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.

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.

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.

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

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

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

• Last Update: 14Aug2013
• DrugDeliveryModel22Feb2013.html (Interactive Web format - Viewable with your browser)
• Model- February 22, 2013 (Magcidraw format)
• biomed_mbse_team_sysml_model_22-feb-2013_standard_zip_for_wiki_upload_trial_.zip| Model- February 22, 2013}} (Magcidraw format but standard zipped for Wiki upload)
• MOF (Meta-Object Facility format)
• Powerpoint IS-2013-Slides
• Update Presentation from INCOSE IW 2014
• Presentation by Drew Piera at INCOSE IW 2014

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

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”