DEFENSE HEALTH AGENCY 18.2 Small Business Innovation Research (SBIR) Program

Proposal Submission Instructions

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

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

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

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

The DHA Program participates in three DoD SBIR BAAs each year. Proposals not conforming to the terms of this BAA will not be considered. Only Government personnel will evaluate proposals with the exception of technical personnel from STS Systems Integration, LLC who will provide technical analysis in the evaluation of proposals submitted against DHA topic number:

DHA182-002 Extended Wear Deep-Fitting Noise Dosimeter

PHASE I PROPOSAL SUBMISSION

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

DHA SBIR Phase I Proposals have four Volumes: Proposal Cover Sheets, Technical Volume, Cost Volume and Company Commercialization Report. A new Volume 5, Supporting Documents, is optional and is available for proposers to include additional files and documents which are not required in the Technical Volume. The Technical Volume has a 20-page limit including: table of contents, pages intentionally left blank, references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any other attachments. Do not duplicate the electronically generated Cover Sheets or put information normally associated with the Technical Volume in other sections of the proposal as these will count toward the 20-page limit.

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

Companies submitting a Phase I proposal under this BAA must complete the Cost Volume using the on-line form, within a total cost not to exceed $150,000 over a period of up to six months.

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

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

PHASE II PROPOSAL SUBMISSION

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

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

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

Small businesses submitting a proposal are required to develop and submit a technology transition and commercialization plan describing feasible approaches for transitioning and/or commercializing the developed technology in their Phase II proposal. DHA SBIR Phase II Cost Volumes must contain a budget for the entire 24-month Phase II period not to exceed the maximum dollar amount of $1,000,000. 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 Sheets, Technical Volume, Cost Volume and Company Commercialization Report. A new Volume 5, Supporting Documents, is optional and is available for proposers to include additional files and documents which are not required in the Technical Volume. The Technical Volume has a 40-page limit including: table of contents, pages intentionally left blank, references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any attachments. Do not include blank pages, duplicate the electronically generated Cover Sheets or put information normally associated with the Technical Volume in other sections of the proposal as these will count toward the 40-page limit.

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

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PHASE II ENHANCEMENTS

The DHA SBIR Program has a Phase II Enhancement Program which provides matching SBIR funds to expand an existing Phase II contract that attracts investment funds from a DoD Acquisition Program, a non-SBIR government program or eligible private sector investments. Phase II Enhancements allow for an existing DHA SBIR Phase II contract to be extended for up to one year per Phase II Enhancement application, and perform additional research and development. Phase II Enhancement matching funds will be provided on a dollar-for-dollar basis up to a maximum $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 18.2 Topic Index

DHA182-001 Clinical Decision Support for Dermatology Diagnosis in No-Communications Theater Environments

DHA182-002 Extended Wear Deep-Fitting Noise DosimeterDHA182-003 Limb Cooling Device to Preserve Ischemic Extremity for Prolonged Field CareDHA182-004 Identification of Open Globe Injuries on the BattlefieldDHA182-005 Development of an Individualized Portable Platform to Deliver Vestibular Rehabilitation

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DHA SBIR 18.2 Topic Descriptions

DHA182-001 TITLE: Clinical Decision Support for Dermatology Diagnosis in No-Communications Theater Environments

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Prototype a clinical decision support system for dermatology differential diagnosis, which employs automatic image recognition, and can operate stand-alone, in a no-communications theater environment.

DESCRIPTION: Military personnel can contract various insect-borne, respiratory, viral, parasitic, and bacterial infections during and after their military service. These conditions result in dermatological manifestations on various body parts. Fast and accurate diagnosis is crucial to proper treatment of these diseases; many of which are not seen frequently in the general civilian population, and are difficult to diagnose. Such diagnoses may be aided by automatic dermatology image recognition embedded into a clinical decision support system. Automatic dermatology image recognition uses artificial-intelligence-based pattern recognition. This technology currently requires massive computer processing power and storage, typically provided through the cloud. The challenge is how to enable automatic image recognition to work in military theater environments, with no communications connectivity.Consider also that future conflicts will likely involve smaller fighting units with less specialized medical care available at the point of injury. Medical evacuation may be delayed. While telehealth capabilities can help bring distant-deployed specialists to the battlefield to support prolonged field care, there will be scenarios where there will be no connectivity, hindering traditional synchronous and asynchronous telehealth capabilities. Hence, having mobile, standalone, clinical decision support tools available for deployed providers will help overcome some of these austere, environmental, clinical management challenges, and enable field medics and general medical officers to practice at a skill level greater than originally trained.

Lastly, there is a gap between acceptable, peer-reviewed medical knowledge, and the care-giver’s ability to apply that knowledge, to make clinical decisions that result in better outcomes at equal or less cost. The 2015 National Academy of Sciences report “Improving Diagnosis in Healthcare” revealed that 1 in 10 diagnoses are made in error. Their final report recommended that decision-support software be used to address the problem of diagnostic error. The late Dr. Lawrence Weed, MD, a world renowned clinical informatics professional, also spoke of the limits of the unaided human mind in decision making and its unfortunate impact on patient outcomes. He subsequently designed applications that linked medical problems with evidence-based knowledge.

Given this background, the Defense Health Agency, a Combatant Command, and the Program Executive Office, Defense Healthcare Management Systems seek technical solutions to the challenge of enabling clinical decision support systems with automatic image recognition to work on platforms where connectivity does not exist. In addition, the envisioned application must provide high diagnostic sensitivity and specificity and be validated in a theater field operation or exercise. U.S. Army Medical Research and Materiel Command, Telemedicine and Advanced Technology Research Center can assist in arranging demonstration of the prototype, when ready, in field exercises. The prototype developed should also be able to use network connections, when they exist, to provide higher levels of image recognition and artificial-intelligence based clinical decision support systems. The desired system is distinct and not confused with laboratory specimen diagnostic systems being designed in the military’s Next Generation Diagnostic Systems (NGDS) program.

PHASE I: Phase I must produce the following deliverables:a. A set of system functional requirements that would support the envisioned clinical decision support system designed to enhance diagnostic accuracy, aid therapeutic decisions, and improve patient safety. The functional requirements should ideally be solicited from non-dermatology trained end users, including medics, physician assistants, nurse practitioners, and general medical officers, as well as board-certified dermatologists, through rapid iterative prototyping and an agile software development methodology.b. A description of how the application will employ machine learning or artificial-intelligence-based automatic image recognition to generate accurate lesion morphology, the critical first step in dermatologic diagnosis.

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c. Various clinical decision support workflows to depict how the user could build a patient-specific differential by entering a suspected diagnosis or otherwise execute the capability to review travel or medication-related events at the point of care:1. The workflows should cover a variety of dermatology-related chief complaints and diagnostic areas that should be of likely interest to Military Health System providers in both theater and garrison-based MTF environments.2. The workflows should also provide an option not to enter diagnosis, but to provide information regarding the morphologies of the skin lesion and other patient findings.d. An explanation of the extent to which the envisioned software requires the user to interpret the correct diagnosis if the software returns multiple possible diagnoses.e. A complete system design document, to include the front end graphical user interface; logical and physical database models; network design; security and continuity of operations plan; and a performance and scalability testing plan. Moreover, the design document should depict various technical architectures to explain how automatic image recognition, machine learning, and artificial intelligence can be provided in a standalone, no-communications environment, but also leverage an environment with communications when available. For example, it may be possible to create a MESH network of existing mobile phones on a battlefield to provide distributed computing power and storage.f. A description of the preprocessing requirements that must occur to obtain and transform the image to send to the application. This description should include the file format, minimum/maximum size, and cropping. The government will supply 100 images from archived repositories at the U.S. Army Tele-Dermatology Program; the Department of Defense Joint Pathology Center; and Walter Reed National Military Medical Center), which can be used to evaluate the preprocessing requirements.

PHASE II: Phase II must provide the following deliverables:a. A working prototype of a mobile, no-communications, clinical decision support system with image recognition for dermatology differential diagnosis, based on the artifacts delivered in Phase I. The prototype should be designed with an overall architecture that would support future approval and accreditation certification under a NIST/DOD Risk Management Framework, should the prototype be placed on a military network (If the prototype works solely without military network connections, there is no need for a DOD Risk Management Framework assessment),b. A measure of the sensitivity and specificity of the prototype’s diagnostic accuracy. U.S. Army TATRC can supply images for analysis and engage dermatology subject matter experts to determine the gold standard for determining diagnosis and recommended treatments. The government will collaborate with the vendor to define and publish an acceptable process to negotiate consensus regarding diagnostic accuracy, should disputes arise.c. A prototype demonstration to a select group of health professionals in a theater-based operation or field exercise over a one-week period. U.S. Army TATRC can provide access to field exercises at Fort Dix, Fort Drum, or Fort Lewis (typically in the summer drill season), or to operational environments via the Special Operations Command or Department of the Navy. Specific details will be provided as soon as available. These demonstrations provide an opportunity to collect general feedback regarding the utility, usability, performance, and security of the prototype, and will not constitute formal testing or evaluation. The vendor should collect general data to validate to what extent the application improves the speed of diagnosis and to what extent the application is accepted by users. Data should also provide insight on the prototype’s physical, technical, performance, and security operating constraints and benefits in theater and operational environments. This focus will determine how well the prototype can provide medical knowledge in such environments and serve as a force multiplier for medical care.d. An explanation of the technical standards by which the application will be able to integrate with commercial Electronic Health Records and third party educational content providers. The government can provide the vendor with access to appropriate testing environments that include commercial EHRs and synthetic patient date for testing purposes on a reimbursable basis.e. An opinion from the FDA as to whether the application developed qualifies as a moderate-risk (Class II) or high-risk (Class III) mobile medical application per reference 5. The vendor should also provide an FDA opinion as to whether the prototype is clinical and patient decision support software, per reference 6.

PHASE III DUAL USE APPLICATIONS: U.S. Army TATRC and Joint Program Committee-1 will assist Phase III vendors in identifying possible transition points within military medicine. Military assistance will include the Program Executive Officer, Defense Healthcare Management Systems (DHMS); the Defense Health Agency (DHA) Solutions Delivery Division; the Joint Operational Medical Information Systems (JOMIS) Program Office; the DHA Chief for Virtual Health; and with the Service Surgeons General Specialty Advisors for Dermatology. The clinical

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decision support algorithms developed as part of this research can likely be extended to other clinical domains for commercialization in the civilian health sector. In addition, the automatic image recognition technology can be extended and adapted for use in the Homeland Security, Supply Chain, Manufacturing, Banking, and Insurance Claims Processing domains.

REFERENCES:1. Maj. General Barbara Holcomb, NC, US, Commander, U.S. Army Medical Research and Materiel Command, Comments at Military Health Services Research Symposium, August, 2017. https://health.mil/News/Articles/2017/08/28/Prolonged-Field-Care-the-New-Normal-says-Army-MRMC-Brass.Maj. General Holcomb stated, “Military leadership designated Prolonged Field Care in a Capability Needs Assessment as the number one capability gap across the Army…We need to adjust both the way we think and the way we execute…and we need to understand that the multi-domain battlefield of the future will not always offer optimal – or even desirable – casualty care scenarios.”

2. Mitchell, AE, Sivitz, LB, Black, RE, Institute of Medicine. “Infectious Diseases Diagnosed In US troops Who Served in the Persian Gulf War, Operation Enduring Freedom, or Operation Iraqi Freedom,” Gulf War and Health: Volume 5: Infectious Diseases. Washington, DC. The National Academies Press, 2007. See: https://www.nap.edu/read/11765/chapter/6?term=campy#72

3. John Ball, Chairman, National Academy of Science, Engineering, and Medicine, “Public Release of the Report of the Committee on Diagnostic Error in Health Care,” September 22, 2015, http://www.nationalacademies.org/hmd/Reports/2015/Improving-Diagnosis-in-Healthcare.aspx

4. Lawrence L. Weed, MD, “New Connections between Medical Knowledge and Patient Care,” BMJ 1997; 315:231. https://doi.org/10.1136/bmj.315.7102.231, 26 July 1997

5. FDA Mobile Medical Application Guidance, https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/default.htm

6. DFA Draft Guidance for Industry: Clinical and Patient Decision Support Software, December 8, 2017, https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM587819.pdf

KEYWORDS: Mobile Medical Application, Clinical and Patient Decision Support Software, No-Communications, Image Recognition, Machine Learning, Artificial Intelligence, Differential Diagnosis, Dermatology, Military Health System, Theater Operations

DHA182-002 TITLE: Extended Wear Deep-Fitting Noise Dosimeter

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop a deep fitting in-the-ear, extended-wear acoustically transparent dosimeter to accurately measure levels and amount of noise exposure near the ear drum.

DESCRIPTION: Military members are exposed to various levels of noise during routine and expeditionary operations. If the noise levels are deemed hazardous, personnel are enrolled in an occupational-based hearing conservation program (HCP) as mandated by the Department of Defense. (1) Hazardous noise levels are identified by measurements from a body-worn (shoulder-mounted) or near-ear (attached to pinna) dosimeters. Although this method is standard for identifying environments with hazardous noise, it does not give a true measurement of actual noise exposure to the service member at the tympanic membrane, because it relies on a mathematical-based transfer

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function to estimate actual exposure at the tympanic membrane. These dosimeters can provide inaccurate measurements for many reasons, to include the anatomy of the pinna and ear canal, head and body shadow effects, and environmental effects. (2) This standard method creates two specific problems in regards to calculating noise exposure for a service member:1) It limits the noise exposure assessment to an occupational work period. In some operational environments or deployed settings, exposures can be varying or ongoing and not defined to a specific duty shift. Further, it ignores off duty non-occupational exposures such as personal music players, motor vehicles, and recreational events.2) Regardless of the quality or type of dosimeter, actual noise exposure to the member is still an estimate, and can fluctuate by 10-15 dB based on resonant properties of the ear canal.

To most accurately measure actual noise exposure at the tympanic membrane, a deep fitting (past the second bend of the external auditory canal) in-the-ear dosimeter is needed. This type of device would eliminate the need to estimate noise exposure with a transfer function and would account for resonant properties of the ear canal. Extended wear would allow for true measurement of noise exposure during longer time periods and potential revision of damage risk criteria. This device would prevent interference from the member and/or environmental factors that typically impact noise measurements, and could be used in conjunction with the service member’s hearing protection devices (HPD) and/or personal music devices.

This device is not intended to replace traditional methods of dosimetry used to estimate hazardous noise environments in standard occupational settings. Instead, it will complement these methods by validating enrollment in the HCP, monitoring and assessing a service member’s compliance with HPDs, and quantifying the noise reduction characteristics of the HPD given the unique composition of the member’s outer ear system (pinna and ear canal). Further, the device will not require Food and Drug Administration (FDA) regulation. Currently, there are no FDA regulations for noise dosimeters as they do not meet the FDA definition of a medical device. The FDA defines a medical device as “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” (3) This device is solely a noise dosimeter utilized for measuring noise exposure and evaluating HPDs, and is not intended to treat disease or other medical conditions.

PHASE I: Phase I will focus on designing a prototype and determining the technical feasibility of creating a deep-fitting, acoustically transparent dosimeter that can accurately measure intermittent and steady state noise for at least a 72-hour period. Specific emphasis is necessary on identifying and overcoming known acoustic and calibration challenges with in-ear dosimetry to include Occluded Ear Canal resonance (OER), Transfer Function of the Open-Ear (TFOE) compared to both on-body and free-field measurements, variable calibration of the sensor for in-ear, on-body, and free-field data collection, and noise introduced by the user themselves, such as their own voice. (4) Phase I deliverable will be a functional prototype of the in-ear dosimeter, demonstrating the ability to measure noise deep in the ear canal. Specifically, the prototype will:

Demonstrate product dimensions and materials. Provide a detailed description on what data variables are collected and stored for analysis. Detailed description of associated peripheral hardware and software components for data analysis. Detailed description on how the device will temporarily store, then transmit data to the management

software. Estimated maximum battery life and product expiration. Demonstration of sound measurements to include bandwidth of detected frequencies and maximum decibel

levels prior to saturation. Estimated cost to produce the device. Description of the insertion and removal process to include applicable placement tools, including

descriptive options for emergency removal and/or disabling the device. Description of analog to digital processing methods to include sampling rate. Descriptive analysis on the susceptibility to environmental factors such as moisture, temperature, dust,

cerumen, and other biologic factors related to the nature of the human ear canal. Associated risks of wearing the device to include potential medical and/or security concerns. Detailed description on the components that allow the device to be acoustically transparent and methods to

overcome OER, TFOE, and calibration concerns.

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Device shall conform, but not be limited to, the dynamic range specified in ANSI S1.25 as identified by NIOSH and OSHA standards. (5) Prefer a dynamic range at or exceeding 70-140 dB.

PHASE II: Based on the product from Phase I, validate the functional, deep-fitting, in-the-ear dosimeter prototype. Specifically, the prototype should have the following attributes:

Specific insertion and removal tools to allow for proper deep placement in the ear canal by an audiologist or physician.

Capable of self-removal by the user in emergency situations, and/or by a field medic if user is incapacitated.

Battery life to allow continued use for a minimum of 72 hours. A non-occluding and stable design that will stay secured in the ear canal through normal everyday

activities, and be rugged enough to operate in industrial and occupational environments, including mild moisture exposure (e.g., showering, perspiration).

Must have a microphone sensitive enough to capture a broad band of frequencies (100 to 10,000 Hz) Must be able to download data to management software for storage and analysis either through a wired or

wireless option. Data must be longitudinal with time stamp to allow for analysis of specific periods of noise exposure

during a service member’s events, and allow for calculation of noise dose over varying periods of time. Device must be designed for one time use; be disposable, and remain comfortable and/or not noticeable to

the user. Must not be harmful to the wearer or have significant risk of damaging any portion of the ear. Be acoustically transparent (less than a 2 dB insertion loss) to minimize the influence of the device on

levels of sound within the ear canal. Show a consistent (plus/minus 2 dB) TFOE compared to both on-body and free-field measurement (in

noise environments of varied level and spectra) between frequency limits of 100 and 10,000 Hz for both steady state and intermittent noise.

PHASE III DUAL USE APPLICATIONS: Phase III will translate the prototype into a validated device that is available to all HCPs in the DoD and non-military populations. The device will have multiple military-specific, government, and commercial uses to include hearing conservation operations, total exposure/total worker health, as well as medical research on noise exposure. The device would be able to be used by the DoD in any operating environments with steady state noise, such as flight lines, ships, industrial shops, and transportation.

REFERENCES:1. Department of Defense Instruction 6055.12, Hearing Conservation Program, 3 Dec 2010. http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/605512p.pdf?ver=2017-10-25-110159-777

2. Smalt, C.J. et al., “Noise Dosimetry for Tactical Environments”, Hearing research, 2016, http://dx.doi.org/10.1016/j.heares.2016.11.008

3. “Is The Product A Medical Device? https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm

4. Bonnet, F., Voix, V., and Nelisse, H., “The Opportunities and Challenges of In-Ear Noise Dosimetry”, Canadian Acoustics, 2015, Vol 43. No. 3 https://jcaa.caa-aca.ca/index.php/jcaa/article/download/2803/pdf

5. DHHS (NIOSH) Publication No. 98–126, Occupational Noise Exposure.

KEYWORDS: acoustic, decibel, dosimeter, dosimetry, extended wear, frequency, hearing, hearing conservation, hearing injury, hearing loss, hearing protection, hearing protection device, in-the-ear, microphone, sound level meter, tinnitus, TWA, Time-Weighted Average

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DHA182-003 TITLE: Limb Cooling Device to Preserve Ischemic Extremity for Prolonged Field Care

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop a light-weight, small cube, field-ready limb cooling device capable of reducing limb temperature to 10-15°C for up to 24 hours

DESCRIPTION: A capability is sought to extend the duration that a tourniquet can be safely used on limbs following extremity vascular injury, this may include mangled and amputated limbs. The use of tourniquets during the wars in Iraq and Afghanistan has significantly improved survival rate for exsanguinating extremity injuries [1]. Currently under standard conditions, tourniquet safety is at least 2 hours, and possibly even up to 6 hours [2]. However, future operational scenarios include delayed evacuation of combat casualties, which could significantly extend the duration of tourniquet application and resulting ischemic injury. Technologies are needed to mitigate damage caused by long-term limb ischemia due to vascular injury and the use of tourniquets, as well as to mitigate the development of extremity compartment syndrome and reduce the development of rhabdomyolysis. Limb cooling has been shown to dramatically reduce local ischemic damage, systemic injury [3], and reduce the development of rhabdomyolysis as a result of severe muscle damage leading to multi-organ dysfunction or failure [4]. Successful completion of this project should result in a field-ready cooling device capable of rapid limb cooling and maintenance of a target temperature over a prolonged period.

PHASE I: Design/develop an innovative concept along with the limited testing of a prototype non-invasive device capable of reducing deep muscle temperature to between 10-15°C as rapidly as possible without causing superficial thermal damage, and to maintain deep muscle temperature within that range for at least 12 hours, assuming an ambient temperature of 20°C. Deep muscle temperature is operationally defined as the temperature of the muscle closest to the bone based on a reference human thigh with a diameter of 18.78 cm. It can also be assumed that there is no blood flow. The demonstration does not require live animal use but could be performed using limbs from large animal (ex-vivo) or appropriately sized physical model.

PHASE II: Required Phase II deliverables:1) Using results from Phase I, demonstrate the operation of a prototype in an ischemic hindlimb of a large animal in vivo. The DOD Directive 3216.1, dated April 17, 1995, provides policy and requirements for the use of animals in DOD-funded research.2) Based on the results from (1), construct and complete design suitable for use on a human upper and lower extremity.

The device must be portable, lightweight (<2 lbs), self-contained, power requirement is replenishable/rechargeable). A plan must be included for any device requiring the addition of coolant (e.g. water) or the disposal of any generated waste. The device should be configurable to accommodate upper or lower extremities and to allow easy access to injured limb for visual inspection and treatment, and be designed for easy reapplication. The Phase II commercialization plans should include a regulatory pathway for FDA clearance.

PHASE III DUAL USE APPLICATIONS: Transition prototype into a functional, field-ready limb cooling device to assist medics, physician’s assistants, nurses, and physicians in triage and management of casualties with extremity trauma in a far forward environment (role of care 1 and 2). The device should be of great commercial interest for all branches of the armed services as well as civilian pre-hospital first responders and mass casualty incident (MCI) response teams worldwide. The small business will need to work with the Air Force Medical Modernization Division, Air Mobility Command to develop an air worthiness/safe-to-fly testing plan. The small business should have in plans to secure funding from non-SBIR government sources and/or the private sector and a transition plan that will bridge the gap between laboratory-scale innovation and entry into a recognized Food and Drug Administration (FDA) regulatory pathway leading to commercialization of the prototype into a viable product for sale in the military and /or private sector markets.

REFERENCES:

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1. Eastridge, B.J., et al., “Death on the battlefield (2001-2011): implications for the future of combat casualty care.” J Trauma Acute Care Surg, 2012. 73(6 Suppl 5): S431-7. https://www.ncbi.nlm.nih.gov/pubmed/23192066

2. Drew, B., et al., Tourniquet Conversion: A Recommended Approach in the Prolonged Field Care Setting. J Spec Oper Med, 2015. 15(3): 81-5. https://www.ncbi.nlm.nih.gov/pubmed/26360360

3. Skjeldal, S., et al., Local hypothermia during ischemia or reperfusion in skeletal muscles. Res Exp Med (Berl), 1993. 193(2): 73-80. http://www.ncbi.nlm.nih.gov/pubmed/8516565

4. Peiris, D., A historical perspective on crush syndrome: the clinical application of its pathogenesis, established by the study of wartime crush injuries. J Clin Pathol, 2017. 70(4): 277-281. https://www.ncbi.nlm.nih.gov/pubmed/27920043

KEYWORDS: extremity trauma; vascular trauma; field-ready; tourniquet; hypothermia; ischemia; limb preservation; rhabdomyolysis

DHA182-004 TITLE: Identification of Open Globe Injuries on the Battlefield

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: To develop a test that can be administered by a medic at Role of Care (ROC) level 1 to easily detect the presence of a penetrating ocular injury.

DESCRIPTION: Ocular injuries sustained during combat have increased in recent wars from approximately 2% in WWI to almost 30% in Operations Iraqi Freedom and Enduring Freedom. Most recently, the number of blast injuries has increased due to the use of improvised explosive devices (IEDs) in the global theatre. In an article authored by Anton Vlasov et al., and published in the Journal of Trauma and Acute Care, noted that of members evacuated, “to Walter Reed Army Institute of Research (WRAIR) from 2001-2011, there were 206 open-globe and 56 closed globe injuries. Open globe Zone III injuries constituted 81.6% and were the number one cause of blindness to the Warfighters, and a majority of the injuries were caused by IEDs (64%).” The overall findings of this retrospective paper show that approximately one third of service members who experience an ocular trauma become legally blind. The article indicates that further research is needed to focus on strategies to diagnose, treat, and prevent ocular penetrating injuries.

Prolonged field care, and longer distances of evacuation will greatly increase the challenges of identifying, evacuating and treating open globe injuries. The US Army Medical Department (AMEDD) is asked to take hours to evacuate from the battlefield and days to receive ROC 2 level of treatment, whereas the first Forward Surgical Team (FST), or area support medical battalion may be readily available in a shorter time frame and thus able to provide more urgent triage capabilities. An open globe that is not identified and closed within 24 hours has a significantly elevated risk of infection that can result in devastating vision loss. Additionally an undiagnosed open globe can result in the immune system being sensitized to the retina antigens resulting in sympathetic ophthalmia, a debilitating inflammatory disease that can cause blindness in the uninjured. In the event of prolonged field care the onus of identifying injured eyes falls on the field medic. Since greater than 70% of the open globes are associated with other significant systemic traumatic injuries, which will divide a medics time and concentration, a quick method of identifying open globes is paramount. Unfortunately, an easy method of identifying Warfighters with ocular penetrating injuries has yet to be addressed. Even in the hands of an experienced ocular surgeon in a hospital setting, it can be difficult to identify an injury that has fully penetrated the globe. Often cases in which an open globe are suspected but cannot not be definitively proven must be taken to the operating room for exploratory surgery to determine if an open globe is present. During a mass casualty situation taking soldiers to the operating room to confirm the presence or absence of an open globe takes time and resources better used for treating actual globe injuries. As a result, a rapid test is needed to determine if the eye is intact to allow for appropriate triage, evacuation,

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and subsequent vision saving treatment.

PHASE I: The desired device should identify key molecular elements specific only to the vitreous and aqueous humor that can easily be tested for in the conjunctival sac. Because injured soldiers often guard their injuries and will not readily open their eyes, an inexperienced medic could cause more trauma by employing a difficult test. Consequently, a test that could sample fluid on the eyelashes is imperative. The design requirements are as follows: non-bulky, inexpensive, simple, and lightweight. It must be stable enough to be used in a deployed environment and applied easily by a medic in stressful situations. As a result, a one-step test is a requirement. It is essential that the mixing of reagents for the test not be required. Shelf life, durability and ease of use must be considered in the design. Given that up to 30% of injured soldiers must be tested, the test must have high accuracy > 95% and high sensitivity to minimize false positive and negatives.

PHASE II: The ocular wound test kit will be fully developed into a functional prototype. Based on Phase I results, Phase II work will test, optimize, and validate the open globe test kit in at least one animal model of globe trauma and validate its efficacy. The device is required to test for penetrating wounds of 1-3mm that enter the sclera and/or limbus. The FDA approval pathway will be outlined and considered at each developmental stage. Parameters including ease of use, overall dimension, stability across a wide range of field conditions, sensitivity and specificity, and extended shelf life will be defined. Validation of efficacy will be determined through animal models, slit lamp photography, and/or other appropriate measures. Clinical experts with insight into ocular trauma and relevant patient populations should be consulted during optimization and animal validation. Potential commercial and clinical partners for Phase III and beyond should be identified, and a detailed explanation should be provided for how the small business will obtain a monetary return on investment within two years of completion of Phase II (e.g., sales, licensing agreements, venture capital, non-SBIR grants.)

PHASE III DUAL USE APPLICATIONS: During Phase III, additional experiments will be performed as necessary to prepare for FDA review of an IND application. It is required that this device to commercialized and made available to the military. A plan for protection of intellectual property will be created and executed. A detailed market analysis will be conducted, an initial application for the test kit will be selected, and a Phase I clinical trial will be initiated. The test kit will be made available to the military to forward deployed medics, FSTs, and Combat Support Hospitals (CSH) as a diagnostic tool for military personnel who suffer from globe trauma as a result of blasts or other battlefield or service-related injuries. This kit will mitigate vision loss by improving the accuracy of diagnosis, and allowing more efficient use of medical resources in the operative theatre and for the evacuation of personnel which can be quite expensive. Health professionals, at all levels of the medical treatment down to and including emergency medical technicians worldwide could utilize this test kit as a diagnostic test to verify the presence of a significant globe injury.

REFERENCES:1. Allen Thatch, et al. (2008). Severe Eye Injuries in the War in Iraq 2003-2005. Ophthalmology. 115 (2): 377-382.

2. Cockerham GCce TA, Hewes EH, Co, Rickerham KP, Lemke S, Wang G, Lin RC, Glynn-Milley C, Zumhagen L. (2011). Closed-eye ocular injuries in the Iraq and Afghanistan wars. N Engl J Med. Jun 2;364(22): 2172-3.

3. Mader, T. (2015). Combat Wounds in Operation Iraqi Freedom and Operation Enduring Freedom. Journal of Trauma and Acute Care Surgery. 79(4): S210-S215.

4. Owens, B. (2008). Combat Wounds in Operation Iraqi Freedom and Operation Enduring Freedom. The Journal of TRAUMA Injury, Infection, and Critical Care. 64: 295-299.

5. Queiroz de Paiva, A. R., Abreu de Azevedo Fraga, L., & Torres, V. L. L. (2016). Surgical Reconstruction of Ocular Surface Tumors Using Fibrin Sealant Tissue Adhesive. Ocular Oncology and Pathology, 2(4), 207–211.

6. Reema, A. (2017). Ex vivo Model for the Characterization and Identification of Drywall Intraocular Foreign Bodies on Computed Tomography. Retina, The Journal of Retinal and Vitreous Diseases. 0:1-4.

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7. Uy, Harvey S. et al. (2013). Surgical outcomes after application of a liquid adhesive ocular bandage to clear corneal incisions during cataract surgery. Journal of Cataract & Refractive Surgery. 39 (11): 1668-1674.

8. Vlasov, Anton DO; Ryan, Denise S. MS; Ludlow, Spencer MD; et al. (2015). Causes of combat ocular trauma-related blindness from Operation Iraqi Freedom and Enduring Freedom. Journal of Trauma and Acute Care Surgery. 79 (4): S210-S215.

KEYWORDS: Open, Globe, Penetrating, Ocular, Wound, Leaking, Aqueous, Vitreous

DHA182-005 TITLE: Development of an Individualized Portable Platform to Deliver Vestibular Rehabilitation

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: To develop a customizable clinic module to assist with vestibular rehabilitation program development using technology to improve efficiency of care delivered to service members, 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 and is typically initiated and progressed by a skilled rehabilitation provider (physical therapist and/or occupational therapist with advanced training in vestibular pathology and rehabilitation). Patients with dizziness are evaluated by ENT and/or audiologists and referred to physical therapy for treatment. Often times, limitations within the Military Health System delays treatment due to access to care by a skilled physical therapist within the DoD. This lack or delay in care may negatively impact the service member by prolonging symptoms, delaying return to duty and increasing potential for secondary psychosomatic symptoms and increased perceived disability.

This goal of this project is to develop a computerized technology module that would allow a clinician or technician in ENT and/or audiology to properly provide patient treatment protocols over basic vestibular exercises to hasten commencement of vestibular rehabilitation. Develop machine learning algorithms, and individualized health technology to develop an easy-to-operate platform that encourages increasing adherence to treatment programs on the patient side and easy-to-interpret patient-compliance reports on the clinician side.

This module would then be used by the rehabilitation provider to further develop and progress the patient through rehabilitation to return to duty. The program would allow for development of a customized individual exercise program based on results of performance on common vestibular testing performed in the audiology lab. The overall objective of this project is to develop a portable and customizable platform to deliver vestibular rehabilitation using software, sensor and gaming technology. Specifically, to develop a more interactive rehabilitation solution that will improve compliance. Ideally, the program will have remote access capabilities to allow for communication and collaboration between health care providers even if not located in the same healthcare facility. This may also allow for telehealth consultation if a specialist provider is not available locally.

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 the ability to assess common components guiding vestibular rehabilitation. This includes detecting speed of head motion, speed of eye motion, accuracy of eye movements, cues to the patient regarding

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performance (visual and/or auditory), gait analysis, the ability to provide meaningful information to the clinician regarding patient performance (including symptom response), the ability to alter complexity of exercises using variables such as speed, visual complexity, and support surface (seated, standing with altered foot position, use of compliant surfaces). This phase will focus on the development of a tool that adds value to the patient and the referring clinician and can speed access to care for the service member.

PHASE II: In Phase II, to produce the porotype platform for implementation of vestibular rehabilitation. Provide beta testing with guidance of a physical therapist. The focus will be on using this tool clinically. The provider at point of entry (ENT technician, audiologist, or potentially a rehabilitation provider) will use the tool to initiate vestibular training in the clinical environment. The theory is that with enhanced, guided instruction in the clinical setting, the patient may have a better understanding of how to properly perform these exercises at home. This tool will be utilized in DoD clinics to improve clinical outcomes in vestibular rehabilitation. During this phase, patient outcomes will be tracked and compared to typical performance of patients in vestibular rehabilitation without this technology. Phase II will establish the process of FDA governance process if required. The organization will engage the FDA to establish procedures for approval. Additional programming may be explored to allow for software to facilitate vestibular evaluation components (record eye movements, record balance, etc.).

PHASE III DUAL USE APPLICATIONS: Phase III will focus on evaluating the utility to integrate this technology to develop vestibular rehabilitation programs for all patients in the military as well as the civilian population. Dizziness in the civilian sector is also quite common and the same barriers to successful rehabilitation exist in the civilian world. The goal of this phase will be to transition the product to the general population to reduce the burden of dizziness on activities of daily living, life and job roles for all individuals.

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

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 Jan-Feb;24(1):14-23

3. Whitney SL, Alghadir AH, Anwer S. Recent Evidence About the Effectiveness of Vestibular Rehabilitation. Curr Treat Options Neurol. 2016 Mar;18(3):13.

KEYWORDS: VOR exercise, mTBI, Adaptation, Concussion, Vestibular Rehabilitation

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