modeling MentorINCOSE MBSE Challenge Leadership / OMG
Gibson, Chad chad.gibson@incose.orgFormer Team Leader & Model Expert-AdminBattelle Memorial Institute
Lott, Michellemichelle.lott@cognition.us General InterestCognition Corporation
Malins, Robertrjmalins@eaglesummittech.comTeam Leader Eagle Summit Technology
Masters, Melissa MastersM@battelle.org General Interest
O'Niel, Meaghan meaghan.oneil@accenture.comGeneral Interest / HWG Leadership Liaison Accenture, Inc.
Pape, Deana dpape@ipmcinc.comGeneral InterestINCOSE HWG
Pape, Louis louis.e.pape-ii@boeing.comGeneral Interest
Ravitz, Alan alan.ravitz@jhuapl.eduGeneral InterestINCOSE HWG / John Hopkins Applied Physics Laboratory
Somers, Tagore tagore.somers@lilly.com General Interest
Stein, Jack jack.stein@incose.orgTeam Leader / Wiki Page / ModelerINCOSE HWG, INCOSE Risk Mgmt. WG, PMI-INCOSE Alliance WG / DSI, Inc.
Thukral, Ajay ajay.thukral@cientivegroup.comTeam Leader / Wiki Page / ModelerINCOSE HWG / Cientive Group
Thukral, Vijay vijay.thukral@cientivegroup.comGeneral Interest Cientive Group
Waterplas, ChristopheChristophe.Waterplas@resmed.com.auGeneral Interest Resmed Ltd

Contact a Team Leader if you are interested in joining the Team …

Tools

Atego and No Magic have volunteered copies of their software for working group members. Contact Steven Corns for access.

Model

A copy of the model is below. NOTE: This is a working version and should not be considered final.

Wiki Articles

Organize and list the article deliverables. Stakeholders need to find the deliverable articles through this wiki article organization.

Publication Area

A paper describing current progress has been submitted to the 2012 INCOSE IS: Gibson, C. and Corns, S. (2012) “A Model-based Reference Architecture for Medical Device Development”

Reference Information

NumberDescriptionReference Link
1Infusion PumpsInfusion Pumps
2Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] SubmissionsDraft Guidance,April 23, 2010
3Oversight of Clinical Investigations - A Risk-Based Approach to MonitoringOMB Control No. 0910-0733
4 INCOSE Healthcare Working Group (BWG)
5 Biomedical Healthcare Challenge Team Reference Repository
6 Tool Tips (Comments Embedded in the Model)
mbse/drugdelivery.txt · Last modified: 2014/12/14 19:04 by ajay.thukral_cientivegroup.com