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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.↗

Long Duration Medical System Foundation for Lunar Orbital and Lunar Surface Exploration Missions

For long-duration lunar orbital and lunar surface (LDLOS) exploration missions, the NASA Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has developed a medical system foundation through which clinical considerations may be represented via a systems engineering-based model. Components of the Long Duration Medical System Foundation model include a concept of operations (ConOps), functional decomposition, medical conditions to be addressed, clinical capabilities and resources, technical requirements, and traces of requirements to NASA standards documents and parent-level (Program- and Vehicle habitat system-level) requirements. The Foundation model offers the means to present information in a readily accessible format that is understandable across all clinical, engineering, scientific, and managerial disciplines. Collectively, these components constitute a foundation that serves future programs with similar long duration mission profiles as a starting point for medical system design. The Foundation was developed by a multidisciplinary team of systems engineers, scientists, and clinicians across NASA. The process started with ConOps development, subsequently decomposed into the functionalities needed to diagnose, treat, and prevent medical conditions. The clinical team identified medical conditions most likely needed to be diagnosed and treated during a long-duration lunar exploration mission. Through these approaches, requirements were codified for the LDLOS medical system. These requirements were then traced to NASA standards, medical conditions, medical capabilities, and medical resources, facilitating stakeholders’ use of the Foundation model to analyze traces and to identify medical system interfaces with other vehicle systems or subsystems. In addition, the Foundation may be used as a basis for performing risk trades on medical system mass and volume allocation. This discussion will focus on the processes through which the LDLOS Medical System Foundation was developed, how the Foundation builds a bridge between the medical and engineering domains, and how these processes may be applied more broadly to a crew health and performance system and other system domains.

Jay Lemery↗

Medical System Concept of Operations for Mars Exploration Mission-11: Exploration Medical Capability (ExMC) Element - Human Research Program

NASA’s exploration missions to Mars will have durations of 2-3 years and will take humans farther away from Earth than ever before. This will result in a paradigm shift for mission planning, spacecraft design, human systems integration, and in-flight medical care. Constraints on real-time communication, resupply, and medical evacuation are major architectural drivers. These constraints require medical system development to be tightly integrated with mission and vehicle design to provide crew autonomy and enable mission success. This concept of operations provides a common vision of medical care for developing a medical system for Mars exploration missions. It documents an overview of the stakeholder needs and goals of a medical system and provides examples of the types of activities the system will be used for during the mission. Development of the concept of operations considers mission variables such as distance from Earth, duration of mission, time to definitive medical care, communication protocols between crewmembers and ground support, personnel capabilities and skill sets, medical hardware and software, and medical data management. The information provided in this document informs the ExMC Systems Engineering effort to define the functions to be provided by the medical system. In addition, this concept of operations will inform the subsequent systems engineering process of developing technical requirements, system architectures, interfaces, and verification and validation approaches for the medical system. This document supports the closure of ExMC Gap Med01: We do not have a concept of operations for medical care during exploration missions, corresponding to the ExMC-managed human system risk: Risk of Adverse Health Outcomes & Decrements in Performance due to Inflight Medical Conditions. This document is applicable to the ExMC Element Systems Engineering process and may be used for collaboration within the Human Research Program.

Urbina, Michelle↗

The Integrated Medical Model - Optimizing In-flight Space Medical Systems to Reduce Crew Health Risk and Mission Impacts

The Integrated Medical Model (IMM) is a decision support tool used by medical system planners and designers as they prepare for exploration planning activities of the Constellation program (CxP). IMM provides an evidence-based approach to help optimize the allocation of in-flight medical resources for a specified level of risk within spacecraft operational constraints. Eighty medical conditions and associated resources are represented in IMM. Nine conditions are due to Space Adaptation Syndrome. The IMM helps answer fundamental medical mission planning questions such as What medical conditions can be expected? What type and quantity of medical resources are most likely to be used?", and "What is the probability of crew death or evacuation due to medical events?" For a specified mission and crew profile, the IMM effectively characterizes the sequence of events that could potentially occur should a medical condition happen. The mathematical relationships among mission and crew attributes, medical conditions and incidence data, in-flight medical resources, potential clinical and crew health end states are established to generate end state probabilities. A Monte Carlo computational method is used to determine the probable outcomes and requires up to 25,000 mission trials to reach convergence. For each mission trial, the pharmaceuticals and supplies required to diagnose and treat prevalent medical conditions are tracked and decremented. The uncertainty of patient response to treatment is bounded via a best-case, worst-case, untreated case algorithm. A Crew Health Index (CHI) metric, developed to account for functional impairment due to a medical condition, provides a quantified measure of risk and enables risk comparisons across mission scenarios. The use of historical in-flight medical data, terrestrial surrogate data as appropriate, and space medicine subject matter expertise has enabled the development of a probabilistic, stochastic decision support tool capable of optimizing in-flight medical systems based on crew and mission parameters. This presentation will illustrate how to apply quantitative risk assessment methods to optimize the mass and volume of space-based medical systems for a space flight mission given the level of crew health and mission risk.

Kerstman, Eric↗

Turning Limitations into Opportunities in the Development of the Orion Medical System: Incorporation of mHealth Devices

INTRODUCTION: Selection of medical devices for the Orion medical system is a complex task which is dependent on the current state of terrestrial technology. In this work we review the interplay between NASA requirements, constraints, and opportunities for synergy during the development of the Orion medical system. METHODS: The “plan to treat” list of conditions, and subsequently the medical resource list for the Orion Artemis II lunar flyby mission was completed using semi-quantitative methods. During this process, some medical resources were excluded to comply with mass and volume limits, while other resources applicable to multiple medical requirements were prioritized for inclusion. Choices were also examined considering NASA level of care standards for the Artemis design reference missions. As a means to optimize capabilities in spite of mass and volume constraints, ideas for integration of multiple devices into a single platform were explored, including a ‘hackathon’ challenge which was conducted to generate and evaluate concepts for combining medical devices into a single app-based mobile device (ultrasound, ECG, etc.). RESULTS: The Orion team identified 128 medical conditions that we “plan to treat”, with 139 unique medical resources to address these conditions, including 5 digital diagnostic devices (ECG, otoscope, stethoscope, pulse oximeter, and blood pressure monitor). During selection of these digital devices the team noted that miniaturized medical devices often use mobile device platforms (mHealth), some displaying and transmitting data exclusively via mobile device. Of the 5 initially selected devices, all are capable of mobile connection, one which cannot function without a mobile device (ECG). Furthermore, only one of these devices connects natively to a Windows platform, which is currently the only operating system available on Orion. DISCUSSION: Significant savings in mass and volume as well as training and usability improvements can be achieved by leveraging mHealth technologies. However, the platform presents significant challenges for deployment within the Artemis Program including lack of internet connectivity, incompatible operating systems, and radiation concerns. Each of these drawbacks are surmountable with investment in the supporting vehicle architecture, which may become necessary to support the technology trends seen in commercially available medical devices today. Objective: Learn about the opportunities and challenges of leveraging mHealth devices in the development of medical capabilities for austere environments. Learn about the constraints of the NASA spaceflight environment with regards to digital medical device integration.

Douglas Ebert↗

Smart medical systems with application to nutrition and fitness in space

Smart medical systems are being developed to allow medical treatments to address alterations in chemical and physiologic status in real time. In a smart medical system, sensor arrays assess subject status, which is interpreted by computer processors that analyze multiple inputs and recommend treatment interventions. The response of the subject to the treatment is again assessed by the sensor arrays, thus closing the loop. An early form of "smart medicine" has been practiced in space to assess nutrition. Nutrient levels are assessed with food frequency questionnaires, which are interpreted by flight surgeons to recommend inflight alterations in diet. In the future, sensor arrays will directly probe body chemistry. Near-infrared spectroscopy can be used to non-invasively measure several blood and tissue parameters that are important in the assessment of nutrition and fitness. In particular, this technology can be used to measure blood hematocrit and interstitial fluid pH. The non-invasive measurement of interstitial pH is discussed as a surrogate for blood lactate measurement for the development and real-time assessment of exercise protocols in space. Earth-based application of these sensors is also described.

NASA Discipline Life Sciences Technologies↗

Smart Medical Systems with Application to Nutrition and Fitness in Space

Smart medical systems are being developed to allow medical treatments to address alterations in chemical and physiological status in real time. In a smart medical system sensor arrays assess subject status, which are interpreted by computer processors which analyze multiple inputs and recommend treatment interventions. The response of the subject to the treatment is again assessed by the sensor arrays, closing the loop. An early form of "smart medicine" has been practiced in space to assess nutrition. Nutrient levels are assessed with food frequency questionnaires, which are interpreted by flight surgeons to recommend in-flight alterations in diet. In the future, sensor arrays will directly probe body chemistry. Near infrared spectroscopy can be used to noninvasively measure several blood and tissue parameters which are important in the assessment of nutrition and fitness. In particular, this technology can be used to measure blood hematocrit and interstitial fluid pH. The noninvasive measurement of interstitial pH is discussed as a surrogate for blood lactate measurement for the development and real-time assessment of exercise protocols in space. Earth-based application of these sensors are also described.

Soller, Babs R.↗

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.↗

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↗

Lessons Learned from Medical System Foundation Development for Long-Duration Lunar Orbit and Lunar Surface Missions

The Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has been tasked with the development of Medical System Foundations for Level of Care IV for both short-duration lunar orbital missions and, subsequently, long-duration lunar orbital and surface operations missions. These Medical System Foundations serve as a framework to aid in early medical system design and mission planning. The content of both Foundation models is similar, consisting of a concept of operations, functional decomposition, clinical content (medical conditions, capabilities, and resources), technical requirements (interface, non-functional, and functional), and traces between these components and to the NASA standards documents and parent-level (Program- and Vehicle habitat system-level) requirements. Additionally, the development of both Foundations employed systems engineering principles and a model-based systems engineering (MBSE) approach. Throughout the development of these Foundations, ExMC has strived to improve the efficiency and robustness of its processes and to be more responsive to change (i.e., in design reference mission parameters and assumptions) and to stakeholders’ feedback. The most significant improvements made between the short- and long-duration Foundation models during this transformation process are the following: • Replacement of the traditional document-based ConOps with a model-based ConOps according to MBSE principles, which facilitated more efficient understanding of the material and the consolidation of all relevant information into a centralized location. • Utilization of an agile approach with tasks organized into sprints. This approach enabled solicitation of more frequent usability feedback from stakeholders, incorporation of more human factors reviews into the sprints, and more efficient tasking of team members. This presentation will discuss the journey of developing both Foundation models, as well as the lessons learned and resulting improvements made between the Short- and Long-Duration models.

M Kaetzer↗

Medical Systems Engineering to Support Mars Mission Crew Autonomy

Human spaceflight missions to Mars face exceptionally challenging resource limitations that far exceed those faced before. Increasing transit times, decreasing opportunity for resupply, communications challenges, and extended time to evacuate a crew to definitive medical care dictate a level of crew autonomy in medical care that is beyond the current medical model. To approach this challenge, a medical systems engineering approach is proposed that relies on a clearly articulated Concept of Operations and risk analysis tools that are in development at NASA. This paper proposes an operational clinical model with key terminology and concepts translated to a controls theory paradigm to frame a common language between clinical and engineering teams. This common language will be used for design and validation of an exploration medical system that is fully integrated into a Mars transit vehicle. This approach merges medical simulation, human factors evaluation techniques, and human-in-the-loop testing in ground based analogs to tie medical hardware and software subsystem performance and overall medical system functionality to metrics of operational medical autonomy. Merging increases in operational clinical autonomy with a more restricted vehicle system resource scenario in interplanetary spaceflight will require an unprecedented level of medical and engineering integration. Full integration of medical capabilities into a Mars vehicle system may require a new approach to integrating medical system design and operations into the vehicle Program structure. Prior to the standing-up of a Mars Mission Program, proof of concept is proposed through the Human Research Program.

Antonsen, Erik↗

Medical System Foundation Overview for Long-Duration Lunar Orbit and Surface Operations Missions

The Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has developed a Medical System Foundation for Level of Care IV, as defined by NASA’s space flight human-system standards, for long-duration lunar orbit and surface operation missions by employing a systems engineering approach using model-based systems engineering tools. This Foundation model includes a concept of operations; functional decomposition; clinical content (medical conditions, capabilities, and resources); associated functional, interface and non-functional technical requirements; and traces to the current versions of NASA standards documents and parent-level (Program- and Vehicle habitat system level) requirements. Collectively, these components constitute a foundation that serves as a starting point for a medical system that meets the Level of Care IV requirement. The Foundation was developed by a multidisciplinary team consisting of systems engineers, scientists, and clinicians across NASA, and information is presented in an easily accessible format that is understandable across disciplines. Stakeholders can use the Foundation to analyze the traces between medical capabilities, medical conditions, medical resources, and requirements and to identify medical system interfaces with other vehicle systems/subsystems. It can also be used as a basis for performing trades on risks vs. medical system mass and volume allocation. This discussion will focus on the processes through which the Medical System Foundation was developed, how the Foundation builds a bridge between the medical and engineering domains and facilitates communication between these communities, and how these processes can be applied more broadly to a crew health and performance system and other system domains. The presentation also discusses Foundation modifications based on the recently updated versions of the NASA 3001 Standards.

S. Lumpkins↗

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↗

ISS Technology Demonstrations for Future Spaceflight Medical Systems

Throughout the history of human spaceflight, crewmembers have experienced various in-flight medical conditions including illness and injury. Planned missions to the Moon and Mars will require capabilities to maintain the health of future space travelers. Mass, power, and volume available in the vehicles and habitats for these missions will be severely constrained; resupply of resources will be limited or non-existent, as will opportunities for evacuation to Earth. Furthermore, ground-based support will be hampered by communication latencies and blackouts. These vehicle and mission constraints will necessitate a medical system that has been efficiently planned, providing on-board procedural guidance in addition to a variety of medical devices and consumable resources. Medical capabilities required for the diagnosis and treatment of potential medical conditions during future spaceflight missions may include real-time health monitoring, medical imaging, and biomarker analyses ( e.g., blood or urine). Terrestrial medicine shares these needs, thus many of these medical capabilities could likely be satisfied by Commercial-Off-The-Shelf (COTS) devices and methodologies; however, in some cases the unique space environment and increased mission duration will drive the need to modify technologies and the way care is provided. NASA’s Human Research Program (HRP) Exploration Medical Capability (ExMC) Element and Mars Campaign Office’s Exploration Medical Integrated Product Team (XMIPT) are working together to decrease medical risk during exploration missions. Flight-tested medical diagnostic and treatment technologies are necessary to effectively manage medical conditions relevant to exploration missions while meeting vehicle constraints, integrating with medical decision-support tools, and enabling increasingly Earth-independent operations. Several projects have leveraged the ISS as a testbed for exploration, including 1) i n- situ blood analysis, 2) medical inventory, 3) intravenous fluid generation, and 4) autonomous medical procedure guidance. Management of several in-flight medical conditions, such as bacterial and viral infections and acute radiation syndrome, is dramatically improved with ability to assess blood cell populations, electrolytes, and metabolites. I n December 2020 and January 2021 ExMC performed an ISS technology demonstration (Tech Demo) of the HemoCue® WBC DIFF analyzer (HemoCue, Brea, CA), a COTS device that was modified to enable functionality in a spaceflight environment. This Tech Demo marked the first time that hematology measurements were successfully performed real-time in microgravity. Also modified and demonstrated was the reusable Handheld Electrolytes and Lab Technology for Humans (rHEALTH) ONE analyzer (rHEALTH, Bedford, MA), which uses flow cytometry and sheath-based hydrodynamic focusing methodologies. The rHEALTH ONE ISS Tech Demo in May 2022 demonstrated test results obtained in-flight matched those on the ground. NASA currently relies on crew self-reporting to manage and maintain medical inventory on ISS.The ability to maintain an accurate inventory becomes more critical during long duration missions since the crew will need to be increasingly autonomous in finding and utilizing medical items, including those scenarios when alternative treatments need to be considered due to limited or no resupply. HRP’s Medical Consumables Tracking (MCT) project was developed by ZIN Technologies, Inc. (Cleveland, OH), and demonstrated real-time tracking of medical supplies aboard the ISS between December 2016 and July 2018. The MCT system design utilized Radio Frequency Identification Device (RFID) technology to perform automated inventory and was installed in the Crew Health Care System (CHeCS) Resupply Stowage Rack (RSR). The challenge of limited shelf life, exacerbated by the lack of resupply opportunities, affects a plethora of medical system components including consumables, pharmaceuticals, and intravenous (IV) fluid. In 2010, ExMC funded ZIN Technologies, Inc. (Cleveland, OH), to develop the Intravenous Fluid Generation (IVGEN) system. IV fluids were successfully generated with IVGEN using the potable water supply on ISS during ISS Expedition 23. The XMIPT is in the process of developing a miniaturized version of the original IVGEN hardware for a future Tech Demo aboard the ISS. Current ISS medical operations rely heavily on preflight training and real-time remote guidance, both of which become impractical or impossible for exploration missions. The primary goal of the Autonomous Medical Officer Support (AMOS) Software Tech Demos on ISS was to confirm telemedical proof-of-concept for autonomous medical imaging in an operational setting. This novel software tool shifts emphasis from preflight training and real-time remote guidance to in-flight just-in-time instruction, a new and necessary paradigm for crew medical autonomy. AMOS introduces a novel, streamlined skill management concept for exploration missions featuring comprehensive training and guidance modules for ultrasound examinations using the ISS Ultrasound 2 (a modified GE Vivid-q™; General Electric HealthCare, Chicago, IL). With no prior crew training or remote guidance, two Tech Demos on the ISS (April 2020 and June 2022) resulted in high quality, clinically useful image sets. We will provide a review of historical, current, and planned medical devices and technologies considered for inclusion within future spaceflight medical systems and summarize hardware development activities and medical device tech demos conducted on the ISS.

Astronaut health and performance↗

Developing a Medical System Concept of Operations for Level of Care IV: Long-Duration Lunar Orbital and Surface Operations

A goal of the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element Systems Engineering (SE) team is to define the technical system needed to support crew medical system capabilities for future exploration missions, including a mission with lunar orbital and long duration surface operations. The medical system concept of operations (ConOps) is the starting point of creating a foundation for a medical system that meets Level of Care IV requirements, as defined by NASA’s space flight human-system standards. This ConOps illustrates how NASA can provide a Level of Care IV medical system for crews within the various cis-lunar orbit and lunar surface habitat environments. The use case scenarios included in this ConOps illustrate required medical system capabilities for Level of Care IV and enable the ExMC SE team to develop integrated medical system requirements and identify capabilities required to meet those requirements. This discussion will focus on how this concept of operations was constructed – by utilizing the lessons learned from ExMC’s existing Short-Duration Lunar Orbit Medical System Concept of Operations, by employing Model-Based Systems Engineering, and by collaborating with stakeholders in order to ensure the necessary assumptions were made.

M. Kaetzer↗

Computer-Based Medical System

SYMED, Inc., developed a unique electronic medical records and information management system. The S2000 Medical Interactive Care System (MICS) incorporates both a comprehensive and interactive medical care support capability and an extensive array of digital medical reference materials in either text or high resolution graphic form. The system was designed, in cooperation with NASA, to improve the effectiveness and efficiency of physician practices. The S2000 is a MS (Microsoft) Windows based software product which combines electronic forms, medical documents, records management, and features a comprehensive medical information system for medical diagnostic support and treatment. SYMED, Inc. offers access to its medical systems to all companies seeking competitive advantages.

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