DEFENSE HEALTH AGENCY (DHA)17.2 Small Business Innovation Research (SBIR)

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.DHAsbir@mail.mil Phone - (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 with the exception of technical personnel from Geneva Foundation and Laulima Government Solutions, will provide Advisory and Assistance Services to DHA, providing technical analysis in the evaluation of proposals submitted against DHA topic numbers:

DHA172-003 “Hybrid Smart Client/Web Browser Based Light MHS GENESIS Application for Agile Theater Operations”

DHA172-004 “Medical Information System Software Maintenance Capability”

DHA172-005 “Finger Pulse Oximeter for Patient Identification and Predictive Algorithms”

PHASE I PROPOSAL SUBMISSION

Follow the instructions in the DoD SBIR Program BAA for program requirements and proposal submission instructions at http://www.acq.osd.mil/osbp/sbir/solicitations/index.shtml.

SBIR Phase I Proposals have four Volumes: Proposal Cover Sheet, Technical Volume, Cost Volume and Company Commercialization Report. 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 Sheet 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 Sheet, 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

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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 $150,000 over a period of up to six months.

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 either in the Phase I award or by subsequent notification.

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 Sheet, 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 $1,000,000. 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 Sheet, 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 Sheet or put information normally associated with the Technical Volume in other sections of the proposal as these will count toward the 40-page limit.

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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.

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/non-STTR government program or 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 $500,000 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 17.2 Topic Index

DHA172-001 Reconfigurable/Recyclable Modules for Patient SimulatorsDHA172-002 eTextile Point of Injury Integrity Integrated CircuitDHA172-003 (This topic has been deleted from this Announcement)DHA172-004 Medical Information System Software Maintenance CapabilityDHA172-005 Finger Pulse Oximeter for Patient Identification and Predictive AlgorithmsDHA172-006 Mobile Causality Display Toolkit for Tactical Combat Casualty CareDHA172-007 Next-Generation Ear Seals for Circumaural Headsets and Hearing ProtectorsDHA172-008 Point of Care Test for Disease Severity and Risk StratificationDHA172-009 Complex Crystalloid Resuscitative FluidDHA172-010 Medical Wearable for First Responder Assessment and Remote MonitoringDHA172-011 Intravenous Ringer's Lactated Ringer's Solution from Any Water Source Without Electrical

PowerDHA172-012 Solutions for Restoration of Urinary Function and ControlDHA172-013 Minimally Invasive Delivery of Therapy to the Inner EarDHA172-014 Development of an Individualized Portable Platform to Deliver Vestibular Rehabilitation

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DHA SBIR 17.2 Topic Descriptions

DHA172-001 TITLE: Reconfigurable/Recyclable Modules for Patient Simulators

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: To create low-cost, sensor-laden soft materials with mechanical properties similar to specific human tissues which can be dissolved and re-fabricated into different shapes with little or no additional materials required, with the exception of replacement sensors. These low-cost, sensor-laden soft materials would provide add-on compatibility with at least one generic manikin or part-task trainer in at least one common anatomic site for intrusive medical interventions.

DESCRIPTION: Human patient simulators (HPS) are designed to support a variety of highly invasive, life-saving medical procedures that care providers may perform in austere environments, such as cricothyrotomy, needle chest decompression, and chest tube insertion. The areas on HPS units involved in these invasive procedures consist of removable, replaceable skin modules which are discarded after a few uses (sometimes even a single use) which can increase material costs for training programs. These consumable modules are made from combinations of rubber, silicone, plastic, and other inexpensive materials, but they can cost hundreds of dollars to replace [1,2]. They are also not cross-compatible with other HPS systems with modules at the same anatomic sites. Materials such as rubber, silicone, and plastic, among others, are known to behave very differently from organic tissues, often requiring far greater amounts of force to tear than human tissues, which introduces the potential for negative training [3]. In addition, these pieces of material cannot sense mechanical changes as a result of cuts, tears, or punctures as a result of medical interventions, such as force or pressure. New skin modules which more accurately simulate the human body are needed, using new designs which take into account emerging medical training standards, such as the Advanced Modular Manikin.

One type of life-saving procedure which uses these modules is a chest tube insertion, which is performed to prevent a collapsed lung. A key part of this procedure involves piercing the pleura, a type of tissue that lines the lungs. In 2016, the Army Research Laboratory performed mechanical tests on several varieties of simulated pleura from manikins used to train Soldiers and compared it to samples of human pleura. A comparison of measurements, including the stretch ratio, ultimate tensile strength, and strain energy, revealed that significant mechanical differences exist between human and simulant tissues [3]. The analyses from these mechanical tests also led to the development of a statistical model for tissue behaviors. This model is intended to inform future efforts aiming to reduce or eliminate differences in mechanical performance between human and synthetic tissues.

Using advanced manufacturing processes and novel materials, reconfigurable/recyclable skin modules would enable medical care providers to practice invasive medical interventions on HPS systems while reducing material costs. New bioplastics and biopolymers made from starches and collagens are now available which can be 3D printed, and they are fully recyclable [4]. Mechanical models derived from data collected from relevant human tissues can be used to describe an acceptable range of simulated tissue properties, so that the skin modules can be designed to more accurately simulate the behavior of human skin. Finally, embedded sensors can provide instructors with valuable performance information to support after-action review. New sensors are available which can be 3D printed at low cost [5]. In addition, multi-touch sensors now exist which are cuttable, and can continue working after being cut [6]. These capabilities introduce new opportunities to integrate sensors into invasive procedures without interfering with the medical procedure being trained.

As a minimum when developing these reconfigurable modules for patient simulators, the following should be considered:

The reconfigurable modules must be easy to insert/remove, they must be self-contained and wireless, and they must be able to be cut, torn, or punctured depending on specific type(s) of medical interventions. Interference with medical procedures performed at the module site as a result of sensors must be reduced or eliminated where feasible. The module must have material properties derived from data obtained from relevant human tissues. The re-fabrication process must use little or no additional materials, with exception of sensors, and it must be usable in

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different environments such as heat, cold, humidity, direct sun, rain, etc. If sensor technology or other technology that transmits energy (amperage/voltage) is used, then system must be designed to not cause injury. Any sensing capabilities must also include the ability to collect and wirelessly transmit performance data into usable data format(s). Other key factors to consider include reusability, maintainability, modularity, and cost effectiveness.

PHASE I: The Phase I will develop a proof of concept of the reconfigurable/recyclable skin modules. The proof of concept will need to demonstrate the skin module’s ability to integrate with at least one commercially available human patient simulator system. This main focus of this first phase is to describe the soft material(s), as well as any associated fabrication/re-fabrication processes, that satisfies the properties described in this topic.

The intent of this phase is to produce an initial design for the reconfigurable/recyclable soft tissues, provide considerations for interoperability with existing manikins or part-task trainers, detailed evaluation of sensor technologies, and plans for the integration of mechanical properties similar to human tissue. This proof of concept must demonstrate the feasibility of the concepts described in this topic. The performer will submit a final report including these analyses and provide an initial demonstration describing the state of the development, along with details of what will be further developed in Phase II.

PHASE II: Using lessons learned from Phase I, the second phase will involve integrating sensor technologies and mechanical properties into the soft tissues to develop the reconfigurable/recyclable skin module. Phase II will involve initial studies to demonstrate the utility and effectiveness of the sensor technologies, and to verify that the mechanical behavior of the relevant simulated tissues is sufficiently similar to the mechanical behavior of real human tissue.

In addition to prototypes that clearly demonstrate successful development per capabilities listed above, the performer will submit a final report that will include the current state of the development of the technology. The performer will provide analysis of the materials suggested vs. those compared or developed during research; provide analysis comparing the mechanical behavior of the reconfigurable/recyclable module against the behavior of relevant human tissue; and provide a detailed report and analysis of outcomes of use of these technologies. The developer will provide a demonstration of the product, to include a demonstration of interoperability with existing generic manikins or part-task trainers.

PHASE III DUAL USE APPLICATIONS: Contingent upon availability of additional funding, concluding in Phase III the developer will have built a viable, commercially available reconfigurable/recyclable skin module product that can be used in a variety of simulation experiences that is easy to use and affordable when compared to current skin modules. Optimization of material properties to address cost, effectiveness, and improved trainee performance should be pursued during Phase III. The product should be available in a variety of wounds relevant to the medical intervention sites on commercially available human patient simulators, such as cricothyrotomy, needle chest decompression, IV insertion, among others. Phase III should also include paths to transition and commercialization. Such paths should explore various military medical training sites and acquisition programs, as well as the commercial marketplace. While point-of-injury care is a more likely candidate for both Department of Defense transition success and commercialization, higher echelons of care should be considered as well.

The performer will demonstrate the product(s) at one or more potential “customer” sites, preferably military medical training sites.

REFERENCES:1. Laerdal Medical. (2017). Chest Tube Insertion Modules. Retrieved from Laerdal: http://www.laerdal.com/us/item/383110

2. Simulab Corporation. (2017). Tissues Product Category. Retrieved from Simulab: https://www.simulab.com/products?f[0]=field_category%3A181

3. Norfleet, J., Morales Tenorio, L., Mazzeo, M., Barocas, V., Palata, K., & Sweet, R. (2016). Thoracostomy Simulations: A comparison of the mechanical properties of. MODSIM World 2016. Virginia Beach, VA. Retrieved

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from: http://www.modsimworld.org/papers/2016/A_comparison_of_the_mechanical_properties_of_human_pleura_vs_synthetic_training_pleura.pdf

4. Li, X. et al (2014). 3D-Printed Biopolymers for Tissue Engineering Application. International Journal of Polymer Science. doi:10.1155/2014/829145. Retrieved from: https://www.researchgate.net/publication/270722480_3D-Printed_Biopolymers_for_Tissue_Engineering_Application

5. Muth, J., Vogt, D., Truby, R., Menguc, Y., Kolesky, D., Wood, R., & Lewis, J. (2014). Embedded 3D Printing of Strain Sensors within Highly. Advanced Materials. doi:10.1002/adma.201400334. Retrieved from: http://lewisgroup.seas.harvard.edu/files/lewisgroup/files/embedded_3d_printing_of_strain_sensors_within_highlystretchable_elastomers.pdf

6. Olberding, S., Gong, N.-W., Tiab, J., Paradiso, J. A., & Steimle, J. (2013). A Cuttable Multi-touch Sensor. Association for Computing Machinery User Interface Software and Technology Symposium (ACM UIST). St. Andrews, United Kingdom. doi:10.1145/2501988.2502048. Retrieved from: https://hci.cs.uni-saarland.de/files/2012/11/ACuttableMultiTouchSensor.pdf

KEYWORDS: reusable/recyclable materials, modular, simulation, sensors, tissue properties

DHA172-002 TITLE: eTextile Point of Injury Integrity Integrated Circuit

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: This research should provide technical non-repudiation of combat-related records generated at the time of injury. The National Institute of Standards and Technology Federal Information Processing Standards (NIST FIPS) 140-2 level 3/4 approved hardware-based cryptographic modules with a weight, size, and power budget no greater than the integrated circuit on a Personal Identity Verification/Common Access Card (PIV/CAC); this will generate a digital signature across the injury record. A prototype will be constructed and the resulting record will be loaded into the warfighter’s medical record. Workflows will be developed for reducing duplicate medical records, ensuring medical information is associated with the correct injured party, ensuring the integrity of the medical sensor information recorded at the time of injury, and back end systems (Purple Heart Medals and VA disability eligibility).

DESCRIPTION: Integrity of information captured at the time of injury is critical for ensuring the warfighter receives the correct care. Incorrect information and duplicate medical records are a continuous challenge, especially during times of combat. The e-Textile point of injury integrated circuit is expected to provide a verifiable integrity seal that can be used by relying systems to detect duplicate patient records and loss of record integrity. The integrated circuit should include a capability to verify the warfighter’s biometric identity based on a separate biometric sensor. That is, illustrate how future biometric sensors could be used to enable the integrated circuit.

The eTextile Point of Injury Record will allow for an injury to be recorded and that recorded data can be read by combat medics or team members to help assess the severity of the injuries and action to take to help get that service member care faster. If a severe injury occurs, this information can be passed to the Forward Operating Hospital to give them the information they need to prepare for their arrival, thus being able to provide care faster. Since the battlefield medical sensors will operate autonomously, there needs to be a mechanism that ties the recorded information to the respective warfighter and ensure the information integrity is preserved. While much work has gone into designs such as PIV/CAC card circuitry, these form factors are nor practicable for combat environments.

We would like to leverage the current ongoing DoD research into e-textiles. The sensors should be capable of monitoring a warfighter at the time of injury. Given the small size of certain health sensors, determining how best to interface to e-textiles (anchoring and connection) requires analysis. The sensor power, weight, volume, and data

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budget must be documented. At a minimum, the sensor should interface with conductive fiber for power and data. Separately, the research could address other technologies, such as fiber optics. The device must withstand one atmosphere of water pressure with operation in water and air. Finally, given the increased risk of electronic warfare, no use of wireless radio approaches for sensor communications should be considered.

PHASE I: Design a concept for using NIST-validated hardware cryptographic digital signature modules with weight and power not exceeding the integrated circuit used on PIV/CAC cards. The concept describes a device that should be enabled by an independent third party prior to entering combat environments (areas where combat pay has been authorized) and disabled otherwise. The device must interface with conductive fiber data busses for capturing combat-related injuries as they occur. The device should include a second enabler to ensure dual authorization of activation. The signed record of injury should include the date and time of injury, obtained from the e-textile data bus. The design will include a capability to activate a signature based by request or future biometric authenticated request. The design should describe how new biometric signatures will be stored. Finally, the resulting signed record should be in a format that can be loaded into the warfighter's medical record. The concept should document how the device can be rooted using a machine digital certificate. That is, the device trust is established with a rooted machine certificate. Enabling the capability requires two digital signatures identifying 1) the user (could be self-signed) and 2) the authorized party attesting to entering a potential combat zone.

PHASE II: Construct and demonstrate the operation of a prototype device. This will include generating records for testing with medical record entry. At least one Government lab, with virtual connection into the MHS Genesis/DES test facility will be available for supporting this research. The lab will be accessible virtually and provide test versions of Theater medical systems. Of particular interest will be recommendations for identifying non-repudiation records.

The Phase II demo will use just the commercial chip used on the PIV/CAC card to demonstrate implementing a dual authorization digital signature capability for e-textile uniforms. For this test, existing connectors used by uniforms could be used. The demo should show enabling by loading information regarding who the warfighter is (could be from the warfighter’s CAC card), and a secondary party indicating the warfighter is entering into a potential combat zone. Note: only the CAC/PIV chips is important for this research. The other functions such as picture, wireless (ISO 14443), and the identity proofing are not part of this effort. This work seeks to build on the technology that’s needed and not try to include technology not needed. Once enabled, sample data from the e-textiles should be signed to show the approach works. The research must address how phase III can operate in at least one atmosphere of water pressure.

PHASE III DUAL USE APPLICATIONS: This phase will focus on prototyping an optimal form factor for e-textiles. This will necessitate getting the PIV/CAC integrated into a different package format. Analysis of the best form factor will be part of this effort. It is expected the resulting packaging will be reduced from the current contacts seen on a PIV/CAC smart card. During this phase, the product will be tested in air and under water.

Disability claims outside the DoD and VA are a challenge. The research that goes into this SBIR should have value in multiple areas. When an injury must be shown to be job-related, the same device could be used for personnel during work hours. Additionally, many jobs, such as commuter train operators, must be physically able to safely operate the equipment. Indications of a black out on the job are grounds to remove that person from their current job. It is therefore important to have solid records that an event did or did not take place. Liability determination must determine if the operator was at fault. This technology directly addresses this gap.

REFERENCES:1. DoD Announces Award of New Revolutionary Fibers and Textiles Manufacturing Innovation Hub Lead in Cambridge, Massachusetts, Release No: NR-115-16, April 1, 2016. http://www.defense.gov/News/News-Releases/News-Release-View/Article/710462/dod-announces-award-of-new-revolutionary-fibers-and-textiles-manufacturing-inno

2. Winterhalter CA, Teverovsky J, Wilson P, Slade J, Horowitz W, Tierney E, and Sharma V., Development of electronic textiles to support networks, communications, and medical applications in future U.S. military protective clothing systems, IEEE Trans Inf Technol Biomed. 2005 Sep; 9(3):402-6.

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https://www.ncbi.nlm.nih.gov/pubmed/16167694

3. NIST Special Publication 800-73-4, Interfaces for Personal Identity Verificationhttp://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-73-4.pdf

4. FIPS 140 validated list. http://csrc.nist.gov/groups/STM/cmvp/documents/140-1/140val-all.htm

5. NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations,http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf

KEYWORDS: FIPS, digital signature, e-textile

DHA172-003 This topic has been deleted from this Announcement

DHA172-004 TITLE: Medical Information System Software Maintenance Capability

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to develop and demonstrate an innovative software maintenance capability on Windows, Linux, and Android-based platforms that enable Military Health System program management offices to establish and perform automated maintenance tasks on file systems, operating systems, webservers, databases, medical information system applications, and other system components through a software maintenance agent. The innovation of this research is prototyping of a technical concept and approach to provide an inclusive cross platform software maintenance application that allows for execution of user specified maintenance instructions with decision support to allow for maintenance of complex systems such as current and future Electronic Health Record. This innovation will incrementally advance the state of the art maintenance mechanisms to remove the training requirement and task performance required of end users to perform information system maintenance in a deployed environment. The prototype would validate the use of the software maintenance capability to perform all maintenance tasks, including software updates and patching, on multiple medical information systems not limited to Department of Defense’s currently deployed medical electronic health record.

DESCRIPTION: This topic is designed to address the common challenge of identifying, conducting initial institutionalized training, maintaining skill proficiency and certification of the personnel that will be the system maintainer. For a medical information system capability, this could potentially be Communication Specialists, Biomedical Maintainers, Medical Information Management Officers, or Clinical Personnel. However, the requirement for employing trained and proficient maintainers to sustain system capabilities in operations results in a training requirement that would have to be incorporated into the initial training and into unit-level training. The potential integration of these maintenance tasks into the curriculum for Military Occupational Specialties often introduces significant delay into the development of new capabilities for the Department of Defense’s Medical Services.

There is potential through utilization of technology for a Program Management Office (PMO) to maintain systems through a software maintenance capability (SMC) that can perform maintenance tasks and predictive maintenance functions on all aspects of a Medical Information Management System. The PMO would provide the schedule of maintenance tasks with corrective actions, which would allow for: performance PMO-defined maintenance actions on the system at PMO-defined intervals and times, and corrective action to be applied when feasible. The maintenance capability would need to ensure that the maintenance actions do not interfere with the end-user performance of operational tasks, and report maintenance to PMO-specified personnel.

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The SMC would perform maintenance on a wide-range of system components and architectures, on the different operating systems (Windows 7, Windows 10, Windows Server 2008, and Windows Server 2012, Linux, and Android) to identify and fix problems. These system components and architectures include but are not limited to Web Servers, Services, Databases, File Systems, Operating Systems, Applications, and virtualization. Additional maintenance tasks would include, but would not be limited to back-ups, restoration actions, system updates, patching, directory monitoring, and system integrity checks. The Medical Information System Software Maintenance Capability should also be able to interrogate the Medical Information System to obtain PMO-specified configuration information that could be used at a higher level of maintenance to facilitate repair of the end-item. The PMO should also be able to automatically update the maintenance directions with newer maintenance directions remotely. The SMC should also be able to provide predictive maintenance information and take appropriate corrective action to reduce the possible of downtime. The PMO should be able to create, publish, and disseminate maintenance directions for SMC to execute.

The SMC would be utilized in the austere conditions ranging from humanitarian assistance to wartime operations. In Echelons at the Brigade and Below, SMC would be utilized with systems that are connected to the classified network through the Tactical Radio Network and would need to minimize network traffic requirements. The SMC would also be able to be utilized with Medical Information Systems on the unclassified network.

In these environments, the SMC would need to attain the cybersecurity authority to operate in the unclassified and classified environment through the Department of Defense’s Risk Management Framework (RMF). More information can be obtained at the Information Assurance Support Environment (http://iase.disa.mil/pages/index.aspx), to include hardware and software configuration guidelines known as Security Technical Implementation Guidelines (STIGS) that provide guidance for consideration during Phase I.

Finally, the SMC should provide both local and remote maintenance reports that are tailored to the different audiences, to include but not limited to clinical end-users, PMO system engineers, and maintenance personnel. When connectivity is available, SMC should be capable of sending the reports to the PMO on a pre-determined and ad-hoc basis to support PMO-level provided maintenance decisions and actions.

PHASE I: Develop system design and Concept of Operations for an Medical Information System Software Maintenance Agent, to include software architecture for different operating systems (Windows 7, Windows 10, Windows Server 2008, and Windows Server 2012, Linux, and Android) as well as supporting virtualization environment that allows for the SMC to perform PMO-defined maintenance at predetermined intervals and times to execute maintenance actions on the system, with the end-user concurrence; and report maintenance to PMO-determined personnel. Concepts incorporating support virtualization architecture for Type II Hypervisors will be preferred. The concept should include the basic properties of software architecture, underpinning hardware technology concepts and description of the system concept that addresses feasibility and benefit in an austere (battlefield) environment with intermittent low-bandwidth communications, to include prolonged periods of no connectivity. The concept should identify key capability parameters and provide predictions that will later be validated in Phase I and II activities. Conduct feasibility testing of system components and provide results of analytical and experimental results that validate the assertions about the key capability parameters identified in the concept.

PHASE II: From the Phase I design, develop prototype of a SMC for a Windows 10 and Microsoft Windows Server 2012R2 with technical cybersecurity controls implemented in the design. Demonstrate the capability to perform maintenance on AHLTA-T with medical personnel without maintenance personnel support and without AHLTA-T maintenance training in a relevant environment. Demonstrate the same capability on an undefined medical information system with Windows 10 or Microsoft Windows Server 2012R2 system and some other application to validate the flexibility of the capability to be adapted to different applications. Demonstrate the maintenance reporting capability locally as well as aggregate maintenance reports for multiple SMC agents at a remote location, replicating a PMO’s system engineering and maintenance office. Provide results of the demonstrations with lessons learned and recommended system improvements based upon system resource impacts, demonstration results and user feedback.

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PHASE III DUAL USE APPLICATIONS: Incorporate system improvements resulting from Phase II evaluation results and obtain the appropriate cybersecurity certification as determined during execution of the Risk Management Framework through a Department of Defense-sponsored Cybersecurity Team. Port SMC to Linux and Android operating systems. Execute system evaluation in a suitable operational environment (e.g. Advanced Technology Demonstration (ATD), Joint Capability Technology Demonstration (JCTD), Marine Corps Limited Objective Experiment (LOE), Army Network Integration Exercise (NIE), etc.). Present the prototype project, as a candidate for fielding, to applicable Army, Navy/Marine Corps, Air Force, Cost Guard, Department of Defense, Program Managers for Combat Casualty Care systems along with the government and civilian program managers for emergency, remote, and wilderness medicine within state and civilian health care organizations, and Departments of Justice, Homeland Security, Interior, and Veteran’s Affairs. Execute further commercialization and manufacturing through collaborative relationships with partners identified in Phase II.

REFERENCES:1. Hoffer, Jeffrey A., Joey F. George, and Joseph S. Valacich. Modern Systems Analysis and Design. 7th ed. N.p.: Pearson, 2013. Print.

2. Sjøberg, Dag I.K. "Managing Change in Information Systems: Technological Challenges." Department of Informatics, University of Oslo, n.d. Web. 20 Sept. 2016.

3. "Automatic Maintenance." Microsoft Developer Resources. Microsoft, n.d. https://msdn.microsoft.com/en-us/library/windows/desktop/hh848037(v=vs.85).aspx. 20 Sept. 2016.

4. Warren, Steven. "Automate Database Upkeep with the SQL Server Maintenance Plan Wizard - TechRepublic." TechRepublic. N.p., 2007. Web. 20 Sept. 2016.

5. Canfora, Gerardo, Aniello Cimitile, and Palazzo Bosco Lucarelli. "Software maintenance." Handbook of Software Engineering and Knowledge Engineering 1 (2000): 91-120.

KEYWORDS: AHLTA-T, Android, application, authentication, automation, information, Linux, maintenance, medical, mobile device, Windows 10, Windows Server 2012

DHA172-005 TITLE: Finger Pulse Oximeter for Patient Identification and Predictive Algorithms

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to research, prototype, and demonstrate a wireless finger pulse oximeter with an on board optical fingerprint sensor integrated with an embedded ultra-wideband wireless transmission capability. The fingerprint sensor will enable the medic treating the casualty to identity of the patient and enhance the capability to associate a variety of vital signs; i.e. Arterial Oxygen Saturation (SPO2), Photoplethysmogram (PPG) waveforms, etc. from multiple patient medical encounters.

DESCRIPTION: This topic is designed to focus on research, prototyping, and demonstration a system that will allow a medic or corpsman the capability to track the identity and vital signs of multiple patients at the point of injury and during en route casualty evacuations. The problem occurs when the medic is treating multiple patients or has to quickly treat a patient prior to evacuation, the vital signs data is not added to the medical encounter or possibly the wrong data is associated to the patient. The medic needs a capability to instantaneously track, associate, and transmit vital signs will allow the data to the correctly be uploaded to the patient’s electronic health record from every medical encounter developed. Additionally, the vital signs data generated by the fingerprint pulse oximeter sensor to the medic’s end user device (EUD) will be leveraged by predictive algorithms/machine learning application onboard an end user device (EUD) to aid the medic in treating the patient. Ideally fingerprint identification would be integrated with a biometric database to automatically associate patients with their electronic

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health records but at the minimum, fingerprint identification should be used to distinguish between patients. The basic concept of operation, the medic will use the fingerprint scan to initially identify the patient manually, and then once the patient is identified, the fingerprint scanner will automatically associate any additional vital signs to the patient’s electronic health record even if the device was used on other patients between encounters.

The medical sensor device should wirelessly transmit via embedded ultra wideband (UWB) both patient identification and physiological data to a medic’s EUD. The capture electronic medical data on the EUD will be uploaded into the electronic DD1380 encounter, and then the encounter is signed and transmitted from the EUD via the military tactical network to an AHLTA-T server to be uploaded in the casualty’s permanent electronic health record. This solution will address the current capability gap of electronically entering patient data directly from medical devices.

PHASE I: Research solutions and design a prototype breadboard solution that can demonstrate the technical challenges on this topic for a feasible solution for a pulse oximeter capable of fingerprint identification that can integrate with a EUD via embedded ultra-wideband. Investigate the ability to integrate with biometric databases to automatically identify patients. Data must be able to be transmitted over limited bandwidth using military tactical radio networks. Explore commercialization potential with civilian emergency medical service systems development and manufacturing companies. Seek partnerships within government and private industry for transition and commercialization of the production version of the product.

RESEARCH INVOLVING ANIMAL OR HUMAN SUBJECTS: Not Applicable for Phase I. Applicable for Phase II and beyond. The SBIR Program discourages offerors from proposing to conduct Human or Animal Subject Research during Phase 1 due to the significant lead time required to prepare the documentation and obtain approval, which will delay the Phase 1 award. All research involving human subjects (to include use of human biological specimens and human data) and animals, shall comply with the applicable federal and state laws and agency policy/guidelines for human subject and animal protection. Research involving the use of human subjects may not begin until the U.S. Army Medical Research and Materiel Command's Office of Research Protections, Human Research Protections Office (HRPO) approves the protocol. Written approval to begin research or subcontract for the use of human subjects under the applicable protocol proposed for an award will be issued from the U.S. Army Medical Research and Materiel Command, HRPO, under separate letter to the Contractor.

Non-compliance with any provision may result in withholding of funds and or the termination of the award.

PHASE II: Develop a ruggedized patient identifying pulse oximeter prototype that can be used with an android mobile EUD via embedded UWB (ultra-wideband) wireless transmission capability versus Bluetooth to reduce electronic signature when used in tactical environments. The prototype at minimum needs to be capable of demonstrating the ability to transmit wirelessly via UWB to a mobile EUD the patient identifying biometric data, heart rate, SPO2 number and PPG waveform in a field environment while distinguishing between different patients. Consider power sourcing and power management as well as miniaturization of the UWB transmitter and antenna technology sufficient to fit into an effective ruggedized pulse oximeter form factor. Begin regulatory (FDA) planning if fingerprint sensor interferes with pulse ox technology.

At or near the end of Phase II, the prototype is expected to be demonstrated and evaluated at the Telemedicine and Advanced Technology Research Center’s (TATRC’s) field evaluation normally held at the CERDEC Ground Activity (CGA) located at Joint Base McGuire-Dix-Lakehurst, New Jersey. This event consists of operational prototype integration with and operation on the Army tactical internet, medic training, and a subjective detailed evaluation of the product. As the prototypes evaluated during this event are early research prototypes, this event does not constitute a formal Operational Test and Evaluation but is expected to provide a detailed review of the product along with a list of recommended technical and operational capability modifications.

Continue development of the Initial Transition Plan / Commercialization Plan, finalizing the document for execution during Phase III.

PHASE III DUAL USE APPLICATIONS: This phase continues to build upon Phase II, with expectation to address the new requirements and advance the operational prototype to a deployable and/or marketable product by refining

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and executing the commercialization plan included in the Phase II Proposal. Continue development and refinement of the prototype in Phase II to develop a production variant of the patient identifying pulse oximeter. The production variant may be evaluated in an operational field environment such as Marine Corps Limited Objective Experiment (LOE), Army Network Integration Exercise (NIE), etc. depending on operational commitments. Present the prototype project, as a candidate for fielding, to applicable Army, Navy/Marine Corps, Air Force, Coast Guard, Department of Defense, Program Managers for Combat Casualty Care systems along with government and civilian program managers for emergency, remote, and wilderness medicine within state and civilian health care organizations, and the Departments of Justice, Homeland Security, Interior, and Veteran’s Administration. Execute further commercialization and manufacturing through collaborative relationships with partners identified in Phase II.

REFERENCES:1. Moulton, S. L., Mulligan, J., Grudic, G. Z., & Convertino, V. A. (2013). Running on empty? The compensatory reserve index. Journal of Trauma and Acute Care Surgery, 75(6), 1053-1059.Chicago [http://www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA616659]

2. Journal of Special Operations Medicine Summer 2010 Volume 10, Edition 3, pg 55. Abstract. Exploration of Prehospital Vital Sign Trends for the Prediction of Trauma Outcomes, by Liangyou Chen, PhD; Andrew T. Reisner, MD; Andrei Gribok, PhD; Jaques Reifman, PhD. http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0CDkQFjAD&url=http%3A%2F%2Fwww.dtic.mil%2Fget-tr-doc%2Fpdf%3FAD%3DADA533789&ei=D943VeOhDcnlsASwqYGIBg&usg=AFQjCNFMSmmAhMWxdGWXXv2fVKzyZGhcOg&sig2=aTFFzvX-5SfGPTN1T8NVig&bvm=bv.91071109,d.eXY

3. US Special Operations Command, "Special Operations Medical Handbook", November 2008; ISBN 978-0-16-080896-8, cvbnmk, l. US Government Printing Office, Printed version: http://bookstore.gpo.gov/actions/GetPublication.do?stocknumber=008-070-00810-6

KEYWORDS: Pulse oximeter, fingerprint scanner, wireless UWB, electronic health record, DD1380 field medical card

DHA172-006 TITLE: Mobile Causality Display Toolkit for Tactical Combat Casualty Care

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: The objective of this topic is to develop and demonstrate a robust and ruggedized mobile causality display toolkit for Tactical Combat Casualty Care (TC3).

DESCRIPTION: This topic seeks the development of a mobile causality display toolkit prototype for use on any mobile device with Bluetooth technology to provide medics and CLSs with a more in-depth TC3 training in live exercises. This new solution for representing causality injuries will enable self, buddy, Combat Livesafer (CLS), and medic care in live exercises and address the need to increase infantry squad capabilities to improve tactical effectiveness while managing casualties. The components of this toolkit will include an android mobile device and tools that support care of preventable deaths. All components of the toolkit should withstand the ruggedness of live exercises. During live exercises, a medic at the time of injury will obtain Combat Causality Care (CCC) information from a mobile device. The mobile device will allow the medic to see the mechanism of the injury, injury, signs and symptoms, and treatment (MIST), in addition to tactical and vital information. With the information obtained from the mobile device, the medic will be able to leverage the tools that support care of preventable deaths to provide the causality with initial treat. The mobile device will provide the medic with dynamic visual updates of MIST, tactical information, and vital signs real-time. This will provide the medic with real-time injury status information allowing the medic to course correct treatment if necessary. The intention of this topic is to utilize mobile technologies to allow self, buddy, CLS, and medic treatment in live exercises. With technologies that provide dynamic visual updates of MIST, tactical information, and vital signs in real-time the individual providing treatment will be able

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treat the causality throughout the duration of the exercise, resulting in a more robust training.

This topic seeks a high fidelity robust and ruggedized mobile solution for TC3 training. The research and development will focus on both the hardware and the software components. The hardware components should be lightweight, rugged enough to withstand live training, and communicate via Bluetooth or similar technology so that the tools that support care of preventable deaths can transmit the type of treatment to the mobile device. In addition, to increase the fidelity of TC3 simulated training in live exercises the hardware should leverage technologies that provide sensory information to the individual providing care, such as haptics, auditory, and olfactory cues and feedback. The software should succinctly display dynamic visual updates of MIST, tactical information, and vital signs real-time. The real-time information should be based on type of treatment provided by the medic in conjunction with physiological models to represent a person’s vitals over time. Physiological models could be derived from software programs such as BiogearsTM and HumModTM (see references) In addition the mobile causality display toolkit should generating real-time data to improve the Commander’s Casualty Response System, individual TC3 training, and After Action Review (AAR).

Research conducted under this effort should focus on Commander’s Casualty Response System, individual TC3 training, and AAR. The final demonstration should show proof-of-concept feasibility for a mobile causality display toolkit that withstands the ruggedness of live training, communicates via Bluetooth to provide treatment updates to the medic via the mobile display, and provides real-time MIST, tactical, and vital information based on physiological models.

PHASE I: Identify one or multiple methods for a robust and ruggedized mobile causality toolkit, ensuring that the toolkit components are rugged enough to withstand live training and that the treatment information can be transmitted from the tools to the mobile display. The effort should clearly analyze and define scientific and technical feasibility, as well as commercial merit, of using a mobile causality display toolkit for TC3. The effort should seek innovative and novel ideas for exploration of concepts to provide a rugged and realistic solution that would allow for hands on training. Phase I deliverables should include a proof of principle prototype demonstration or a set of technical drawings in electronic format that would provide a view of all components of the proposed system, Phase II design plans, and exploration of commercialization with potential medical development and manufacturing companies. The offeror shall identify innovative technologies being considered, technical risks of the approach, costs, benefits, plan for development, notional schedule associated with development, and a literature search to support feasibility.

PHASE II: From the Phase I design, develop a ruggedized prototype and demonstrate the real-time presence of the mobile causality display toolkit and sensory cues and feedback. The prototype toolkit can be initially demonstrated in an area where Bluetooth signal is strong, knowing that the goal of the prototype is for Bluetooth to work in areas where signal strength is less than ideal. The offeror shall conduct usability studies during development of the system. The offeror shall provide projection of costs to manufacture, maintain and resupply, as well as the equipment lifecycle. The offeror shall conduct a training effectiveness evaluation (TEE) of the final prototype with combat medics. The evaluation shall provide quantitative measures of the effectiveness of the system. Data from the usability studies and the TEE shall be provided, analyzed, and presented in a final report. The offeror shall continue commercialization planning and relationship development with military and civilian end users and begin to execute transition to Phase III transition and commercialization in accordance with the Phase I commercialization plan.

PHASE III DUAL USE APPLICATIONS: Refine and execute the commercialization plan included in the Phase II Proposal. After Phase III development, the final production model of mobile causality display toolkit for TC3 must be ruggedized for shock, dust, sand, and water resistance to enable reliable, uninterrupted operation in combat environments. Service members will wear the mobile display and medics will carry the tools, thus size and weight are important factors. The ultimate goal of the system would be to enable simulated real-time assessment, monitoring, and intervention of causalities during live training. Additionally, the toolkit should generate real time data to improve the Commander’s Casualty Response System, individual TC3 training, AAR. Execute proof-of-concept evaluation in a suitable operational environment (e.g. military operations in urban terrain site).

REFERENCES:

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1. Milham, L. M., Phillips, H. L., Ross, W. A., Townsend, L. N., Riddle, D. L., Smith, K. M., ... & Johnston, J. H. (2016). Squad-level training for Tactical Combat Casualty Care: instructional approach and technology assessment. The Journal of Defense Modeling and Simulation: Applications, Methodology, Technology, 1548512916649075.Link: http://dms.sagepub.com/content/early/2016/05/25/1548512916649075.abstract

2. Townsend, L., Milham, L., Riddle, D., Phillips, C. H., Johnston, J., & Ross, W. (2016, July). Training Tactical Combat Casualty Care with an Integrated Training Approach. In International Conference on Augmented Cognition (pp. 253-262). Springer International Publishing.Link: http://link.springer.com/chapter/10.1007/978-3-319-39952-2_25

3. Metoyer, Rodney, Bergeron, Bryan, Clipp, Rachel B., Webb, Jeffrey B., Thames, M. Cameron, Swarm, Zachary, Carter, Jenn, Gebremichael, Y., and Heneghan, Jeremiah. Multiscale Simulation of Insults and Interventions: The BioGears Showcase Scenarios. Medicine Meets Virtual Reality Conference. Los Angelos, CA Link: https://biogearsengine.com/documentation/index.html

4. Hester, R., Brown, A., Husband, L., Iliescu, R., Pruett, W. A., Summers, R. L., & Coleman, T. (2011). HumMod: a modeling environment for the simulation of integrative human physiology. Frontiers in physiology, 2, 12.Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3082131/

KEYWORDS: Tactical combat casualty care, casualty simulation, live training mobile devices

DHA172-007 TITLE: Next-Generation Ear Seals for Circumaural Headsets and Hearing Protectors

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop improved circumaural ear seals for hearing protection and communication devices that have the ability to better fit to the features of the Service member’s head and eyewear providing an improved seal, reducing environmental stress while providing an improved level of noise attenuation to help reduce incidence of noise induced hearing loss (NIHL) and improve communications.

DESCRIPTION: Servicemembers are exposed to high noise environments on a daily basis. Aviation, mechanized, light and armored units are all exposed to environments well in excess of the permissible noise levels. In aviation alone, flight crews spend a majority of their day in aircraft and; even when not flying, are still subjected to the high noise levels of an active airfield. Ground crews carry headsets with them for aircraft run ups and maintenance checks. It is vital that these groups be able to protect their hearing while maintaining the ability to communicate effectively to accomplish the mission safely and effectively. Hearing loss and auditory disorders are the most prevalent service-connected disabilities for military service members [1, 2]. In addition to improving the hearing protection provided by the headset, achieving improvements in attenuation of communication headsets can provide for improved speech intelligibility.

The ear seal plays a substantial role in the efficacy of circumaural hearing protectors. However, ear seal technology has changed very little in the last 40+ years. Proper fit of ear seals against the head can be compromised by eyewear, facial hair, and the anatomy of the Servicemember’s head. Acoustic leaks caused by eyewear have been shown to be detrimental to the amount of noise attenuation provided by the headset [3]. Eyewear is important personal protective equipment for the Servicemember, so the design of next-generation ear seals should take into account the presence of eyewear, and conform around it for a better acoustic seal.

In addition to the conformability improvements of the ear seals, it is also desirable for the actual materials composing the ear seal to provide increased attenuation properties, and to be lightweight. Since headsets are often worn for very long periods of time, it is also desirable for the ear seal to reduce pressure points and hot spots against the Servicemember’s head. Ear seals are currently unable to distribute the clamping pressure across their contact surface, even when clamped to a flat plate, let alone when used on a human head [4]. Discomfort from headsets can

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create environmental stress, as described in the Army Aeromedical Training doctrine: “which might divert their attention from performing operational duties” or may cause the Servicemember to remove the headset. The proposed solution will provide a more even distribution of the clamping force than existing ear seal technology, significantly reduce acoustic leaks, and increase the overall attenuation of the headset.

PHASE I: To show feasibility, build working prototypes of improved ear seals for three headsets routinely used in military aviation and infantry personnel and show their ability to reduce acoustic leaks, compared to the stock ear seals) by conforming around the temples of eyeglasses listed on the U.S. Army Authorized Protective Eyewear List (APEL) using an acoustic test fixture. Demonstrate, in accordance with ANSI/ASA S12.42-2010 [5], that the materials in the ear seal provide an improved attenuation of the headset versus the same headset with the stock ear seals, especially in the frequencies below 500 Hz where the “pumping” effect of the hearing protector acting as a mass/spring system is observed [6]. Identify further improvements to be implemented in Phase II.

PHASE II: Based on Phase I results develop a series of improved ear seals for all three headsets and demonstrate, in accordance with ANSI/ASA S12.6-2016 [7], an increase in attenuation versus the stock ear seal for each headset of 2 dB or more. Demonstrate a significant acoustic advantage of reduced leakage around glasses for all three headsets. Perform quantitative measurements to show an improvement in distributing clamp force more evenly across the contact surface of the ear seals. The ear seal designs should make them easy to attach as a replacement component for fielded helmets and headsets.

PHASE III DUAL USE APPLICATIONS: The comfort of hearing protectors is one of the chief factors affecting the willingness of individuals in industry, military, and society in general. If a hearing protector is not comfortable, it will not be worn or the user will compromise the protector to make it less uncomfortable and less effective. Hearing protection and communication are essential for the safety and communication of Servicemembers, particularly those in ground and air vehicles. The deployment of a next-generation design of circumaural ear seals should improve the hearing protection of the wearer, improve communication, and reduce the environmental stress associated with wearing headsets for extended periods of time. Furthermore, improved ear seals will improve the use of hearing protection in all areas of society where hearing protection is mandated or advised.

REFERENCES:1. Veterans Benefit Administration, Annual Benefits Report. Fiscal Year 2014. 2014, U.S. Department of Veterans Affairs.

2. McGeary, M., et al., A 21st century system for evaluating veterans for disability benefits. 2007: National Academies Press.

3. Reeves, E.R., E. Gordon, and S. Nomura, Noise Attenuation Loss Due to Wearing APEL Eye Protection with Ear-Muff Style Headset Systems, Sensory Research Division, Editor. 2012, U.S. Army Aeromedical Research Laboratory: Fort Rucker, AL.

4. Gerges, S.N.Y., D. Sanches, and R.N.C. Gerges. Earmuff Comfort. in Proceedings of 20th International Congress on Acoustics, ICA 2010. 2010. Sydney, Australia.

5. ANSI/ASA., S12.42-2010 American National Standard Methods for the Measurement of Insertion Loss of Hearing Protection Devices in Continuous or Impulsive Noise Using Microphone-in-Real-Ear or Acoustic Test Fixture Procedures. 2010, Acoustical Society of America: Melville, NY.

6. Berger, E.H., EARLog #5 - Hearing Protector Performance: How They Work - And - What Goes Wrong in the Real World. Sound and Vibration, 1980. 14(10): p. 14-17.

7. ANSI/ASA, S12-6-2016 American National Standard Methods for Measuring the Real-Ear Attenuation of Hearing Protectors. 2016, Acoustical Society of America: Melville, NY.

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KEYWORDS: Hearing protection; ear seals, comfort, attenuation, noise, and headset

DHA172-008 TITLE: Point of Care Test for Disease Severity and Risk Stratification

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop an easy to use diagnostic tool for risk stratification and disease severity at point of care utilizing the complete blood count test.

DESCRIPTION: Early recognition of disease severity and early treatment interventions are critical to reducing the rates of morbidity and mortality. Risk stratification of patients with acute or severe conditions is an important step to guide the initial triage, therapeutic management, and suitability for discharge. Early identification of these at-risk patients may provide an opportunity to intervene and thereby improve outcomes and optimize resource allocation. In recent years, there has been an increasing interest in the stratification of patients using inexpensive, common and standardized blood tests.

The complete blood count (CBC) is a routine laboratory test to evaluate white blood cell, neutrophil, and lymphocyte, neutrophil to lymphocyte ratio, hemoglobin, hematocrit, red cell distribution width, mean corpuscular volume, platelet count, mean platelet volume, and platelet distribution width.

Several of these parameters, such as red cell distribution width (RDW) and neutrophil to lymphocyte ratio, have been suggested as biomarkers for systemic inflammation and severity of disease. Such a simple biomarker could provide a tool to facilitate focused interventions and triage decisions for patients at high risk for poor clinical outcomes. These biomarkers are quickly and cheaply obtained with routine CBC analysis.

For example, RDW elevation can occur in any condition such as inflammatory disease and sepsis. In addition to diagnosing anemia, recent studies have demonstrated that RDW also gives information regarding the prognosis of sepsis and infectious disease (primary concerns) along with heart disease, hepatitis, and cancer (secondary concerns). It also has shown promise for predicting severity for triage in the emergency department and intensive care units.

PHASE I: Develop a CBC analyzer. The analyzer and any necessary components should be (less than 35lbs) 50% less weight than the average desk-top analyzer and 1.5 cubic feet with no cold chain requirements for the system reagents. The analyzer should be easy to use at the point of care (Role I or higher) for disease severity analysis and risk stratification. It is expected that the design will employ innovative technology to affect improved/reduced size/weight/cube and the design should be vectored towards a Clinical Laboratory Improvement Program (CLIP) waived test. The contractor will deliver an integrated package of design results in a mutually agreed digital format with concept drawings (including isometric), concept schematics, conceptual blood analysis process flow diagrams and other engineering data necessary for government design evaluation. The package must also include an explanation of why the employed technology is considered “innovative”.

PHASE II: Build the prototype equipment based on the results of Phase I and any forthcoming subsequent technological improvements based on government evaluation of Phase I. The unit will be intended for point of care use by HRT medical personnel (non-lab tech) in Level I or higher echelons of care.

The prototype should produce a white blood cell (WBC); neutrophil (NEU) count and percentage; lymphocyte (LYM) count and percentage, monocyte (MONO) count and percentage; eosinophil (EOS) count and percentage; neutrophil to lymphocyte ration, hemoglobin (Hb), hematocrit (Htc), red cell distribution width (RDW), mean corpuscular volume (MCV), platelet count, mean platelet volume (MPV), and platelet distribution width (PDW).

The contractor will update and deliver the integrated package of design results provided in Phase I based on the prototype build. This will be in a mutually agreed digital format.

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Develop and submit for approval, a test plan and associated procedures to demonstrate system operation and accuracy, linearity and precision, side-by-side against a quantitative, high complexity analyzer with samples of known value. Testing should be conducted by the contractor or their fully qualified independent laboratory and may be witnessed by the government. Testing should be vectored toward a CLIP waived test so it can be performed by a trained individual, e.g. nurse, EMT, or MD, other than a lab technician. Results will be provided to the government. The above testing should be rigorous enough to be used in the FDA approval process.

The contractor should conduct initial planning for FDA approval.

Also, the contractor will provide to the government a list of any notable manufacturing considerations should the item proceed into Phase III.

PHASE III DUAL USE APPLICATIONS: Provided that the prototype performs successfully, the vendor, topic author and AFMSA Advanced Development Cell (ADC) will work together to transition the item to meet MIL-STD 810, is FDA approved, and is affordable and producible for both HRT and small civilian clinic settings.

REFERENCES:1. Lorente L, Martín MM, Abreu-González P, Solé-Violán J, Ferreres J, et al. Red blood cell distribution width during the first week is associated with severity and mortality in septic patients. PLoS One. 2014;9(8):e105436. PubMed PMID: 25153089; PubMed Central PMCID: PMC4143268. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0105436

2. Hunziker S, Celi LA, Lee J, Howell MD. Red cell distribution width improves the simplified acute physiology score for risk prediction in unselected critically ill patients. Crit Care. 2012 May 18;16(3):R89. PubMed PMID: 22607685; PubMed Central PMCID: PMC358063 https://ccforum.biomedcentral.com/articles/10.1186/cc11351

KEYWORDS: in-vitro diagnostics, severity, sepsis, cardiac disease, infectious disease, complete blood count, red blood cell indices

DHA172-009 TITLE: Complex Crystalloid Resuscitative Fluid

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop a novel crystalloid resuscitative fluid which improves outcome following severe hemorrhage when compared to the current standard of care crystalloid.

DESCRIPTION: The current prehospital standard of care for hemorrhage is to use a crystalloid solution such as Normal Saline or a colloid solution such as albumin, gelatin, or starch. These standard of care therapies have been shown to be less than optimal with some negative outcomes following severe hemorrhage to include hyperchloremic acidosis and tissue edema for the crystalloids.[1,2] The colloids have been associated with renal injuries and increased bleeding risks and have been shown to no survival improvements over the crystalloids.[3] The requested technology is for a novel resuscitative fluid that decreases the risks associated with the current standard of care. The requested technology may function by various mechanisms to include but are not limited to enhanced cellular resuscitation, enhanced tissue recovery and replacement of lost cellular factors. The all components of the fluid must have a clearance mechanism from the body.

PHASE I: The expectations for this phase are the design and development of a prototype fluid and the completion of a proof of concept in vitro cell based study. This study should examine the ability of the resuscitative fluid to improve cell function and viability vs a standard of care crystalloid solution in a cell culture model of endothelial cell activation. Additionally, the expectation for this phase is the development and conduct of a proof of concept study to test the prototype fluid in a rodent model of acute hemorrhagic shock. The study endpoints should be

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improvements in outcome compared to a standard of care crystalloid solution.

PHASE II: In this phase, the Offeror will develop and conduct a small animal evaluation of the technology compared to normal saline (current standard of care) and whole blood in a model of severe hemorrhage/hemorrhagic shock. The size of the study should be appropriately powered to ensure that the results are statistically significant. The study should be designed to include the evaluation of the solution for the acute phase of hemorrhage/hemorrhagic shock and long-term outcomes. These outcome measures should include survival, evaluation of inflammatory markers, evaluation of coagulation parameters, and evaluation of metabolic parameters. The study should be conducted under Good Laboratory Practice (GLP) or GLP-like conditions. Design and conduct a proof of concept evaluation of the technology in a large animal model of hemorrhage/hemorrhagic shock. The study should examine the translation of the technology from the rodent model to a large animal (swine, sheep, etc). The study should include the evaluation of the solution for the acute phase of hemorrhage/hemorrhagic shock and mid to long term outcomes. These outcome measures should include survival, evaluation of inflammatory markers, evaluation of coagulation parameters, and evaluation of metabolic parameters. Develop a business strategy for the development and commercialize the technology. Initiate discussions with the FDA on the regulatory pathway for the technology.

PHASE III DUAL USE APPLICATIONS: The technology developed will address the Defense Health Program gaps for improved resuscitation and prolonged prehospital care. The likely path for transition of the technology will be through either the Army or Navy Advanced Medical Development Program or the Defense Health Program Medical Development Program as all three are currently involved in the development of related products, dried plasma and a multifunction resuscitation fluid (blood substitute). It is envisaged that the product developed will be procured for use by all of the Services for primary use in the field/prehospital environment.

In this phase the Offeror in consultation with the FDA will conduct a GLP or GLP-like large animal validation study. The study should be appropriated powered for determination of statistical significance of the results. The study should involve a large animal model of hemorrhage/hemorrhagic shock (swine, sheep, non-human primates, etc). The Offeror will conduct Investigational New Drug (IND) enabling studies to establish safety/toxicity in an appropriate Good Laboratory Practice (GLP) animal model and an appropriate product stability studies. The Offeror should also conduct other IND enabling studies such as pharmacokinetic/pharmacodynamics as deemed necessary following discussions with the FDA. The end state of this research is to conduct all appropriate studies required to receive IND approval for the conduct of human clinical trials. The Offeror will be encouraged to identify and apply for other government sources of funding or private funding to conduct the clinical trials.

REFERENCES:1. Santry, H.P. and Alam, H.B. (2010) Fluid Resuscitation: Past, Present, and the Future. Shock. 33; 3, 229-241. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4988844/

2. Cotton, B.A., Guy, J.S., Morris, J.A., and Abumrad, N.N. (2006) The cellular, metabolic, and systemic consequences of aggressive fluid resuscitation strategies. Shock. 26;2, 115-121. https://www.researchgate.net/publication/6908643_The_cellular_metabolic_and_systemic_consequences_of_aggressive_fluid_resuscitation_strategy

3. Perel, P. and Roberts, I. (2011) Colloid versus crystalloid for fluid resuscitation in critically ill patients. Cochrane Database of Systematic Review. 3; CD000567. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000567.pub6/full

KEYWORDS: Resuscitation Fluid, Trauma, Hemorrhage, Crystalloid, Tissue, Cell, Recovery

DHA172-010 TITLE: Medical Wearable for First Responder Assessment and Remote Monitoring

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TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop and deliver a low power biometric wearable device capable of collection, storage, and transmission of electrocardiogram (EKG) rhythm, temperature, pulse, and other vital human physiological function data. System must provide near real-time remote patient monitoring in combat, transport, and surgical environments.

DESCRIPTION: Injured warfighter’s operating in remote environments require both assessment and monitoring, often while the maneuver element is still engaged with enemy forces. Combat casualties are evaluated and treated under a phased continuum of care that begins with Combat Casualty Care administered by embedded combat medical personnel in the battle field. Subsequent phases of care include casualty evacuation, field hospital, etc. Throughout this care continuum, medical care providers require accurate and timely patient biometric data to ensure appropriate triage and deliver of life saving measures. No system is currently available continuous monitoring in an operationally suitable form factor. Additionally, records of care provided at each echelon must be passed to the subsequent medical echelon to ensure safe continuity of care. Current procedures for passing patient condition and care history require a written record or verbal communication. Both of these communication modes are problematic in combat environments.

This topic seeks development of a small wearable device that can be quickly placed on injured personnel capable of collecting essential biometric data and providing the capacity to remotely deliver collected data in real-time to a range of medical care providers, including on-scene combat medics and surgeons at remote field hospitals. This new capability will provide a force multiplier through remote assessment, increased survivability, and free engaged warfighters from direct monitoring thus improving combat effectiveness and increasing situational awareness.

The device should be designed to provide key biometric data and transmit the collected data along existing throughput constrained military communication channels. In light of the limited throughput capacity at the tactical edge, the system should leverage data management schemes that provide a high probability of successful transmission.

Additionally, the device should incorporate an intuitive user interface that can be interpreted by minimally trained care providers.

PHASE I: The Phase I effort will focus on developing a proof-of-concept for a remote medical monitoring wearable in a compact ruggedized form factor and determine the technical feasibility of the proposed topic.

PHASE II: The Phase II effort will develop a prototype biometric wearable based on the PHASE I proof-of-concept. The Phase II effort will increase the pertinent physiological medical data set collection to include, temperature, heart rate variability, pulse, and blood oxidation. This data needs to be collected continually and in a suitable digital form for dedicated communication channel for analysis and monitoring. The Phase II effort will also provide data collection to ensure accurate medical assessment, and to diagnose operational effectiveness, in an effort to provide appropriate remote treatment and improve triage efficiency under appropriate environmental conditions and weather. Because treatment will be based upon data collected appropriate FDA assessment and evaluation will be required in PHASE II. This assessment could include the regulatory pathway necessary for FDA approval.

PHASE III DUAL USE APPLICATIONS: Phase III efforts will be directed toward refining a final deployable design; incorporating design modifications based on results from tests conducted during Phase II; and improving engineering/form factors, equipment hardening, and manufacturability designs to meet U.S. Army CONOPS and USASOC Medical requirements. It is expected that commercialization of this wearable with real-time remote connectivity will greatly enhance first responder’s ability to prevent loss of life and maintain situational awareness.

REFERENCES:1. Thayer, J. F., Åhs, F., Fredrikson, M., Sollers, J. J., & Wager, T. D. (2012). A meta-analysis of heart rate variability and neuroimaging studies: Implications for heart rate variability as a marker of stress and health. Neuroscience & Biobehavioral Reviews, 36(2), 747–756

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2. Billman, G. E. (2011). Heart Rate Variability? A Historical Perspective. Frontiers in Physiology, 2.

3. Ursino, M., & Magosso, E. (2003). Role of short-term cardiovascular regulation in heart period variability: a modeling study. American Journal of Physiology - Heart and Circulatory Physiology, 284(4), H1479–H1493.

KEYWORDS: EKG, Wearable, Heart Rate Variability, Medical monitoring, Biometric Data, Triage

DHA172-011 TITLE: Intravenous Ringer's Lactated Ringer's Solution from Any Water Source Without Electrical Power

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop an FDA-approved concentrated Lactated Ringer's injection solution at reduced weight, cube and/or cost of current product(s) that requires no power source.

DESCRIPTION: Effective application of critical care concepts in a timely fashion is vital to the survival of the wounded Soldier on the battlefield. Intravenous (IV) fluids, such as Lactated Ringer’s (LR) solution, are given to patients to either replete a deficit in intravascular volume or prevent the development of such a deficit (1). Ringers Injection Lactated USP, 1000ml Bag is a DHA MEDLOG recognized item identifiable via National Stock Number (NSN: 6505-013306267). 1000ml LR weighs approximately 2.2 pounds per bag. Reconstituting LR using a local water supply introduces an opportunity to reduce weight, cube and potentially cost associated with transporting LR to forward locations. NASA has conducted developmental efforts and testing associated with customized IV bags and fluid therapy systems (2). It appears these efforts have not led to the development of a commercially viable product or system. PMO-MD/USAMMA seeks Lactated Ringer’s injection solution at decreased weight, cube, and/or cost of current product(s).

PHASE I: Identify, assess, and select potential water filtration technologies to develop a concept and functional prototype associated with reconstitution of concentrated Lactated Ringer’s injection solution using varied sources of water supply. Conduct related feasibility studies determining / demonstrating the innovative technology; associated testing that verifies key parameters can be achieved including FDA high purity water systems standards as applicable; technical risks; costs, benefits, and schedule associated with development of the prototype. Phase I deliverables include a prototype and associated laboratory test results as applicable.

PHASE II: Provide a detailed plan outlining development, demonstration and validation of a concentrated Lactated Ringer’s Injection solution manufacturable at reduced weight, cube and cost of currently product(s). Refine and validate the technical concepts and prototype developed in the phase I effort into a ruggedized prototype. Conduct quality testing to statistically verify and validate that the system will consistently deliver Lactated Ringer’s Injection solution meeting associated USP / FDA quality standards. Design must minimize the size and weight of current Lactated Ringer’s injectable solutions, ensuring ease-of-use for rapid deployment and use. Deliverables include at least ten (10) developed pre-production prototypes for joint military utility assessment and independent lab verification of quality metrics meeting or exceeding applicable FDA standards.

PHASE III DUAL USE APPLICATIONS: Development of a commercial capability to manufacture a next generation technology producing concentrated Lactated Ringer’s injectable solution to be used in conjunction with varied source water supply, and a quality assurance and control plan that ensures consistency for device production. Final production model and packaging must be ruggedized to withstand environmental testing to enable reliable ease of use. Work may result in technology transition to an Acquisition Program of Record and/or commercialization of this technology capability. Developer shall seek additional funding from other government sources and/or the private sector investors to develop or transition the prototype into a viable product for sale to the military and private sector markets. The culmination of the Phase III will result in a system which enables DoD medical support staff to reconstitute concentrated Lactrated Ringer’s Injection solution from varied source water supply as needed and at any location to save the lives of US Service Members and coalition forces. In addition, the commercial applications of

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this system will enable Lactated Ringer’s Injection solution to be reconstituted upon demand by emergency medical technicians in forward locations using varied sources of water supply.

REFERENCES:1. Emergency War Surgery (4th Edition 2013) Borden Institute, pp 131-133http://www.cs.amedd.army.mil/borden/FileDownloadpublic.aspx?docid=0a17a2a8-ae58-4c90-bcec-ce432cb1096d

2. Medical Grade Water Generation for Intravenous Fluid Production on Exploration Missions, NASA/TM—2008-214999, Niederhaus, Barlow, Griffin and Miller http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20080022376.pdf

KEYWORDS: Ringer’s, Lactated, injection, intravenous, parenteral, IV, solution, high purity water system

DHA172-012 TITLE: Solutions for Restoration of Urinary Function and Control

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: To develop, design, and demonstrate new technology or therapies that will replace or restore damaged, missing or non-functional urinary system and allow patient control over urination.

DESCRIPTION: The Department of Defense has an urgent need for clinical genitourinary technologies that will give surgeons the ability to replace missing, damaged, or non-functional urinary tracts following traumatic injury or disease.

Urinary dysfunction may be the result of traumatic injury to the lower body or may be neurogenic in nature, resulting from damage or disease of the central nervous system [1]. Traumatic injuries may involve damage or complete loss of tissues necessary for urinary function. Neurogenic damage may not affect specific genitourinary tissues, but can still prevent control over urinary function. Approximately 70-84% of spinal cord injury (SCI) patients will have neurogenic bladder dysfunction (NBD), translating to ~32,000 SCI veterans with NBD [2].

The current clinical standard for treatment of bladder and urinary tract defects is catheterization, which can range from intermittent catheterization, requiring no surgery or permanent implants, to creation of a stoma, bypassing the urethra to empty the bladder directly. Intermittent catheterization is the use, several times a day, of a straight catheter that can be done independently by some patients, or a Foley catheter that allows continuous drainage into a drainage bag worn by the patient. The alternative is creation of a stoma that allows insertion of a catheter. The drawbacks for these procedures are the need for repeated catheter insertion and the need for external collection bags.

The injuries stained by Service Members, mean that the use of a catheter may be required for decades. There is an inherent risk of infection and catheters may become blocked. Some evidence indicates certain bacteria encourage the development of encrustations that may block the catheter within 24 hours [3]. Catheter related urinary tract infections contribute to more than 40% of nosocomial hospital infections [4]. In addition to these risks, the ongoing costs for lifelong catheterization can be high. The average life span post SCI is over 40 years [5]. With catheters, pads and other supplies costing ~$600/month, this translates to almost $350,000 in a lifetime. For the VA alone, this adds up to over $23 million per year.

The ultimate goal of this project is to develop new technologies or therapies that can be used to restore urinary function and control. The ability to restore urinary function to injured Service Members would improve quality of life and reduce the need for hospital visits for catheter care.

PHASE I: In the Phase I effort, innovative efforts for restoring urinary function will be conceptualized and designed. Such solutions may include devices, and/or cellular, tissue or biological components. Phase I efforts can support early concept work (i.e., in vitro studies), or efforts necessary to support a regulatory submission, which do not

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include animal or human studies, such as stability studies, shipping studies, etc. Proposed technologies or therapies should be formulated, and the fabrication or production procedures should be developed for a representative device or therapy. The Phase I effort should also include fabrication experiments and benchmarking that demonstrate an adequate capability for meeting the expected challenges in fabricating the proposed technology. It is expected that physical attributes of devices such as patency, user control, and infection control will be predicted as a function of the material and device structure. Specific milestones for devices include the ability for the user to control urination, to control potential bacterial colonization or infection, and to maintain patency. Specific milestones for non-device therapies should include reasonable expectation of improved urinary function and control following treatment.

PHASE II: In the Phase II effort, a prototype technology or therapy should be fabricated and demonstrated. The performance of the technology should be fully evaluated in terms of patency, user control and ability to resist bacterial colonization or infection. The last requirement is especially critical for implanted devices as unresolved bacterial contamination could be life threatening and require removal of the implant. Other regenerative or restorative therapies should demonstrate safety and efficacy in pre-preclinical testing. Phase II results should demonstrate understanding of requirements to successfully enter Phase III, including how Phase II testing and validation will support a regulatory submission. Phase II studies may include animal or human studies, portions of effort associated with the same, or work necessary to support a regulatory submission which does not involve animal or human use, to include, but not limited to: manufacturing development, qualification, packaging, stability, or sterility studies, etc. The researcher shall also describe in detail the transition plan for the Phase III effort.

The Food and Drug Administration regulatory requirements vary depending on the device classification. As part of the phase II effort, the performer is expected to develop a regulatory strategy to achieve FDA clearance for the new technology. Interactions with the FDA regarding the device classification and an Investigational Device Exemption (IDE), as appropriate, should be initiated. Essential design and development documentation to support FDA clearance, as described in the Quality System Regulation (21 CFR 820.30), should be capture including but not limited to design planning, input, output, review, verification, validation, transfer, changes, and a design history file. The project needs to deliver theoretical/experimental results that provide evidence of efficacy in animal models. The studies should be designed to support an application for FDA clearance.

PHASE III DUAL USE APPLICATIONS: During phase III, it is envisioned that requirements to support an application for device clearance from the FDA should be completed. As part of that, scalability, repeatability and reliability of the proposed technology should be demonstrated. Devices should be fabricated using standard fabrication technologies and reliability. The proposal should include a commercialization or technology transition plan for the product that demonstrates how these requirements will be addressed. They include: 1) identifying a relevant patient population for clinical testing to evaluate safety and efficacy and 2) GMP manufacturing sufficient materials for evaluation. The small business should also provide a strategy to secure additional funding from non-SBIR government sources and /or the private sector to support these efforts.

This technology therapy is envisioned for use in surgical intervention to repair urinary dysfunction in fixed medical treatment facilities. As such, the technology should have both military and civilian applications. Procurement of such technology would be at the discretion of the medical treatment facility.

REFERENCES:1. Panicker JN, et al. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015 Jul;14(7):720-32. http://www.sciencedirect.com/science/article/pii/S0022510X15301118

2. Dorsher PT, McIntosh PM. Neurogenic Bladder. Adv Urol. 2012; 2012:816274. doi: 10.1155/2012/816274. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3287034/

3. Wilde, MH, et al. Long-term urinary catheter users self-care practices and problems. J Clin Nurs. 2013 Feb;22(3-4):356-67. http://onlinelibrary.wiley.com/doi/10.1111/jocn.12042/full

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4. Ksycki MF, Namias N. Nosocomial urinary tract infection. Surg Clin North Am. 2009 Apr. 89(2):475-81, ix-x. http://www.sciencedirect.com/science/article/pii/S0039610908001503

5. Middleton JW, Dayton A, Walsh J, Rutkowski SB, Leong G, Duong S. Life expectancy after spinal cord injury: a 50-year study. Spinal Cord. 2012 Nov;50(11):803-11. doi: 10.1038/sc.2012.55. http://www.nature.com/sc/journal/v50/n11/full/sc201255a.html

KEYWORDS: Catheter, urinary dysfunction, neurogenic dysfunction, genitourinary, intermittent catheterization

DHA172-013 TITLE: Minimally Invasive Delivery of Therapy to the Inner Ear

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: To develop an easily-administered medical device that will safely deliver intratympanic medical treatments to the inner ear, where the hearing and vestibular systems are housed.

DESCRIPTION: Noise is a major occupational and environmental hazard that negatively impacts quality of life and causes hearing loss, sleep disturbance, fatigue, and hypertension. Military personnel are routinely exposed to high levels of harmful noise and as a result U.S. Advancements in technology and the increasing demand for specific drugs has made direct inner ear drug delivery a high priority. Pre-clinical studies have shown efficacy in studies to treat hearing loss and other auditory and vestibular conditions via intratympanic injection or medicated round window application.[1] However, innovative drug delivery systems for human use are lacking, limiting the ability to treat hearing loss, tinnitus, and other conditions such as ototoxicity, Meniere’s disease, and vestibular loss in Service Members. There are numerous drugs under current development for direct delivery to the inner ear with several undergoing clinical trials (Epselen, AM-101 and AM-111, among others).[2] To date, clinical research to treat these conditions via oral delivery have not shown the high levels of efficacy shown in corresponding animal experiments, suggesting a gap in translation possibly attributable to delivery route.[3]

Direct drug delivery through the middle ear requires clinical expertise and specialized equipment. Military members have limited access to care while deployed in remote settings, where many of these noise-related injuries are sustained. Systemic drugs may have unwanted effects on other systems of the body which can also impede readiness. An innovative medical device system to treat various inner ear diseases such as noise exposure, ototoxicity, sudden sensorineural hearing loss, autoimmune inner ear disease, and for preserving neurons and protecting sensory cells is needed. The middle and inner ear are the best structures for local drug delivery, which can be done using either intratympanic or intracochlear methods, to access the afflicted areas in the ear.[4]

PHASE I: Define a conceptual approach for an inner ear delivery system that meets the intent of the SBIR topic for trans-tympanic or cochlear delivery of therapeutics.

PHASE II: By the end of the Phase II, deliver a viable prototype, preferably with demonstrated success in large-animal trials with preparation for entry into human trials and/or FDA approval of a medical device to enable human clinical testing. Phase II deliverables include a developed prototype system, technical reports documenting the appropriate performance measurements for the medical device, and a proposed roadmap addressing additional activities, cost, and time required to make the technology commercially available.

PHASE III DUAL USE APPLICATIONS: Develop a plan and cost/time estimate for additional development and clinical study activities required to achieve the FDA and other regulatory approvals needed to make the technology commercially available for clinical use, including military field testing as necessary.

REFERENCES:

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1. Wang and Puel (2008) From Cochlear Cell Death Pathways to New Pharmacological Therapies. Mini-reviews in Medicinical Chemistry; 8:1006-1019.

2. Yankaskas (Jan 2013) Prelude: noise-induced tinnitus and hearing loss in the military. Hearing research; 295:3-8.

3. Kopke et al. (May 2015) Efficacy and safety of N-acetylcysteine in prevention of noise induced hearing loss: A randomized clinical trial. Hearing Research; 323:40-50.

4. Perez, Libman and Van DeWater (2012) Local Drug Delivery for Inner Ear Therapy. Audiological Medicine; 10:1-20.

KEYWORDS: hearing loss, drug delivery, intratympanic, cochlea, vestibular system, medical device

DHA172-014 TITLE: Development of an Individualized Portable Platform to Deliver Vestibular Rehabilitation

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: To develop a customizable platform to deliver vestibular rehabilitation using technology to improve compliance to home program, adapt rehab strategies to individual needs, and return individuals to duty more efficiently.

DESCRIPTION: Dizziness is a common complaint in individuals after mTBI/concussion. Over 22% of soldiers in a single Brigade Combat Team returning from Iraq sustained at least one TBI (Terrio et al, 2009). Dizziness was reported by 58.3% of the soldiers post-injury, with an additional 5.1% complaining of dizziness post-deployment (Terrio et al, 2009). Dizziness can also occur in individuals without mTBI/concussion with injury or pathology to the vestibular system (the system in the inner ear responsible for equilibrium). Dizziness and disorientation can negatively affect an individual’s readiness for duty with impact on activities of daily living as well as ability to perform job related tasks. Vestibular rehabilitation has been shown in many studies to improve symptoms of dizziness related to inner ear pathology and mTBI/concussion. Vestibular rehabilitation consists of a series of specific exercises that coordinate head and eye movements. These exercises are to be performed several times per day and often result in a temporary increase in symptoms for the patient as the body adapts to the movement. Compliance with a prescribed exercise program is a barrier to success for patients. There are many reasons for a lack of compliance including a lack of understanding of the given instructions, lack of motivation to perform the exercises, and simply forgetting to perform the exercises throughout the day.

In vestibular rehabilitation, one of the most commonly prescribed exercises address the vestibular ocular reflex (the reflex between the inner ear, the detects head movement, and the muscles that control the eye, that counter rotate the eye to allow the eye to stay fixed on a visual target). Traditionally this exercises is performed by hold a single target (a typed letter written on a notecard or Popsicle stick) at an arm's length, or taped to a wall. The patient then turns his/her head left/right or up/down while attempting to maintain visual fixation on the target. If the image appears to blur or shift, it indicates a breakdown in this reflex. This exercises is performed for several repetitions, multiple time throughout the day. Compliance with this exercise becomes a challenge to success with the rehab process, and in the military setting translates to continued subjective complaints of dizziness and a longer recovery period with missed days from work role. Compliance is also often challenge by a lack of patient understanding of the instructions for the exercise itself.

The goal of this project will be to develop a more interactive format that will allow for improved compliance with the exercise as it takes on the appeal of a video game more so than a homework exercise, will address compliance and the patient will record sessions and will share them with the referring provider (accountability beyond self-report of compliance) and will allow for the patient to share videos with the provider between sessions for feedback on performance. If the provider believes changes should be made in the way the patient performs the activity, that

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feedback can be given. If the patient has met success and is ready to progress with the exercise, the advice can be given between clinic visits.

PHASE I: Phase I of this project will be to develop a concept design of the technology itself. Key components of the design will include portability potentially utilizing components of smart phone technology already in existence such as audio cues to guide speed of exercises (metronome), a visual display that can be manipulated from a simple background to become more dynamic and complex as the patient progresses through rehabilitation (including optokinetics), and the ability to record video of the individual who performs the exercises (utilizing the self-facing camera) and transmit those videos to the prescribing rehab provider either through email or digital messaging. This phase will focus on the development of a tool that is portable and simple to use and will bring value to the clinical interaction between patient and provider.

PHASE II: During Phase II, the focus will be use of this tool in the clinical setting and feedback on its value and attributes that could be altered to enhance the patient interaction.

The attribute that will likely be manipulated most often will be the video backdrop/display. Early in in rehab that patient will require the most simple visual background. A control will be appropriate to adjust the brightness of the visual display. A simple display will likely be a black letter (optotype) presented about a white background. As the patient progresses, the complexity of the visual display will need to be adjustable to be more visually dynamic such as a checkerboard or chevron pattern, or potentially job or task related such as wooded scene with trees or a helicopter dashboard. The image or optotype itself can also be manipulated to become more complex such as a changing display of letters or words, also potentially moving on the screen. Eventually optokinetics of the visual display can be added in as well to further challenge the patient. All of these controls should be able to be manipulated remotely by the provider while the program itself should provide a log of how many times, and how often the exercise is performed.

In addition the device should allow for the patient to record video sessions of each time he/she performs the exercise. These videos can be played back by the provider to determine if they are being performed correctly and for the provider to offer feedback throughout the session.

During Phase II of this program, ideally this clinical treatment portion for the device can begin to be utilized with both the patient and the provider offering feedback on its ease of use.

PHASE III DUAL USE APPLICATIONS: Phase III will focus on integrating this technology into vestibular rehabilitation for patients throughout the DoD and VA populations. With the ease of portability this technology could be used in a deployed setting by a novice clinician less familiar with vestibular rehabilitation who could share the data and recordings with a more experienced subject matter expert located elsewhere within the DoD system for guidance and treatment of a patient downrange vice moving that patient to a higher level of care.

A consistent barrier with technology within the military system is communication with the current medical record. To combat this challenge, it might be appropriate to allow the device to develop a printable data sheet (a progress report in a pdf format) that can be scanned into the current, or any future, medical record to allow providers throughout the continuum of care to reference the progress that the patient has made, or the challenges that were met along the way. This device would also be appropriate to use at any Military Treatment Center that currently evaluates and treats individuals with dizziness and well as all VA settings as dizziness is more often insidious and commonly seen across the lifespan than seen as a result of trauma. The printable pdf report could also be used within the VA healthcare electronic record.

REFERENCES:1. Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93 https://www.ncbi.nlm.nih.gov/pubmed/20588094

2. Terrio H, Brenner LA, Ivins BJ, Cho JM, Helmick K, Schwab K, Scally K, Bretthauer R, Warden D. Traumatic brain injury screening: preliminary findings in a US Army Brigade Combat Team. J Head Trauma Rehabil. 2009

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Jan-Feb;24(1):14-23 https://www.ncbi.nlm.nih.gov/pubmed/19158592

3. Whitney SL1,2, Alghadir AH3, Anwer S. Recent Evidence About the Effectiveness of Vestibular Rehabilitation. Curr Treat Options Neurol. 2016 Mar;18(3):13. https://www.ncbi.nlm.nih.gov/pubmed/26920418

4. FDA Mobile Medical Application (Uploaded in SITIS on 5/31/17)

KEYWORDS: Dizziness, mTBI, adaptation, concussion, vestibular rehabilitation

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