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Using A Model-Based Systems Engineering Approach For Exploration Medical System Development

NASA's Human Research Program's Exploration Medical Capabilities (ExMC) element is defining the medical system needs for exploration class missions. ExMC's Systems Engineering (SE) team will play a critical role in successful design and implementation of the medical system into exploration vehicles. The team's mission is to "Define, develop, validate, and manage the technical system design needed to implement exploration medical capabilities for Mars and test the design in a progression of proving grounds." Development of the medical system is being conducted in parallel with exploration mission architecture and vehicle design development. Successful implementation of the medical system in this environment will require a robust systems engineering approach to enable technical communication across communities to create a common mental model of the emergent engineering and medical systems. Model-Based Systems Engineering (MBSE) improves shared understanding of system needs and constraints between stakeholders and offers a common language for analysis. The ExMC SE team is using MBSE techniques to define operational needs, decompose requirements and architecture, and identify medical capabilities needed to support human exploration. Systems Modeling Language (SysML) is the specific language the SE team is utilizing, within an MBSE approach, to model the medical system functional needs, requirements, and architecture. Modeling methods are being developed through the practice of MBSE within the team, and tools are being selected to support meta-data exchange as integration points to other system models are identified. Use of MBSE is supporting the development of relationships across disciplines and NASA Centers to build trust and enable teamwork, enhance visibility of team goals, foster a culture of unbiased learning and serving, and be responsive to customer needs. The MBSE approach to medical system design offers a paradigm shift toward greater integration between vehicle and the medical system and directly supports the transition of Earth-reliant ISS operations to the Earth-independent operations envisioned for Mars. Here, we describe the methods and approach to building this integrated model.

Hanson, A.

Exploration Medical System Technical Development

The Exploration Medical Capability (ExMC) Element systems engineering goals include defining the technical system needed to implement exploration medical capabilities for Mars. This past year, scenarios captured in the medical system concept of operations laid the foundation for systems engineering technical development work. The systems engineering team analyzed scenario content to identify interactions between the medical system, crewmembers, the exploration vehicle, and the ground system. This enabled the definition of functions the medical system must provide and interfaces to crewmembers and other systems. These analyses additionally lead to the development of a conceptual medical system architecture. The work supports the ExMC community-wide understanding of the functional exploration needs to be met by the medical system, the subsequent development of medical system requirements, and the system verification and validation approach utilizing terrestrial analogs and precursor exploration missions.

McGuire, K.

Evaluating the Viability of Compact and Portable X-Ray Systems for an Exploration Medical System in a Ground Demonstration

MOTIVATION FOR INCLUDING X-RAY CAPABILITIES For upcoming exploration missions, the need for enhanced medical care becomes critical due to extended mission durations, significant communication delays, and minimal evacuation opportunities. Previous evidence by our team has revealed that among the 119 medical conditions targeted for management during spaceflight within NASA Exploration Medical Capability’s IMPACT Condition List, at least 36 could benefit from radiography (XR). Utilizing XR for diagnosis and management is hypothesized to significantly improve management of crew health by enabling the immediate evaluation and confirmation of potential injuries or illnesses. Beyond clinical applications, XR also holds potential for non-destructive testing (NDT). This includes applications such as assessing the structural integrity of the spacecraft, analyzing surface and meteorite samples, and inspecting onboard electronics. THREE CANDIDATE X-RAY SYSTEMS CHOSEN FOR GROUND DEMONSTRATION The Exploration Medical Capability Element (ExMC) and the Exploration Medical Integrated Product Team (XMIPT) of the Mars Campaign Office initiated early background work for ground demonstrations. In FY21, ExMC published a Concept of Operations to guide requirements development. By FY23, XMIPT and yet2, a technology scouting and open innovation consulting firm, had completed a market survey and trade study to identify potential miniature XR systems. Selection criteria included commercial-off-the-shelf availability, low mass and volume, and regulatory compliance. The top three candidate devices—Remedi REMEX-KA6, MinXray Impact, and FujiFilm Xair—were acquired to characterize the requirements and capabilities of each device. To facilitate testing, phantoms, and radiographic personal protective equipment (PPE) were purchased, and a dedicated space was designated for XRS usage at Glenn Research Center. During this presentation, the mass, volume, and power requirements for each of the three piloted devices are revealed, as well as information regarding the detector, mA, and kV of the devices. GOAL AND OBJECTIVES OF A MINI XRS GROUND DEMONSTRATION The primary goal of ExMC/XMIPT technology demonstrations is to bridge the gap in available, flight-ready medical device technology by flight-testing diagnostic and treatment technologies essential for managing medical conditions during exploration missions. These technologies must adhere to vehicle constraints such as mass, volume, power, and data requirements, integrate seamlessly with medical decision-support tools, and support increasingly Earth-independent operations. There are three main objectives for the future ground demonstration of these three devices. First, we aim to determine the full capabilities of these three miniature XR systems within the context of the spaceflight environment. While medical applications are the primary focus for the miniature XR, a comprehensive exploration of non-medical uses has been initiated by an XMIPT-sponsored NASA SPARK campaign to identify collaborators. Second, we plan to establish criteria and to use insights gained from evaluating each miniature XR against those criteria to select the most suitable system among the three candidates. Third, we intend to evaluate their suitability for flight certification, which includes assessing its durability for launch, reentry, and exposure to high background radiation, as well as its compatibility with existing data architecture systems. Numerous subject matter experts from NASA and partner institutions will support these objectives.

C A Haddix

Exploration Medical System Demonstration

BACKGROUND: Exploration class missions will present significant new challenges and hazards to the health of the astronauts. Regardless of the intended destination, beyond low Earth orbit a greater degree of crew autonomy will be required to diagnose medical conditions, develop treatment plans, and implement procedures due to limited communications with ground-based personnel. SCOPE: The Exploration Medical System Demonstration (EMSD) project will act as a test bed on the International Space Station (ISS) to demonstrate to crew and ground personnel that an end-to-end medical system can assist clinician and non-clinician crew members in optimizing medical care delivery and data management during an exploration mission. Challenges facing exploration mission medical care include limited resources, inability to evacuate to Earth during many mission phases, and potential rendering of medical care by non-clinicians. This system demonstrates the integration of medical devices and informatics tools for managing evidence and decision making and can be designed to assist crewmembers in nominal, non-emergent situations and in emergent situations when they may be suffering from performance decrements due to environmental, physiological or other factors. PROJECT OBJECTIVES: The objectives of the EMSD project are to: a. Reduce or eliminate the time required of an on-orbit crew and ground personnel to access, transfer, and manipulate medical data. b. Demonstrate that the on-orbit crew has the ability to access medical data/information via an intuitive and crew-friendly solution to aid in the treatment of a medical condition. c. Develop a common data management framework that can be ubiquitously used to automate repetitive data collection, management, and communications tasks for all activities pertaining to crew health and life sciences. d. Ensure crew access to medical data during periods of restricted ground communication. e. Develop a common data management framework that allows for scalability, extensibility, and interoperability of data sources and data users. f. Lower total cost of ownership for development and sustainment of peripheral hardware and software that use EMSD for data management. g. Provide a better standard of healthcare for crew members through reductions in the time required by crew and ground personnel to provide medical treatment and the number of crew errors experienced during treatment.

Rubin, D. A.

Exploration Medical System Demonstration (EMSD) Project

The Exploration Medical System Demonstration (EMSD) is a project under the Exploration Medical Capability (ExMC) element managed by the Human Research Program (HRP). The vision for the EMSD is to utilize ISS as a test bed to show that several medical technologies needed for an exploration mission and medical informatics tools for managing evidence and decision making can be integrated into a single system and used by the on-orbit crew in an efficient and meaningful manner. Objectives: a) Reduce and even possibly eliminate the time required for on-orbit crew and ground personnel (which include Surgeon, Biomedical Engineer (BME) Flight Controller, and Medical Operations Data Specialist) to access and move medical data from one application to another. b) Demonstrate that the on-orbit crew has the ability to access medical data/information using an intuitive and crew-friendly software solution to assist/aid in the treatment of a medical condition. c) Develop a common data management framework and architecture that can be ubiquitously used to automate repetitive data collection, management, and communications tasks for all crew health and life sciences activities.

Chin, Duane

Exploration Medical System Technical Architecture Overview

The Exploration Medical Capability (ExMC) Element Systems Engineering (SE) goals include defining the technical system needed to support medical capabilities for a Mars exploration mission. A draft medical system architecture was developed based on stakeholder needs, system goals, and system behaviors, as captured in an ExMC concept of operations document and a system model. This talk will discuss a high-level view of the medical system, as part of a larger crew health and performance system, both of which will support crew during Deep Space Transport missions. Other mission components, such as the flight system, ground system, caregiver, and patient, will be discussed as aspects of the context because the medical system will have important interactions with each. Additionally, important interactions with other aspects of the crew health and performance system are anticipated, such as health & wellness, mission task performance support, and environmental protection. This talk will highlight areas in which we are working with other disciplines to understand these interactions.

Cerro, J.

Conceptual Drivers for an Exploration Medical System

Interplanetary spaceflight, such as NASA's proposed three-year mission to Mars, provides unique and novel challenges when compared with human spaceflight to date. Extended distance and multi-year missions introduce new elements of operational complexity and additional risk. These elements include: inability to resupply medications and consumables, inability to evacuate injured or ill crew, uncharted psychosocial conditions, and communication delays that create a requirement for some level of autonomous medical capability. Because of these unique challenges, the approaches used in prior programs have limited application to a Mars mission. On a Mars mission, resource limitations will significantly constrain available medical capabilities, and require a paradigm shift in the approach to medical system design and risk mitigation for crew health. To respond to this need for a new paradigm, the Exploration Medical Capability (ExMC) Element is assessing each Mars mission phase-transit, surface stay, rendezvous, extravehicular activity, and return-to identify and prioritize medical needs for the journey beyond low Earth orbit (LEO). ExMC is addressing both planned medical operations, and unplanned contingency medical operations that meld clinical needs and research needs into a single system. This assessment is being used to derive a gap analysis and studies to support meaningful medical capabilities trades. These trades, in turn, allow the exploration medical system design to proceed from both a mission centric and ethics-based approach, and to manage the risks associated with the medical limitations inherent in an exploration class mission. This paper outlines the conceptual drivers used to derive medical system and vehicle needs from an integrated vision of how medical care will be provided within this paradigm. Keywords: (Max 6 keywords: exploration, medicine, spaceflight, Mars, research, NASA)

Antonsen, Erik

Enabling Space Exploration Medical System Development Using a Tool Ecosystem

The NASA Human Research Program’s (HRP) Exploration Medical Capability (ExMC) Element is utilizing a Model Based Systems Engineering (MBSE) approach to enhance the development of systems engineering products that will be used to advance medical system designs for exploration missions beyond Low Earth Orbit. In support of future missions, the team is capturing content such as system behaviors, functional decompositions, architecture, system requirements and interfaces, and recommendations for clinical capabilities and resources in Systems Modeling Language (SysML) models. As these products mature, SysML models provide a way for ExMC to capture relationships among the various products, which includes supporting more integrated and multi-faceted views of future medical systems. In addition to using SysML models, HRP and ExMC are developing supplementary tools to support two key functions: 1) prioritizing current and future research activities for exploration missions in an objective manner; and 2) enabling risk-informed and evidence-based trade space analysis for future space vehicles, missions, and systems. This paper will discuss the long-term HRP and ExMC vision for the larger ecosystem of tools, which include dynamic Probabilistic Risk Assessment (PRA) capabilities, additional SysML models, a database of system component options, and data visualizations. It also includes a review of an initial Pilot Project focused on enabling medical system trade studies utilizing data that is coordinated across tools for consistent outputs (e.g., mission risk metrics that are associated with medical system mass values and medical conditions addressed). This first Pilot Project demonstrated successful operating procedures and integration across tools. Finally, the paper will also cover a second Pilot Project that utilizes tool enhancements such as medical system optimization capabilities, post-processing, and visualization of generated data for subject matter expert review, and increased integration amongst the tools themselves.

Amador, Jennifer R.

Enabling Space Exploration Medical System Development Using a Tool Ecosystem

The NASA Human Research Program's (HRP) Exploration Medical Capability (ExMC) Element is utilizing a Model Based Systems Engineering (MBSE) approach to enhance the development of systems engineering products that will be used to advance medical system designs for exploration missions beyond Low Earth Orbit. In support of future missions, the team is capturing content such as system behaviors, functional decompositions, architecture, system requirements and interfaces, and recommendations for clinical capabilities and resources in Systems Modeling Language (SysML) models. As these products mature, SysML models provide a way for ExMC to capture relationships among the various products, which includes supporting more integrated and multi-faceted views of future medical systems. In addition to using SysML models, HRP and ExMC are developing supplementary tools to support two key functions: 1) prioritizing current and future research activities for exploration missions in an objective manner; and 2) enabling risk-informed and evidence-based trade space analysis for future space vehicles, missions, and systems. This paper will discuss the long-term HRP and ExMC vision for the larger ecosystem of tools, which include dynamic Probabilistic Risk Assessment (PRA) capabilities, additional SysML models, a database of system component options, and data visualizations. It also includes a review of an initial Pilot Project focused on enabling medical system trade studies utilizing data that is coordinated across tools for consistent outputs (e.g., mission risk metrics that are associated with medical system mass values and medical conditions addressed). This first Pilot Project demonstrated successful operating procedures and integration across tools. Finally, the paper will also cover a second Pilot Project that utilizes tool enhancements such as medical system optimization capabilities, post-processing, and visualization of generated data for subject matter expert review, and increased integration amongst the tools themselves.

Amador, Jennifer R.

Exploration Medical System Demonstration Project

A near-Earth Asteroid (NEA) mission will present significant new challenges including hazards to crew health created by exploring a beyond low earth orbit destination, traversing the terrain of asteroid surfaces, and the effects of variable gravity environments. Limited communications with ground-based personnel for diagnosis and consultation of medical events require increased crew autonomy when diagnosing conditions, creating treatment plans, and executing procedures. Scope: The Exploration Medical System Demonstration (EMSD) project will be a test bed on the International Space Station (ISS) to show an end-to-end medical system assisting the Crew Medical Officers (CMO) in optimizing medical care delivery and medical data management during a mission. NEA medical care challenges include resource and resupply constraints limiting the extent to which medical conditions can be treated, inability to evacuate to Earth during many mission phases, and rendering of medical care by a non-clinician. The system demonstrates the integration of medical technologies and medical informatics tools for managing evidence and decision making. Project Objectives: The objectives of the EMSD project are to: a) Reduce and possibly eliminate the time required for a crewmember and ground personnel to manage medical data from one application to another. b) Demonstrate crewmember's ability to access medical data/information via a software solution to assist/aid in the treatment of a medical condition. c) Develop a common data management architecture that can be ubiquitously used to automate repetitive data collection, management, and communications tasks for all crew health and life sciences activities. d) Develop a common data management architecture that allows for scalability, extensibility, and interoperability of data sources and data users. e) Lower total cost of ownership for development and sustainment of peripheral hardware and software that use EMSD for data management f) Provide better crew health via the reduction in crew errors, crew time, and ground time.

Chin, D. A.

Overview of an Integrated Medical System for Exploration Missions

The Exploration Medical Capability (ExMC) element of the NASA Human Research Program (HRP) is charged with addressing the risk of unacceptable health and mission outcomes due to limitations of inflight medical capabilities. The Exploration Medical System Demonstration (EMSD) is a project within the ExMC element aimed at reducing this risk by improving the medical capabilities available for exploration missions. The EMSD project will demonstrate, on the ground and on ISS, the integration of several components felt to be essential to the delivery of medical care during long ]duration missions outside of low Earth orbit. The components of the EMSD include the electronic medical record, assisted medical procedure software, medical consumables tracking technology and RFID ] tagged consumables, video conferencing capability, ultrasound device and probes (ground demonstration only), peripheral biosensors, and the software to allow communication among the various components (middleware). This presentation seeks to inform our international partners of the goals and objectives of the EMSD and to foster collaboration opportunities related to this and future projects.

Watkins, Sharmila

Conceptual Drivers for an Exploration Medical System

Interplanetary spaceflight provides unique challenges that have not been encountered in prior spaceflight experience. Extended distance and timeframes introduce new challenges such as an inability to resupply medications and consumables, inability to evacuate injured or ill crew, and communication delays that introduce a requirement for some level of autonomous medical capability. Because of these challenges the approaches used in prior programs have limited application to a proposed three year Mars mission. This paper proposes a paradigm shift in the approach to medical risk mitigation for crew health and mission objectives threatened by inadequate medical capabilities in the setting of severely limited resources. A conceptual approach is outlined to derive medical system and vehicle needs from an integrated vision of how medical care will be provided within this new paradigm. Using NASA Design Reference Missions this process assesses each mission phase to deconstruct medical needs at any point during a mission. Two operational categories are proposed, nominal operations (pre-planned activities) and contingency operations (medical conditions requiring evaluation) that meld clinical needs and research needs into a single system. These definitions are used to derive a task level analysis to support quantifiable studies into a medical capabilities trade. This trade allows system design to proceed from both a mission centric and ethics-based approach to medical limitations in an exploration class mission.

Antonsen, E.

Exploration Medical System Trade Study Tools Overview

ExMC is creating an ecosystem of tools to enable well-informed medical system trade studies. The suite of tools address important system implementation aspects of the space medical capabilities trade space and are being built using knowledge from the medical community regarding the unique aspects of space flight. Two integrating models, a systems engineering model and a medical risk analysis model, tie the tools together to produce an integrated assessment of the medical system and its ability to achieve medical system target requirements. This presentation will provide an overview of the various tools that are a part of the tool ecosystem. Initially, the presentation's focus will address the tools that supply the foundational information to the ecosystem. Specifically, the talk will describe how information that describes how medicine will be practiced is captured and categorized for efficient utilization in the tool suite. For example, the talk will include capturing what conditions will be planned for in-mission treatment, planned medical activities (e.g., periodic physical exam), required medical capabilities (e.g., provide imaging), and options to implement the capabilities (e.g., an ultrasound device). Database storage and configuration management will also be discussed. The presentation will include an overview of how these information tools will be tied to parameters in a Systems Modeling Language (SysML) model, allowing traceability to system behavioral, structural, and requirements content. The discussion will also describe an HRP-led enhanced risk assessment model developed to provide quantitative insight into each capability's contribution to mission success. Key outputs from these various tools, to be shared with the space medical and exploration mission development communities, will be assessments of medical system implementation option satisfaction of requirements and per-capability contributions toward achieving requirements.

Mindock, J.

Autonomous, In-Flight Crew Health Risk Management for Exploration-Class Missions: Leveraging the Integrated Medical Model for the Exploration Medical System Demonstration Project

The Integrated Medical Model (IMM) captures organizational knowledge across the space medicine, training, operations, engineering, and research domains. IMM uses this knowledge in the context of a mission and crew profile to forecast risks to crew health and mission success. The IMM establishes a quantified, statistical relationship among medical conditions, risk factors, available medical resources, and crew health and mission outcomes. These relationships may provide an appropriate foundation for developing an in-flight medical decision support tool that helps optimize the use of medical resources and assists in overall crew health management by an autonomous crew with extremely limited interactions with ground support personnel and no chance of resupply.

Butler, D. J.