OUSD (R&E) MODERNIZATION PRIORITY: General Warfighting Requirements (GWR) TECHNOLOGY AREA(S): Bio Medical OBJECTIVE: Develop and validate a technology solution for the early detection and monitoring of wound infections in a prolonged care setting. The technology must improve upon the current ability to identify a wound infection. The end goal is to detect infections early and inform wound infection treatment as early as possible in order to ensure the most positive patient outcome. DESCRIPTION: The future conflicts anticipates division-on-division combat operations with causality volumes and medical intervention times that mirror what was observed in WWI and WWII. When Soldiers suffer from polytraumatic wounds commonly associated with blast injury include, severe blood loss, polymicrobial infections, a number of physiological, neurological and metabolic changes that are poorly understood or tracked. Moreover, these changes significantly increase susceptibility to infection and alter how the body metabolizes antibiotics, resulting in less than optimal treatments. Another compounding problem is that multiple microorganisms (ESKAPEE & other bacteria, fungi) involved in these combat wound infections exhibit complex pathogenesis and are becoming more and more resistant to multiple, sometimes all, antibiotics through various mechanisms. This scenario becomes more complex in these conflicts, where the deployment of anti-access and area denial (A2AD) technologies will not only limit evacuation to degrade the Golden Hour timeline for medical support but also constrain medical resupply, leaving wounded Warfighters and first line medical support providers stranded in prolonged care (PC) scenarios for unknown durations. Furthermore, repeated mass casualty events will create greater dependency on PC (limited resources while being mobile) increasing the number of deaths from wounds as infection rate rise within 72hrs among wounded Warfighters. PC leads to the perfect storm involving; deranged combat physiology, empiric treatment, increasing resistant of infectious agents, and delayed surgical debridement. An obvious opportunity here is for innovative solutions that are massively scalable and distributive (i.e. affordable and for all combatants) focused on amplifying self/ buddy care (i.e. fire and forget solutions that enables less supply to be carried for longer duration) is the Army's IFAK (Improved First-Aid Kit) or rucksack ready rapid diagnostics tool. This topic explores the development of a device not only as an infection detection tool but also an infection monitoring device capable of identifying clinically relevant aspects of an infection such as Gram status, fungi or bacteria to inform treatment, return to duty, and triage decisions. The ultimate goal of the technology in this request is, but not limited to, to detect a pathogenic organism that could or is currently leading to an infection in or around the wound bed starting at the earliest time possible after injury to include Role 1 care and continue to provide information throughout the continuum of care. In doing so, this convergent technology should detect infection development and inform subsequent treatment choices at various stages of care as well capture transitions in infections, which are leading cause of failed treatment outcomes such as sepsis (i.e. continued treatment of untreatable infection due to the emergent multi-drug resistance). Thus the flexible concept of use is to provide continuous monitoring of wound infections either directly on the injury (on skin, on bandage,..etc.) or within proximity of injury (within uniform, hyperthermia bag, etc.) The aim of this SBIR is to develop a technology with commercial viability that addresses infection detection, but not limited to, sensors, detectors, or emissions (i.e. small molecule-based, photonics, isotopes, chemical reactivity, monoclonal antibodies, and/or bacteriophage) for the purpose of early detection of wound infections. This request will not accept wound dressings in any form. The technology is not limited to but should consider, the factors below: The technology must include a plan for FDA or equivalent device clearance Detection and monitoring of infection via built-in electrical sensors, VOC sniffers, chemicaldetector, photonics ...etc. must be light weight with minimal user training Ease of use technology (simple readout with minimal interpretation) should be operable withlittle training or background with unambiguous primary output (readout may include LED, LCD,colorimetric, digital, or other uncomplicated readout to include wirelessly communicating todevices and telemedicine tools) Contactless and physically applied devices will both be considered provided either approach isdeemed viable and practical (for instance solutions that need skin contact should considersterility of product prior to application and consider packaging requirement) Technology should have the ability at minimum to distinguish between Gram+ and Gram- bacteria as well as fungi as agents of infection Proposal should describe and discuss a miniaturization, ruggedization, re-usability (if any)plan to include minimal logistical support Modular designs with an ability to be incorporated to already existing sets and kits (IFAK,Medic rucksack, CLS components...etc.) are preferred. Designs must have a manual fail-safe backup option if motorized or automated designs areused as an active component Technology should be capable of at least 72 hours of continuous usage without recharge,replacement, or exchange Dimensions should not exceed that of a credit card with less than a 0.25 inch thickness Ease of applications, ability to withstand water, high positive and negative pressures, hot andcold temperatures and minimal storage conditions will be factored in the nomination process Engineering solutions overall should require minimum logistical support and should becompatible with applications in extreme environments including hot and cold temperature) PHASE I: Given the short duration of Phase I and the high order of technology integration required, Phase I should focus on system design and development of proof-of-concept prototypes that address the detection requirement. Proposals may include early versions detections systems that may combine classes of applications into different sets of designs. At the end of this phase, fabricated prototypes should demonstrate feasibility, proof-of-concept and establish reasonable qualitative infection signal detection, using relevant testing platforms for the proposed technology. This phase should down-select promising design as well as identify a pre-clinical animal model for use in Phase II. Evaluation of the product's durability for detecting infection with several select organisms and should include data for the first 6, 24, 48, and 72 hours at a minimum, if not longer. The above time points do not represent system application on subjects but used as a bench mark and quantify efficacy of detection of infection in the wound bed. Parameters used for measurements, such as targets, as well as quantification limits should be adequately described. PHASE II: During this phase, the lead integrated system should be further refined from proof-of-concept into a viable prototype. Further optimization of the technology for earlier and more robust detection of infection at traumatized wound bed should demonstrated during this phase. Qualitative and quantitative outcomes of product with regards to quantification of CFU/ml, identification of invading organism, and/or characteristics of invading organisms such as gram stain, catalase reactivity, antibiotic resistance...etc in a diverse inoculum, preferably ESKAPEE pathogens and combat relevant fungi . This testing should be controlled and rigorous conditions. Product miniaturization should achieve desirable dimensions and weight. Testing and evaluation of the fieldable prototype shall demonstrate operational effectiveness in simulated environments. Price estimate and comparison analysis for new design relative current fielded equipment and treatment shall be provided to forecast the potential cost of product and commercial viability. The offeror shall articulate the regulatory strategy and provide a clear plan on how FDA clearance will be obtained. Offeror may also consider a pre-pre-submission communication with the FDA as an early communication for guidance. PHASE III DUAL USE APPLICATIONS: The ultimate goal of this phase is to secure FDA submission by developing partnerships to demonstrate and commercialize a technology enabling the detection of infection in prolonged care situations such as post-surgery wound monitoring in elder care situations with the proper regulatory clearance or authorization for human or Department of Defense use exemption. The global market for elder care services is worth over 900 billion dollars and is expected to grow significantly in the future. Appropriate partnerships to advance the technology above is encouraged. Alternatively, further development, testing and evaluation of monitoring or diagnostic product developed by phase II of this SBIR can be supported by CDMRP, JWMRP, and other DOD opportunities. Accompanying application instructions, simplified procedures, and training materials should be drafted in a multimedia format for use and integration of the product into market. Once developed and demonstrated, the technology can be used both commercially in civilian or military settings to save lives. The selected contractor shall make this product available to potential military and civilian users. REFERENCES: 1. Murray, C. K. (2017). "Field Wound Care: Prophylactic Antibiotics." Wilderness Environ Med 28(2S): S90-S102. Tribble, D. R., et al. (2015). "Environmental Factors Related to Fungal Wound Contamination after Combat Trauma in Afghanistan, 2009-2011." Emerg Infect Dis 21(10): 1759-1769. Zion Market Research. Elder Care Services Market - Global Industry Analysis. Elder Care Services Market - Latest Industry Insights, Growth Analysis Forecast 2020 2026, 21 Sept. 2020, https://www.zionmarketresearch.com/report/elder-care-services-market. Benov A, et al. Antibiotic treatment-what can be learned from point of injury experience. Mil Med 2018;183: 466 471 U.S. Army. TRADOC. First Aid (TC 4-02.1) 01/21/2016 KEYWORDS: infection detection, wearable, sensors, diagnosis, monitoring, trauma, prolonged care
