mbse:drugdelivery
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| ===== Purpose ===== | ===== 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 Biomedical-Healthcare Working Group (BHWG) members a reference design to adopt for their specific drug, device, and/or biological product development efforts. | + | 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 ===== | ===== Measure of Success ===== | ||
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| |Develop MBSE Team modeling guideline| |Complete|Steve Corns and Chad Gibson| | |Develop MBSE Team modeling guideline| |Complete|Steve Corns and Chad Gibson| | ||
| |Update Biomedical-Healthcare MBSE Challenge Team Charter| |Complete|Steve Corns / Melissa Masters / Ajay Thukral / Jack Stein| | |Update Biomedical-Healthcare MBSE Challenge Team Charter| |Complete|Steve Corns / Melissa Masters / Ajay Thukral / Jack Stein| | ||
| - | |Organize the model to allow integration of additional focus areas|15-Dec-2013|Preliminary complete|Steve Corns| | + | |Organize the model to allow integration of additional focus areas|15-APR-2014|Preliminary complete|Steve Corns| |
| - | |Create structure for Standards-Regulations section of model|30-Sept-2013|Initiated|Jack Stein| | + | |Create structure for Standards-Regulations section of model|30-Mar-2014|Initiated|Jack Stein| |
| - | |Elaborate on Safety Assurance / Risk Management section of the model| 31-Dec-2013 |Initiated |Jack 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 Friedenthal|04-Sept-2013|Initiated|Steve Corns / Jack Stein / Ajay Thukral| | + | |Review proposal for updated model structure with Sandy Friedenthal|04-Sept-2014|Initiated|Steve Corns / Jack Stein / Ajay Thukral| |
| - | |Develop library of standards and regulations|31-Dec-2013|Initiated|Ajay Thukral| | + | |Develop library of standards and regulations|31-May-2014|Initiated|Ajay Thukral| |
| - | |Write Paper for INCOSE 2014 IS|20-Jan-2014|Draft #1 Submitted, #2 in process |Steve Corns / Ajay & Vijay Thukral / Dustin Nottage / Jack Stein| | + | |Write Paper for INCOSE 2014 IS|20-Jan-2014|accepted |Steve Corns / Ajay & Vijay Thukral / Dustin Nottage / Jack Stein| |
| + | |Develop Use Cases for using the framework|03-Jul-2014|Initiated |Group| | ||
| ===== Schedule (all times EST/EDT) ===== | ===== Schedule (all times EST/EDT) ===== | ||
| ^Milestone^Date^Notes^ | ^Milestone^Date^Notes^ | ||
| |Kick-off Meeting|06-Mar-2011| Completed | | |Kick-off Meeting|06-Mar-2011| Completed | | ||
| - | |Bi-Weekly Meetings|Every other Wed.| A new one-hour time is being set beginning 04-Sept-2013| | + | |Bi-Weekly Meetings|Every Thur.| A new one-hour time is being set beginning 20-Feb-2014| |
| - | |Next Meeting|15-Jan-2014|WebEx at 12 Noon EST (Organizer - Steve Corns)| | + | |Next Meeting|9-Oct-2014|WebEx at 3:00 EST (Organizer - Steve Corns)| |
| ===== Team Members ===== | ===== Team Members ===== | ||
| ^Name^Preferred Email Address^Team Role(s)^Affiliations^ | ^Name^Preferred Email Address^Team Role(s)^Affiliations^ | ||
| - | |Campeau, Greg |gregcampeau at Hotmail.com |Modeler|INCOSE BHWG | | + | |Campeau, Greg |gregcampeau at Hotmail.com |Modeler|INCOSE HWG | |
| |Castex, Julien |Julien.Castex at adn.fr |General Interest| | | |Castex, Julien |Julien.Castex at adn.fr |General Interest| | | ||
| - | |Celentano, Mike |Mike.Celentano at roche.com |General Interest|INCOSE BHWG | | + | |Celentano, Mike |Mike.Celentano at roche.com |General Interest|INCOSE HWG | |
| |Collins, Patricia |patricia.collins at bd.com |General Interest| | | |Collins, Patricia |patricia.collins at bd.com |General Interest| | | ||
| - | |Corns, Steven |cornss at mst.edu|Team Leader / Wiki Page|INCOSE BHWG / Missouri University of Science and Technology| | + | |Corns, Steven |cornss at mst.edu|Team Leader / Wiki Page|INCOSE HWG / Missouri University of Science and Technology| |
| |Friedenthal, Sanford |safriedenthal at gmail.com|Team and Modeling Mentor|INCOSE MBSE Challenge Leadership / OMG | | |Friedenthal, Sanford |safriedenthal at gmail.com|Team and Modeling Mentor|INCOSE MBSE Challenge Leadership / OMG | | ||
| |Gibson, Chad |chad.gibson at incose.org|Former Team Leader & Model Expert-Admin|Battelle Memorial Institute| | |Gibson, Chad |chad.gibson at incose.org|Former Team Leader & Model Expert-Admin|Battelle Memorial Institute| | ||
| - | |Laux, Channy |Channy_Laux at bd.com |General Interest| | | ||
| |Masters, Melissa |MastersM at battelle.org |General Interest| | | |Masters, Melissa |MastersM at battelle.org |General Interest| | | ||
| - | |O'Niel, Meaghan |meaghan.oneil at accenture.com|General Interest / BHWG Leadership Liaison|INCOSE BHWG (Co-Chair) / Accenture, Inc. | | + | |O'Niel, Meaghan |meaghan.oneil at accenture.com|General Interest / HWG Leadership Liaison| Accenture, Inc. | |
| - | |Pape, Deana |[email protected]|General Interest|INCOSE BHWG | | + | |Pape, Deana |[email protected]|General Interest|INCOSE HWG | |
| |Pape, Louis |louis.e.pape-ii at boeing.com|General Interest| | | |Pape, Louis |louis.e.pape-ii at boeing.com|General Interest| | | ||
| - | |Ravitz, Alan |[email protected]|General Interest|INCOSE BHWG / John Hopkins Applied Physics Laboratory| | + | |Ravitz, Alan |[email protected]|General Interest|INCOSE HWG / John Hopkins Applied Physics Laboratory| |
| |Somers, Tagore |tagore.somers at lilly.com |General Interest| | | |Somers, Tagore |tagore.somers at lilly.com |General Interest| | | ||
| - | |Stein, Jack |jack.stein at incose.org|Team Leader / Wiki Page / Modeler|INCOSE BHWG, INCOSE Risk Mgmt. WG, PMI-INCOSE Alliance WG / DSI, Inc.| | + | |Stein, Jack |jack.stein at incose.org|Team Leader / Wiki Page / Modeler|INCOSE HWG, INCOSE Risk Mgmt. WG, PMI-INCOSE Alliance WG / DSI, Inc.| |
| - | |Thukral, Ajay |ajay.thukral at cientivegroup.com|Team Leader / Wiki Page / Modeler|INCOSE BHWG / Cientive Group | | + | |Thukral, Ajay |ajay.thukral at cientivegroup.com|Team Leader / Wiki Page / Modeler|INCOSE HWG / Cientive Group | |
| + | |Thukral, Vijay |vijay.thukral at cientivegroup.com|General Interest | Cientive Group | | ||
| + | |Ravitz, Alan |Alan.Ravitz at jhuapl.edu|General Interest | Johns Hopkins University | | ||
| + | |Waterplas, Christophe|Christophe.Waterplas at resmed.com.au|General Interest | Resmed Ltd | | ||
| + | |Malins, Robert|rjmalins at eaglesummittech.com|General Interest | Eagle Summit Technology | | ||
| Contact a Team Leader if you are interested in joining the Team ... | Contact a Team Leader if you are interested in joining the Team ... | ||
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| * {{http://web.mst.edu/~cornss/incose/Drug Delivery Project 2011-08-18.zip| MOF}} (Meta-Object Facility format) | * {{http://web.mst.edu/~cornss/incose/Drug Delivery Project 2011-08-18.zip| MOF}} (Meta-Object Facility format) | ||
| * {{:mbse:is_2013_slides.pptx|Powerpoint IS-2013-Slides}} | * {{:mbse:is_2013_slides.pptx|Powerpoint IS-2013-Slides}} | ||
| - | * {{http://web.mst.edu/~cornss/incose/IW2014BHWGCT.ppt| Update Presentation from INCOSE IW 2014}} | + | * {{http://web.mst.edu/~cornss/incose/IW2014BHWGCT.pptx| Update Presentation from INCOSE IW 2014}} |
| - | * {{http://web.mst.edu/~cornss/incose/Applying_MBSE_to_ECMO_Therapy.ppt| Presentation by Drew Piera at INCOSE IW 2014}} | + | * {{http://web.mst.edu/~cornss/incose/Applying_MBSE_to_ECMO_Therapy.pptx| Presentation by Drew Piera at INCOSE IW 2014}} |
| ===== Wiki Articles ===== | ===== Wiki Articles ===== | ||
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| |2|Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions|[[http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM209337.pdf|Draft Guidance,April 23, 2010]]| | |2|Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions|[[http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM209337.pdf|Draft Guidance,April 23, 2010]]| | ||
| |3|Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring|[[http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf|OMB Control No. 0910-0733]]| | |3|Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring|[[http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf|OMB Control No. 0910-0733]]| | ||
| - | |4| |[[http://www.incose.org/practice/techactivities/wg/biomed/|INCOSE Biomedical Working Group (BWG)]]| | + | |4| |[[http://www.incose.org/practice/techactivities/wg/biomed/|INCOSE Healthcare Working Group (BWG)]]| |
| - | |5| |[[http://web.mst.edu/~cornss/INCOSE/MBSE_Biomedical_Challenge_Team/|Biomedical Challenge Team Reference Repository]]| | + | |5| |[[http://web.mst.edu/~cornss/INCOSE/MBSE_Biomedical_Healthcare_Challenge_Team/|Biomedical Healthcare Challenge Team Reference Repository]]| |
| |6| |[[mbse:drugdelivery:tooltips|Tool Tips (Comments Embedded in the Model)]]| | |6| |[[mbse:drugdelivery:tooltips|Tool Tips (Comments Embedded in the Model)]]| | ||
mbse/drugdelivery.txt · Last modified: 2014/12/14 19:04 by ajay.thukral_cientivegroup.com
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