Army 18. 1 Small Business Innovation Research (sbir) Proposal Submission Instructions

PHASE I: Research solutions to prototype, integrate and demonstrate intelligent DIAGNOSTIC algorithms as components of a ruggedized light-weight autonomous combat casualty care for supporting combat trauma patients during Prolonged Field Care (PFC) and in non-MEDEVAC ground and air casualty evacuation (CASEVAC) vehicles. Analysis of inputs from multiple types of monitors should be addressed to include: 1) soldier worn or medic placed monitors, 2) DIAGNOSTIC imaging, and 3) DIAGNOSTIC laboratory analysis. Conduct conceptual and preliminary design of the proposed component capability or capabilities to demonstrate the feasibility of the proposed component-level technology. Further develop the conceptual design of the larger system of systems for a complete enroute care capability and demonstrate how the proposed component-level technology fits into the complete system concept.

PHASE II: From Phase I work, develop and demonstrate intelligent combat trauma DIAGNOSTIC algorithms as components of the conceptual overall system. Demonstrate an operational prototype component capability in field exercise with medics/corpsmen as coordinated by US Army TATRC. Provide proof of concept demonstration of intelligent combat trauma DIAGNOSTIC algorithms with ultimate objective system of systems using integration and data standards discussed above. Consider requirements for FDA certification in Phase III and plan for Phase III integration of the prototype capabilities with a larger system of systems, if necessary, before demonstrating with patients during Phase II prototype user feed-back evaluations in a field environment. Further develop commercialization plans that were developed in the Phase II proposal for execution during Phase III, which may include exploring commercialization potential with civilian emergency medical service systems development and manufacturing companies. Seek partnerships within government and private industry for transition and commercialization of the production version of the product.

While the focus of Phase II research effort is not the physical hardware implementation of the intelligent DIAGNOSTIC algorithms, the Phase II prototype capabilities must demonstrate the feasibility to satisfy certain system requirements driven by the forward operating environment when integrated into a complete system concept. One of the important set of system requirements for the complete system concept is for the system to be ruggedized for shock, dust, sand, and water resistance to enable reliable, uninterrupted operation in combat environments to include operation and storage at extreme temperatures. Other important considerations for the system concept include: 1) If a separate battery is used, it should be easy and quick to replace the battery in the capability. 2) No new or proprietary display devices should be proposed; if a display is needed for the initial human-in-the loop attended or tele-operated prototyping phases, any required display should be designed to use a standard military issued Android End User Device (EUD) such as the Army Nett Warrior or SOCOM Android Tactical Assault Kit. 3) If intra-device communications are involved in proposed prototype capability, Ultra-Wideband (UWB) communications technology (Ref 15-17) is the desired communications protocol for connecting component technologies together and/or to tactical radios for remote teleoperations since UWB is being actively pursued as a secure wireless technology with minimal electronic signature for Open Body Area Networks (OBAN) in combat environments. Other innovative solutions for providing secure short-range wireless communications in a tactical environment will also be considered for system designs that require wireless intra-device communications.

PHASE III DUAL USE APPLICATIONS: Refine and execute the commercialization plan included in the Phase II Proposal. The Phase III plan shall incorporate military service specifications from the U.S. Army, U.S. Air Force, U.S. Navy, and U.S. Marine Corps as they evolve in order to meet their requirements for fielding. Specifications will be provided in Phase II as they become available. The prototype system component may be integrated into a system of systems design and evaluated in an operational field environment such as Marine Corps Limited Objective Experiment (LOE), Army Network Integration Exercise (NIE), etc. depending on operational commitments. Present the product ready capability as a candidate for spiral development fielding (even without completion of the entire system of systems objective), to applicable Department of Defense. Army, Navy/Marine Corps, Air Force, Program Managers for Combat Casualty Care systems along with government and civilian program managers for emergency, remote, and wilderness Medicine within state and civilian health care organizations. Execute further commercialization and manufacturing through collaborative relationships with partners identified in Phase II.

REFERENCES:

1. Trauma Pod Robot to Save Soldiers' Lives on the Battlefield. 2005. PHYS ORG. https://phys.org/news/2005-03-trauma-pod-robot-soldiers-battlefield.html

2. Trauma Pod: A Semi-Automated Robotic Surgery System. 2009. International Journal of Medical Robotics and Computer Assisted Surgery · Impact Factor: 1.53. https://www.researchgate.net/publication/255219448_Trauma_Pod_A_Semi-Automated_Robotic_Surgery_System

3. Tomorrow’s Tech: The Automated Critical Care System. 2014. Naval Science and Technology Future Force Staff. http://futureforce.navylive.dodlive.mil/2014/09/tomorrows-tech-the-automated-critical-care-system-web-exclusive/

4. Autonomous Patient Care Fact Sheet. 2017. Office of Naval Research. https://www.onr.navy.mil/en/Media-Center/Fact-Sheets/Autonomous-Patient-Care.aspx

5. Salinas, Jose. 2015. A phased approach to development of closed loop and autonomous critical care systems. US Army Institute of Surgical Research. Power point briefing. https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM467496.pdf

6. Medical Data Integration with SNOMED-CT and HL7. 2015. Longheu A., Carchiolo V., Malgeri M. (2015) Medical Data Integration with SNOMED-CT and HL7. 2015. In: Rocha A., Correia A., Costanzo S., Reis L. (eds) New Contributions in Information Systems and Technologies. Advances in Intelligent Systems and Computing, vol 353. Springer, Cham
http://link.springer.com/chapter/10.1007/978-3-319-16486-1_115

7. Health Information Technology Standards. 2017. Public Health Data Standards Consortium. http://www.phdsc.org/standards/health-information/D_Standards.asp

8. Parag Batavia, R. Ernst, K. Fisherkeller, D. Gregory, R. Hoffman, A Jenning, G. Romanski, B. Schechter & G. Hunt. 2016. The UAS Control Segment Architecture. http://www.raytheon.com/news/rtnwcm/groups/public/documents/content/rtn11_auvsi_uas_whitepaper.pdf

9. Unmanned Systems (UxS) Control Segment (UCS) Architecture: Architecture Description - SAE AS9131. 2016. SAE International. https://global.ihs.com/doc_detail.cfm?&item_s_key=00699100&item_key_date=830031&input_doc_number=SAE%20AS9131&input_doc_title=

10. Unmanned Systems (UxS) Control Segment (UCS) Architecture: Conformance Specification. 2017. SAE International –SAE AS 6513. SAE International. http://standards.sae.org/wip/as6513/

11. Soft Robotics. 2017. IEEE Robotics & Automation Society. http://www.ieee-ras.org/soft-robotics

12. Greenemeir, Larry. 2013. Soft Touch: Squishy Robots Could Lead to Cheaper, Safer Medical Devices. Scientific American. 24 Sep 2013. https://www.scientificamerican.com/article/soft-robotics-biomedical-surgery/

13. Gent, Ed. 2016. The Octobot is Just the Beginning of Soft Robotics. Singularity Hub. 14 Dec 2016. https://singularityhub.com/2016/12/14/the-octobot-is-just-the-beginning-for-soft-robotics/

14. Soft Robotics Journal. 2017. Mary Anne Liebert Publications. 4:1 March 2017. http://online.liebertpub.com/loi/SORO

15. Ultra-Wideband Technology for Short- or Medium-Range Wireless Communications, by: Jeff Forster, Evan Green, Srinivasa Somayazulu, and David Leeper.

16. Pushing the Ultrawideband Envelope, by Henry S. Kenyon.

17. Medical Applications of Ultra-Wideband (UWB), by Jianli Pan.

18. Nett Warrior (NW), US Army Acquisition Support Center.

19. Android Tactical Assault Kit, ATAKmap.com

KEYWORDS: Autonomous Enroute Care, Trauma Pod, Autonomous Critical Care System, Unmanned Systems, CASEVAC, HL7, UCS, Ultra-Wideband (UWB) Communications, combat casualty care

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to prototype intelligent trauma INTERVENTION algorithms to be used to facilitate the medical stabilization of combat casualties in a pre-hospital setting through autonomous therapeutic INTERVENTION and closed-loop patient management systems. This topic seeks to research, develop, and demonstrate intelligent INTERVENTION algorithms that would enable autonomous medical capabilities during Prolonged Field Care (PFC) and in non-MEDEVAC ground and air casualty evacuation (CASEVAC) vehicles. The intended implementation of these capabilities would be as part of an integrated autonomous combat casualty care system that is sufficiently light-weight and ruggedized to be carried by a dismounted combatant along with their other combat equipment.

DESCRIPTION: Future combat will likely involve greater dispersion and near isolation over great distances necessitating units to be more self-sufficient and less dependent on logistical and other support from supporting units. Use of unmanned air, ground and maritime systems is likely to greatly increase as autonomous capabilities of those systems develops. It would be difficult to increase the availability of manned evacuation platforms to adequately support dispersed warfare in multiple domain battlefields; indeed many combat environments will not be accessible by manned platforms due to distances, lack of air superiority, employment of weapons of mass destruction, and/or heightened intensity of conflict with peer/near-peer adversaries. The potential lack of availability of medical evacuation assets, e.g. due to anti-access and area denial challenges, pose a difficult dilemma for combat commanders with wounded, sick or otherwise incapacitated personnel. Ultimately they will resort to evacuation of those personnel on nonmedical vehicles of opportunity (the Army definition of CASEVAC) or face degradation of medical resources and encumbered combat mobility. As defined by the Army, CASEVAC without medical attendance or oversight poses problems with lack of sufficient enroute care, and even may be considered patient abandonment.

As many attempts to develop such a capability in the past have shown (Ref 1-5); it can only be approached by attempting to develop small chunks of the ultimate capability, a few at a time. In that case, a feasible approach is to begin with onboard attendant or tele-operated capabilities from remote locations gradually being replaced by autonomous capabilities. Some of the high level subsystem capabilities needed are: 1) comprehensive patient monitoring, 2) diagnostic medical imaging, 3) diagnostic laboratory analysis, 4) Differential diagnosis formulation 5) enroute care treatment plan formulation, and 6) INTERVENTION. Addressing all of these capabilities is far beyond the scope of a single SBIR topic but prototyping enabling technologies for these capabilities are well within that scope. This SBIR topic is intended to address just the intelligent algorithms needed to dynamically and continuously analyze input from separately generated autonomous diagnostic algorithms (not part of this SBIR topic) used to formulate combat trauma diagnoses in order to select and implement appropriate INTERVENTIONS. These INTERVENTIONS will likely involve robotic manipulators. Proposers may use any robotic manipulators as long as the algorithms developed are generalizable to any robotic system. Proposals must address a step-wise approach to prototyping algorithms for each capability to include initial manned capability prototypes, followed by tele-operated prototypes, followed by initial autonomous capabilities. Creative and inventive approaches are sought. Each proposal must include a complete system design concept for a complete autonomous combat casualty care patient monitoring and support system that is well thought out and documented in the Phase I proposal. While this SBIR topic will only address the combat trauma INTERVENTION component of the system, the proposal must clearly illustrate how all the component technologies will be integrated into the complete system design concept using a “system of systems” approach to achieve a complete casualty care capability.

Potential for future integration within a system of systems from diverse sources from government, industry, and academia requires adherence to open standards architecture, consistent data standards and an integrating reference architecture capability to be designed into components at the start. Proposals to this system of system research effort, should incorporate within the systems design, the medical HL7 data standards (Ref 6,7) and the DOD Unmanned Systems Control Segment (UCS) (Ref 8-10) Architecture interoperability specifications. Likewise, while this SBIR topic is focusing on enabling algorithms (software) only, emerging integrated soft and hardware technologies such as so-called “soft robotics” (Ref 11-14) should be considered for all proposed components of the ultimate system of systems in order to achieve levels of capability needed within the size, weight and ruggedization constraints of devices which must be carried, set up and attached to a patient by a single dismounted combatant. Proposed component capability solutions will not be considered that may, on their own, meet such criteria but do not take into consideration and specifically address in the proposal the overall weight and cube that would be required once all component capability prototypes are integrated into a complete enroute care system of systems.

PHASE I: Research solutions to prototype, integrate and demonstrate intelligent combat trauma INTERVENTION algorithms as components of a ruggedized light-weight autonomous combat casualty care for supporting combat trauma patients during Prolonged Field Care (PFC) and in non-MEDEVAC ground and air casualty evacuation (CASEVAC) vehicles. Analysis of inputs from separate combat trauma algorithms and multiple types of monitors should be addressed. Conduct conceptual and preliminary design of the proposed component capability or capabilities to demonstrate the feasibility of the proposed component-level technology. Further develop the conceptual design of the larger system of systems for a complete enroute care capability and demonstrate how the proposed component-level technology fits into the complete system concept.

PHASE II: From Phase I work, develop and demonstrate intelligent combat trauma INTERVENTION algorithms as components of the conceptual overall system. Demonstrate an operational prototype component capability in field exercise with medics/corpsmen as coordinated by US Army TATRC. Provide proof of concept demonstration of proposed intelligent combat trauma INTERVENTION algorithms with ultimate objective system of systems using integration and data standards discussed above. Consider requirements for FDA certification in Phase III and plan for Phase III integration of the prototype capabilities with a larger system of systems, if necessary, before demonstrating with patients during Phase II prototype user feed-back evaluations in a field environment. Further develop commercialization plans that were developed in the Phase II proposal for execution during Phase III, which may include exploring commercialization potential with civilian emergency medical service systems development and manufacturing companies. Seek partnerships within government and private industry for transition and commercialization of the production version of the product.

While the focus of Phase II research effort is not the physical hardware implementation of the intelligent diagnostic algorithms, the Phase II prototype capabilities must demonstrate the feasibility to satisfy certain system requirements driven by the forward operating environment when integrated into a complete system concept. One of the important set of system requirements for the complete system concept is for the system to be ruggedized for shock, dust, sand, and water resistance to enable reliable, uninterrupted operation in combat environments to include operation and storage at extreme temperatures. Other important considerations for the system concept include: 1) If a separate battery is used, it should be easy and quick to replace the battery in the capability. 2) No new or proprietary display devices should be proposed; if a display is needed for the initial human-in-the loop attended or tele-operated prototyping phases, any required display should be designed to use a standard military issued Android End User Device (EUD) such as the Army Nett Warrior or SOCOM Android Tactical Assault Kit. 3) If intra-device communications are involved in proposed prototype capability, Ultra-Wideband (UWB) communications technology (Ref 15-17) is the desired communications protocol for connecting component technologies together and/or to tactical radios for remote teleoperations since UWB is being actively pursued as a secure wireless technology with minimal electronic signature for Open Body Area Networks (OBAN) in combat environments. Other innovative solutions for providing secure short-range wireless communications in a tactical environment will also be considered for system designs that require wireless intra-device communications.

PHASE III DUAL USE APPLICATIONS: Refine and execute the commercialization plan included in the Phase II Proposal. The Phase III plan shall incorporate military service specifications from the U.S. Army, U.S. Air Force, U.S. Navy, and U.S. Marine Corps as they evolve in order to meet their requirements for fielding. Specifications will be provided in Phase II as they become available. The prototype system component may be integrated into a system of systems design and evaluated in an operational field environment such as Marine Corps Limited Objective Experiment (LOE), Army Network Integration Exercise (NIE), etc. depending on operational commitments. Present the product ready capability as a candidate for spiral development fielding (even without completion of the entire system of systems objective), to applicable Department of Defense. Army, Navy/Marine Corps, Air Force, Program Managers for Combat Casualty Care systems along with government and civilian program managers for emergency, remote, and wilderness Medicine within state and civilian health care organizations. Execute further commercialization and manufacturing through collaborative relationships with partners identified in Phase II.

REFERENCES:

1. Trauma Pod Robot to Save Soldiers' Lives on the Battlefield. 2005. PHYS ORG. https://phys.org/news/2005-03-trauma-pod-robot-soldiers-battlefield.html

2. Trauma Pod: A Semi-Automated Robotic Surgery System. 2009. International Journal of Medical Robotics and Computer Assisted Surgery · Impact Factor: 1.53. https://www.researchgate.net/publication/255219448_Trauma_Pod_A_Semi-Automated_Robotic_Surgery_System

3. Tomorrow’s Tech: The Automated Critical Care System. 2014. Naval Science and Technology Future Force Staff. http://futureforce.navylive.dodlive.mil/2014/09/tomorrows-tech-the-automated-critical-care-system-web-exclusive/

4. Autonomous Patient Care Fact Sheet. 2017. Office of Naval Research. https://www.onr.navy.mil/en/Media-Center/Fact-Sheets/Autonomous-Patient-Care.aspx

5. Salinas, Jose. 2015. A phased approach to development of closed loop and autonomous critical care systems. US Army Institute of Surgical Research. Power point briefing. https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM467496.pdf

6. Medical Data Integration with SNOMED-CT and HL7. 2015. Longheu A., Carchiolo V., Malgeri M. (2015) Medical Data Integration with SNOMED-CT and HL7. 2015. In: Rocha A., Correia A., Costanzo S., Reis L. (eds) New Contributions in Information Systems and Technologies. Advances in Intelligent Systems and Computing, vol 353. Springer, Cham
http://link.springer.com/chapter/10.1007/978-3-319-16486-1_115

7. Health Information Technology Standards. 2017. Public Health Data Standards Consortium. http://www.phdsc.org/standards/health-information/D_Standards.asp

8. Parag Batavia, R. Ernst, K. Fisherkeller, D. Gregory, R. Hoffman, A Jenning, G. Romanski, B. Schechter & G. Hunt. 2016. The UAS Control Segment Architecture. http://www.raytheon.com/news/rtnwcm/groups/public/documents/content/rtn11_auvsi_uas_whitepaper.pdf

9. Unmanned Systems (UxS) Control Segment (UCS) Architecture: Architecture Description - SAE AS9131. 2016. SAE International. https://global.ihs.com/doc_detail.cfm?&item_s_key=00699100&item_key_date=830031&input_doc_number=SAE%20AS9131&input_doc_title=

10. Unmanned Systems (UxS) Control Segment (UCS) Architecture: Conformance Specification. 2017. SAE International –SAE AS 6513. SAE International. http://standards.sae.org/wip/as6513/

11. Soft Robotics. 2017. IEEE Robotics & Automation Society. http://www.ieee-ras.org/soft-robotics

12. Greenemeir, Larry. 2013. Soft Touch: Squishy Robots Could Lead to Cheaper, Safer Medical Devices. Scientific American. 24 Sep 2013. https://www.scientificamerican.com/article/soft-robotics-biomedical-surgery/

13. Gent, Ed. 2016. The Octobot is Just the Beginning of Soft Robotics. Singularity Hub. 14 Dec 2016. https://singularityhub.com/2016/12/14/the-octobot-is-just-the-beginning-for-soft-robotics/

14. Soft Robotics Journal. 2017. Mary Anne Liebert Publications. 4:1 March 2017. http://online.liebertpub.com/loi/SORO

15. Ultra-Wideband Technology for Short- or Medium-Range Wireless Communications, by: Jeff Forster, Evan Green, Srinivasa Somayazulu, and David Leeper.

16. Pushing the Ultrawideband Envelope, by Henry S. Kenyon.

17. Medical Applications of Ultra-Wideband (UWB), by Jianli Pan.

18. Nett Warrior (NW), US Army Acquisition Support Center.

19. Android Tactical Assault Kit, ATAKmap.com

KEYWORDS: Autonomous Enroute Care, Trauma Pod, Autonomous Critical Care System, Unmanned Systems, CASEVAC, HL7, UCS, Ultra-Wideband (UWB) Communications, combat casualty care

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to prototype smart patient MONITORING algorithms as a subsystem for integration into a ruggedized light-weight autonomous combat casualty care capability that can be carried by a single dismounted combatant along with other combat equipment and quickly set up and attached to a combat casualty at point of care and/or within a hasty casualty evacuation (CASEVAC) platform. The intent of this topic is to research, develop and demonstrate smart patient MONITORING methods and algorithms to provide a comprehensive patient MONITORING capability that would support future systems capable of remote diagnostics and therapeutic interventions.