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INCOSE MBSE Biomedical Working Group/Drug Delivery Model

INCOSE MBSE Biomedical Working Group/Drug Delivery Model. Project Overview: Involve BWG members in the use of MBSE and expand the application beyond defense and aerospace industry related projects.

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INCOSE MBSE Biomedical Working Group/Drug Delivery Model

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  1. INCOSE MBSEBiomedical Working Group/Drug Delivery Model • Project Overview: • Involve BWG members in the use of MBSE and expand the application beyond defense and aerospace industry related projects. • To develop a framework or template that can be used to accelerate the development and approval of biomedical devices. • Investigate the integration of risk and issues with regulatory environment. • Milestones for the year: • Elaborate on the model to provide a method to start a more specific project that could be applied to a detailed analysis for a specific device. • Incorporate Risk and Regulatory environment into framework • Include engineering technical risks and business risks • Expand model to include enterprise level views • Establish methods for introducing safety assurance within the established architecture. • Focus on patient impact from failures • Prepare a conference paper describing the process for submission to the INCOSE annual conference in 2014. • Prepare a briefing to be presented at the 2014 IW.

  2. INCOSE MBSEBiomedical Working Group/Drug Delivery Model • Recent Accomplishments: • MBSE short course for working group members. • Preliminary framework created. • Wiki site updated to share information on progress • How do members get involved: • Subject Matter Experts in device development are required to review the model (anyone with Pharma experience would also be greatly appreciated!) • Review the MBSE initiative and target goals of MBSE approaches: • Integration of models and data • Executable architectures • Trade studies associated with software and hardware specific models • Willingness to meet with group bi-weekly to review model (online and offline) will help! • Contact a MBSE initiative member in the BWG • Steven Corns (cornss@mst.edu) • Sandy Friedenthal (safriedenthal@gmail.com) • Jack Stein (jack.stein@me.com) • Ajay Thukral (ajay.thukral@cientivegroup.com)

  3. Objectives – 2013 Case Study: Generic Pump Library : Standards & Guidelines Reference Model Risk Assessment Publications

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