L. Drew Pihera’s research while affiliated with Georgia Tech Research Institute and other places

ECMO therapy is used to treat patients with severe cardiac and/or respiratory failure and has been shown to improve patient survival rates.ECMO was introduced in the 1970’s and is now used in more than 230 medical centers worldwide.Despite the widespread use of ECMO therapy, the technology has not been subjected to the rigorous development cycle needed to improve system performance and correlate system architectures to patient outcomes.For example, the lack of formal standards for the arrangement of components that make up the ECMO circuit have resulted in a large number of unique ECMO solutions with unknown differential effectiveness.In addition, best practices for operation and maintenance, or training and certification of ECMO specialists are areas of the ECMO domain that have not been explored.Collaboration between systems engineering (SE) and medical professionals leverages SE principles to understand and solve ECMO technological and safety challenges.In the following case study, the SE approach is used to evaluate a children’s hospital’s ECMO system using model based systems engineering (MBSE) to capture the ECMO domain, concept of operations, need statement, high level use cases, requirements, system and user behaviors, and both abstract and physical structural designs.The system model is then used to enable the development of an ECMO Data Collaboration Tool (EDCT) concept that will one day allow the medical community to document ECMO circuits for best-of-breed analyses.

This chapter investigates several extracorporeal membrane oxygenation (ECMO) circuits, characterizes the system of systems (SoS) architecture using Model-Based Systems Engineering (MBSE), and offers recommendations for the medical community in implementing Systems Engineering (SE) best practices. It introduces modeling efforts undertaken for the improvement of ECMO, a fielded and complex medical system that had been constructed in an ad hoc and unstructured manner. The chapter examines why the various models were used and how they fostered communication from the engineers to the medical staff and vice versa, from the medical staff to the engineers. It provides an overview of MBSE and an introduction to the modeling techniques one used to characterize this stage of ECMO. The chapter describes the first phase modeling process and also describes the refinement and extension of the model in the second phase. Finally, it provides recommendations on where future modeling and simulation (M&S) can be applied.

The Department of Defense (DoD)’s Science & Technology (S&T) priority for Engineered Resilient Systems (ERS) calls for adaptable designs with diverse system models that can easily be modified and re-used, the ability to iterate designs quickly and a clear linkage to mission needs. Towards this end, tradespace analysis is of great importance. The Georgia Tech Research Institute (GTRI) has been developing web-based, collaborative modeling and simulation tools that use a Model-Based Systems Engineering approach to address the analysis of alternatives for acquisition programs to assess cost, schedule and performance risk; of particular note is the United States Marines Corps (USMC) funded Framework for Assessing Cost and Technology (FACT). In parallel, the United States (U.S.) Army Research Laboratory (ARL) has been pursuing the Executable Architecture Systems Engineering (EASE) research project, which links analytical, experimental and training objectives with the technical complexity of modeling and simulation in an easy to use, scalable tool. This paper details an effort to develop a formal Application Programming Interface (API) between FACT and EASE, which creates the ability to develop system concepts and assess Measures of Performance (in FACT), and then send those system concepts to a combat simulation to assess Measures of Effectiveness (through EASE), and finally back to FACT for a high-level trade study. It further describes a proof-of-concept demonstration using a Force Protection use case that allows a user to tune parameters of detection on an unmanned platform that is then simulated in an operational scenario to collect performance data. This effort effectively lays the framework for future simulation-enabled tradespace analysis that will be a pillar of ERS and can be adapted by other simulation efforts.

Extracorporeal Membrane Oxygenation (ECMO) therapy provides stable heart and lung functions via mechanical means for patients with severe but reversible cardiac or respiratory failure [1]. As a result, the survival rate of these patients can improve from 25% to nearly 75% [2]. While there are over 235 medical centers world-wide that employ ECMO [3], no formal standards exist for the composition of an ECMO ‘circuit,’ best practices for operation and maintenance, or training and certification of ECMO specialists. Since 2011 the Professional Masters of Applied Systems Engineering (PMASE) program at the Georgia Institute of Technology (GIT) and medical staff from ECMO centers have collaborated to characterize and improve upon state- of-the-art ECMO therapies. This paper details the collaborators’ work in applying systems engineering principles and practices to ECMO therapies including the use of model based systems engineering (MBSE) to capture the ECMO domain, concept of operations, need statement, high level use cases, requirements, system and user behaviors, and both abstract and concrete structural designs. Finally, the paper explains how this work is applicable towards improvements in data collection, human factors, trade-off analysis for future technology insertions, and other ECMO improvement projects.

Extracorporeal Membrane Oxygenation (ECMO) is a vital lifesaving therapy. Though it has achieved approximately 75% survival rates for patients starting with less than a 25% chance of survival, ECMO was not designed and implemented in a rigorous engineering process. This paper will introduce a Systems of Systems (SoS) Engineering approach to characterizing the ECMO architecture and formally documenting it using Model Based Systems Engineering (MBSE), developed in a partnership between Children's Healthcare of Atlanta (CHOA) and the Georgia Institute of Technology's Professional Masters of Applied Systems Engineering (PMASE) program. Finally, the authors will describe possible areas of future work that may be undertaken as projects for future PMASE cohorts or others. The primary and unique contribution of this work is an initial application of formal MBSE to one of the most complex medical system of systems.

Though able to boost survival rates from below 25% to nearly 75% in patients that qualify for treatment, the complexity of the currently implemented Extracorporeal Membrane Oxygenation (ECMO) system of systems keeps it from being used across an even wider range of patients. Representatives from the Children's Healthcare of Atlanta asked a team from the Georgia Tech Professional Masters in Applied Systems Engineering for assistance in reducing the complexity of the current implementation as well as help provide a way forward for future improvement to the therapy. This paper examines the application of systems engineering methodologies as performed by the team, including Model Based Systems Engineering (MBSE), gap analysis of the system architecture and data visualization prototyping. Additionally the paper describes how the selection of tools and models fostered dialog between two groups of distinctly different backgrounds and provides a proposed roadmap for robust system design, development and future work.