DEFENSE HEALTH AGENCY 19.1 Small Business Innovation Research (SBIR) Program

Proposal Submission Instructions

The Defense Health Agency (DHA) SBIR Program seeks small businesses with strong research and development capabilities to pursue and commercialize medical technologies.

Broad Agency Announcement (BAA), topic, and general questions regarding the SBIR Program should be addressed according to the DoD SBIR Program BAA. For technical questions about a topic during the pre-release period, contact the Topic Author(s) listed for each topic in the BAA. To obtain answers to technical questions during the formal BAA period, visit https://sbir.defensebusiness.org/sitis.

Specific questions pertaining to the DHA SBIR Program should be submitted to the DHA SBIR Program Management Office (PMO) at:

E-mail - usarmy.detrick.medcom-usamrmc.mbx.dhpsbir@mail.milPhone - (301) 619-5047

The DHA Program participates in three DoD SBIR BAAs each year. Proposals not conforming to the terms of this BAA will not be considered. Only Government personnel will evaluate proposals.

PHASE I PROPOSAL SUBMISSION

Follow the instructions in the DoD SBIR Program BAA for program requirements and online proposal submission instructions.

DHA SBIR Phase I Proposals have four Volumes: Proposal Cover Sheets, Technical Volume, Cost Volume and Company Commercialization Report. Please note that the DHA SBIR will not be accepting a Volume Five (Supporting Documents) as noted at the DoD SBIR website. The Technical Volume has a 20-page limit including: table of contents, pages intentionally left blank, references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any other attachments. Do not duplicate the electronically generated Cover Sheets or put information normally associated with the Technical Volume in other sections of the proposal as these will count toward the 20-page limit.

Only the electronically generated Cover Sheets, Cost Volume and Company Commercialization Report (CCR) are excluded from the 20-page limit. The CCR is generated by the proposal submission website, based on information provided by small businesses through the Company Commercialization Report tool. Technical Volumes that exceed the 20-page limit will be reviewed only to the last word on the 20th page. Information beyond the 20th page will not be reviewed or considered in evaluating the offeror’s proposal. To the extent that mandatory technical content is not contained in the first 20 pages of the proposal, the evaluator may deem the proposal as non-responsive and score it accordingly.

Companies submitting a Phase I proposal under this BAA must complete the Cost Volume using the on-line form, within a total cost not to exceed $162,500 over a period of up to six months.

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The DHA SBIR Program will evaluate and select Phase I proposals using the evaluation criteria in Section 6.0 of the DoD SBIR Program BAA. Due to limited funding, the DHA SBIR Program reserves the right to limit awards under any topic and only proposals considered to be of superior quality will be funded.

Proposals not conforming to the terms of this BAA, and unsolicited proposals, will not be considered. Awards are subject to the availability of funding and successful completion of contract negotiations.

PHASE II PROPOSAL SUBMISSION

Phase II is the demonstration of the technology found feasible in Phase I. All DHA SBIR Phase I awardees from this BAA will be allowed to submit a Phase II proposal for evaluation and possible selection. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the DHA SBIR PMO. Submission instructions are typically sent toward the end of month five of the phase I contract. The awardees will receive a Phase II window notification via email with details on when, how and where to submit their Phase II proposal.

Small businesses submitting a Phase II Proposal must use the DoD SBIR electronic proposal submission system (https://sbir.defensebusiness.org/). This site contains step-by-step instructions for the preparation and submission of the Proposal Cover Sheets, the Company Commercialization Report, the Cost Volume, and how to upload the Technical Volume. For general inquiries or problems with proposal electronic submission, contact the DoD SBIR/STTR Help Desk at (1-800-348-0787) or Help Desk email at sbirhelp@bytecubed.com (9:00 am to 6:00 pm ET).

The DHA SBIR Program will evaluate and select Phase II proposals using the evaluation criteria in Section 8.0 of the DoD SBIR Program BAA. Due to limited funding, the DHA SBIR Program reserves the right to limit awards under any topic and only proposals considered to be of superior quality will be funded.

Small businesses submitting a proposal are required to develop and submit a technology transition and commercialization plan describing feasible approaches for transitioning and/or commercializing the developed technology in their Phase II proposal. DHA SBIR Phase II Cost Volumes must contain a budget for the entire 24-month Phase II period not to exceed the maximum dollar amount of $1,075,000. These costs must be submitted using the Cost Volume format (accessible electronically on the DoD submission site), and may be presented side-by-side on a single Cost Volume Sheet. The total proposed amount should be indicated on the Proposal Cover Sheet as the proposed cost. DHA SBIR Phase II Proposals have four Volumes: Proposal Cover Sheets, Technical Volume, Cost Volume and Company Commercialization Report. The Technical Volume has a 40-page limit including: table of contents, pages intentionally left blank, references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any attachments. Do not include blank pages, duplicate the electronically generated Cover Sheets or put information normally associated with the Technical Volume in other sections of the proposal as these will count toward the 40-page limit.

Technical Volumes that exceed the 40-page limit will be reviewed only to the last word on the 40 th page. Information beyond the 40th page will not be reviewed or considered in evaluating the offeror’s proposal. To the extent that mandatory technical content is not contained in the first 40 pages of the proposal, the evaluator may deem the proposal as non-responsive and score it accordingly.

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PHASE II ENHANCEMENTS

The DHA SBIR Program has a Phase II Enhancement Program which provides matching SBIR funds to expand an existing Phase II contract that attracts investment funds from a DoD Acquisition Program, a non-SBIR government program or eligible private sector investments. Phase II Enhancements allow for an existing DHA SBIR Phase II contract to be extended for up to one year per Phase II Enhancement application, and perform additional research and development. Phase II Enhancement matching funds will be provided on a dollar-for-dollar basis up to a maximum $537,500 of SBIR funds. All Phase II Enhancement awards are subject to acceptance, review, and selection of candidate projects, are subject to availability of funding, and successful negotiation and award of a Phase II Enhancement contract modification.

DISCRETIONARY TECHNICAL ASSISTANCE

The DHA SBIR Program does not participate in the Discretionary Technical Assistance Program. Contractors should not submit proposals that include Discretionary Technical Assistance.

The DHA SBIR Program has a Technical Assistance Advocate (TAA) who provides technical and commercialization assistance to small businesses that have Phase I and Phase II projects.

RESEARCH INVOLVING ANIMAL OR HUMAN SUBJECTS

The DHA SBIR Program discourages offerors from proposing to conduct human subject or animal research during Phase I due to the significant lead time required to prepare regulatory documentation and secure approval, which will significantly delay the performance of the Phase I award.

The offeror is expressly forbidden to use or subcontract for the use of laboratory animals in any manner without the express written approval of the US Army Medical Research and Material Command's (USAMRMC) Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for this award will be issued in the form of an approval letter from the USAMRMC ACURO to the recipient. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation.

Research under this award involving the use of human subjects, to include the use of human anatomical substances or human data, shall not begin until the USAMRMC’s Office of Research Protections (ORP) provides authorization that the research protocol may proceed. Written approval to begin research protocol will be issued from the USAMRMC ORP, under separate notification to the recipient. Written approval from the USAMRMC ORP is also required for any sub-recipient that will use funds from this award to conduct research involving human subjects.

Research involving human subjects shall be conducted in accordance with the protocol submitted to and approved by the USAMRMC ORP. Non-compliance with any provision may result in withholding of funds and or termination of the award.

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DHA SBIR 19.1 Topic Index

DHA191-001 Augmented Reality Surgical Visualization Tool for Combat Casualty CareDHA191-002 Intelligent Patient Simulation PlatformDHA191-003 Local Patient Record Transfer Modernization in Theater/Operational Settings in Support of

JOMIS Patient Movement Requirements Definition Package (RDP) RequirementsDHA191-004 Delayed/Disconnected, Intermittently-Connected, Low-Bandwidth (DIL) Communications

Capability in Support of Military Medical Systems Availability in Dispersed and Denied Operations

DHA191-005 Delay / Disruption Tolerant Networking for Mobile Operational MedicineDHA191-006 Novel Cell-Based Biosensor for Rapid Field Water Toxicity DetectionDHA191-007 A Universal Device for Performing Needle DecompressionDHA191-008 Antiseptic, Warming, and Pressure Relieving Casualty Transport PadDHA191-009 Automated Framework for the Design of Passive Prosthetic & Orthotic InterfacesDHA191-010 Ruggedized Inertial Measurement Unit System to Assess Movement Dysfunction in Austere

EnvironmentsDHA191-011 Magnetic Field Peripheral Ring Nerve Blocks

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DHA SBIR 19.1 Topic Descriptions

DHA191-001 TITLE: Augmented Reality Surgical Visualization Tool for Combat Casualty Care

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Design and develop an Augmented Reality (AR) surgical tool to provide visualization of human internal anatomy, obtained from a USARIEM anatomical avatar, superimposed on the view of an injured Warfighter, with the ability to selectively remove layers of obstructing/obscuring anatomy.

DESCRIPTION: Care for the wounded Warfighters in austere and remote settings makes medical knowledge, skills and efficiency of the military medical professional paramount, especially given the limited medical resources. The US military has taken on broader responsibilities, resulting in fewer evacuation assets and surgical capabilities to meet the Golden Hour. These concerns for delayed evacuation to surgical and definitive care, also known as Prolonged Field Care (PFC), further emphasize the necessity to ensure maximal resources and state-of-the-art-medicine are available in the battlefield setting. For wounds that extend deep into internal anatomy, proper visualization of internal anatomy can enable more efficient and effective evaluation with safe and optimal treatment when presented to medical providers positioned close to the point of injury (POI), much in the way that CTs have enabled better musculoskeletal care at forward medical units.

Visualization aids for surgery were introduced 25 years ago for improved outcomes in hospital surgical procedures [1]. We envision an AR tool as a heads-up visualization aid for medics and caregivers in the field, in which 3D surface mesh renderings of a patient’s internal anatomy are displayed overlaid onto the real-time view of the patient during a procedure. The tool helps a caregiver visualize vessels and anatomy deep below the body surface. The AR tool would use “best estimate” individualized wholebody anatomy in the form of a USARIEM avatar [2] (Government furnished digital data) as a substitute for medical imaging information for a medic operating in remote PFC environments. Avatar data could be carried by a Warfighter in a miniature storage chip. A smartphone-sized computer would ‘register’ [3], i.e. scale, rotate and translate, the avatar anatomy to align with the view of the injured Warfighter acquired from a helmet-mounted video camera, projecting surface rendered anatomy onto the patient view to the caregiver in a ‘smart glasses’ or visor personal display.

With the AR tool, the medical caregiver sees partially-transparent projection images of 3D internal avatar anatomy along with the real scene, e.g. an enhanced capability to “look through” [4] the body. This offers incredible insight into the anatomy of the injured Warfighter, advancing aiding in treatment in austere environments. Also, the real-world scene can be augmented with additional visual (cine or graphics) and audio data, in real-time, providing an enhanced or enriched experience. Further, displayed information can be interactive, modified by the user by, e.g. to visualize local vasculature near trauma, benefitting hemorrhage control. The AR display can also play a valuable role by providing anatomy information in low light conditions during PFC, such as during nighttime or in sheltered, dark interiors. The AR display can play a role in the field for 3D surgery or treatment planning, that is, as a navigational aid in planning medical interventions, followed by aid during the surgery or treatment by displaying otherwise obscured anatomy and nearby vessels, thus aiding safety, efficiency and contributing to better outcomes.

Secondarily, the AR display can also play a role in the classroom as well as in the field. The AR tool can serve as a training tool for medical caregivers, applied with a human subject or a medical manikin. Under these controlled circumstances, additional graphics and text information can be added into the overlaid information.

PHASE I: The main goal is to identify the components that will be used to construct a prototype system for the portable AR surgical visualization tool in Phase II. Initially, a design for the overall system and communications software should be completed. Project hardware should be chosen when possible to use components approved for DoD applications. Software requiring custom programming should be identified. Software design should focus on open standard languages. The hardware and any relevant open source software (to be used when possible) should be

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acquired. The lightweight miniature hardware components must include: a miniature extremely lightweight video camera that can be attached to a helmet; an AR personal display system that is incorporated into or integrated with a product on the Army PEO Soldier Authorized Protective Eyewear List (APEL) and able to display the complete torso and anatomy of a subject; and, a smartphone-sized computer able to perform all necessary combined registration computations and graphics computations at a rate >5 screen updates per second, and provide a miniSD chip port and microphone pick-up if verbal commands to alter the AR scene are used. The AR tool component system is to operate by battery for 4hrs, and have secondary capability to attach to a power source and recharge batteries. If time is available, software can be produced to test the connectivity of the video camera – computer – visor display hardware system. The computer is to be chosen capable of performing the necessary computations in near real-time, i.e. >5 updates per second. Likewise, the computer must have graphics capability to provide real-time display of 3D surface rendered anatomy projections.

PHASE II: Using results from Phase I, the main objective of Phase II is to create a complete prototype system of the AR surgical visualization tool including hardware and software. As an initial step, a prototype software suite for surface mesh anatomy transformations must be demonstrated on a standard workstation (i.e., initially not loaded or executing on the AR tool) before the end of Year One. The prototype software suite must contain all the necessary software modules necessary for the scaling, and transformation of avatar data for repositioning, and registration with the real scene observed in the video images. Based in the hardware identified in Phase I and the software developed in the first part of Phase II, complete the hardware integration and software programming by the end of Q3 in Year Two. Demonstrate the working system in Q4 Year Two using a human male who is similar in size and build to an existing USARIEM avatar, with the anatomy from that avatar used. The demonstration must be performed in an exterior setting devoid of equipment having wifi, cell phone or satellite connections. The system’s input must include: wholebody anatomy as a high-resolution USARIEM avatar, including 3D surface rendered internal anatomy, contained on a miniature computer chip; and, the video images acquired from a scene of a prone individual acquired with the miniature video camera.

For the demonstration, a person will be outfit with a helmet-fixed camera and the personal display device. The smart-phone sized computer would provide the resource for all computations. Surface renderings of anatomy are to be transmitted to the medic’s display, showing the registered, scaled, rotated and translated and repositioned avatar anatomy, aligned with a video camera’s view of the Warfighter viewed in the natural scene. The anatomy is to be displayed as a partially transparent graphic corresponding to the Warfighter anatomy within the physical scene in the field-of-view. The aim is for the medic to see the real physical scene augmented with the anatomy in a PFC setting. A vocal method (or similarly effective method) should be devised for describing and activating a modification of the displayed avatar anatomy. That is, eliminating or replacing displayed anatomical components, or selectively removing or replacing an entire anatomy layer(s).

PHASE III DUAL USE APPLICATIONS: Develop training software, sample input and manuals for the system so that the system can be disseminated to military medical professionals. Train in-house personnel to be educators regarding use of this system and to be able to teach military medical professionals the use of this system. Provide training sessions for the initial group of adapters. The main target for the commercial product is the US military. The contractor should propose use to the Army through the Office of the Deputy for Acquisition of the US Army Medical Research and Material Command, and to the Navy through the Acquisition & Analytics Directorate of the Navy’s Bureau of Medicine and Surgery contracting program, under the Naval Medical Logistics Command. Private sector commercial potential also exists. Small primary and secondary hospitals that do not wish to invest in a large surgical visualization platform are a market for a portable AR surgical visualization system. The system can be modified with the addition of third party automatic segmentation software running on an attached laptop PC, to input the auto-segmented surface rendered anatomy of a patient from a medical imaging source, to enable visualization of all or portions of their anatomy registered with the real-world scene. The AR tool hardware system and registration and display software is also valuable outside of the medical market. The hardware and software can be marketed, without the medical application features, to a commercial application developer that can use the system as an inspection tool, or more general employee workbench aid, laboratory bench aid or training aid.

REFERENCES:

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1. W. Lorensen, H. Cline, C. Nafis, R. Kikinis, D. Altobelli, L. Gleason, G. Co, N. Schenectady, "Enhancing reality in the operating room", IEEE Conf. on Visualization, pp. 410-415, 1993.

2. G.P.Zientara, R.W. Hoyt, Individualized avatar with complete anatomy constructed from the ANSUR II 3-D anthropometric database, Intl J Digital Human 1(4), pp. 389-411, 2017.

3. W. E. L. Grimson, T. Lozano-Perez, W. M. Wells, G. J. Ettinger, S. J. White, R. Kikinis, "An automatic registration method for frameless stereotaxy image guided surgery and enhanced reality visualization", IEEE Trans. Med. Imag., vol. 15, no. 2, pp. 129-140, Apr. 1996.

4. M.Hart, “Augmented Reality Technology Poised to be a Game-Changer in Radiology”, Radiological Soc North America, July 1, 2017.

KEYWORDS: Medical visualization, Augmented Reality, wholebody anatomy, internal anatomy, visor display, battlefield care, hemorrhage control.

DHA191-002 TITLE: Intelligent Patient Simulation Platform

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Define, demonstrate, develop, and test an Intelligent Patient Simulation software architecture to be used for building intelligent patient simulators that provide realistic medical training experiences, by leveraging natural language processing and advanced Artificial Intelligence (AI) technologies.

DESCRIPTION: Standardized patients, high-fidelity mannequin simulators, task trainers, and screen based virtual patient simulators are universally accepted medical education tools. The recent advancement in natural language processing and AI technology have created opportunities to further enhance the realism of these tools. AI technology could enhance medical simulation tools, creating close-to-real-life training experiences, by making mannequin and screen based virtual patient simulators more intelligent.

• The goal of this topic is to create software that adds natural language processing and artificial intelligent features to medical mannequins and screen based virtual patient simulators, using the latest technologies, to provide enhanced training experiences. The software shall provide capabilities for learners to ask questions and receive responses from the simulator in natural language (e.g. how are you doing today?) and carry out commands from the instructor for changing the physiology (e.g. increase heart rate). The AI functions would allow this software to learn from available sources or trainings to understand questions asked in different ways. Currently, many who run simulation must observe the learner and also run the simulator. Cognitive load in this case can be overwhelmed and key features of the performance by the learner may be missed. Therefore, any system that allows learners and instructors to interact with the simulator by voice commands or code words will allow more cognitive space for the instructor to observe the performance of the learner. The learner and the instructor should be able to carry out a dialogue with the simulator (mannequin or virtual screen based patient) in a natural way without having to speak in certain pre-defined sentences. When the Application Programming Interface (API) for controls of a mannequin or a virtual patient are available, the platform shall allow an instructor (or student) to control the mannequin or screen based virtual patient simulator via voice commands to conduct scenarios for training. The mannequin or screen based virtual patient simulator may use AI to adjust its parameters by itself, based on what has been learnt or trained previously. Other AI features may include building a library of patient scenarios with various clinical findings and personalities.

The aim of this project is to deliver software that can integrate with most of the Department of Defense (DOD)-funded mannequins (such as the Laerdal 3G, KGS, etc…) , the BioGears, an open source human physiology engine. as well as virtual screen based patient simulators (e.g. Simcoach ) for developing proof-of-concept demos.

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The performer may decide to develop the needed AI technologies on its own, when feasible within the required time frame and funding resource, or use existing available advanced commercial AI technologies.

The AI functionalities built into the platform should be generic, so that it can be used with both medical mannequin and virtual patient simulators.

An Intelligent Patient Simulator built with the platform developed for this topic should:• Accurately understand learner’s questions in various ways in natural conversations (e.g. how are you doing? Do you have any pain anywhere? What brings you in today? Where are you hurt?)• Respond to commands by the instructor to change the physiology (e.g. slow down breathing, increase heart rate, become unresponsive, cough, etc.…)• Answer and ask questions in a sensible way in the context of medical training• Learn from available sources or trainings to understand questions asked in different ways• Develop simulated patient’s personalities through learning and coaching (AI/machine learning)• Build a library of trained patient simulators for different training scenarios• Provide structure for future use with multiple languages (other than English)• Be compatible with DOD funded simulators• Integrate with DOD Virtual Patient Simulator• Leverage tools provided with the DOD Biogears physiology engine

PHASE I: Phase I will focus on demonstrating proof of concept that natural language processing software will work in a DoD funded mannequin and a virtual patient to 1) answer questions posed by the learner and 2) carry out commands posed by the instructor.

A high-level technical requirement for the platform should be defined, based on the evaluation of the technologies relevant to this topic, and the status of the mannequin and virtual patient technologies. An initial concept design of the platform should then be performed.

The following technological challenges should be addressed with proof-of-concept that demonstrate:

• Feasibility of configuring a medical mannequin simulator using voice commands and adjusting its parameters using voice commands.• Feasibility of training a screen based patient simulator to carry out a conversation, in a medical context with an instructor or a student in a natural way without the need of using pre-formulated sentences.• Feasibility of developing a screen based patient simulator’s personality through training.

The intent of this phase is for the performer to demonstrate this capability on a mannequin and virtual patient and submit a final report describing the feasibility of the concept, software development and application, and the details of what will be further developed in Phase II. This will likely be in the Maryland, Northern Virginia, or Washington, DC area where the topic authors are located.

PHASE II: The intent of this phase is development of AI software that can learn from available sources or trainings to understand questions asked in different ways; develop simulated patient’s personalities through learning and coaching (AI/machine learning); build a library of trained patient simulators for different training scenarios; and provide structure for future use with multiple languages (other than English). The performer must also address the types of risk anticipated. Building upon the development and lessons learned of Phase I, Phase II will deliver details on the design and performance of the product in an intelligent patient simulation platform in the following areas:• functional requirement• architecture design• component design• coding• testing of the software• delivery of the software (on DoD funded mannequins and screen based simulators )

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Because of the nature of this project as a prototype effort, an iterative agile development methodology is expected.

A medical mannequin simulator and a screen based virtual patient simulator should be identified as candidates to test the platform developed. It is anticipated that any of the commercially available human patient simulators purchased by the DoD may be used. For screen based virtual patient simulators, any of the currently funded JPC-1 or SBIR screen based patient simulators (e.g., Simcoach, Virtuoso, Perceptive Patient, and Character) may be used as a test bed.

Tactical Combat Casualty Care specific medical training scenarios (e.g. hemorrhage control, airway compromise, tension pneumothorax, fasciotomy, or Advanced Cardiac Life Support scenarios) should be identified for testing the capability of the platform developed in either the mannequin or screen based patient platform. Many of these scenarios have already been developed for mannequin based and screen based patient simulators and are currently available from MTF simulation centers or simulation manufactures. These scenarios should target learners with different levels of clinical knowledge and degrees of difficulty. For screen based patient virtual patients, DoD relevant psychiatric cases such as PTSD, anxiety disorder, and suicide may be considered as scenario topics, especially since some of these scenarios have already been developed for this type of simulator.

With the selected mannequin simulator, screen based virtual patient simulator, and training scenarios, the platform can be tested to prove the concept of configuring and adjusting parameters on a medical mannequin simulator or screen based virtual patient simulator using voice commands. For screen based patients, the platform could also be used to prove the concept of assigning a personality to a patient in the scenario.

The Phase II product will need to demonstrate the usefulness of the platform developed with appropriate collection of usability and reliability data from participants who would use the product in the demonstration phase.The performer will submit a final report that will include the results of the survey of appropriate users, reliability data on the product in the demonstration phase and the current state of the software application. The performer will provide a demonstration of the product, along with details of what will be further developed in Phase III. This demonstration most likely will occur in the Maryland, Northern Virginia, or Washington, DC area where the topic authors are located and where potential DoD end user sites exist.

PHASE III DUAL USE APPLICATIONS: Concluding in Phase III, the performer will have built a viable, commercially available software product accessible in a downloadable application that can be used in a medical training classroom. Preferably, the capability will be based on state of the art software and hardware principles, use validated data from publicly available sources, and anatomically correct patient simulators that can be used in medical training curriculum.

It is anticipated that DoD customers will include all facilities that have mannequin based and/or screen based patient simulators in their simulation center inventories. These include the US Army Medical Simulation and Training Centers, the Army Central Simulation Committee MTF based Simcenters, The Air Force and Navy Medical Modelling and Simulation Training MTF based centers (NMMAST/AFMMAST), the joint Medical Education and Training Center (METC) campus and the Uniformed Services University. This is a total of over 121 distinct training sites worldwide with thousands of students. These centers would receive this software for integration into DoD Funded simulators via the advanced developer for this project which has been identified as the Joint Program Office for Medical Modeling and Simulation at PEO-STRI, Orlando, FL. Iterations of this capability would be included in future efforts which, as envisioned, would also require a virtual patient in which to perform medical procedures, interviews, etc.

Commercial markets that could benefit from this novel product would include: emergency/first responder training, undergraduate medical training, nursing school, graduate medical/dental/pharmacology schools/veterinary (including residency/fellowship), and simulation training centers. Manufacturers of medical mannequins and virtual patient simulators could benefit from such a product, resulting in a “value-added” improvement of their commercial products. The AI software produced here should be ready for integration into: 1) screen-based simulators; 2) a commercially available human patient simulator purchased by the DoD and 3) AMM (if/when available).Upon completion, the performer will submit a final report describing the software application and the demonstration

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results.

REFERENCES:1. Advanced Modular Manikin: https://www.advancedmodularmanikin.com/about.html

2. Sweet, R. M. (2017). "The CREST Simulation Development Process: Training the Next Generation." J Endourol 31(S1): S69-s75.

3. Meeker D, Cerully JL, Johnson M, Iyer N, Kurz J, Scharf DM. SimCoach Evaluation: A Virtual Human Intervention to Encourage Service-Member Help-Seeking for Posttraumatic Stress Disorder and Depression. Rand Health Q. 2016 Jan 29;5(3):13. eCollection 2016 Jan 29.

4. BioGears Physiology Engine: https://www.biogearsengine.com/

5. David A Cook, Marc M Triola. Virtual patients: a critical literature review and proposed next steps. Medical Education. Volume 43, Issue 4 April 2009 Pages 303–311.

6. NLP skills not ready for reliable medical conversations. https://healthitanalytics.com/news/alexa-siri-nlp-skills-not-ready-for-reliable-medical-conversations

KEYWORDS: Artificial Intelligence, Medical Training, Medical Simulation, Patient Simulation, Patient Communication, Speech Recognition, Machine Learning, Voice Command.

DHA191-003 TITLE: Local Patient Record Transfer Modernization in Theater/Operational Settings in Support of JOMIS Patient Movement Requirements Definition Package (RDP) Requirements

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition - USAMRMC

OBJECTIVE: The objective of this topic is to develop and field a reliable means to transfer patient care data between electronic medical record systems, mobile or laptop device to mobile or laptop device, in austere deployed locations with little to no telecommunications connectivity. Although this is primarily a DoD patient movement challenge, other process areas and commercial markets would likely be able to take advantage of improved data file transfer capabilities across austere care settings, such as between healthcare providers during humanitarian efforts, possibly in the home health environment, definitely between ambulance service providers as well as other modes of patient transportation like non-military “life flight” rotary wing missions or even regional disaster response medical evacuations and those corresponding sending and/or receiving medical facilities. A technological solution to accommodate patient records transfer from one care setting to the next (lateral patient hand offs), agnostic to the type of information technology platform/device in hand, might also provide unforeseen utility for non-medical purposes.

DESCRIPTION: Currently, the amount of work required to move patient records in low / no telecommunications areas during expeditionary or other military operational activities frequently causes patient safety risks because the information related to earlier stages of a patient’s condition and/or care that has been provided (medications, devices used, etc.) is often needed later by the higher echelons of care that receive the patient next. The current process is prone to error, requiring about 30 total discrete steps to move patient records horizontally along with the patient, including data export via archaic external CD ROM, and later the import of records from CDs. Once the process is completed other "clean-up" processes must occur to decrease the likelihood of duplication of patient records. Current software and procedures were not designed for existing business practices and must be modernized to address safety as well as to ensure wounded warrior permanent patient records are complete as they are necessary to

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get military personnel the future care and benefits they have earned from their service and sacrifices.

Some of the topic areas for the R&D to be supported under this FOA include, but are not limited to:• Electronic patient documentation needs to transfer laterally / horizontally between the various types of IM/IT hardware that supports operational / theater medicine, such as Windows OS, Android OS, potentially iOS, and perhaps others. Hardware is typically commercial off the shelf (COTS). Patient hand offs between escalating echelons of medical care typically requires the support of dedicated patient movement service providers such as rotary wing MEDEVAC, fixed wing Aeromedical Evacuation, and ground based patient transport teams. A technological solution that enables electronic patient documentation to flow horizontally through these patient movement teams whenever they pick up and/or deliver patients to Roles 1, 2, 3 & 4 Military Treatment Facilities (MTFs) would help solve the problem of patient records not following patients through each of their hand off events.• The medical record device-to-device transfer software user interface requires a significant improvement and innovation to create a simple to use, streamlined and reliable means to move selected patient records via some form of wireless data transfer.• This R&D effort will facilitate replacing the current CD ROM with alternative transfer technology. Identifying all viable alternative solutions is critical to this effort, such as Near Field Communications (NFC), that can be supported in deployed environments and meet all RMF and Health Insurance Portability & Accountability Act (HIPAA) requirements. Current technologies may not fit all circumstances, like if NFC is deemed unreliable when used proximate to rotary wing aircraft due to a static electrical field that is generated across a wide perimeter.• Medical record transfer / data import improvements are needed, also. Once patient records are made available to the receiving patient care transport service provider or the next higher echelon of care, those records should be imported using a simple and reliable user interface. As indicated earlier, the current process is cumbersome and unreliable.• NOTE: An upcoming challenge is that the DoD will enter a transition period over the next 5+ years in which multiple different patient records systems will exist, both old and new. In garrison facilities are migrating from legacy AHLTA, Essentris, CHCS, etc. over to MHS GENESIS which is based on Cerner and Henry Shein products. Operational / expeditionary theater medical missions are intended to migrate from AHLTA-Theater, TC2, etc. over to MHS GENESIS Theater, a low comm/no comm capable version of the garrison solution.

Example Patient Hand Off Scenario: Navy Corpsman treats Marines at Role 1 medical station, hands off to Army rotary wing MEDEVAC crew, helicopter arrives at Air Force Theater Role 3 facility, patient gets procedure and transitions to En Route Patient Staging System (ERPSS) unit by flight line, once fixed wing aircraft arrives patient is ground transported to plane and handed off to Aeromedical Evacuation crew who care for patient for several hours until arriving at an OCONUS military base where patient is handed off to another ERPSS team that takes the patient to a Role 4 Army hospital (such as Landstuhl in Germany or Tripler in Hawaii) for further treatment, and the cycle repeats one more time to get the Marine patient transported to a CONUS Role 4 hospital like Walter Reed Bethesda. The very realistic scenario above involves no less than ten patient hand offs The capability should utilize not more than 16GB total storage and the ability to transfer data or images with a file size up to 6MBs.

PHASE I: Research and design a technical solution including feasible approaches to innovate existing data transfer processes based upon requirements described above. This design must be based upon multiple modality transfer technologies which are selected based upon data transfer location issues such as security and environmental (e.g., rotary wing propeller wash) constraints. As examples, Bluetooth, Near Field Communications, ZigBee, IrDA, ANT, and other commercial or government transfer technologies should be considered in the final design. The design must work across various designated government infrastructure environments securely and will leverage current and future standardized medical record software. The designed solutions must provide analysis of predicted performance in various operational environments, payload constraints and other technical specifications related to data transfer and security technical constraints. Working in conjunction with the Joint Operational Medicine Information Systems (JOMIS) Program Management Office (PMO) and associated service APMs (the APMs provide contacts for service personnel who can provide network availability, capability and restrictions), demonstrate a potential path to integrate the solution with the future electronic health record systems using existing industry and international standards-based approaches.

PHASE II: Complete component design, fabrication and laboratory characterization piloting. The prototype the design from Phase I. Develop, demonstrate, and validate a ruggedized prototype that demonstrates the end to-end

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functionality of the design. At the end of Phase II, work with the JOMIS PMO to demonstrate a field testable prototype in a government sponsored military exercise or testing event held at the Operational Medicine Government Approved Laboratory (OM GAL), Fort Detrick, MD. The prototype system will be evaluated by operational medics and clinicians across all four Service branches in a relevant operational field environment. Flesh out commercialization plans contained in the Phase II proposal for elaboration or modification in Phase III. Collect Feedback data from the operational medics and clinicians that have evaluated the prototype. Use this feedback to improve the design, 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(s) of the application that would support either military or civilian patient movement requirements. Incorporate applicable feedback and other considerations from the collaborative relationships and agreements into the production variant. The production variant will be presented to Service and Joint patient movement stakeholders: Air Force, Army, Marine Corps, Navy, USTRANSCOM, and DHA. Following that presentation, the JOMIS PMO will coordinate with these key stakeholders and others to have the capability evaluated in an operational field environment. The capability will then be considered by the JOMIS PMO as a candidate for fielding via inclusion in the JOMIS acquisition program baseline, and will also be presented to non-DoD entities such as the Coast Guard, 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. It is highly conceivable that the resulting technological solution would benefit non-military patient transfer activities, to include disaster response patient evacuations in which traditional telecommunications may be unavailable, overseas humanitarian medical support activities, but also the technology might provide unforeseen value to non-healthcare related industries even.

The solution should operate on DISA approved devices (Laptops, Tablets, Phones, etc).

REFERENCES:1. Joint Operational Medicine Information Systems Patient Movement Requirements Definition Package (16 Apr 2018 - Draft)

2. Theater Medical Information Requirements (TMIR) – Capabilities Development Document (CDD) February 2017.

3. Joint DOTMLPF Change Recommendation for Forward Resuscitative Care (August 2017)

4. Joint Concept for Health Services (JCHS) 2015 - http://afrims.amedd.army.mil/media/joint_concept_health_services.pdf

5. National Institute of Standards and Technology (NIST). (2009). Risk Management Framework (RMF) – Special Publication 800-37 Rev. 1. https://csrc.nist.gov/publications/detail/sp/800-37/rev-1/final

KEYWORDS: Patient Movement, Local Patient Record, Patient Records Transfer, Low Communications Environment, DIL, Aeromedical Evacuation, Patient Records Integrity.

DHA191-004 TITLE: Delayed/Disconnected, Intermittently-Connected, Low-Bandwidth (DIL) Communications Capability in Support of Military Medical Systems Availability in Dispersed and Denied Operations

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TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Develop next generation technical architecture using computing and network virtualization that seamlessly supports network resiliency and availability of applications resources in both no-bandwidth and severely limited communications environments. The features include dynamic adaptation in real-time to the available conditions and resources with no pause or disruption in availability or the integrity of the data captured or processed. That is, the government is seeking from industry novel forms of network and computing infrastructure research and development supporting application prioritization, storing, sending and processing of medical records and related clinical systems in a network fault tolerant manner supporting local processing (and queueing) when no bandwidth conditions exist and automatic recovery/re-synchronization and transfer of records bi-directionally when network capabilities are available/restored without detection of impact by the clinical application. The target architecture, systems and network infrastructure should support virtualization of network and “containerization” of software application functions (e.g. network function virtualization) such that seamless operations of medical records and application processing continues unabated across a spectrum of reliability challenges including latency, transactions and clinical applications at the point of care/point of injury far forward in austere environments supporting the Military Health System (MHS) Genesis implementation of the Cerner Millenium suite as the source electronic health records system.

DESCRIPTION: The Joint Operational Medical Information System (JOMIS) provides the definitive electronic medical record for use in Theater/Operational Medicine settings. As stated in the United States Army-Marine Corps White Paper “Multi-Domain Battle: Combined Arms for the 21st Century” the emerging and anticipated future operational environment will be significantly different from past engagements which experienced total air, land, sea supremacy and assured evacuation of combat injured personnel within the first critical hour. By contrast, the future battlefield and theater of operations is likely confront unconventional and sophisticated adversaries in dispersed operations far forward and in denied environments and in overmatch situations that challenge the military’s medical reach and ability to delivery medical care. The Joint Concept for Health Services (2015) foresees medical capabilities with significantly reduced footprints. Documentation at the point of injury in the future battlefield is essential to timely delivery of medical care by combat medics and corpsmen on the front line and includes the evacuation of patients at battalion aid stations to forward surgical teams, combat support hospitals and ultimately for definitive care in medical treatment facilities. Yet, the infrastructure and network capabilities necessary to support documentation of patient care far forward is anticipated to be minimal or non-existent.

PHASE I: The Phase I section briefly describes expectations and desired results/end product. Keep in mind that a Phase I is a feasibility study that should demonstrate or determine the scientific, technical, and commercial merit and feasibility of a selected concept. Phase I projects cover a 6-month, $100K (max) effort. The following are key words and phrases that may be helpful in writing the Phase I section:• Define, determine and demonstrate feasible concepts and potential solutions to achieving network function virtualization for reliable access and use of higher order medical and clinical applications in denied and dispersed environments requiring patient care and evacuation with precise and accurate electronic medical record documentation across the continuum. Demonstrate a path to integration of the solution with the MHS Genesis electronic health record system.• The proposed system should focus on virtualized network functions that implement a flexible, extensible mechanisms to manage data handling, cacheing, and replication that can function in low-bandwidth and intermittently-disconnected environments. Mechanisms to instantiate, configure, and manage/administer virtualized infrastructure in such environments should be part of the Phase-I product. Note in this case that managing / administration must be achievable by someone with minimal to moderate training (i.e. not an expert in network virtualization).A successful Phase-I effort will produce:• A lab quality prototype demonstrating the ability to instantiate, configure, manage, and destroy virtualized network functions supporting end-to-end communications in eventually-connected environments (i.e. environments where contemporaneous end-to-end communications paths are not always present, but where eventual piecewise connectivity between a source and a destination is present).

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PHASE II: Similar to the Phase I section, the Phase II section briefly describes expectations and minimum required deliverable. Phase II represents a major research and development effort, culminating in a well-defined deliverable prototype (i.e., a technology, product or service) meeting the requirements of the original solicitation topic and which can be made commercially viable. Phase II projects cover a 2-year, $1.0M (max) effort.

• Refine the product from in Phase I as well as deliver a reference implementation with ‘running code’ that achieves network function virtualization supporting continuous clinical systems operations under no and low-communications conditions and in optimal conditions, demonstrates seamless recovery and re-synchronization when the underlying infrastructure is restored with no perceived impact to the clinical records systems functionality, availability, response time performance or data integrity.• The Phase-II product should be at technology readiness level 6 (System Adequacy Validated in Simulated Environment) in order to be considered for incorporation into the JOMIS program which is in the technology maturation and risk reduction (TMRR) phase.

PHASE III DUAL USE APPLICATIONS: SBIR Phase III refers to work that derives from, extends, or logically concludes effort(s) performed under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III work is typically oriented towards technology transition to Acquisition Programs of Record and/or commercialization of SBIR research or technology. In Phase III, the small business is expected to obtain funding from non-SBIR government sources and/or the private sector to develop or transition the prototype into a viable product or service for sale in the military or private sector markets. The Phase III description must include the "vision" or "end-state" of the research. It must describe one or more specific Phase III military applications and/or supported S&T or acquisition program as well as the most likely path for transition of the SBIR from research to operational capability. Additionally, the Phase III section must include (a) one or more potential commercial applications OR (b) one or more commercial technology that could be potentially inserted into defense systems as a result of this particular SBIR project.

Note that there is no limit on the number, duration, type, or dollar value of Phase III SBIR/STTR awards made to a business concern. There is no limit on the time that may elapse between a Phase I or Phase II award and Phase III award or between a Phase III award and any subsequent Phase III award. Also, the small business size limits for Phase I and Phase II awards do not apply to Phase III awards. Congress intends that agencies that pursue R&D or production developed under the SBIR/STTR programs give preference, including sole source awards, to the awardee that developed the technology. Phase III awards may be made by any Government entity without further competition. The competition for SBIR and STTR Phase I and Phase II awards satisfies any competition requirement when processing Phase III awards. Therefore, an agency is not required to conduct another competition in order to satisfy any statutory provisions for competition.

REFERENCES:1. United States Army-Marine Corps White Paper - Multi-Domain Battle: Combined Arms for the 21st Century https://ccc.amedd.army.mil/PolicyPositions/Multi-Domain%20Battle%20-%20Combined%20Arms%20for%20the%2021st%20Century.pdf

2. Joint Concept for Health Services (JCHS) 2015 - http://afrims.amedd.army.mil/media/joint_concept_health_services.pdf

KEYWORDS: Network function virtualization, fault-tolerant network and application infrastructure, resilient clinical applications during network disruptions

DHA191-005 TITLE: Delay / Disruption Tolerant Networking for Mobile Operational Medicine

TECHNOLOGY AREA(S): Biomedical

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ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Mature Delay / Disruption Tolerant Networking (DTN) mechanisms to support operational medicine.

DESCRIPTION: Some systems have to operate in Delayed, Intermittently-Connected, Low-Bandwidth (DIL) environments without connectivity to the Internet or an IP-enabled infrastructure but still need to communicate, both point-to-point and across multiple hops. The multi-hop communications may NOT be able to leverage end-to-end connectivity among devices or a predefined network topology. That is, the multi-hop communications may need to leverage time-disjoint network paths in networks with time-varying, unknown, and/or unpredictable topologies. The Delay / Disruption Tolerant Networking (DTN) architecture put forth by NASA and DARPA provides these types of services, but work is needed to apply the technology to Mobile Operational Medicine. For example:• The DTN architecture allows for environment-specific link layer mechanisms, but none have been developed that are accredit-able for use in operational medical environments such as forward-deployed tactical. Examples might include screen-to-camera transfers, near-field communications, etc.• Routing mechanisms/protocols that support Operational Medicine data flows: Automatically sharing information among a configured set of mobile units Allowing a particular unit to request all patient data from nearby nodes (data attractor) Under user direction, forwarding patient information (possibly across multiple hops) to a particular mobile unit or gateway device, and possibly beyond (e.g. if the gateway device has network connectivity)

PHASE I: Investigate communications mechanisms that can be implemented on Android and iOS devices without external hardware/infrastructure that are suitable for use in EMCON / LPI/LPD environments. Solutions to this problem should include an analysis of the ‘interceptability’ of the mechanisms proposed (at least in terms of identifying the physical mechanism of communications, the type of equipment that would be needed to identify / locate it) as well as analyses of the data rates that should reasonably be achievable in tactical environments. The communications mechanisms should support data transfer (transfer of variable-sized, delimited sequences of bytes) of up to several MegaBytes. Example communications mechanisms include optical, near-field, vibration, or acoustic communications; utilizing Internet technologies over the link layers to achieve the required transfer sizes is within scope (e.g. segmenting the data into IP datagrams and sending them as a sequence of QR codes). The communication mechanism must work in a noisy (acoustic noise, bright/low/variable lighting, crowded RF) environment as appropriate and must be integrated as a ‘convergence layer’ into an implementation of the Bundle Protocol [RFC5050]. Only point-to-point communications are required, however mechanisms that support multipoint communications (multicast / broadcast) are preferred.

Work with the cyber-security community to identify the issues involved in accrediting the communications mechanisms for use in forward-deployed tactical environments.

The following CONOPS should drive the design of the data transfer mechanism(s):• Several medics treat a number of wounded soldiers at or near the point of injury. Each electronically documents his activities using software on a mobile device. There is no infrastructure (i.e. no cellular, no WiFi).• Medics should be able to share information among each other (e.g. to hand off patients). The mechanics of the operational medicine applications invoking the data sharing are beyond the scope of this SBIR; the ability to share at a physical / data-link layer (point-to-point and possibly point-to-multipoint) is the subject of this work.• For evacuation, those medics must all send the information on their activities to a new medic who arrives with an ambulance.

Prototype of one or more of the communications mechanisms implemented on an Android / iOS device without hardware modifications. Document the implementation in an open forum and/or make the source code publicly available.

A working Phase-I artifact will:• Enable the transmission of data between two mobiles as described above (transfers of up to several MB without recourse to outside infrastructure).• Include an analysis of the achievable data transfer rates as a function of environmental noise (for whatever definition of ‘noise’ is appropriate to the transfer mechanism).

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• Be integrated as a ‘convergence-layer protocol’ into an implementation of the DTN Bundle Protocol (e.g. NASA’s ION implementation or IBR-DTN).

PHASE II: Design data forwarding / routing mechanisms and associated control / configuration mechanisms that operate in the context of RFC5050 or Compressed Bundle Header Encoding (CBHE) addresses and that implement the data forwarding mechanisms identified during Phase I. Document the protocol / mechanism in an open forum (standards body, conference, or journal).

The routing mechanism(s) should support the CONOPS above and should operate in Mobile Ad-Hoc Network (MANET) environments where the connectivity among devices ins variable and unknown in advance. It can be assumed that particular data transfer operations (e.g. mobile-to-mobile sharing, data accumulation for transport, etc.) are user-directed from the application(s).

A successful Phase-II artifact will:• Implement the data transfer mechanisms from Phase-I along with routing developed in Phase-II.• Be at technology readiness level 6 (System Adequacy Validated in Simulated Environment) in order to be considered for incorporation into the JOMIS program which is in the technology maturation and risk reduction (TMRR) phase.• Be of sufficient maturity and include sufficient documentation to allow it to be instantiated, configured, and tested using the CONOPS above in the JOMIS Operational Medicine Government Approved Lab (OM-GAL).

PHASE III DUAL USE APPLICATIONS: SBIR Phase III refers to work that derives from, extends, or logically concludes effort(s) performed under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III work is typically oriented towards technology transition to Acquisition Programs of Record and/or commercialization of SBIR research or technology. In Phase III, the small business is expected to obtain funding from non-SBIR government sources and/or the private sector to develop or transition the prototype into a viable product or service for sale in the military or private sector markets. The Phase III description must include the "vision" or "end-state" of the research. It must describe one or more specific Phase III military applications and/or supported S&T or acquisition program as well as the most likely path for transition of the SBIR from research to operational capability. Additionally, the Phase III section must include (a) one or more potential commercial applications OR (b) one or more commercial technology that could be potentially inserted into defense systems as a result of this particular SBIR project.

Note that there is no limit on the number, duration, type, or dollar value of Phase III SBIR/STTR awards made to a business concern. There is no limit on the time that may elapse between a Phase I or Phase II award and Phase III award or between a Phase III award and any subsequent Phase III award. Also, the small business size limits for Phase I and Phase II awards do not apply to Phase III awards. Congress intends that agencies that pursue R&D or production developed under the SBIR/STTR programs give preference, including sole source awards, to the awardee that developed the technology. Phase III awards may be made by any Government entity without further competition. The competition for SBIR and STTR Phase I and Phase II awards satisfies any competition requirement when processing Phase III awards. Therefore, an agency is not required to conduct another competition in order to satisfy any statutory provisions for competition.

REFERENCES:1. Joint Concept for Health Services (JCHS) 2015 - http://afrims.amedd.army.mil/media/joint_concept_health_services.pdf

2. DTN Architecturehttps://tools.ietf.org/html/rfc4838

3. Bundle Protocol Specificationhttps://tools.ietf.org/html/rfc5050

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4. NASA ION DTN Implementationhttps://sourceforge.net/projects/ion-dtn/

5. IBR-DTN DTN Implementationhttps://github.com/ibrdtn/ibrdtn

6. IETF DTN WGhttps://datatracker.ietf.org/wg/dtn/documents/

KEYWORDS: Delay / Disruption Tolerant Networking (DTN) low communications environment (DIL), mobile solution, fault-tolerant network and application infrastructure, resilient clinical applications during network disruptions

DHA191-006 TITLE: Novel Cell-Based Biosensor for Rapid Field Water Toxicity Detection

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Incorporate novel toxicity sensing methods using a platform compatible with the Environmental Sentinel Biomonitor (ESB) for testing Army field water with the goal of increasing toxicant sensitivity and reducing consumable size and cost.

DESCRIPTION: The ESB is scheduled for fielding in 2019 to provide a rapid test for chemical-related toxicity in Army field drinking water supplies. One of the two sensor components of the ESB uses electric cell-substrate impedance sensing (ECIS) technology in a 1-hour test to monitor changes in electrical impedance of living rainbow trout gill epithelial cells (RTgill-W1 cell line; Bols et al., 1994) seeded on fluidic biochips as an indicator of possible chemical contamination (Widder et al., 2015, Brennan et al., 2016). The ECIS sensor is useful because it responds to a wide range of chemicals in the desired sensitivity range between the Military Exposure Guideline (MEG) concentration and the estimated Human Lethal Concentration (HLC) with virtually no responses to uncontaminated water (deionized water containing cell media only), while the RTgill-W1 cells used in testing can survive on fluidic biochips for at least 9 months without maintenance when stored at 6° Celsius. The current ECIS device responds to 7 of 18 chemicals in a test set within the MEG-HLC range (Widder et al., 2015). (Note that these 18 chemicals were selected to represent a range of toxic modes of action, not because they are the sole concern for detection.) This ECIS device has a dedicated reader, but a planned ESB improvement will utilize an ECIS sensor whose data will be analyzed on a smart device (e.g., a smart phone). The primary goal of this effort is to utilize novel, innovative approaches to provide increased sensitivity to toxicants. A secondary goal is to reduce the size and cost of consumables; at present, one fluidic biochip seeded with cells (measuring 9 cm by 4 cm by 1 cm; length by width by depth) costing approximately $120 is required per test. The proposed device does not have to use the current ECIS reader, but should use eukaryotic cells and produce data suitable for analysis on a smart device, while meeting performance criteria described below. Innovations might involve novel or genetically modified cell types or new endpoint measures (Horvath et al., 2016). The product of this effort will enhance the toxicant detection capabilities of the current ESB system by increasing the number of chemicals that can be detected in the desired sensitivity range and by decreasing the size and cost of consumables for each test, while retaining or improving upon the ability of the ESB to function under field-relevant conditions.

PHASE I: Provide a proof of concept demonstration of a eukaryotic cell-based toxicity sensor that will be original or will represent significant extensions, applications, or improvements over published approaches. It is anticipated that the new device will include three main components: (1) a consumable comparable to the fluidic biochip in the current ESB ECIS sensor that stores live cells prior to testing; (2) a reader that takes data from cells exposed both to control (deionized) and test water and transmits the data to (3) a smart device where the sensor data are analyzed and interpreted. Design and performance considerations for a proof of concept demonstration are listed below.• Detect 8 of the following 9 chemicals in the test set between the MEG and the HLC (the Army HLC in

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Widder et al. (2015)) without responses to uncontaminated (control) water: sodium pentachlorophenate, sodium cyanide, mercuric chloride, sodium azide, thallium sulfate, phenol, nicotine, sodium fluoroacetate and acrylonitrile.• Complete testing in one hour or less;• Utilize consumables, including biological components and chemical reagents, that have shelf lives of at least 9 months when stored at 6° Celsius or above; having a range of storage temperatures beyond 6 - 25° Celsius is desirable. In Phase I, demonstrate consumable viability under long-term storage conditions for at least 30 days.• Utilize eukaryotic cells that do not require feeding, supplemental carbon dioxide or other interventions during storage to maintain viability until use;• Provide a consumable/reader design that allows for introduction of distinct test and control water samples and provide a connection for data transmission and analysis. To ensure long-term cell viability, the consumable must remain sterile until needed for water sample analysis, but sterility need not be maintained during the 1-hour water test.• For the ECIS endpoint, cells should form a monolayer with impedance levels of at least 1000 ohms and should be contact inhibited once the monolayer is formed;• Explain how the proposed device can be made suitable for use in a field environment with further development.• The size and cost of the consumable components should be no greater than the currently-used fluidic biochips. Provide a written plan for Phase II to reduce the size and cost of the consumable component. The goal is to reduce size an order of magnitude smaller than the current fluidic biochip and to reduce consumable to less than $10 per test.

PHASE II: Expand upon Phase I proof of concept demonstration to develop a prototype system that includes the cell-based consumables, a reader device for cell monitoring, and a smart device (such as an Android smartphone) for data analysis and interpretation. Based on the plan furnished in Phase I, minimize the size (and subsequent cost) of test consumables and utilize the refined consumable for remaining tests. Minimize the need for user manipulations and simplify system operation to the extent possible. Develop the smart device software for a user interface comparable to the current ECIS/ESB device (e.g., Brennan et al., 2016). To show that the prototype system has appropriate sensitivity to toxicants, demonstrate the ability of the device to detect the 18 chemicals in the Army test set between the MEG and HLC levels (Widder et al. 2015) as well as the response of the prototype to possible interferences in water (chlorine, chloramine, humic and fulvic acids, and hardness; Widder et al. 2015) in a 1-hour test. Show that test results are repeatable and that responses to control (blank) samples do not occur. Final chemical testing should be done by an independent contractor following procedures similar to the U.S. Environmental Protection Agency’s Environmental Technology Verification program (https://archive.epa.gov/nrmrl/archive-etv/web/html/). Demonstrate that the shelf life of test consumables under the temperature conditions selected in Phase I is nine months or more. Design concepts should minimize size, weight, power requirements, and provide for simplified operation with automated analysis of results.

PHASE III DUAL USE APPLICATIONS: Provide the prototype system for integration into Water Quality Analysis Set – Preventive Medicine (WQAS-PM) for field use by Army preventive medicine personnel. Offer the new technology to other military services, which have the same drinking water monitoring requirements as the Army (Departments of the Army, Navy and Air Force, 2010). The increased toxicant sensitivity of the enhanced ESB will increase detection of toxic chemicals in water and thereby reduce potential adverse health effects, while the reduced size of the test consumables will lower sustainment cost of the ESB. Field tests will involve shipping the transportation and analysis system to Army field sites and testing toxicity sensing capabilities. Given on-going concerns regarding accidental or intentional contamination of water supplies, this technology will have broad application beyond the military. The new sensor could be offered for use by water utilities to evaluate either treated or untreated drinking water for potential toxicity. In addition, state and local governments and first responders could use the sensor as a rapid method for screening water samples.

REFERENCES:1. Bols, N.C, A. Barlian, M. Chirino-Trejo, S.J. Caldwell, P. Goegan, L.E.J. Lee. 1994. Development of a cell line from primary cultures of rainbow trout, Oncorhynchus mykiss (Walbaum), gills. J. Fish Diseases 17:601-611.

2. Brennan, L.M., M.W. Widder, M.K. McAleer, M.W. Mayo, A.P. Greis, and W. H. van der Schalie. 2016. Preparation and testing of impedance-based fluidic biochips with RTgill-W1 cells for rapid evaluation of drinking

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water samples for toxicity. JoVE 109: 53555.

3. Departments of the Army, Navy and Air Force. 2010. Sanitary Control and Surveillance of Field Water Supplies. TB MED 577, NAVMED P-5010-10, AFMAN 48-138_IP. Washington, DC.

4. Horvath, P., N. Aulner, M. Bickle, A.M. Davies, E. Del Nery, D. Ebner, M.C. Montoya, P. Östling, V. Pietiäinen, and L.S. Price. 2016. Screening out irrelevant cell-based models of disease. Nat. Rev. Drug Discov. 15(11):751-769.

5. Widder, M.W., L.M. Brennan, E.A. Hanft, M.E. Schrock, R.R. James, and W. H. van der Schalie. 2015. Evaluation and refinement of a field-portable drinking water toxicity sensor utilizing electric cell-substrate impedance sensing and a fluidic biochip. J. Appl. Toxicol. 35(7):701-708.

KEYWORDS: Toxicity sensor, impedance sensing, drinking water, vertebrate cells.

DHA191-007 TITLE: A Universal Device for Performing Needle Decompression

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: To develop a device for automating needle decompression to more effectively manage tension pneumothorax on the battlefield.

DESCRIPTION: Needle decompression is an emergency procedure to relieve tension pneumothorax, a condition wherein air fills the pleural space. Tension pneumothorax may be caused by blunt or penetrating trauma, which were reported in nearly 10% of wounded US personnel in Iraq and Afghanistan [1]. Left untreated, tension pneumothorax increases intrapleural pressure to the point of lung collapse and obstruction of venous return to the heart. The ensuing respiratory failure and cardiovascular collapse lead to death. In the large majority of cases, however, decompression (ultimately performed via chest tube) is the only intervention needed to successfully manage the condition [2]. A number of decompression needles and catheters are available to purchase, including extended length, 8 cm devices. Unfortunately, users continue to perform needle decompression incorrectly, with inaccurate siting noted to be a common error [3, 4].

The incidence of thoracic trauma, lethality of tension pneumothorax, and high failure rate of prehospital chest decompression [5, 6] explain why tension pneumothorax is a significant cause of preventable combat death [7]. Development of an automated battlefield solution for tension pneumothorax that can be used by minimally trained combat medics and promotes both procedural success and avoidance of complications (e.g., inadvertent injury to the lung heart, or great vessels) is of critical importance.

PHASE I: Phase I will consist of designing schematics and diagrams along with limited testing of a prototype for a minimally-invasive device to automate needle decompression, to include identifying the presence of a pneumothorax, locating the appropriate site for treatment, and performing the procedure. The device will be designed such that necessary steps, from diagnosis to dressing application and preparation for transport, are considered and easy to perform – either facilitated by the novel device or unencumbered by it. Specific emphasis will be placed on usability, materials, and design for the particular challenges of the battlefield environment (to include no or low light, loud conditions, cramped space, extreme environments, etc.) and use by all providers, including combat medics with EMT level training. An argument for the approach chosen, to include recognized open questions in the literature, will be included. The phase will also outline a plan for IACUC or HRPO approval (for phase II animal and/or cadaver testing) and a regulatory path for gaining FDA approval or clearance.

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PHASE II: This phase will consist of further developing the automated needle decompression device demonstrating its utility, and validating the prototype(s) through relevant testing. During the first year, the prototype(s) will be tested in simulated and/or large animal model environments in order to determine their practical viability. The second year will involve refinement and more rigorous testing of the chosen design in human trauma models, such as large animal, human cadaver, or simulation. Testing and refinement will involve the device’s adherence to battlefield constraints; the device must be portable, lightweight (<2 lbs), self-contained, have low power requirements, and be useable by providers with only EMT level training. The phase II commercialization plans should include a regulatory plan for FDA clearance. In addition, the contractor should begin establishing relationships with appropriate commercialization partners (manufacturing, marketing, etc.) to facilitate technology transition.

PHASE III DUAL USE APPLICATIONS: The technology developed under this SBIR effort will have applicability to both civilian and military emergency medicine. Phase III will consist of finalizing the device design and delivering manufactured devices (in their final form) for military-relevant testing (e.g. environmental, operational, etc.) and FDA-related testing (e.g. biocompatibility, sterilization, packaging validation, etc.). The device will be functional for use by medics, physician assistants, nurses, and physicians in far forward environments (roles 1 and 2 of care). Phase III will also include developing and finalizing training methods and protocols for the new device. In addition, the regulatory package should be in its final form ready for submission to the FDA, including all relevant test data.

REFERENCES:1. Ivey, K.M., et al., Thoracic injuries in US combat casualties: a 10-year review of Operation Enduring Freedom and Iraqi Freedom. J Trauma Acute Care Surg, 2012. 73(6 Suppl 5): p. S514-9.

2. Luchette, F.A., et al., Practice Management Guidelines for Prophylactic Antibiotic Use in Tube Thoracostomy for Traumatic Hemopneumothorax: the EAST Practice Management Guidelines Work Group. Eastern Association for Trauma. J Trauma, 2000. 48(4): p. 753-7.

3. Netto, F.A., et al., Are needle decompressions for tension pneumothoraces being performed appropriately for appropriate indications? Am J Emerg Med, 2008. 26(5): p. 597-602.

4. Ferrie, E.P., N. Collum, and S. McGovern, The right place in the right space? Awareness of site for needle thoracocentesis. Emerg Med J, 2005. 22(11): p. 788-9.

5. Aylwin, C.J., et al., Pre-hospital and in-hospital thoracostomy: indications and complications. Ann R Coll Surg Engl, 2008. 90(1): p. 54-7.

6. Waydhas, C. and S. Sauerland, Pre-hospital pleural decompression and chest tube placement after blunt trauma: A systematic review. Resuscitation, 2007. 72(1): p. 11-25.

7. Eastridge, B.J., 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): p. S431-7.

KEYWORDS: Chest decompression; needle decompression; needle thoracostomy; tension pneumothorax; pneumothorax; thoracic trauma; FDA; battlefield death.

DHA191-008 TITLE: Antiseptic, Warming, and Pressure Relieving Casualty Transport Pad

TECHNOLOGY AREA(S): Biomedical

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ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition - USAMRMC

OBJECTIVE: Develop a light-weight, small cube(space occupying/volume when stored), field-ready antiseptic, warming, and pressure relieving casualty transport padding for up to 72 hours of litter evacuation.

DESCRIPTION: Mattresses capable of reducing pressure ulcers using dynamic cycling are currently used clinically but are not available for far forward military applications [1, 2]. A capability is sought to provide a casualty transport pad that is capable of warming and relieving pressure during extended litter evacuation times that also has antiseptic properties in order to reduce morbidity of prolonged field care (PFC). Pressure ulcers are associated with significant increases in mortality and morbidity in the critically injured and may develop the tissue conditions leading to these wounds as soon as 2 hours of immobility [3]. Prolonged field care requires the ability to care for multiple critically injured trauma patients for up to 72-96 hours. Prevention of pressure ulcers, preventing hypothermia, and development of secondary infection are all essential tasks. In critically injured casualties evacuated from Afghanistan the vacuum spine board (VSB) did not statistically significantly prevent pressure ulcer development over standard treatment during 8-9 hours of immobility during evacuation and VSBs are not compact enough for PFC [4]. Successful completion of this project should result in a light-weight, small cube, field-ready antiseptic, warming, and pressure relieving casualty transport pad.

PHASE I: Design/develop an innovative concept along with the limited testing of a pressure relieving and warming casualty pad capable of maintaining temperatures of 35-37º C as well as the ability to dynamically cycle pressure in the pad to prevent development of pressure ulcers in casualties with body weights of up to 130 kg. It should also be sturdy enough to allow lifting the patient with the pad alone. Due to nutritional and fluid needs and ongoing casualty voiding during this time period the material and surface must be antiseptic in order to prevent secondary infection development. The pad should also include a disposable/replaceable moisture wicking cover for fluids and sweat. The pad should also include a disposable/replaceable moisture wicking cover for fluids and sweat, and could be used in conjunction with currently fielded temperature management solutions, e.g., Ready Heat™.

PHASE II: Required Phase II deliverables:1) Using results from Phase I, demonstrate the operation of a prototype. 2) Based on the results from Phase I, construct and complete design suitable for use in dismounted, ground vehicle, shipboard, and air platform evacuation litter settings. The device must be portable, lightweight (objective: <2 lbs), self-contained, power requirement is replenishable/rechargeable). A plan must be included for any device requiring the addition of thermal liquid (e.g. water) or the disposal of any generated waste. Ideally the device will easily fit into the current talon type or NATO litters as well as potentially fitting into the collapsed litters for storage. The Phase II commercialization plans should include a regulatory pathway for FDA clearance as required although the device does not have pharmacologic activity.

PHASE III DUAL USE APPLICATIONS: Transition prototype into a functional, field-ready warming and pressure relieving pad device to assist medics, physician’s assistants, nurses, and physicians in prolonged management of critically injured and immobile casualties in a far forward environment (role of care 1 and 2). The device should be of potential interest for the Military Health Systems as well as civilian pre-hospital first responders and mass casualty incident (MCI) response teams worldwide particularly in delayed evacuation or remote location scenarios. The field ready device will be subject to initial airworthiness/safe to fly requirements per the Joint En Route Care Equipment Test Standard (JECETS). Stakeholders for transition include, the Air Force Medical Modernization Division, Air Mobility Command and the United States Army Aeromedical Research Lab to develop an air worthiness/safe-to-fly test program. These are the lead agencies for the Air Force and Army for approval for patient movement items (PMI) once the patient enters the regulated medical evacuation system. Plans should bridge the gap between laboratory-scale innovation and entry into a recognized Food and Drug Administration (FDA) regulatory pathway leading to commercialization of the prototype into a viable product for sale in the military and /or private sector markets.

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REFERENCES:1. Vanderwee, K., M. Grypdonck, and T. Defloor, Alternating pressure air mattresses as prevention for pressure ulcers: a literature review. Int J Nurs Stud, 2008. 45(5): p. 784-801.

2. Reddy, M., S.S. Gill, and P.A. Rochon, Preventing pressure ulcers: a systematic review. JAMA, 2006. 296(8): p. 974-84.

3. Bansal, C., et al., Decubitus ulcers: a review of the literature. Int J Dermatol, 2005. 44(10): p. 805-10.

4. Mok, J.M., et al., Effect of vacuum spine board immobilization on incidence of pressure ulcers during evacuation of military casualties from theater. Spine J, 2013. 13(12): p. 1801-8.

KEYWORDS: Decubitus ulcer; pressure ulcer; critically injured, immobility, prolonged care.

DHA191-009 TITLE: Automated Framework for the Design of Passive Prosthetic & Orthotic Interfaces

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Develop, demonstrate, and commercialize an automated and data-driven computational framework for the design and optimization of passive prosthetic & orthotic (P&O) interfaces. Such a framework will predict the equilibrium shape and compliant mechanical properties of an optimized P&O interface, enhancing user comfort, mitigating soft tissue injury, and ultimately, improving the quality of life for the P&O user.

DESCRIPTION: Musculoskeletal injury is the leading cause of health problems for the military. It can be caused by traumatic combat injuries and physically straining risk factors such as military training, repeated combat deployment, carrying heavy loads, and standing for extended periods of time, walking long distances and participating in sports [1]. There have been over 1700 major limb amputations from the current conflicts with more than 82% of those affecting the lower extremity, with lower extremity involvement exceeding 95% of civilian amputations.

Prosthetic and orthotic (P&O) interfaces are mechanical structures that form the interface between a P&O device and a tissue region which functions to appropriately transfer and distribute mechanical loads to couple the device to the tissue region without causing discomfort or injury. Residual-limb soft tissues are not designed to bear weight yet must endure large compression and shear forces from conventional prosthetic sockets, directly contributing to tissue injury [2]. Currently, P&O interface design is largely an artisan procedure performed by prosthetists and orthotists with varying experience. This conventional design process is also not standardized, and often does not include sufficient quantitative, patient-specific data. Hence, across P&O practitioners, discrepancies exist in the quality of P&O interfaces. The manual nature of the current design process does not lend itself to the inclusion of detailed biological data such as internal bone and soft tissue geometries, patient-specific biomechanical properties and loading data.

Proposals are sought to develop a patient-specific, automated, and data-driven framework for the design and optimization of passive P&O interfaces.

PHASE I: Demonstrate the feasibility of producing an advanced patient-specific, data-driven P&O interface design framework for the quantitative design and optimization of passive P&O interfaces. The required Phase I deliverables will include: 1) a research plan for engineering the quantitative design for the interface of a prosthesis,

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and 2) a preliminary prototype, either physical or virtual, to demonstrate the proof-of-concept capability of the design framework. Other supportive data may also be provided during this effort. Due to the short timeline of a Phase I project, human and animal use is not allowed. A Phase I project should demonstrate a proof of concept and/or efficacy of the design framework in handling computer-generated data.

PHASE II: The performer shall design, develop, test, finalize and validate the practical implementation of the prototype system that implements the Phase I methodology. The testing and practical implementation of the prototype system should be relevant to Service members who have experienced limb trauma requiring the use of a prosthesis. These patients are often young and have previously demonstrated the need to perform Return to Duty, occupation, and other life activities which cannot be completed with sub-optimal P&O device interface fit. As such, all human use testing should be on individuals physiologically similar to the active duty population. The demonstration of prototype should show applicability to prosthetic and orthotic devices alike, regardless of manufacturer or whether those legs are passive or microprocessor controlled. The system should produce P&O device interfaces that also account for different activity specific devices such as running feet or high activity orthotic devices.

PHASE III DUAL USE APPLICATIONS: The performer is encouraged to work with commercial partners (prosthetics manufacturers and amputee care providers) and military clinics (For example, a military treatment facility that treats patients with amputation. The three main centers include Walter Reed National Military Medical Center, San Antonio Military Medical Center, and the Naval Medical Center, San Diego) to develop a final commercial product that will allow prosthetists to develop an optimal design of passive prosthetic & orthotic interfaces.

REFERENCES:1. Yancosek, K. E., Roy, T., & Erickson, M. (2012). Rehabilitation programs for musculoskeletal injuries in military personnel. Current Opinion in Rheumatology, 24(2), 232“236. doi:10.1097/BOR.0b013e3283503406

2. Salawu, A., Middleton, C., Gilbertson, A., Kodavali, K. and Neumann, V. (2006). Stump ulcers and continued prosthetic limb use. Prosthetics and orthotics international, vol. 30, pp. 279-285.

KEYWORDS: Prosthetics, Orthotics, Socket, Design, Interface.

DHA191-010 TITLE: Ruggedized Inertial Measurement Unit System to Assess Movement Dysfunction in Austere Environments

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition - USAMRMC

OBJECTIVE: Current balance and gait assessment practices in deployed or field environments lack adequate sensitivity to measure subtle but potentially duty limiting deficits in Warfighter performance. Inertial Measurement Units (IMUs) represent an emerging technical solution to augment return to duty decision making however, commercially available off the shelf technologies are neither currently suitable for field use nor easily integrated into clinical practice by most providers given feasibility constraints. This SBIR topic aims to support the development and demonstration of a sensitive, clinically feasible, and ruggedized IMU system (with state of the art accelerometer, gyroscope and magnetometer capabilities) to assess acute movement dysfunction secondary to injury in a field environment. The technology must include a highly portable, ruggedized, user interface and processing unit that provides the clinician with objective, readily interpretable information about a patient’s performance relative to age and gender based norms. The system should be modular (i.e., suitable to assess a wide variety of injury patterns by using 1 or more sensors); adaptable to constraints of the field clinic or testing environment; and allow for the range of simple to complex assessment protocols based on available time, testing space, or complexity of patient presentation. System versatility should allow clinicians to assess the broad range of Service Member (SM)

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performance ranging from quiet stance to complex agility task characterization by simply adjusting the number of sensors and the assessment paradigm to best meet the mission needs.

DESCRIPTION: Deployed military providers including physical and occupational therapists are increasingly consulted to provide timely, sensitive, evidence based, assessment and prognosis of Service Members injured in field training or operational environments from both combat and non-combat related injuries. Current practice patterns use non-instrumented clinical assessments such as the Balance Error Scoring System (BESS) or clinical gait evaluation to assess static and dynamic stability however, when performing this test an examiner primarily relies on visual inspection and counts errors in body position while the patient attempts to maintain balance with eyes closed in various stances. While evaluation by a highly trained clinician, when available, is invaluable, subtle signs of instability are not often detectable to the human eye. Using wearable IMU’s to assess postural and dynamic instability can significantly increase sensitivity and objectivity in detecting subtle balance deficits post-concussion. While these devices have been used with some preliminary success to assess SM performance in military populations, IMU’s are not presently appropriate for use in an operational environment given design limitations that preclude implementation in austere environments characterized by extreme temperatures, strong vibrations, wet or dusty conditions. Recent efforts to develop sensitive, clinically feasible, and ecologically valid return to duty (RTD) assessment measures for SM with post concussive sequelae have demonstrated the utility of IMU’s in both laboratory and clinical environments for characterizing subtle, duty limiting impairments (Weightman et al 2017, Weightman et al 2015, Kelley et al 2017). The development of sensitive RTD assessment practices is particularly important in cases where subtle sensorimotor deficits may go underappreciated in a clinical examination, resulting in a premature or inappropriate RTD decision which can affect not only the well-being of the SM, but the safety and mission success of the entire unit (Scherer, 2013).

PHASE I: Develop and provide a prototype of the ruggedized IMU system (3 axes accelerometers, gyroscope, magnetometers) that are waterproof, temperature tolerant, vibration resistant, and impact resistant. Prototype system should include a minimum three sensor package, a data storage and processing unit (DPU), data display capability (either stand alone or integrated with the DPU), and proof of concept algorithms with demonstrated adherence to aforementioned technical and output specifications..

Required Phase I deliverables will include: 1) a research design for engineering the device; 2) A preliminary ruggedized IMU prototype system with limited testing to demonstrate the ability to capture, transmit, process, store, analyze, and report kinematic data with the capability to characterize in 3 axes static postural stability, turns, and multidirectional gait; 3) demonstrate capability to deliver aforementioned data from the DPU in a clinically useful format to inform return to duty/activity/play decision making. Sensors should not transmit data to DPU using Bluetooth or other potentially trackable technology.

PHASE II: Validate the prototype of a compact, modular, ruggedized IMU system that can be used in an operational (field) setting to collect and analyze inertial data and display clinically relevant results of assessment in a compact system. The Phase II system should consist of 5 sensors which can be used in a modular manner (e.g., 1, 3, or 5 sensors) to administer distinct assessment protocols for a variety of injury presentations Sensors should be synched to the DPU to deliver clinical outputs.

Required Phase II deliverables will include:• Modular system that will enable injury agnostic assessment obtaining measurements at multiple (1- n) anatomical positions (e.g, head, trunk, extremities)• Validated ruggedization standards should include system’s ability to perform in wet conditions (ie., waterproof and submersible to 50 m), temperature tolerant and function within a Temperature Range 0-60 C range, vibration tolerant to support transport without damage on military aircraft and vehicles, and impact resistant sufficient to withstand a drop of up to 5 feet by an end user.• Battery life should be sufficient to support at least 12 hours of continuous field use before re-charging.• Mass of sensors should not exceed 300 grams (with battery) for each sensor and 1kg for the DPU.• Internal Storage ≥ 500 Gb (sufficient to store unique patient data for at least 25 unique patient encounters)• Dimensions < 150 x 80 x 20 mm (LxWxH)• Recharging should be compatible with existing military power source availability and require no longer than 60 minutes to achieve a full charge

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• Sampling rate, and resolution should be sufficient to reliably characterize the bandwidth of operationally relevant physical performance including:o Assessment of static postural sway (very low frequency movements)o Running and highly dynamic agility drills to include starts, stops and rapid turnso Min Sample Rate:100 Hzo Min Bandwidth: 50 Hzo Min Resolution: 14 bits• Algorithms supporting computation of kinematic clinical outcome measures should be open architecture and allow for system updates on movement assessment as the state of the science advances.• System and supporting algorithms should record, process, report, import, and export data that is stable, reliable, and valid in the time domain (e.g., acceleration, velocity, position, etc) and frequency domain.• System should readily identify relevant events and signal characteristics in a military relevant complex movement pattern• Relevant clinical outputs from the DPU should include evidence based characterization of postural sway, turning, gait, running and agility performance• Performance data should be referenced to age, gender matched norms obtained from a collegiate athlete or Warfighter population• Patient specific data outputs from DPU should be exportable to a stand-alone monitor or printable format. (Export capability in a format that may be saved within a patient’s electronic medical record is highly desirable)• User’s manual and provisional instructions for use should support reasonable clinical adoption and sustainment with 10 hours of instruction• Preliminary validation testing should characterize human performance under field conditions in a sample of Active Duty Service Members or a like age, gender and ability matched cohort• Deliver a plan for the FDA clearance process and deliver a manufacturing plan.

PHASE III DUAL USE APPLICATIONS: System should be capable of generating an output report that can be modified and customized to the needs of the military end user. For example, a system output that could aggregate performance data from one or more tests to estimate of duty readiness (e.g., “Green”, “Yellow”, “Red” dashboard) on the clinician interface would provide a useful indicator of how closely patient performance approximates that of healthy control and duty ready personnel.

The system should provide the clinician with a more sophisticated means of generating a report and printable graphical representations of static sway, dynamic stability, gait, or agility performance to guide patient education, clinical and return to duty decision making, or for inclusion in the patient’s medical record as appropriate.

If transitioned this technology would be subject to cyber security guidelines in the DoD Instruction 8510.01, DoD Risk Management Framework (RMF) for DoD Information Technology (IT) March 12. This document regulates requirements for all devices which will touch the network or store patient data.

Open architecture programming is desirable to allow for synergies with ongoing DoD funded efforts in the assessment and management of movement dysfunction to include the Health Readiness And Performance System (HRAPS) to assist with gait assessment for Soldier fatigue and protection against injury.

Plans on the commercialization/technology transition and regulatory pathway should lead to eventual FDA clearance/approval. The small business should also consider a strategy to secure additional funding from non-SBIR government sources and /or the private sector to support these efforts. In addition to the stated DoD purpose of assessing injured Service Members with suspected movement dysfunction in the training or operational environments, potential civilian customers for this technology may include clinicians or organizations who assess persons with suspected falls risk or functional movement deficits in rural, remote, and underserved regions. Additionally, clinicians or trainers assessing pre- and post-injury performance in athletes at risk for acquired head injury in pediatric, collegiate, or professional populations also likely constitute a strong commercial target group.

REFERENCES:1. Armed Forces Health Surveillance Center (AFHSC). Causes of medical evacuations from Operations Iraqi Freedom (OIF), New Dawn (OND) and Enduring Freedom (OEF), active and reserve components, U.S. Armed

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Forces, October 2001-September 2010. MSMR. 2011 Feb;18(2):2-7. PubMed PMID: 21793603.

2. Weightman MM, McCulloch KL, Radomski MV, Finkelstein M, Cecchini AS, Davidson LF, Heaton KJ, Smith L, Scherer MR. Further Development of the Assessment of Military Multitasking Performance: Iterative Reliability Testing. PLoSONE 2017 12(1): e0169104. doi:10.1371/journal.pone.0169104

3. Weightman M, Radomski M, McCulloch K et al. ASSESSMENT OF MILITARY MULTITASKING PERFORMANCE ADMINISTRATION MANUAL (2015), Office of the Surgeon General, Rehabilitation and Reintegration Division.

4. Kelley A, Estrada A, Crowley J, et al. Return to Duty Toolkit: Assessments and Tasks for Determining Military Functional Performance Following Neurosensory Injury, USAARL Report 2017-19.

5. Scherer, M. R., Weightman, M. M., Radomski, M. V., Davidson, L. F., & McCulloch, K. L. (2013). Returning service members to duty following mild traumatic brain injury: exploring the use of dual-task and multitask assessment methods. Physical Therapy, 93(9), 1254-1267.

6. DoD Instruction 8510.01, DoD Risk Management Framework (RMF) for DoD Information Technology (IT) March 12, 2014, Incorporating Change 2, July 28, 2017

7. Technical specifications: Feb 21, 2014 - APN-064. Rev A. IMU Errors and Their Effects. Introduction. An Inertial Navigation System (INS) uses the output from an Inertial MeasurementAccessed 19 September 2018 at: https://www.novatel.com/assets/Documents/Bulletins/APN064.pdf

KEYWORDS: Return to Duty assessment; multi-sensory deficit assessment following TBI.

DHA191-011 TITLE: Magnetic Field Peripheral Ring Nerve Blocks

TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition- USAMRMC

OBJECTIVE: Develop and demonstrate a battery operated device that uses magnetic fields to induce peripheral ring nerve blocks. The device is to provide anesthesia at the point of injury and/or during medical evacuation.

DESCRIPTION: Current analgesic capabilities do not allow for point of injury application of peripheral ring nerve blocks (PRNB) due to the training required for this analgesia method. Furthermore, PRNBs require the use of injectable analgesics that can pose a risk of diversion and require extensive training. The solution is to create a noninvasive PRNB capability that can be applied with minimal training. Training should be enable proficiency by a high school graduate in no more than three training hours. Pharmacological PRNBs provide analgesia by preventing the action potentials of peripheral pain nerves from reaching the central nervous system. A potential way to modify neuronal action potentials is by using magnetic fields to manipulate a nerve’s current and by extension action potential propagation. The ability to change nerve current with magnetic fields has been demonstrated both in mathematical modeling and in ex vivo nerve fibers. An analgesic effect has also been achieved in rats using rotating magnets demonstrating a proof of concept.

The proposed solution would be an externally wearable, non-invasive, battery operated device capable of providing analgesia equivalent to pharmacological PRNBs by manipulating nervous system activity with magnetic fields. The device should be designed so that it can be used without the magnetic fields interfering other medical equipment such as those found in a hospital, ambulance, helicopter, airplane, and fresh water and salt water boat. The device should have autonomous capabilities so that it can provide PRNB for up to 72hrs without being connected to an external power socket and automatically adjust to changes in pain signaling without user input. The device should be

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adjustable so that it can fit all four extremities for 99% of the population and have a configuration so that it can be used on trapped limbs. Since the device will be used at the point of injury, it must be able to operate in a wide variety of temperature extremes and resistant to water (fresh and salt) and body fluids. Finally, device operational competency must be obtained within 3 training hours or less by a high school graduate.

The benefits of such a device are many. The device can be used at the point of injury to provide immediate pain relief for mangled and/or amputated limbs. It could also be used for field amputations in the event that a patient’s extremity is trapped under debris. Placing the device on a patient in the field would also have the PRNB ready for physicians at higher levels of care to perform surgical procedures without having to wait for a pharmacological PRNB to take effect. An easy to use and train device would allow Soldiers and first responders to push PRNB capabilities to the point of injury without the oversight of a physician or anesthesiologist.

PHASE I: In this phase determine technical feasibility and produce a conceptual design of the device. Demonstration of analgesic capacity, autonomous operation, or duration of operation is not required in this phase. Provide methodological and technical approaches to achieve analgesic efficacy and other performance parameters in the subsequent phases. Determine approach to finding the magnet parameters, properties, and requirements such as strength, penetration depth, frequency, and size. Establish pathways to achieve those parameters.

PHASE II: In this phase, develop demonstration success criteria then demonstrate and validate a fully functioning battery operated prototype capable of producing PRNB analgesia in a large animal model (e.g. pig, goat). Analgesia must be provided continuously for at least 72 hrs independent of an external power source. Analgesia must be demonstrated for both hind limbs and forelimbs. Any animal work is subject to be reviewed by the Medical Research and Materiel Commands (USAMRMC) Animal Care and Use Review Office (ACURO). The device must demonstrate analgesia equal to a pharmacological PRNB that is suitable for peripheral trauma/pain states and invasive surgery on those areas. Trauma/pain state examples include crush injury, compartment syndrome, traumatic amputation, thermal injuries, tourniquet application, orthopedic injuries, degloving injuries, high and low velocity penetration wounds, and microbiological infections. Examples of surgeries include wound debridement, amputation, open/closed bone reduction, and CBRN decontamination. Provide a detailed plan for scale up and commercialization of the device. Provide a detailed plan for FDA approval of the device.

PHASE III DUAL USE APPLICATIONS: The vision for this device is to have a portable, easy-to-use and easy-to-learn tool that provides reliable and valid PRNB for warfighters in operational work settings, as well as a tool for clinical and first responder use. Potential customers include Navy Medical Logistics Command (NAVMEDLOGCOM) or US Army Medical Materiel Agency (USAMMA). Other potential civilian customers include hospitals and first responders. In the hands of a trained individual, the device would be able to provide PRNB analgesia to the same level as a classical pharmacological ring block at the point of injury and during in route care without interfering with other medical equipment.

To obtain this goal, awardees must complete environmental testing and demonstrate the device functioning in temperature and humidity extremes including precipitation. They must also demonstrate the device functioning despite the presence of body fluids, dirt, mud, or other common contaminants found in battlefield injuries. Awardees are expected to pursue FDA clearance/approval as a Class I/II medical device for clinical use, contingent on additional funding from non-SBIR government sources and/or the private sector.

REFERENCES:1. http://www.jpier.org/PIERM/pierm27/16.12100915.pdf

2. https://onlinelibrary.wiley.com/doi/epdf/10.1002/mus.20571

3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1550723/pdf/1471-2202-7-58.pdf

KEYWORDS: Analgesia, ring block, peripheral, magnetic, magnets, nerve, point of injury, axon.

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