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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 Healthcare Working Group (HWG) 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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|Review proposal for updated model structure with Sandy Friedenthal|04-Sept-2014|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-May-2014|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 |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| | |Develop Use Cases for using the framework|03-Jul-2014|Initiated |Group| | ||