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.
|Milestone||Due Date||Status||Point of Contact|
|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|
|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-Mar-2014||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-2014||Initiated||Steve Corns / Jack Stein / Ajay Thukral|
|Develop library of standards and regulations||31-May-2014||Initiated||Ajay Thukral|
|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|
|Weekly Meetings||Every Thu||WebEx at 3:00 pm (Organizer - Ajay Thukral)|
|Name||Preferred Email Address||Team Role(s)||Affiliations|
|Campeau, Greg||gregcampeau@Hotmail.com||Modeler||INCOSE HWG|
|Castex, Julien||Julien.Castex@adn.fr||General Interest|
|Celentano, Mike||Mike.Celentano@roche.com||General Interest||INCOSE HWG|
|Collins, Patriciafirstname.lastname@example.org||General Interest|
|Corns, Steven||cornss at mst.edu||Team Leader / Wiki Page||INCOSE HWG / Missouri University of Science and Technology|
|Friedenthal, Sanfordemail@example.com||Team and Modeling Mentor||INCOSE MBSE Challenge Leadership / OMG|
|Gibson, Chadfirstname.lastname@example.org||Former Team Leader & Model Expert-Admin||Battelle Memorial Institute|
|Lott, Michelleemail@example.com||General Interest||Cognition Corporation|
|Malins, Robertfirstname.lastname@example.org||Team Leader||Eagle Summit Technology|
|Masters, Melissa||MastersM@battelle.org||General Interest|
|O'Niel, Meaghanemail@example.com||General Interest / HWG Leadership Liaison||Accenture, Inc.|
|Pape, Deanafirstname.lastname@example.org||General Interest||INCOSE HWG|
|Pape, Louisemail@example.com||General Interest|
|Ravitz, Alanfirstname.lastname@example.org||General Interest||INCOSE HWG / John Hopkins Applied Physics Laboratory|
|Somers, Tagoreemail@example.com||General Interest|
|Stein, Jackfirstname.lastname@example.org||Team Leader / Wiki Page / Modeler||INCOSE HWG, INCOSE Risk Mgmt. WG, PMI-INCOSE Alliance WG / DSI, Inc.|
|Thukral, Ajayemail@example.com||Team Leader / Wiki Page / Modeler||INCOSE HWG / Cientive Group|
|Thukral, Vijayfirstname.lastname@example.org||General Interest||Cientive Group|
|Waterplas, Christophe||Christophe.Waterplas@resmed.com.au||General Interest||Resmed Ltd|
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.
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”
|1||Infusion Pumps||Infusion Pumps|
|2||Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions||Draft Guidance,April 23, 2010|
|3||Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring||OMB 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)|