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

Casualties in the military operational environment will be transferred between care providers at multiple hand-offs as they are evacuated to a military hospital. These hand-offs offer additional opportunity for loss of record of care for the patient. According to Dr. Emily Patterson, Editorial Advisory Board member for The Joint Commission Journal on Quality and Patient Safety, “the impacts of less-than-ideal hand-offs likely include adverse events, delays in medical diagnosis and treatment, redundant communications, redundant [medical] activities.” This study focused on credential providers within a medical facility and did not delve into the issues of the lack of pre-hospital documentation. However, the salient point is that failures in medical information exchange impacts patient care and therefore impacts patient outcomes.

The future potential capabilities are highly reliant upon network connectivity and cloud computing to facilitate the exchange of information as a patient is being evacuated to a military hospital. However, these advanced capabilities have not yet been realized in the pre-hospital environment for the medic treating casualties. In a networked environment that is degraded through enemy denial of service attacks, the exchange of medical information through communication networks may not be feasible.

This desired capability will allow for the transfer of patient information through a persistent and durable mechanism that can be easily maintained with the patient through multiple patient hand-offs as the patient transitions through the continuum of care from the Point of Injury (Role I) to a Combat Support Hospital (Role III). This mechanism will feature a minimal risk of loss of the information or the medium on which it is conveyed. This capability would need to be compatible with Nett Warrior End User Devices (EUDs) that utilizes Samsung Galaxy S5 phones loaded with securely configured Android 5.0 operating system. The capability will need to interface with the currently deployed Electronic Health Record. Information must be transferrable between Nett Warrior EUDS through an interface, as well as DoD’s currently deployed Electronic Health Record. Capability concepts with smaller footprints and lower consumption of supplies are preferred. Capability concepts that do not require modification of the Nett Warrior End User Device hardware will also be given preference.

PHASE I: Design and develop an innovative concept for a capability that allows for the medical information exchange of pre-hospital care in military operational environment that persists throughout multiple patient exchanges and the continuum of care to a deployed military hospital in theater. The capability should be compatible with mobile Nett Warrior Android-based EUDs and be able to interface with the currently deployed Electronic Health Record. Produce a conceptual design and breadboard of the patient transportable tactical combat casualty care documentation capability to identify measures and predicted performance in Phase II. Explore 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.

PHASE II: Finalize the design from Phase I. Complete component design, fabrication and laboratory characterization experiments. Develop, demonstrate, and validate a ruggedized prototype and evaluate end to-end functionality without a transmission over an Internet Protocol-based military tactical radio/cellular network. At the end of Phase II, demonstrate a field testable prototype the in a government sponsored military exercise and without requirement for connection to a military tactical network. The prototype system will be evaluated by operational medics and clinicians in a relevant operational field environment; such as at a USA Army TRADOC Battle Lab. Flesh out commercialization plans contained in the Phase II proposal for elaboration or modification in Phase III. Firm up collaborative relationships and establish agreements with military and civilian end users to conduct proof-of-concept evaluations in Phase III.

PHASE III DUAL USE APPLICATIONS: Continue development and refinement of the prototype in Phase II to develop a production variant of the application. The production variant may be 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 prototype project, as a candidate for fielding, to applicable Army, Navy/Marine Corps, Air Force, Coast Guard, Department of Defense, 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, and the Departments of Justice, the Department of Homeland Security, the Department of the Interior, and the Department of Veteran’s Affairs. Execute further commercialization and manufacturing through collaborative relationships with partners identified in Phase II.

REFERENCES:

1. Butler, Frank K. "Tactical combat casualty care: update 2009." Journal of Trauma and Acute Care Surgery 69.1 (2010): S10-S13.

2. Garner, Alan. "Documentation and tagging of casualties in multiple casualty incidents." Emergency Medicine 15.5-6 (2003): 475-479.

3. Killeen, James P., et al. "A wireless first responder handheld device for rapid triage, patient assessment and documentation during mass casualty incidents." AMIA annual symposium proceedings. Vol. 2006. American Medical Informatics Association, 2006.

4. Patterson, Emily S., and Robert L. Wears. "Patient handoffs: standardized and reliable measurement tools remain elusive." The joint commission journal on quality and patient safety 36.2 (2010): 52-61.

5. Stahl, Kenneth, et al. "Enhancing patient safety in the trauma/surgical intensive care unit." Journal of Trauma and Acute Care Surgery 67.3 (2009): 430-435.

KEYWORDS: Pre-Hospital Care, Documentation, Role I, Tactical Combat Casualty Care Capability, Medical Information Exchange, Electronic Health Record

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to research, develop and demonstrate a capability to harvest energy from human motion and/or body heat to power into an integrated small disposable wireless adhesive medical sensor placed on a casualty.

DESCRIPTION: Current and future small patient medical devices and sensors placed on a casualty during field care near the point of injury or while en-route during extraction and evacuation are battery powered with a limited life span. As the DoD moves toward “prolonged field care” were a medic or corpsman may have to hold onto a casualty longer, up to 72 hours, current battery life on these medical devices and sensors is not sufficient. Future small disposable wireless adhesive medical sensors will be required to measure SPO2, HR, ECG, temperature, and other human factors in addition to wirelessly transmitting this medical data to an End User Device (EUD), i.e. an Android smartphone, to be displayed on a GUI, something similar to the U.S. Air Force Research Laboratory’s Battlefield Assisted Trauma Distributed Observation Kit (BATDOK). An integrated capability for medical sensors to harvest energy from human motion and/or body heat would allow medical sensors to operate for 72+ hours without requiring either a large battery or connection to an external power source. This integrated capability on the medical sensor can either replace the existing battery or provide an additional alternative source of energy to augment the existing battery.

The human body has the ability to produce enough equivalent energy to power a 100 watt light bulb, ref #5. A capability that can harvest this energy would be significant and enhance a medic’s ability to monitor casualty vital signs for a greater length of time. Harvesting energy from the body to power medical sensors has the potential to reduce a medic’s or soldier’s load. Medics and Soldiers currently have to carry extra batteries to extend the life of their devices, which add additional weight and space in their field pack. If devices can be powered by harvested energy, then the medic and soldiers can eliminate the need to carry extra batteries.

PHASE I: Design and develop an innovative approach to power a small disposable wireless adhesive medical sensor by integrating a capability of harvesting energy from the human. Conduct a feasibility study of the proposed approach to inform the development of a conceptual design of the integrated sensor package. Using software and/or hardware prototypes develop a breadboard/proof of concept demonstrator capable of capturing and storing energy to power portable devices that can be further developed into a test bed product that can be field tested during the Phase II research period.

This Phase will demonstrate the feasibility of the proposed approach through successful demonstration of harvested energy from the human body, and will inform success criteria and performance metrics for the Phase II system design.

PHASE II: From the results of the Phase I feasibility study and concept demonstration, continue preliminary design of the integrated energy harvesting medical sensor system. This capability needs to provide enough energy to power a small disposable wireless adhesive medical sensor that is collecting vital signs data (Heart Rate, Blood Pressure, and Respirations), ECG, and skin temperature on a patient/casualty continuously for 24 hours a day during prolonged field care and during en-route care. This capability also needs to provide enough energy to power a wireless (Ultra-Wideband, Tunable Narrowband, or an acceptable DoD wireless capability in an operational environment) radio within the medical sensor that will transmit the medical data collected continuously from the medical sensor to an End User Device (EUD), Android smartphone, to be displayed on the EUD GUI. Integrate the energy harvesting capability with current or future disposable wireless adhesive medical sensor, and develop prototype integrated devices that can be evaluated and tested in simulated combat casualty care missions in an operationally-relevant field environment.

During Phase II; develop a ruggedized prototype that can possibly be taken to the field for initial evaluation testing with medics around the 1 year mark. If a field evaluation test is possible, the medics provide their guidance and recommendations on the continued development of the device. Consider developing a ruggedization plan for Phase III and Advance development

Develop a commercialization plan. If IRB is required during Phase II, submit an IRB package to US Army MRMC HRPO.

PHASE III DUAL USE APPLICATIONS: Continue development and refinement of the prototype Human powered wireless medical sensor to a capability that is ruggedized, complies with space, weight, and power specifications informed by the Phase II medic field evaluations, is disposable, and moves the prototype capability towards advanced development/acquisition.

REFERENCES:

1. Popular Science – Harvesting Energy from Humans. http://www.popsci.com/environment/article/2009-01/harvesting-energy-humans

2. Utility Drive – 5 Ways you can use the human body to generate electricity. http://www.utilitydive.com/news/5-ways-you-can-use-the-human-body-to-generate-electricity/280709/

3. Business Insider – Scientists have found a way to Generate Electricity from the Human Body. http://www.businessinsider.com/scientists-have-found-a-way-to-generate-electricity-from-the-human-body-2012-11

4. ARS Technica – Your body, the battery: Powering gadgets from human “biofuel”. https://arstechnica.com/science/2015/07/your-body-the-battery-powering-gadgets-from-human-biofuel/

5. Extreme Tech – Will your body be the battery of the future? https://www.extremetech.com/extreme/135481-will-your-body-be-the-battery-of-the-future

KEYWORDS: Human generated, Alternative Energy, Harvesting, Human power, Human biofuel, Human battery, Matrix

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to develop and demonstrate novel intravenous therapies and technologies for pre-hospital management of combat-associated non-compressible traumatic hemorrhage and resuscitation at point-of-injury and en route care.

DESCRIPTION: In far forward combat scenarios, trauma-associated uncontrolled non-compressible hemorrhage (proximal extremity or truncal) remains the leading cause of fatality for the military, and many of these deaths could be potentially survivable with effective point-of-injury and en route treatment [1-2]. In such hemorrhage scenarios in austere battlefield conditions, transfusion of whole blood and blood components (RBCs, plasma, platelets and coagulation factors), as per Damage Control Resuscitation (DCR) guidelines, can significantly reduce trauma-associated morbidity and mortality [3]. Overwhelming evidence from military based resuscitation studies has indicated the benefits of such blood product transfusion to treat hemorrhagic shock, but the limited availability and portability, special storage requirements and potential contamination risks of these blood products (e.g. platelet concentrates) present severe logistical challenges for their efficient application in combat casualty care in pre-hospital scenarios [4-5].

In this solicitation, we are requesting proposals focused on intravenous transfusable treatments and technologies that address the pre-hospital point-of-injury and en route management of combat-associated traumatic non-compressible hemorrhage and resuscitation. Specifically, this solicitation is seeking intravenously administered molecules, drugs or therapeutic technologies (e.g. nanoparticles) for use at point-of-injury or during en route care to control bleeding and prevent or mitigate hypothermia, acidosis and coagulopathy. The proposal shall address not only preliminary data to support the treatment claims, but it should also provide a plan for effective, logistically supportable deployment during remote Damage Control Resuscitation (rDCR) and prolonged field care (PFC) by medics/corpsmen. In other words, the product should be portable in small volume in a medic or corpsman bag without special storage requirements, shelf-stable for long periods under variety of environmental conditions (cold or heat, ranging from 0-40°C, high altitudes) and easily intravenously administrable.

PHASE I: Phase I should be aimed at developing a promising and innovative therapy or technology, and evaluating the technical feasibility of said therapy to control hemorrhage through in vitro/ex vivo analysis. Research and development should take into account the challenges of employing the therapy in a far-forward operational environment (e.g. portability, stability, ease of administration) and provide a plan for practical deployment of the proposed solution. The effort should be far enough along that the submitter should not pursue animal studies during this phase.

PHASE II: Building on the Phase I effort, Phase II prototype development should demonstrate the systemic safety and therapeutic potential of the treatment/technology upon intravenous administration in appropriate models of traumatic hemorrhage in vivo. The focus of these studies would be to establish systemic safety, pharmacology/toxicology parameters and reduction in blood loss, prevention or alleviation of hypothermia, amelioration of acidosis and overall enhancement in survival. Phase II should also provide a detailed plan for practical implementation of the therapies at Point of Injury or en route care including dosage parameters (dosing limits, therapeutic window, etc). The submitter should assess and verify the Technology Readiness Level (TRL) of the proposed therapy at the conclusion of Phase II. The offeror will provide a clear regulatory plan on how they propose to achieve FDA clearance.

Follow-on activities shall include the necessary studies requested by the FDA to gain clearance of the technology and/or drug for use in treatment of traumatic non-compressible hemorrhage. The offeror shall focus on working towards getting the therapy FDA-approved for the indication to treat traumatic bleeding

PHASE III DUAL USE APPLICATIONS: The submitter should demonstrate the work they would be ready to perform should they be further funded. The submitter shall produce a protocol (dosage and timing of intervention) demonstrating potential medical utility in accordance with the success criteria developed in Phase II, and further develop these capabilities to TRL-5 or -6. The submitter must describe one or more specific Phase III military applications and/or supported S&T or acquisition program as well as most likely path for transition of the SBIR from research to operational capacity. The offeror will provide a clear plan on how FDA clearance will be obtained and to include a detailed commercialization plan and milestones chart.

REFERENCES:

1. Eastridge, et al. “Death on the battlefield (2001-2011): Implications for the Future of Combat Casualty Care.” J Trauma Acute Care Surg. 2012;73(6 Suppl 5):S431-7. Accession Number: ADA609264

2. McManus, et al. “Hemorrhage control research on today’s battlefield: Lessons applied.” J Trauma. 2007;62(6 Suppl):S14. Accession Number: ADA627857

3. Butler, et al. “Fluid resuscitation for hemorrhagic shock in tactical combat casualty care: TCCC Guidelines Change 14-01 – 2 June 2014.” J Spec Oper Med. 2014;14(3):13-38. Accession Number: ADA614492

4. Cap, et al. “Blood Far Forward: Time to Get Moving!” J Trauma Acute Care Surg. 2015;78(6 Suppl 1):S2-6. Accession Number: ADA621564

5. Spinella, et al. “Constant Challenges and Evolution of US Military Transfusion Medicine and Blood Operations in Combat.” Transfusion. 2012;52(5):1146-53. Accession Number: ADA615634

KEYWORDS: Combat Casualty Care, Trauma, Hemorrhage, Hemostasis, Transfusion, Damage Control Resuscitation

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to research, develop, and demonstrate intelligent DIAGNOSTIC algorithms intended for use during pre-hospital enroute care and Prolonged Field Care (PFC). These intelligent DIAGNOSTIC algorithms are required to enable assisted or automated DIAGNOSTICS, a key component and enabler of future medical systems that could provide remote critical care to combat casualties. Ultimately, the intelligent algorithms developed for automated DIAGNOSTICS will be a component of a ruggedized and light–weight autonomous casualty care system carried by a single dismounted combatant that is capable of facilitating the medical stabilization and treatment of patients in a pre-hospital environment.

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 soldier worn or medic placed monitors, diagnostic imaging, and DIAGNOSTIC laboratory analysis devices (not part of this SBIR topic) and formulate combat trauma diagnoses. 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 DIAGNOSIS 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.