MITRE SE Roles & Expectations: The MITRE systems engineer (SE) is expected to have a sound knowledge of the system being modeled and the software process for developing the model in order to provide effective technical guidance in the design and execution of plans to verify and/or validate a model, or to provide specialized technical expertise in the collection and analysis of varying types of data required to do so.
A MITRE SE is expected to be able to work directly with the developer of the system and the simulation model to provide technical insight into model verification and validation.
To this effect, a real-time Virtual Heart Model (VHM) has been developed to model the electrophysiological operation of the functioning (i.e.
during normal sinus rhythm) and malfunctioning (i.e. We present a methodology to construct a timed-automata model by extracting timing properties of the heart.
By connecting the VHM with a pacemaker model, we are able to pace and synchronize the heart during the onset of irregular heart rhythms.
The VHM has also been implemented on a hardware platform for closed-loop experimentation with existing and virtual medical devices.
M&S is used during development to explore the design trade space and inform design decisions, and in conjunction with testing and analysis to gain confidence that the design implementation is performing as expected, or to assist troubleshooting if it is not.
Validation is the process of determining the degree to which a simulation model and its associated data are an accurate representation of the real world from the perspective of the intended uses of the model .
This encompasses 41% of the devices recalled and continues to increase in frequency.
There is currently no formal methodology or open experimental platform to validate and verify the correct operation of medical device software.
INTRODUCTION The need to get the information across to owners and shareholders makes organizations seek alternatives to add promptness to their management processes, to enable better decision making and to boost competitive advantages.
The trend is not to just surmised to the company itself, but to the whole supply chain and to accomplish the strategic and tactical plan for the chain, in addition to the company's operations ().