- Medical System Content Development - 2019: Develop clinical content to inform medical system design; Iterate on content with wider ExMC (Exploration Medical Capability) team; Capture processes used to perform these tasks. - Using model content to inform system design - SME (Subject Matter Expert) collaboration to refine systems using clinical content

Bardina, Jorge

Cerro, Jeff

Hailey, Melinda

Hanson, Andrea

McGuire, Kerry

Mindock, Jennifer

Urbina, Michelle

NASA Technical Reports Server

National Aeronautics and Space AdministrationNational Aeronautics and Sp ce Administration
Exploration Medical Capability 
Medical System Recommendations 
for Gateway
2019 NASA Human Research Program Investigators' Workshop
January 22 - 25, 2019 | Galveston Island Convention Center
Melinda Hailey, MSN RN
Jorge Bardina, PhD 
Kerry McGuire, PhD 
Michelle Urbina, MS
Andrea Hanson, PHD 
Jeff Cerro, MS
Jennifer Mindock PhD
https://ntrs.nasa.gov/search.jsp?R=20190001025 2019-08-30T10:30:19+00:00Z
Acknowledgements
– Erik Antonsen, MD PhD
– Tina Bayuse, PharmD RPh
– Gary Bevan, MD
– Rebecca Blue, MD MPH
– Lynn Boley, MSN RN
– Eric Kerstman, MD MPH
– Kris Lehnhardt, MD
– Derek Nusbaum, MD PhD MPH
– Shira Okon
– David Reyes, MD MPH
National Aeronautics and Space Administration 2
Medical System Content Development - 2019
Develop clinical content to inform medical system 
design
Iterate on content with wider ExMC team
Capture processes used to perform these tasks
National Aeronautics and Space Administration 3
Overview of Talk
• Medical System content development
• Using model content to inform system design
• SME collaboration to refine systems using clinical 
content
National Aeronautics and Space Administration 4
Habitat System
Ground System
Crew as 
Caregiver 
Crew as 
Explorer or 
Patient 
Structures Avionics & Software
Guidance, 
Navigation and 
Control
Comm & 
Tracking Power etc.
Crew Health and Performance
Environmental 
Health
Crew 
Performance
Crew Health
and Wellness
Medical Subsystem Of A Habitat CH&P System
5
MedOps
5
Medical
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ExMC Activities to get to Requirements 
6
DRM Inputs
Med Sys 
ConOps
Med Sys
Functions
Med Sys Functional
Requirements
History of 
conditions (IMM)
NASA-STD-3001 
Interpretation 
Accepted Medical 
Condition List
Unplanned 
activities
Planned 
activities
Med Sys 
Capabilities
Med Sys 
Resources
Med Sys Detailed
Requirements
Do we have the capabilities to meet the needs?
Do we need altered allocations?
Sys Eng Activities Medical Domain Activities 
Higher Level 
Requirements
Team 
works 
closely 
together
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Planned Activities
7
DRM Inputs
Med Sys 
ConOps
Med Sys
Functions
Med Sys Functional
Requirements
History of 
conditions (IMM)
NASA-STD-3001 
Interpretation 
Accepted Medical 
Condition List
Unplanned 
activities
Planned 
activities
Med Sys 
Capabilities
Med Sys 
Resources
Med Sys Detailed
Requirements
Do we have the capabilities to meet the needs?
Do we need altered allocations?
Sys Eng Activities Medical Domain Activities 
Higher Level 
Requirements
Team 
works 
closely 
together
Scheduled medical care that is expected or required to occur
Planned Activities – Methodology
• Review of ISS Documentation - IDRD 
• Mission Assumptions / Medical Care Philosophy
– DRM 
– Level of Care based upon ExMC interpretation of NASA STD 3001
– ‘Program’ goals and objectives
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Planned Activities
Scheduled medical care that is expected or required 
to occur 
– Maintain crew health
– Monitor for potential contingency medical events
– Provide a test bed for future exploration missions
9
Examples 
Planned Activities 
• Private Medical 
Conference
• Periodic Eye Exam
Testbed Planned 
Activities 
• Periodic Dental Exam
• Bone Health Evaluation
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National Aeronautics and Space Administration
Team activities to get to requirements 
10
DRM Inputs
Med Sys 
ConOps
Med Sys
Functions
Med Sys Functional
Requirements
History of 
conditions (IMM)
NASA-STD-3001 
Interpretation 
Accepted Medical 
Condition List
Unplanned 
activities
Planned 
activities
Med Sys 
Capabilities
Med Sys 
Resources
Med Sys Detailed
Requirements
Do we have the capabilities to meet the needs?
Do we need altered allocations?
Sys Eng Activities Medical Domain Activities 
Higher Level 
Requirements
Team 
works 
closely 
together
Unplanned Activities
Medical care not expected or required to occur but addressed on 
an as-needed basis
Accepted Medical Condition List - Methodology
• Process uses list of conditions that influence mission 
planning
• ExMC started with the IMM Condition List 
– Has evidence base and metrics that support the likelihood of occurrence 
– Each condition as defined by best case and worst case
• Process has stakeholders rank order list, thus 
providing context for discussion  
– Probability of occurrence 
– Complexity score – Large # resources or difficult management 
– Futility score – likely to result in death or disability despite treatment
11
Source: Development of an Accepted Medical Condition List for Exploration Medical Capability Scoping, ExMC Working Group, July 2018
National Aeronautics and Space Administration
Accepted Medical Condition List - Example
12
Medical Condition Best / Worst Definition Plan to Treat Characterization
SKIN RASH Best The best case scenario is defined as mild to moderate and uncomplicated skin rash that responds to treatment. Plan toTreat N/A
SKIN RASH Worst
The worst case scenario is defined as a moderate to 
severe skin rash, covering an extensive area and that 
might be refractory to treatment.
Plan to 
Treat with 
Conditions
Treat to best case 
only
SMALL BOWEL 
OBSTRUCTION
Best
The best case scenario is defined as an uncomplicated 
course of small bowel obstruction which responds to 
conservative medical treatment (antibiotics and 
symptomatic treatment) and involves relatively minor 
functional impairment.
Plan to 
Treat N/A
SMALL BOWEL 
OBSTRUCTION
Worst
The worst case scenario is defined as having a 
complicated course of small bowel obstruction that is not 
responsive to conservative treatment and involves 
significant systemic symptoms, such as severe pain, such 
as fever, leukocytosis, tachycardia, elevated BUN, serum 
amylase or alkaline phosphatase, metabolic acidosis and a 
major functional impairment.
Plan to 
Treat with 
Conditions
Treat to best case, add 
antipyretics/pain 
control, IV fluids; 
consider medical evac
Team activities to get to requirements 
Capabilities and Resources
13
Do we have the capabilities to meet the needs?
Do we need altered allocations?
DRM Inputs
Med Sys 
ConOps
Med Sys
Functions
Med Sys Functional
Requirements
History of 
conditions (IMM)
NASA-STD-3001 
Interpretation 
Accepted Medical 
Condition List
Unplanned 
activities
Planned 
activities
Med Sys 
Capabilities
Med Sys 
Resources
Med Sys Detailed
Requirements
Sys Eng Activities Medical Domain Activities 
Higher Level 
Requirements
Action provided by a caregiver to address a condition or planned activity
Tangible and intangible assets used for a planned activity or condition 
National Aeronautics and Space Administration
Team 
works 
closely 
together
Capabilities and Resources– Methodology
• Review existing documentation
– ISS Medical Kit contents list / Med Checklist
– IDRD Annex 4
– IMED database – resources
• Medical Optimization Network for Space 
Telemedicine Resources (MONSTR) database
• Trace to planned activity and condition
National Aeronautics and Space Administration 14
Capabilities and Resources
18 categories of capabilities, 165 unique capabilities
440 unique resources
Each Planned and Unplanned (condition) activity is 
traced to capabilities and resources using SysML model
National Aeronautics and Space Administration 15
Capabilities and Resources - Examples
16
Condition Capability Category Capability Resources
DENTAL 
AVULSION 
(TOOTH LOSS)
Administer and 
Manage 
Medications
Medication - Injectable (IV, 
IO, SQ, Intraarticular, 
Intraocular)
EMR interface,Refrigerator,Needle (23G) 
1.5",Needle [25g] 1.5",Syringe (3cc),Syringe 
(10cc),Syringe (5cc),Intraosseous Injection 
device,Bandaid (2x3),Bandaid Dot,Bandaid 
strip (1x3),Syringe (1cc Insulin syringe with 
SQ needle),PPE - Nitrile gloves (multiple 
sizes, pair),Sharps container, Biohazard 
Trash Bag,BZK wipes
DENTAL 
AVULSION 
(TOOTH LOSS)
Administer and 
Manage 
Medications
Medication - Oral EMR interface, Potable water
DENTAL 
AVULSION 
(TOOTH LOSS)
Administer and 
Manage 
Medications
Medication - Topical
EMR interface,Refrigerator,Cotton swabs -
sterile, Cotton swabs - clean, Cotton 
balls,PPE - Nitrile gloves (multiple sizes, 
pair),Biohazard Trash Bag
Medical Content seen in SysML model
National Aeronautics and Space Administration 17
Capabilities and Resources - Examples
18
Resource Capability
Syringe (10cc)
Airway - Endotracheal Intubation,
Medication - Injectable (IV, IO, SQ, Intraarticular, 
Intraocular),
Breathing - Needle Thorocostomy,
Circulation - IO Access,
Circulation - IV Access,
GI/GU/Chest - Percutaneous drainage 
Bladder/Gallbladder/Appendix/Chest,
Nose - Nasal Packing (Anterior + Posterior),
GI/GU - Urinary Catheterization,
Screening Exam/Test - Intracranial pressure,
Wound Care - Repair, multiple layer,
Wound Care - Repair, Single layer
Syringe (1cc Insulin syringe with SQ 
needle)
Medication - Injectable (IV, IO, SQ, Intraarticular, 
Intraocular)
Syringe (3cc) Medication - Injectable (IV, IO, SQ, Intraarticular, Intraocular)
Syringe (5cc)
Medication - Injectable (IV, IO, SQ, Intraarticular, 
Intraocular),
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Medical Content seen in SysML Model
National Aeronautics and Space Administration 19
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Functional Requirements
20
DRM Inputs
Med Sys 
ConOps
Med Sys
Functions
Med Sys Functional
Requirements
History of 
conditions (IMM)
NASA-STD-3001 
Interpretation 
Accepted Medical 
Condition List
Unplanned 
activities
Planned 
activities
Med Sys 
Capabilities
Med Sys 
Resources
Med Sys Detailed
Requirements
Do we have the capabilities to meet the needs?
Do we need altered allocations?
Sys Eng Activities Medical Domain Activities 
Higher Level 
Requirements
Team 
works 
closely 
together
Key Requirement Development Concepts
• Type of requirements – project goal was high-level functional
– Functional – what has to be done
– Performance – how well it has to be done, often quantitative
– Interface – define in relation to external systems 
• e.g., mechanical, information, electrical
– -ilities, operational, physical characteristics
• Level of detail
– Starting point for this set is the clinical capability categories 
• Binned many individual capabilities to become lower level child requirements
• Identified placeholders for higher level parent requirements
• Content
– Single requirement can cover input from planned activities, testbed planned 
activities, unplanned activities, and functional decomposition content (based on 
ConOps)
21
In scope
Not in 
scope
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Example Inputs to Requirements
Clinical Capability Listing example
22National Aeronautics and Space Administration
Requirements Organization  
• Provide Appropriate 
Level of Care
• Environment 
Configuration for 
Medical Care
– Configure Environment for Care
– Habitat Medical Systems Inventory
• Knowledge-Based 
Support for Crew 
Performing Medical 
Tasks
– Augment Crew Knowledge
– Analyze Health Data
– Data Presentation
– Support Crew Performing Tasks
• Crew
– Crew as Caregiver
– Crew as Patient
– Crew as Crewmember
23
• Caregiver/Patient 
Interactions
– Interview Patient
– Perform Physical Exam and 
Conduct Screening exams/tests
– Assess and Monitor Vital Signs
– Administer and Manage 
Medications
– Perform Imaging
– Perform Laboratory Analysis
– Perform Procedures
– Personal Protection
• Medical Assessment 
and Monitoring
– Dietary Control/Nutrition 
Monitoring
– Monitor and Assess Environment
– Monitor and Control Sleep and 
Fatigue
– Support Behavioral Health
– Support Musculoskeletal Health
• Maintaining Current 
State of Medical 
System
– Document Care
– Update Habitat Medical System
– Analyze Engineering Data
• In-Flight Prevention
– Equipment Procedure
– Exercise Protocol
– Hygiene
– Personal Protection
– Radiation Exposure
– Private Conference
National Aeronautics and Space Administration
Example of Applying Inputs from Clinical Capability 
Category
Clinical Capability Category:  Perform imaging
24
Text
The Habitat 
Medical System 
shall  perform 
imaging. 
Rationale
This capability supports the periodic eye exam 
planned activity, testbed planned activities such 
as physical exams, dental exams, and HSI 
assessments, and diagnosis and treatment of 
many medical conditions. Specific imaging 
modalities and target anatomical areas are 
specified at Level 5.
Imaging capability is essential for all medical 
aspects.  This includes medical examinations for 
internal physiological health to surface 
physiological health. 
National Aeronautics and Space Administration
Requirement Examples
National Aeronautics and Space Administration
25
ID Name Text Rationale
Hab-
MedSys-
0024
Provide 
pharmacy 
The Habitat 
Medical System 
shall provide an in-
flight pharmacy to 
the crew members.
Pharmaceutical intervention and prevention, as 
provided by the in-flight pharmacy, is an essential 
component of risk management planning for crew 
healthcare during spaceflight. This includes prepare, 
administer, document, monitoring, inventory, analyze 
efficacy of med, titrate, or choose new medication if 
needed. Pharmaceutics assist crewmembers with 
adaptation to the spaceflight environment as well as 
help manage unexpected medical events that could 
occur, such as illness or injury. Types of medications 
needed are specified at Level 5.
Hab-
MedSys-
0005
Track 
medical   
inventory
The Habitat 
Medical System 
shall track medical 
inventory.
Ensure that medical inventory (supplies, equipment, 
and medications) is tracked at all times including when 
inventory is dispensed. Specific medical inventories, 
including quantities, availability, track history, etc., are 
specified at Level 5.
Hab-
MedSys-
0204
Perform  
genitourinary 
procedures
The Habitat 
Medical System 
shall enable 
caregivers to 
perform 
genitourinary 
procedures.
The medical system needs to provide capabilities (e.g., 
tools, technology, skills, medications) to perform 
genitourinary (GU) procedures (such as 
decompression of bladder). These procedures are 
needed for treatment of conditions such as urinary 
retention. Types of GU procedures are specified at 
Level 5.
Requirements Relationships to Discipline Inputs  
26
Input from clinicians -
Capability Category:
Administer and 
Manage Medications
This is building the 
bridge between SME 
content and 
engineering language!
Output from 
Rqmts Team -
Rqmt: Provide 
Pharmacy
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Visualizing the Substance Behind Requirements
27
Level 4 rqmt name Rationale support by clinical 
capability category (green) inputs 
and ConOps-derived functions 
(pink) 
Child rqmts will be based on 
more detailed input (e.g., 
clinical capabilities) (blue)
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Habitat System
Ground System
Crew as 
Caregiver 
Crew as 
Explorer or 
Patient 
Structures Avionics & Software
Guidance, 
Navigation and 
Control
Comm & 
Tracking Power etc.
Crew Health and Performance
Environmental 
Health
Crew 
Performance
Crew Health
and Wellness
Collaborations
28
MedOps
28
Medical
National Aeronautics and Space Administration
Collaborations – Trade Space Tool Suite
29
Provide a means for the medical community’s and crew’s interests 
to be represented during deep space mission development to 
quantify the mass, volume, power impacts, and risks that a 
potential medical capability could have on crew health outcomes to 
inform medical capability in context of mission architectures
Mission + 
Medical 
Capability
Tool 
Set
Predicted 
Outcomes
Mission 
Architectures
Mission 
Planners
Iterate
Validate
Iterate
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Collaborations – Medical Data Architecture
National Aeronautics and Space Administration 30
31
Collaborations - Medical Workstation
32
Collaborations - Power Calculation
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33
Collaborations - Power Calculation
National Aeronautics and Space Administration
Summary
Build a bridge between engineering and medical 
domains and developed a common language
Established processes and products to integrate 
between medical and exploration programs
Provided notional content for a medical system that 
can be used to inform initial Gateway planning 
National Aeronautics and Space Administration 34
Questions? 
Thank you! 
National Aeronautics and Space Administration 35
BACK-UP SLIDES
36


Exploration Medical Capability Medical System Recommendations for Gateway

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