Defense health program (dhp) 16. 1 Small Business Innovation Research (sbir) Proposal Submission Instructions



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DEFENSE HEALTH PROGRAM (DHP)

16.1 Small Business Innovation Research (SBIR)

Proposal Submission Instructions

The DHP SBIR Program seeks small businesses with strong research and development capabilities to pursue and commercialize medical technologies.


Solicitation, topic, and general questions regarding the SBIR Program should be addressed according to the DoD Program Solicitation. For technical questions about the topic during the pre-release period, contact the Topic Authors listed for each topic in the Solicitation. To obtain answers to technical questions during the formal Solicitation period, visit https://sbir.defensebusiness.org/sitis.
PHASE I PROPOSAL SUBMISSION
Follow the instructions in the DoD Program Solicitation at http://www.acq.osd.mil/osbp/sbir/solicitations/index.shtml for program requirements and proposal submission.
SBIR Phase I Proposals have four Volumes: Proposal Cover Sheets, 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 include blank pages, duplicate the electronically generated cover pages 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 you 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 solicitation must complete the Cost Volume using the on-line form, within a total cost of $150,000 over a period of up to six months.
The DHP SBIR Program will evaluate and select Phase I proposals using the evaluation criteria in Section 6.0 of the DoD Program Solicitation. Due to limited funding, the DHP 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 solicitation, 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
Beginning with SBIR Phase II’s resulting from a 13.1 Phase I award, invitations are no longer required.
All Phase I awardees from this Solicitation will be allowed to submit an initial Phase II proposal for evaluation and selection. The details on the due date, content, and submission requirements of the initial Phase II proposal will be provided by the DHP SBIR Program Office either in the Phase I award or by subsequent notification. All SBIR Phase II awards made on topics from solicitations prior to FY13 will be conducted in accordance with the procedures specified in those solicitations.
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).
Section 4(b)(1)(ii) of the SBIR Policy Directive permits the Department of Defense and by extension the DHP SBIR Program, during fiscal years 2012 through 2017, to issue a Phase II award to a small business concern that did not receive a Phase I award for that Research/Research & Development. The DHP SBIR Program will NOT be exercising this authority for Phase II awards. In order for any small business firm to receive a Phase II award, the firm must be a recipient of a Phase I award under that topic.
The DHP SBIR Program will evaluate and select Phase II proposals using the evaluation criteria in Section 8.0 of the DoD Program Solicitation. Due to limited funding, the DHP 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. DHP 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.

 

DHP SBIR Phase II Proposals have four Volumes: Proposal Cover Sheets, Technical Volume, Cost Volume and Company Commercialization Report. The Technical Volume has a 40-page limit including: table of contents, pages intentionally left blank, references, letters of support, appendices, technical portions of subcontract documents (e.g., statements of work and resumes) and any attachments. Do not include blank pages, duplicate the electronically generated cover pages 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 40th 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.
DISCRETIONARY TECHNICAL ASSISTANCE
In accordance with section 9(q) of the Small Business Act (15 U.S.C. 638(q)), the DHP SBIR Program will provide technical assistance services to small businesses engaged in SBIR projects through a network of scientists and engineers engaged in a wide range of technologies. The objective of this effort is to increase DHP SBIR technology transition and commercialization success thereby accelerating the fielding of capabilities to Soldiers and to benefit the nation through stimulated technological innovation, improved manufacturing capability, and increased competition, productivity, and economic growth.
The DHP SBIR Program has a Technical Assistance Advocate (TAA) available to provide technical assistance to small businesses that receive Phase I and Phase II contracts. As noted in Section 4.22 of this solicitation, firms may request technical assistance from sources other than those provided by the DHP SBIR Program. All such requests must be made in accordance with the instructions in Section 4.22. PLEASE NOTE: If approved for discretionary technical assistance from an outside source, the firm will not be eligible for the DHP’s Technical Assistance Advocate support.
PHASE II ENHANCEMENTS
The DHP 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 Phase II DHP SBIR contract to be extended for up to one year per Phase II Enhancement application, to perform additional research and development. Phase II Enhancement matching funds will be provided on a one-for-one 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.
RESEARCH INVOLVING ANIMAL OR HUMAN SUBJECTS
The DHP SBIR Program discourages offerors from proposing to conduct Human or Animal Subject Research during Phase I due to the significant lead time required to prepare the documentation and obtain approval, which will delay the Phase I 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.
FOREIGN NATIONALS
If the offeror proposes to use a foreign national(s) [any person who is NOT a citizen or national of the United States, a lawful permanent resident, or a protected individual as defined by 8 U.S.C. 1324b (a)(3) – refer to Section 3.5 of this solicitation for definitions of “lawful permanent resident” and “protected individual”] as key personnel, they must be clearly identified. For foreign nationals, you must provide country of origin, the type of visa or work permit under which they are performing and an explanation of their anticipated level of involvement on this project. Please ensure no Privacy Act information is included in this submittal.

DHP SBIR 16.1 Topic Index



DHP16-001

Warrior Health Avatar

DHP16-002

Severe Trauma Female Simulation Training System

DHP16-003

Value Based Monitoring of Cycles of Care

DHP16-004

Automated Vision Tester Technology Development for Aircrew Clinical Vision Screening

DHP16-005

Iron Status Determination Point-of-Care Device

DHP16-006

Diagnostic Device for Detecting Biomarkers of Early Multiorgan Injury in Saliva

DHP16-007

Creating Sterile Water for Injection (SWFI) at/near Point of Injury (POI)

DHP16-008

Selective Brain Cooling for Traumatic Brain Injury

DHP16-009

Selective Aortic Arch Perfusion Technologies for Hemorrhage-induced Cardiac Arrest

DHP16-010

Filtration Technologies for Bridge Dialysis in Austere Medicine

DHP16-011

Device to Prevent Retained Hemothorax

DHP16-012

Genitourinary Tissue Repair, Restoration and Protection: Preserving Fertility and Function in Wounded Warriors


DHP SBIR 16.1 Topic Descriptions



DHP16-001

TITLE: Warrior Health Avatar

TECHNOLOGY AREA(S): Biomedical

OBJECTIVE: Develop and demonstrate a simulation framework and physiology based modeling tools of a warfighter body that could enable definite assessment of his/her health status, physical and physiological performance, and injury trajectory by both the user and medical personnel using mobile computing platforms.

DESCRIPTION: The experience of recent military conflicts indicates that highly trained medical personnel and combat casualty care physicians, at all levels in the theater, from the far-forward to field hospital to rehabilitation centers, are able to save lives of wounded soldiers at unprecedented rates. However, evolving asymmetric threats and smaller, more disperse military operations may not have the advantage of the organized logistics and casualty care systems and will rely on self- and buddy-care. As the U.S. Military’s medical training requirements continue to increase in scope and complexity the resources, including time, manpower, and funding, are becoming limited [CBO 2014]. Therefore, new medical technologies are needed to advance warfighter medical skills in primary and combat casualty care. In the last few years, remarkable progress has been achieved in personalized medicine, wearable physiological and activity sensors, mobile computing, bioinformatics and computational medicine. All of these technologies could be integrated in an advanced platform, a Warrior Health Avatar, to support growing demands for preventive and primary medical military health care as well as acute and combat trauma care.

In spite of spectacular progress in wearable, non-invasive biomedical sensor technology, which can collect large amount of physiological, physical activity and environmental data, there are no established methods to utilize that data in a predictive fashion [Friedl 2007]. Typical physiological sensor data processing algorithms involve data mining and stochastic correlations which have limited predictive capability. A fundamental, physiology based, “personalizable” mathematical model of a human body, calibrated on broad range of physiological and clinical data, could provide the predictive capability of human body responses to various stimuli and stressors such a physical exercise, surrounding environment or injury.

Personalized medicine is becoming the cornerstone of medical practice with prospects of the customization of healthcare - with medical decisions, practices, treatments tailored to the individual patient [Katsanis 2008, Snyderman 2012]. The use of genetic information and biomarkers has played a major role in personalized medicine in oncology and other chronic diseases such as asthma and diabetes [FDA 2013]. Effective deployment of personalized medicine is still limited by the diagnostic technology and limited capabilities of computational systems physiology and biology [Xie 2014, Reifman 2010]. The goal of this solicitation is to develop a simulation framework and physiology based modeling tools of a warfighter body that could enable definite assessment of his/her health status, physical and physiological performance as well as body responses to various injuries including blast wave, ballistic and blunt impact. For the model to be functional in military health care it should account for the subject specific body parameters such as gender, anthropometry, physical fitness, physiological vitals as well as other parameters used in contemporary personalized medicine. Because of its potential complexity the models and software tool could be first developed on conventional computers. However, the ultimate goal is to transition this technology to mobile computing platforms for the use by military medics and individual warfighters in the form of a Warrior Health Avatar. For this Avatar to be successful, it must be not only personal but also predictive, preventive, and participatory (P4) [Hood 2011]. Therefore, the simulation framework and the user interface in particular, should be designed to demonstrate the capability to address the above P4 requirements and provide military medicine functionality such as:


• Visual setup of the human body anthropometric parameters and basic physiological vitals,
• Simulate one selected human body physiological system (e.g., cardiovascular, respiratory) and its response to various stressors and activities,
• Simulate human body physiological responses to various injury patterns,
• Enable model calibration on patient specific parameters and vitals,
• Facilitate dynamic correlation between the physiological parameters collected from wearable sensors and the mathematical model parameters. Be portable to desktop and mobile computing systems,
• Provide user specific (medic, warrior, and scientist) graphical interface for model setup, execution, dynamic adjustment of parameters, interface to wearable sensors and analysis of results.

Development and deployment of such a framework will require collaboration between private, academia, and government teams and may have to accommodate both open source and commercial software components. There are several ongoing programs in the US, Europe, and worldwide developing open source tools for various aspects of personalized medicine including genomics, (e.g., OncoBlocks, http://bcb.dfci.harvard.edu/~cerami/gsoc.html for cancer genetics or BioGears for computational physiology https://www.biogearsengine.com/). Therefore it is envisioned that this project will establish a commercializable research engine that starts with the integration of open source/open access components but adds specific predictive algorithms and modules.

PHASE I: Formulate and design the Warrior Health Avatar simulation framework, its key functionalities, main components, communication with wearable sensors and the user interface. Select/develop software tools for modeling human body physiology, performance and injury in military related applications. Develop and demonstrate prototype tools on selected desktop and mobile computing platforms. Identify open source tools, framework, and models developed by academia and/or government that could be utilized in this effort. Prepare the Phase I final report describing details of the proposed simulation framework, preliminary results of relevant military applications, and rationale for further model development, validation and military deployment.

PHASE II: Develop and demonstrate a functional prototype of the Warrior Health Avatar. Develop interfaces to existing human anatomical, physiological and injury databases and models to enable model personalization and calibration. Validate model components on available experimental and clinical data. Develop direct interfaces to select at minimum one “off the shelf” sensor modality, such as physical activity, environmental, physiological, nutrition, etc. Demonstrate the capability of model calibration on static and dynamic wearable sensor data. Demonstrate the prototype Warrior Health Avatar to military medicine stakeholders.

PHASE III DUAL USE APPLICATIONS: The Warrior Health Avatar will have immense potential application in military, veteran and civilian medicine. Successful proposers should envision the transition of this technology into military health system supporting warfighters from enlistment, to service, to discharge to the veteran system. The target military users should include both military medics and individual warfighters. Interfaces to military physiological and injury wearable sensor and monitoring systems should be pursued. Ultimately the Warrior Health Avatar could become a ubiquitous through the US Military. The technology developed in this SBIR project could also support various civilian health systems in personalized health and medicine, in model-based management of chronic diseases, sports and performance medicine, drug discovery, clinical trials, geriatrics, rehabilitation, and many others.

REFERENCES:



  1. CBO 2014, Approaches to Reducing Federal Spending on Military Health Care, Congress of the United States Congressional Budget Office, January 2014, http://www.cbo.gov/sites/default/files/44993-MilitaryHealthcare.pdf



  2. Friedl, KE. (2007) Is it Possible to Monitor the Warfighter for Prediction of Performance Deterioration?. RTO Human Factors and Medicine Panel (HFM) Workshop held in Paris, France, 7-9 Feb 2007 Proc. RTO-MP-HFM-151 https://www.cso.nato.int/pubs/rdp.asp?RDP=RTO-MP-HFM-151



  3. FDA 2013, Paving the Way for Personalized Medicine, FDA’s Role in a New Era of Medical Product Development, http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf



  4. Katsanis, SH., Javitt, J., Hudson, K. (2008) A Case Study of Personalized Medicine, Science v320;4, 53-54



  5. Xie L, Ge X, Tan H, Xie L, Zhang Y, et al. (2014) Towards Structural Systems Pharmacology to Study Complex Diseases and Personalized Medicine. PLoS Comput Biol 10(5): e1003554



  6. Reifman, J., Chen, L., Khitrov, MY., Reisner, AT. (2010) Automated Decision-Support Technologies for Prehospital Care of Trauma Casualties, RTO-MP-HFM-182, 40, https://www.cso.nato.int/pubs/rdp.asp?RDP=RTO-MP-HFM-182



  7. Snyderman, R (2012) Personalized health care: From theory to practice. Biotechnol. J. v7, 973–979
    Hood L, Friend SH. (2011) Predictive, personalized, preventive, participatory (P4) cancer medicine. Nat. Rev. Clin. Oncol. 8(3), 184–187



KEYWORDS: human body model, computational physiology, injury, wearable sensors, personalized medicine, combat casualty care, force protection, modeling and simulation.



DHP16-002

TITLE: Severe Trauma Female Simulation Training System

TECHNOLOGY AREA(S): Biomedical



OBJECTIVE: Develop a realistic simulation-based training system to support the development of psychomotor skills to treat severe trauma on female casualties at point of injury.

DESCRIPTION: Pre-hospital care plays a vital role in battlefield medicine. The primary mission of military medical personnel on the battlefield is to treat the wounded and save lives. The Army combat medic, also known as a 68W health care specialist, is responsible for providing the first line of medical care to casualties at the point of injury. We know that the majority of casualties who die in combat do so before they reach a definitive care facility. Army medics must assess a situation in a timely manner, and decide on an appropriate course of action in order to save lives under combat conditions. Tactical Combat Casualty Care has become the standard of care on the battlefield; establishing when and how much care can be provided based on the tactical situation. These care providers must act diligently, as the decisions that they make, and the treatments applied, directly impact the survivability of the casualty. First responders must be trained in a realistically accurate combat environment to ensure they have the necessary skills to treat the wounded effectively. Along with the increased understanding of wounding patterns, and how best to treat the acutely wounded in a tactical combat environment, the application of Tactical Combat Casualty Care (TC3) principles has proven highly effective. This is a major reason why the casualty fatality rate in recent US Overseas Contingency Operations (OCO) is lower than in any other conflict in the history of the United States. As of 2013, 14.9% of the United States’ active-duty military force of 1.4 million was comprised of females. Although women have typically been excluded from combat arms roles in the past, they have been represented in significant numbers in front-line positions. Female Engagement Teams played a prominent role in the conflict in both theaters over the past ten years. Recent studies have shown that military female casualties are far more likely to die of their wounds than males, in contrast with civilian reports of females demonstrating higher survival rate than males with comparable injury. In fact, data from the Joint Theatre Trauma Registry showed that female casualties presented with a greater proportion of abdominal injuries, and tended to have more chest injuries than their male counterparts who survived. In a study of sucking chest wounds and other traumatic chest injuries, data showed that when assessed by gender, the Needle Chest Decompression (NCD) procedure was successful in less than a quarter of attempts in females compared to males were the procedure was successful in three quarters of attempts. Current human patient simulation models used to train first responders are decidedly masculine in appearance. Female simulation is unrealistic, and most of the time appears as a mere adjunct to the male-centric training device. This lack of a realistic female simulation model for first responders to practice lifesaving procedures on, in conjunction with ingrained societal taboos, both contribute to male medical personnel reacting differently to immediate medical needs of female patients in emergency situations. At point of injury, during which a male emergency care provider might be required to expose and/or touch a female Soldier’s body parts, lack of proper training can induce hesitation, which could potentially compromise the chance of saving a critically injured female Soldier. Following Defense Secretary Leon Panetta’s decision to lift the ban of women serving in combat arms in 2013, the number of females in combat roles is projected to increase drastically in the next few years. The female morality rate is predicted to rise as well, in keeping with this increase. Based on the given data and the decision to make combat roles available to females, a change in how we train medics to provide battlefield care for females may prove necessary. Force health protection policies, training, and equipment must be better tailored to the characteristics of the deployed force. Therefore, capabilities in the training environment should incorporate realistic female anatomy. In order to make male Soldiers more comfortable with providing care to women, and more capable of reacting without hesitation in life-threatening situations, male trainees should be given the opportunity to work with realistic female anatomy during training and be exposed to female severe trauma injury patterns observed at point of injury.

Research conducted under this effort should focus on the development and evaluation of a low cost female simulation-based model to support the training of medics in the development of psychomotor skills to treat severe trauma on female casualties at point of injury. The concept should address modularity and interoperability with a variety of existing human patient simulators. The proposed solution should consider retrofitting to currently commercialized systems as well as modular mannequins yet to be commercialized.

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