Search NASA⌕ Search

SEARCH · Search NASA

Results for “ExMC”

Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 91 records · Page 5
All sourcesNASA NTRSDOE OSTI
NASA NTRSDate not supplied

Implementation of a SysML Model-Based Concept of Operations for Level of Care IV: Long-Duration Lunar Orbital and Surface Operations

One 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 orbital and surface operations for long duration lunar missions. This is accomplished through the development of a Medical System Foundation, which communicates medical system requirements, capabilities, conditions, and resources that define a starting point for a medical system that meets the specification for design reference missions and associated Levels of Care (as defined by NASA-STD-3001). The starting point for creating this Medical System Foundation Model is the development of a Concept of Operations (ConOps) that describes the operation of the system from the point of view of the users. It includes a comprehensive and thoroughly vetted list of the users, their specific needs, the goals of the system, key assumptions about the system, and definitions of the system’s operational environments. The use case scenarios included in the 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. For this “Long Duration” Medical System Foundation development effort, ExMC replaced the traditional document-based ConOps with a model-based ConOps using model-based systems engineering. This approach has several advantages, including the facilitation of more efficient understanding of the material through information-dense images with less opportunity for misinterpretation than text alone, the roll-out of changes to the ConOps to stakeholders in real-time as they are approved, and the consolidation of all salient information into one centralized location. This discussion will focus on both how the model represents the ConOps content and how the SE team utilized lessons learned in an agile environment to improve the way this information was created and presented to stakeholders.

Mary Susan Kaetzer↗
NASA NTRSDate not supplied

rHealth One Demonstration Aboard ISS: A Microfluidic Bioanalyzer Based on Sheath/Hydrodynamic Focusing Flow Cytometry

The Exploration Medical Capability (ExMC) element aims to provide astronauts with the means for their own health monitoring, diagnosis, and treatment during exploration missions. As space flight ventures further from earth, the need for autonomous medical care increases under greater constraints on size, mass, and resources. One pillar for diagnosis that crew would be separated from is laboratory analysis. Even now on ISS, blood samples must be collected and returned to earth for testing. In response, ExMC is assessing how assays for hematology, bone health, radiation exposure etc. could be addressed through commercial-off-the-shelf (COTS) and Small Business Innovation Research (SBIR) funded bioanalyzers that are miniaturizing lab technology. Since missions will reach distances where there are no timely replacements, validation on the International Space Station (ISS) is a necessary part of that assessment. In partnership with NASA Johnson Space Center (JSC) Immunology Lab and the Research Operations and Integration (ROI) element, ExMC conducted a technology demonstration on ISS of the rHEALTH ONE, a flow cytometry based bioanalyzer, to assess future devices based on this design. In flow cytometry, there are predominantly three ways to focus the cells (or particles) into a single file stream: hydrodynamic focusing, microcapillary, and acoustic focusing. The rHEALTH ONE utilizes the commercial standard, sheath-based hydrodynamic focusing. rHEALTH itself represents both a company and a suite of medical tools NASA has funded through SBIR grants towards the development of a promising diagnosis instrument for exploration missions. rHEALTH ONE is the interim version of the technology, functional as a benchtop analyzer and test bed for the next generation of rHEALTH in development. Several modifications were made to the rHEALTH ONE analyzer for operation in microgravity. For function, fluid management was key. A sheath-based analyzer uses sheath fluid to flow the sample, cleaning fluid to prevent biological contamination, and a reservoir to collect the liquid waste. The rHEALTH ONE analyzer uses bottles dependent on gravity to separate the air and liquid pathways and keep the liquids contained. It uses only 1 psig of air pressure to directly push the liquid through the device, requiring little-to-no resistance at inlet and outlet. A microtubing assembly with self-sealing luer connectors was designed – featuring 0.014 mm thick durable medical balloons to hold water inside the supply bottles – to create safe containment and easy access for the crew while maintaining the analyzer’s function. For safety, copper tape was added to the interior of the plastic housing to reduce electromagnetic interference, fluid and electrical connections were secured against vibration and leaks, and gaps were further sealed to ensure containment of the optical block and lasers. Water as the sheath and cleaning fluid and TOX 0 samples were used to reduce the biohazard risk to the crew. In May 2022, European Space Agency astronaut Samantha Cristoforetti demonstrated the rHEALTH ONE aboard ISS for its sample loading, flow cytometry, and data collection capability in microgravity. The JSC Immunology Lab provided flow cytometry expertise, designed the sample test protocol, and manufactured and benchmarked the flight samples on a ‘gold-standard’ flow cytometer. The analyzer was primed with water, purged of air, and four calibration solutions of polystyrene microparticles were tested to characterize its performance. Tightly controlled procedures and excellent execution prevented air bubble interference during air/water separation, fluid transfer, sample mixing and loading. Data showed a slight increase in signal noise on 3 of 5 channels and an anomaly of fluorophores migrating in one sample (confirmed by JSC post-flight). Flight results correctly detected the change in sample, matched the analyzer’s ground performance, and were consistent with the gold-standard’s ground results. Although areas were noted for improvement, these outcomes signified complete mission success.

R. S. Miller↗
NASA NTRS2024

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↗
NASA NTRSDate not supplied

Artemis III and IV Crew Health and Performance System Model Development

To maintain Crew Health and Performance (CHP) during an Artemis mission, the NASA Human Research Program (HRP) and Exploration Medical Capabilities (ExMC) element recognize the challenge that many different vehicles, habitats, and operational groups must come together to develop and implement cross program capabilities. To address this challenge, the ExMC team created the prototype 2023 Artemis CHP System Model to analyze how human system requirements are implemented throughout an Artemis mission and help understand the effects of changing an individual vehicle or habitat requirement on a full mission. Since presenting this work at the 2024 HRP Investigators’ Workshop, ExMC has continued this effort, now called the Artemis III and IV CHP System Model, to better support its operational end users within the NASA Human Health and Performance Directorate (HHPD) workforce. In this presentation, we will recapitulate how visualizing requirements and their relationships using a Model-Based Systems Engineering approach (MBSE) serves to improve understanding of an Artemis mission’s CHP capabilities along with discussion on updates made to the model to increase accessibility for users within HHPD so that it may be used in the development of cross program CHP capabilities at NASA.

Crew Health and Performance↗
NASA NTRS2023

Exploration Medical Capability Clinical Decision Support System Architecture Recommendation

A new era in space exploration has arrived with the goal of establishing a long-term presence on the Moon and using those learning to take the next giant leap: sending the first astronauts to Mars. These ambitious goals will require significant changes in in-flight medical care due to constraints on mass, volume, power, crew time, and medical evacuation capabilities. Furthermore, while crews currently rely on real-time communications with ground-based medical providers, as distance from Earth increases, so do communication delays and disruptions. The crew will need to autonomously detect, diagnose, treat, and prevent medical events. These constraints require development of transformative solutions and new technologies. Through participation in the Human Research Program’s (HRP) Exploration Medical Capability (ExMC) research, NASA has developed and demonstrated a Medical Data Architecture (MDA), a platform upon which a robust capability of Clinical Decision Support (CDS) can be built. As a result, NASA is now positioned to build an advanced autonomous CDS System (CDSS) which will aid in crew health decision-making. The CDSS combines data management aspects of a system that would lead to the autonomy required by NASA-STD-3001, Section 3, Health and Medical Care Standards. The project addresses the ExMC gap Medical-701: We need to increase inflight medical capabilities and identify new capabilities that (a) maximize benefit and/or (b) reduce “costs” on human system/mission/vehicle resources. This architecture recommendation document introduces an integrated data architecture that provides self-sufficient medical care for crews on long-duration spaceflight missions.

ExMC↗
NASA NTRS2011

The Near Earth Asteroid Medical Conditions List

Purpose: The Exploration Medical Capability (ExMC) element is one of six elements within NASA s Human Research Program (HRP) and is responsible for addressing the risk of "the inability to adequately recognize or treat an ill or injured crewmember" for exploration-class missions. The Near Earth Asteroid (NEA) Medical Conditions List, constructed by ExMC, is the first step in addressing the above-mentioned risk for the 13-month long NEA mission. The NEA mission is being designed by NASA's Human Space Flight Architecture Team (HAT). The purpose of the conditions list is to serve as an evidence-based foundation for determining which medical conditions could affect a crewmember during the NEA mission, which of those conditions would be of concern and require treatment, and for which conditions a gap in knowledge or technology development exists. This information is used to focus research efforts and technology development to ensure that the appropriate medical capabilities are available for exploration-class missions. Scope and Approach: The NEA Medical Conditions List is part of a broader Space Medicine Exploration Medical Conditions List (SMEMCL), which incorporates various exploration-class design reference missions (DRMs). The conditions list contains 85 medical conditions which could occur during space flight and which are derived from several sources: Long-Term Surveillance of Astronaut Health (LSAH) in-flight occurrence data, The Space Shuttle (STS) Medical Checklist, The International Space Station (ISS) Medical Checklist, and subject matter expert opinion. Each medical condition listed has been assigned a clinical priority and a clinical priority rationale based on incidence, consequence, and mitigation capability. Implementation: The conditions list is a "living document" and as such, new conditions can be added to the list, and the priority of conditions on the list can be adjusted as the DRM changes, and as screening, diagnosis, or treatment capabilities change. The NEA medical conditions list was used recently as the basis for identifying gaps in in-flight medical evaluation (screening) capabilities. Learning Objectives: The audience will become familiar with the approach taken by NASA's Exploration Medical Capability element in addressing the risk of inability to recognize and treat medical conditions in the setting of a Near Earth Asteroid mission. Which one of the following statements is incorrect? a) The Near Earth Asteroid (NEA) medical conditions list includes 85 medical conditions which could occur during space flight. b) Each condition on the NEA medical conditions list has been assigned a clinical priority and a clinical priority rationale. c) The NEA medical conditions list targets a mission to Mars. d) The NEA medical conditions list should be viewed as a "living document" where new conditions can be added and clinical priorities adjusted to address changes in the design reference mission or medical capabilities. The incorrect answer is c). The NEA medical conditions list targets a mission to a Near Earth Asteroid.

Barr, Yael R.↗
NASA NTRS2012

Exploration Laboratory Analysis - ARC

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk, Risk of Inability to Adequately Treat an Ill or Injured Crew Member, and ExMC Gap 4.05: Lack of minimally invasive in-flight laboratory capabilities with limited consumables required for diagnosing identified Exploration Medical Conditions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability in future exploration missions. Mission architecture poses constraints on equipment and procedures that will be available to treat evidence-based medical conditions according to the Space Medicine Exploration Medical Conditions List (SMEMCL). The SMEMCL provided diagnosis and treatment for the evidence-based medical conditions and hence, a basis for developing ELA functional requirements.

Krihak, Michael K.↗
NASA NTRS2013

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↗
NASA NTRS2014

Identification of Medical Training Methods for Exploration Missions

As the National Aeronautics and Space Administration (NASA) and its international partner agencies anticipate eventual exploration missions of longer duration, there is a need to plan for the medical capabilities necessary to maximize crew health and provide the best likelihood of mission success. Current spaceflights consist of 5- to 6-month excursions to the International Space Station (ISS) in low-Earth orbit (LEO), and a 12-month ISS mission is currently in planning stages. However, missions to a near-Earth asteroid (NEA), a return to the moon, or even a mission to Mars will demand unprecedented medical capabilities, particularly relating to the training of the crew medical officers (CMOs). In its attempts to address the questions about medical preparation for spaceflight beyond LEO, the Exploration Medical Capability (ExMC) element within NASA's Human Research Program (HRP) defines a series of gaps. These gaps are shortcomings in knowledge, training, or technology that require resolution before an exploration mission can be undertaken. The ExMC element maintains current information about measures to close these gaps while developing plans for further investigation and research. Data pertaining to the gaps and their present status are available to the general public on the NASA Human Research Wiki and the NASA Human Research Roadmap Web sites (34, 36). One such gap, Gap 3.01, identifies a lack of knowledge about the optimal training methods for in-flight medical conditions identified on the Exploration Medical Condition List (EMCL), taking into account the crew medical officer s (CMOs) clinical background (33). This broad statement encompasses several related issues with the current methods of training CMOs and the medical ground support staff, specifically flight surgeons and biomedical engineers (BMEs) located in mission control, in addition to questions pertaining to the ways in which training will need to be adapted for the medical contingencies unique to exploration missions. To determine the optimal methods of medical training for an exploration medical crew and their ground support team, the historical context of medical operations, the current CMO training methods, and potential alternative training methods were identified.

Long duration space flight↗
NASA NTRS2015

Clinical Outcome Metrics for Optimization of Robust Training

The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.

Ebert, D.↗
NASA NTRS2016

Clinical Outcome Metrics for Optimization of Robust Training

Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance (pre-IMM analysis) and overall mitigation of the mission medical impact (IMM analysis); 2) refine the procedure outcome and clinical outcome metrics themselves; 3) refine or develop innovative medical training products and solutions to maximize CMO performance; and 4) validate the methods and products of this experiment for operational use in the planning, execution, and quality assurance of the CMO training process The team has finalized training protocols and developed a software training/testing tool in collaboration with Butler Graphics (Detroit, MI). In addition to the "hands on" medical procedure modules, the software includes a differential diagnosis exercise (limited clinical decision support tool) to evaluate the diagnostic skills of participants. Human subject testing will occur over the next year.

Ebert, D.↗
NASA NTRS2016

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↗
NASA NTRS2017

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.↗
NASA NTRS2017

Exploration Medical Capability System Engineering Introduction and Vision

Human exploration missions to beyond low Earth orbit destinations such as Mars will require more autonomous capability compared to current low Earth orbit operations. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element's approach to enabling the necessary autonomy. The Element's work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is applying systems engineering principles and practices to accomplish its integrative goals. This talk will briefly introduce the discipline of systems engineering and key points in its application to exploration medical capability development. It will elucidate technical medical system needs to be met by the systems engineering work, and the structured and integrative science and engineering approach to satisfying those needs, including the development of shared mental and qualitative models within and external to the human health and performance community. These efforts are underway to ensure relevancy to exploration system maturation and to establish medical system development that is collaborative with vehicle and mission design and engineering efforts.

Mindock, J.↗
NASA NTRS2017

The Pathway to a Safe and Effective Medication Formulary for Exploration Spaceflight

PURPOSE: Exploration space missions pose several challenges to providing a comprehensive medication formulary designed to accommodate the size and space limitations of the spacecraft; while addressing the individual medications needs and preferences of the Crew; the negative outcome of a degrading inventory over time, the inability to resupply before expiration dates; and the need to properly forecast the best possible medication candidates to treat conditions that will occur in the future. METHODS: The Pharmacotherapeutics Discipline has partnered with the Exploration Medical Capabilities (ExMC) Element to develop and propose a research pathway that is comprehensively focused on evidence-based models and theories, as well as on new diagnostic tools and treatments or preventive measures aimed at closure of the Med02 “Pharmacy” Gap; defined in the Human Research Program’s (HRP) risk-based research strategy. The Med02 Gap promotes the challenge to identify a strategy to ensure that medications used to treat medical conditions during exploration space missions are available, safe, and effective. It is abundantly clear that pharmaceutical intervention is an essential component of risk management planning for astronaut healthcare during exploration space. However, the quandary still remains of how to assemble a formulary that is comprehensive enough to prevent or treat anticipated medical events; and is also chemically stable, safe, and robust enough to have sufficient potency to last for the duration of an exploration space mission. In cases where that is not possible, addressing this Gap requires exploration of novel drug development techniques, dosage forms, and dosage delivery platforms that enhance chemical stability as well as therapeutic effectiveness. RESULTS: The proposed research pathway outlines the steps, processes, procedures, and a research portfolio aimed at identifying a capability that will provide a safe and effective pharmacy for any specific exploration Design Reference Mission (DRM). The proposed approach to building this research portfolio is to seek research projects that concentrate on four major focus areas; (1) Formulary selection, (2) Formulary potency and shelf life, (3) Formulary safety and toxicity, and (4) Novel technology and innovation such as portable real-time chemical analysis innovative drug therapies and dosage and delivery platforms. CONCLUSION: The research pathway has been completed and presented to the HRP. In spring 2017, it is scheduled to be reviewed by a panel of pharmaceutical and clinical experts that will evaluate the scientific merit and operational feasibility of the research pathway, as well as make suggestions for any warranted additions or improvements. Once finalized, the ExMC Element will proceed with the execution of this research pathway with the goal of gathering as much data, and learning as much as possible, to provide a safe and effective pharmaceutical formulary for use during exploration missions.

Daniels, V. R.↗
NASA NTRS2017

Systems Engineering for Space Exploration Medical Capabilities

Human exploration missions to beyond low Earth orbit destinations such as Mars will present significant new challenges to crew health management during a mission compared to current low Earth orbit operations. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element's approach to enabling the necessary autonomy. The Element's work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is applying systems engineering principles and practices to accomplish its integrative goals. This paper discusses the structured and integrative approach that is guiding the medical system technical development. Assumptions for the required levels of care on exploration missions, medical system guiding principles, and a Concept of Operations are early products that capture and clarify stakeholder expectations. Mobel-Based Systems Engineering techniques are then applied to define medical system behavior and architecture. Interfaces to other flight and ground systems, and within the medical system are identified and defined. Initial requirements and traceability are established, which sets the stage for identification of future technology development needs. An early approach for verification and validation, taking advantage of terrestrial and near-Earth exploration system analogs, is also defined to further guide system planning and development.

Mindock, Jennifer↗
NASA NTRS2017

Systems Engineering for Space Exploration Medical Capabilities

Human exploration missions that reach destinations beyond low Earth orbit, such as Mars, will present significant new challenges to crew health management. For the medical system, lack of consumable resupply, evacuation opportunities, and real-time ground support are key drivers toward greater autonomy. Recognition of the limited mission and vehicle resources available to carry out exploration missions motivates the Exploration Medical Capability (ExMC) Element's approach to enabling the necessary autonomy. The Element's work must integrate with the overall exploration mission and vehicle design efforts to successfully provide exploration medical capabilities. ExMC is applying systems engineering principles and practices to accomplish its goals. This paper discusses the structured and integrative approach that is guiding the medical system technical development. Assumptions for the required levels of care on exploration missions, medical system goals, and a Concept of Operations are early products that capture and clarify stakeholder expectations. Model-Based Systems Engineering techniques are then applied to define medical system behavior and architecture. Interfaces to other flight and ground systems, and within the medical system are identified and defined. Initial requirements and traceability are established, which sets the stage for identification of future technology development needs. An early approach for verification and validation, taking advantage of terrestrial and near-Earth exploration system analogs, is also defined to further guide system planning and development.

Mindock, Jennifer↗
NASA NTRS2018

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.↗