OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Military Operational Medicine OBJECTIVE: This open topic is intended for technology proven ready to move directly into Phase II and is accepting Direct to Phase II proposals only. This SBIR topic seeks innovative solutions to monitor ocular injuries in pre, during and post care in real-time and/or infection development, ensuring that military personnel receive timely and effective care in the field and throughout the echelons of care. DESCRIPTION: Large-scale combat operations of the future involving division-on-division combats promise high casualty volumes with medical intervention times that mirror WWI and WWII. As a result, the delay in evacuation either on ground or sea will limit rear echelon medical support and resupply, leaving the wounded warfighter with limited options for advanced care for an extended time. Provided eye-maxillofacial and neck (EMFN) injuries accounted 30- 36% of injuries depending on studies, massively scalable and distributive affordable solution are essential to improve care starting from point of injury to hospital care. Furthermore, any technology that amplifies the impact of medical care and efficiency of decision making is transformative for EMFN injuries particularly for the prevention of eye loss. Furthermore, military personnel are frequently exposed to environments where eye injuries are prevalent, directly affecting combat readiness and effectiveness with minimal return-to-duty options since these injuries often lead to severe conditions that lower the quality of life of survivors significantly. Common ocular injuries in military settings account up to 13% of all injuries and include corneal abrasions, chemical burns, penetrating eye injuries, and blast injuries, all of which may be complicated by secondary infections. While immediate care is essential for the prevention of eye loss, following the progression of disease, and monitoring for infections without disturbing the injured eye observations critical for the effective treatment and management of these injuries to prevent long-term vision impairment or loss. The goal of this SBIR initiative is to develop a mobile real time system for monitoring the injured eye post the provision of care without the need for disturbing the dressing system. Such goal can be achieved by continuously assessing the injury for real-time feedback on the status of the injuries and/or infections. The system should be compact, durable, and easy to use both by civilian or military medical personnel including first responders starting from point of injury, transport, definitive care, and hospital care. The technology is not limited to, but may consider the factors below: Detection or monitoring of the injury and/or infection development may include electrical sensors, VOC sniffers, chemical detectors, as well as optical sensors and photonics technologies or any combination thereof. PHASE I: This topic is intended for technology proven ready to move directly into Phase II. Therefore, the offeror shall provide detail and documentation which demonstrates the accomplishment of a "Phase I like" effort, including a feasibility study that demonstrate and determine the scientific and technical of the proposed product. This include but not limited to Proposed design is wearable and has real-time monitoring of the ocular injuries and/or the secondary infections. Share the outcome of the technical testing and evaluation effort, including initial performance specifications, bill of materials, and use case analysis. Design specifications for the protype PHASE II: This phase will focus on integration and assembly of an advanced prototype for pre-clinical testing and evaluation of the most promising design. Further optimization of the technology for robust detection of changes in the injury, detection of infections, user operation features are expected. The testing should be under controlled and rigorous conditions. This may include: Develop a proof-of-concept prototype demonstrating the ability to detect biomarkers of specified ocular injuries and/or the presence of organisms, color changes in real time arising from relevant to the injuries and/or the secondary infections using in vitro system. Engage with military medical experts to refine the design and ensure the system meets operational needs. Conduct pre-clinical testing to validate the system's performance in detecting and diagnosing ocular injuries and/or infections in animal models. Collect solid evidence supporting the system's precision, accuracy, reliability, (i.e. sensitivity, specificity, NPV, PPV) and usability (i.e. customer survey or user input from a medic or first-responder). Product miniaturization to desirable dimensions. Technology should be light weight, miniaturized, single use, simple interface, and minimal user training (minimal interpretation and unambiguous output) for end users. For products intended for military medical sets and kits, dimensions should not exceed 3 inches in diameter and 0.25 inches in thickness. Adhesive use is optional but must comply with biocompatibility and safety standard for use in humans. Ease of application, ability to withstand water, high positive and negative pressures, hot and cold temperatures must be described. Address any technical issues identified during Phase I and refine the system to enhance its diagnostic capabilities. The offeror should consider early interactions through Q-submission (Q-SUB) process with FDA for guidance on planned pre-clinical testing. The offeror should provide a comprehensive regulatory strategy outlining details of proposed pre-clinical & pivotal testing along with specific regulatory plans. The end result of this phase should be a prototype system that can consistently deliver accurate results, maintain reliability over extended periods, and be easily used by military personnel in real-world scenarios. This evidence is essential for gaining confidence in the system's potential and for supporting its transition to Phase III. PHASE III DUAL USE APPLICATIONS: This phase will focus on developing a final, market-ready product through rigorous clinical studies and trials to validate the system's effectiveness and safety in monitoring ocular injuries. During this phase, a follow up Q-sub meeting to align with FDA requirements from both validation studies and market authorization perspectives should be considered. The offeror should also consider performing QMS assessment of selected industry partner to assure a robust quality system or plan is in place. This phase is critical as it transitions the prototype from an advanced development stage to a fully vetted product ready for real-world use. Refine the development of a commercialization plan that may include development of different pathways, including both military and private sectors. This product should be applicable to a broad spectrum of civilian use markets, from first responder to youth sport applications. In addition, the work may result in technology transition to Acquisition Program managers within DoD. These efforts will be crucial in turning the prototype into a commercially viable product that can be rapidly deployed in military operations. Clinical studies should be planned thoroughly evaluate the system's performance across a broad spectrum of conditions and patient profiles. The goal is to demonstrate that the system can reliably and accurately diagnose ocular injuries in a variety of settings, ensuring that it meets the highest standards of safety and effectiveness before being introduced to the market. Accompanying applications, instructions, simplified training materials should be drafted in a multimedia format here as part of market readiness. REFERENCES: 1. Eric D Weichel , Marcus H Colyer. Combat ocular trauma and systemic injury. Curr Opin Ophthalmol. 2008 Nov;19(6):519-25. 2. Harvey MM, Justin GA, Brooks DI, Ryan DS, Weichel ED, Colyer MH. Ocular Trauma in Operation Iraqi Freedom and Operation Enduring Freedom from 2001 to 2011: A Bayesian Network Analysis. Ophthalmic Epidemiol. 2021 Aug;28(4):312-321. 3. Christian I Wade , Todd D Whitescarver ,Cody R Ashcroft , Samuel D Hobbs, Boonkit Purt , Ashvini K Reddy, Marcus H Colyer, Grant A Justin . Endophthalmitis: a bibliographic review. Int Ophthalmol. 2021 Dec;41(12):4151-4161. 4. Erika Ponzini . Tear biomarkers. Adv Clin Chem. 2024:120:69-115. 5. Jayoung Kim , Alan S Campbell, Berta Esteban-Fern ndez de vila , Joseph Wang. Wearable biosensors for healthcare monitoring. Nat Biotechnol. 2019 Apr;37(4):389-406. 6. Petersen K, Colyer MH, Hayes DK, Hale RG, Bell RB; Prevention of Combat-Relatd Infetions Guidelines Panel. Prevention of infections associated with combat-related eye, maxillofacial, and neck injuries. J Trauma. 2011 Aug; 71 ( 2 suppl 2): S264-0. Doi:10.1097/TA.0b013e318227ad9a. PMIID: 21814092. KEYWORDS: Military ocular injuries, diagnostic, real time, direct sampling from the eye, portable diagnostics, rapid diagnostics, wearable technology, filed diagnostics, biomarker detection, eye injury detection, advanced prototyping
