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Exploration Medical Capability (ExMC) Projects

During missions to the Moon or Mars, the crew will need medical capabilities to diagnose and treat disease as well as for maintaining their health. The Exploration Medical Capability Element develops medical technologies, medical informatics, and clinical capabilities for different levels of care during space missions. The work done by team members in this Element is leading edge technology, procedure, and pharmacological development. They develop data systems that protect patient's private medical information, aid in the diagnosis of medical conditions, and act as a repository of relevant NASA life sciences experimental studies. To minimize the medical risks to crew health the physicians and scientists in this Element develop models to quantify the probability of medical events occurring during a mission. They define procedures to treat an ill or injured crew member who does not have access to an emergency room and who must be cared for in a microgravity environment where both liquids and solids behave differently than on Earth. To support the development of these medical capabilities, the Element manages the development of medical technologies that prevent, monitor, diagnose, and treat an ill or injured crewmember. The Exploration Medical Capability Element collaborates with the National Space Biomedical Research Institute (NSBRI), the Department of Defense, other Government-funded agencies, academic institutions, and industry.

Wu, Jimmy↗

The Research Plan: Closing the ExMC Med02 "Pharmacy" Gap

HRP Human Research Roadmap: Risk and Gap Risk of Adverse Health Outcomes and Decrements in Performance due to Inflight Medical Conditions. Med02 "Pharmacy" Gap: We do not have the capability to provide a safe and effective medication formulary for exploration missions delivering a recommendation for a chemically stable, safe, and effective medication formulary that will support the operational needs of exploration space missions research strategy evidence-based formulary and models innovative analytical tools and methodologies novel treatments and preventive measures Planned review by a panel of experts from the pharmaceutical industry, regulatory, and academic scientific communities Formulary Selection Formulary Potency and Shelf life Formulary Safety and Toxicity Novel Technology Proof-of-Concept Portable real-time chemical analysis Innovative drug development / design

Daniels, Vernie↗

A Model-Based Systems Engineering Journey to Developing a Concept of Operations

Starting in 2017, NASA’s Human Research Program (HRP) Exploration Medical Capability (ExMC) element began a systems engineering transition from traditional, document-centric development to model-centric development when defining its foundation medical systems. These foundation medical systems define a Concept of Operations (ConOps) and identify the generic requirements for a medical system based on assumptions about a generic crew and mission environments and guidance from NASA standards (e.g., Medical “Levels of Care”). By making the transition, ExMC intends to improve communication among stakeholders about foundation medical system requirements and content. In addition, this transition will enable ExMC to lower both development and crew treatment risks for future, mission-specific medical systems. ExMC followed a Model Based Systems Engineering (MBSE) paradigm when developing the foundation medical systems. A model-based approach provides several advantages over a traditional, document-centric approach. First, when Systems Engineers (SE) develop diagrams in a model using a standard modeling language, they produce information dense pictures that facilitate understanding much more efficiently with less room for misinterpretation than text. Second, due to the evolving nature of projects, documentation becomes out of date the minute it is published. This can result in people making decisions based on information that is no longer current, especially if they are referencing a locally-stored copy of a document. A model, on the other hand, is always up to date with the latest approved changes and information. It serves as a single point of truth. Third, a model-centric approach centralizes all important information in one place. Rather than having to flip through separate ConOps documents, design specifications, requirements specifications, and the like to coordinate information, a model captures the content in one, integrated spot. This integration makes tracing information from end-to-end easier with greater reliability. The ExMC Systems Engineering Lifecycle follows a well-defined process. ExMC Systems Engineers perform all major steps of the process, regardless of the development methodology. One of the first steps in the process is developing the ConOps that describes the operation of the system from the point of view of the users. It includes a list of the users and their needs, the goals of the medical system, key assumptions about the system, and definitions of the medical system’s operational environments. For this development effort, ExMC chose to replace the traditional text-based ConOps document with a model. While the decision to change the development workflow was not difficult, implementing the structural and organizational workflows were. It required showing ExMC’s users, most of whom are not Systems Engineers, how the information they require would be presented in the model and to gain their acceptance of this approach. This paper documents key lessons learned during the ConOps transformation by focusing on how the model represents information, the agile workflow used by SEs when developing the model and how it integrates into a project plan, how leadership influenced key users to accept the transformation, and how the users interact with the model information.

Jeffrey Robert Cohen↗

The NASA Human Research Wiki - An Online Collaboration Tool

The Exploration Medical Capability (ExMC) element is one of six elements of the Human Research Program (HRP). ExMC is charged with decreasing the risk of: "Inability to adequately recognize or treat an ill or injured crew member" for exploration-class missions In preparation for exploration-class missions, ExMC has compiled a large evidence base, previously available only to persons within the NASA community. ExMC has developed the "NASA Human Research Wiki" in an effort to make the ExMC information available to the general public and increase collaboration within and outside of NASA. The ExMC evidence base is comprised of several types of data, including: (1)Information on more than 80 medical conditions which could occur during space flight (a)Derived from several sources (b)Including data on incidence and potential outcomes, as captured in the Integrated Medical Model s (IMM) Clinical Finding Forms (CliFFs). (2)Approximately 25 gap reports (a)Identify any "gaps" in knowledge and/or technology that would need to be addressed in order to provide adequate medical support for these novel missions.

Barr, Yael↗

Exploration Medical Capability

Exploration Medical Capability (ExMC) is an element of NASA's Human Research Program (HRP). ExMC's goal is to address the risk of the Inability to Adequately Recognize or Treat an Ill or Injured Crewmember. This poster highlights the approach ExMC has taken to address this goal and our current areas of interest. The Space Medicine Exploration Medical Condition List (SMEMCL) was created to identify medical conditions of concern during exploration missions. The list was derived from space flight medical incidents, the shuttle medical checklist, the International Space Station medical checklist, and expert opinion. The conditions on the list were prioritized according to mission type by a panel comprised of flight surgeons, physician astronauts, engineers, and scientists. From the prioritized list, the ExMC element determined the capabilities needed to address the medical conditions of concern. Where such capabilities were not currently available, a gap was identified. The element s research plan outlines these gaps and the tasks identified to achieve the desired capabilities for exploration missions. This poster is being presented to inform the audience of the gaps and tasks being investigated by ExMC and to encourage discussions of shared interests and possible future collaborations.

Watkins, Sharmila↗

Medical Data Architecture Platform and Recommended Requirements for a Medical Data System for Exploration Missions

The Medical Data Architecture (MDA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the ExMC MDA project addresses the technical limitations identified in ExMC Gap Med 07: We do not have the capability to comprehensively process medically- relevant information to support medical operations during exploration missions. This gap identifies that the current in-flight medical data management includes a combination of data collection and distribution methods that are minimally integrated with on-board medical devices and systems. Furthermore, there are a variety of data sources and methods of data collection. For an exploration mission, the seamless management of such data will enable a more medically autonomous crew than the current paradigm of medical data management on the International Space Station. ExMC has recognized that in order to make informed decisions about a medical data architecture framework, current methods for medical data management must not only be understood, but an architecture must also be identified that provides the crew with actionable insight to medical conditions. This medical data architecture will provide the necessary functionality to address the challenges of executing a self-contained medical system that approaches crew health care delivery without assistance from ground support. Hence, the products derived from the third MDA prototype development will directly inform exploration medical system requirements for Level of Care IV in Gateway missions. In fiscal year 2019, the MDA project developed Test Bed 3, the third iteration in a series of prototypes, that featured integrations with cognition tool data, ultrasound image analytics and core Flight Software (cFS). Maintaining a layered architecture design, the framework implemented a plug-in, modular approach in the integration of these external data sources. An early version of MDA Test Bed 3 software was deployed and operated in a simulated analog environment that was part of the Next Space Technologies for Exploration Partnerships (NextSTEP) Gateway tests of multiple habitat prototypes. In addition, the MDA team participated in the Gateway Test and Verification Demonstration, where the MDA cFS applications was integrated with Gateway-in-a-Box software to send and receive medically relevant data over a simulated vehicle network. This software demonstration was given to ExMC and Gateway Program stakeholders at the NASA Johnson Space Center Integrated Power, Avionics and Software (iPAS) facility. Also, the integrated prototypes served as a vehicle to provide Level 5 requirements for the Crew Health and Performance Habitat Data System for Gateway Missions (Medical Level of Care IV). In the upcoming fiscal year, the MDA project will continue to provide systems engineering and vertical prototypes to refine requirements for medical Level of Care IV and inform requirements for Level of Care V.

Krihak, M.↗