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TRISH is soliciting proposals for the rapid transformation of emerging point-of-care (POC) technologies into viable, clinically-focused solutions that facilitate diagnosis of conditions on NASA’s Medical Conditions List during long-duration space flights as well as in terrestrial clinical settings. The solicitation seeks technologies that have a commercial potential that would benefit from investments that make them suitable for long-duration spaceflights. For example, miniaturizing a table-top device into a hand-held device, reducing the need for and extending the shelf-life of consumables, and improving ease-of-use, are all important developments.

While astronauts are generally healthy, medical issues can occur during long-duration space flights as on Earth, and space flight increases the risks for certain medical complications, including muscle atrophy, bone demineralization, cardiovascular deconditioning, motion sickness, visual problems (perhaps related to elevated intracranial pressure), kidney stones (resulting in part from bone demineralization), back pain, urinary retention, toxic exposure, decompression, ear infection, and corneal abrasions (due to an excess of floating objects in-flight) (Strangman, 2017). 

The key variables for medical technologies developed for use in deep space are related to performance/accuracy, mass, volume, power, speed, ease of use, reliability/durability, shelf life, and mass/volume of consumables; each of these should be optimized when designing devices for clinical monitoring. Additionally, fluids behave very non-intuitively in microgravity and hence considerable caution and pre-flight testing is required approaches involving fluids. Microfluidics, which depend on capillary action rather than bulk fluid flow, are highly preferred as they significantly reduce these concerns. Other examples of limitations imposed by long-duration space flight and related desirable attributes/specifications for use during long-duration space flights are shown in the following table (adapted from Strangman, 2017):

Spaceflight Limitation

Device Design Attributes/Specifications

 

Low-resource environment

 

Multiuse devices

Reusable device components

Low maintenance components, minimize moving parts

Components robust to failure in space environment

 

Long distances and high cost to orbit

Minimize mass

Minimize volume

Minimize consumables

 

Communication delays

Easy-to-use devices

Built-in self-guidance or just-in-time training systems

Automated data management

 

Fluids in microgravity

Noninvasive devices

Minimize fluid samples

Reduce or eliminate fluids required

Analog testing (e.g., parabolic flight)

Sealed environment

Use nontoxic materials and fluids

Off-gas testing

Limited power generation capabilities

Minimize power demands

Busy astronaut schedules

Minimize time required for training, setup, use, breakdown, and data management

The specific focus of this call for proposals is on the development of noninvasive or minimally-invasive (e.g., finger stick) devices to conduct standard medical assessments of multiple blood components (complete blood count, basic metabolic panel, and liver function tests) for onboard clinical diagnosis in long-duration space flights, with all aspects of the device’s form factor and operation appropriate for use in outer space given the constraints shown in the above table as well as others that may apply. Preference may be given to multi-function or flexible/modular systems that enable examination of additional analytes.

Ideally, solutions would cover all of the desired blood components with a single platform, but a platform that can be demonstrated for a subset of these components and that has the potential to expand to other components is allowable.

To accelerate clinical adoption of these technologies for use in space as well as terrestrial clinical settings, the following performance criteria apply for this solicitation:

  1. Result Availability: Results must be available within 10 to 20 minutes or sooner so that decisions can be made in a timely fashion based on the test results.
  2. Ease of Use: The user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats.
  3. Reducing Operator Errors: The device should have built in software safeguards to ensure proper operation and reduce common errors such as lock-out for failed quality control (or failure to perform quality control), lock-out of expired consumables, etc.
  4. Sample Types: Samples that do not require a trained phlebotomist such as capillary finger-stick whole blood or saliva is significantly preferred to venous blood samples.
  5. Storage of Consumables: All consumables including reagents, calibrators and quality control materials should be able to be stored at room temperature. The minimum shelf life is 2 years, although 5 years is preferred.
  6. Device Footprint: Devices should be designed to have as small a footprint as possible. Small handheld devices, or devices that are easily integrated into a spaceflight vehicle, are optimal.
  7. Information Connectivity: All devices should be capable of being interfaced to an electronic medical record system.
  8. Analytic Performance: As a general rule, the device should be equivalent to central laboratory instruments with regard to analytical accuracy, reportable range, and precision.

Strangman G. Space biomedical instrumentation. In: Young LR, Young JP, eds. Encyclopedia of bioastronautics. Springer 2017.

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