DEFENSE HEALTH AGENCY (DHA)
17.A Small Business Technology Transfer (STTR) Program
Proposal Submission Instructions
The Defense Health Agency (DHA) STTR Program (previously known as the Defense Health Program STTR Program) seeks small businesses with strong research and development capabilities to pursue and commercialize medical technologies.
The DHA STTR Program harnesses the collective knowledge and experience of scientists and engineers, to identify and put forward research and development (R&D) topics to stimulate a partnership of ideas and technologies between innovative Small Business Concerns (SBCs) and Research Institutions (RIs) through Federally-funded R&D to address DHA needs.
Broad Agency Announcement (BAA), topic, and general questions regarding the DoD STTR Program should be addressed according to the DoD STTR 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 STTR Program should be submitted to the DHA STTR Program Management Office (PMO) at:
E-mail -
Phone - (301) 619-5047
PHASE I PROPOSAL SUBMISSION
Follow the instructions in the DoD Program BAA for program requirements and proposal submission instructions at http://www.acq.osd.mil/osbp/sbir/solicitations/index.shtml.
STTR 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, 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 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.
The electronically generated Cover Sheet, Cost Volume and Company Commercialization Report (CCR) do not have a 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.
The DHA STTR Program will evaluate and select Phase I proposals using the evaluation criteria in Section 6.0 of the DoD STTR Program BAA. Due to limited funding, the DHA STTR 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.
If a small business concern is selected for a STTR award they must negotiate a written agreement between the small business and their selected Research Institution that allocates intellectual property rights and rights to carry out follow-on research, development, or commercialization.
PHASE II PROPOSAL SUBMISSION
Phase II is the demonstration of the technology found feasible in Phase I. All DHA STTR 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 STTR PMO either in the Phase I award or by subsequent notification.
Small businesses submitting a Phase II Proposal must use the DoD STTR 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 (9:00 am to 6:00 pm ET).
The DHA STTR Program will evaluate and select Phase II proposals using the evaluation criteria in Section 8.0 of the DoD STTR Program BAA. Due to limited funding, the DHA STTR 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 STTR 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 STTR 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 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 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.
PHASE II ENHANCEMENTS
The DHA STTR Program has a Phase II Enhancement Program which provides matching STTR funds to expand an existing Phase II contract that attracts investment funds from a DoD Acquisition Program, a non-SBIR/non-STTR government program or private sector investments. Phase II Enhancements allow for an existing DHA STTR 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 STTR 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 (DTA)
The DHA STTR Program does not participate in the Discretionary Technical Assistance Program. Contractors should not submit proposals that include Discretionary Technical Assistance.
The DHA STTR 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 HUMAN OR ANIMAL SUBJECTS
The DHA STTR 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.
DHA STTR 17.A Topic Index
DHA17A-001 / Medical Electro-Textile Sensor SimulationDHA17A-002 / Smart Morphing Medical Moulage
DHA17A-003 / Principled Design of an Augmented Reality Trainer for Medics
DHA17A-004 / Non-invasive Telemetric Assessment of Gut Microbiota Activity in Situ
DHA17A-005 / Wireless Non-Invasive Advanced Control of Microprocessor Prostheses and Orthoses
DHA17A-006 / Medical Device to Assess the Viability of Tissue Prior to Skin Grafting
DHA - 16
DHA STTR 17.A Topic Descriptions
DHA17A-001 / TITLE: Medical Electro-Textile Sensor SimulationTECHNOLOGY AREA(S): Biomedical
OBJECTIVE: The objective of this topic is to create a simulator to provide what-if scenarios to aid in developing smart combat uniform sensors and technology to record electromagnetic field activity of the war-fighter. The model will be developed for Joint use and is based on the e-textile work performed by the Services; in particular the Revolutionary Fibers and Textiles Institute located at the U.S. Army’s Natick Soldier Research Development and Engineering Center (NSRDEC).
DESCRIPTION: Electro-Magnetic Fields (EMF), result from electrical currents. Within the electromagnetic (EM) spectrum, there are many frequencies radiating from humans. For instance, infrared (IR) imaging is used to detect heat signatures of humans in otherwise dark conditions. Likewise, the human body is rich in EMFs resulting from nerve firings. However, with the exception of IR, the EMFs generated from humans are weak when compared to those from external electrical devices. Having the ability to monitor a warfighter’s EMF at various locations could provide valuable evidence of trauma and other conditions impacting the warfighter’s ability to perform normal combat operations. The logical placement of such sensors is within the domain of electro-textile combat uniforms.
Currently, research into smart combat uniforms continues to advance with integration of power and data. The goal of this research is to simulate monitor and capture the signal data resulting from the human body. This will simulate advanced technologies such as conductive fibers embedded in uniforms. For this to be ultimately viable, the conductive fibers need to pick up weak EMFs. Ideally, signal processing capabilities would also be available to the warfighter to digitally filter out signals of no interest (noise). This effort is focused on the EMFs indicating from the human body and being received by conductive fibers. The conductive fibers act as an antenna and capture EMFs to depict the state of the warfighter prior to injury, and use those as a base (a quiescent state). The quiescent state would then be stored using embedded processors. Upon injury and periodically thereafter, the dynamic changes of warfighter nerve impulses or other radiating signals would be captured and recorded. These records would establish a medical record of important nerve activity before, during, and following injury.
At one end of the electromagnetic spectrum, infrared radiation emanating from the human body is examined at airports to detect passengers with fevers. At the other end, electrodes attached to the skin are used to record electro-cardiographs. This research seeks to explore the electromagnetic frequency range between these two extremes to see is the human body is radiating other signals that could be used to ascertain health. The effort’s deliverable should rely on signals received as a method for sensing changes to the human body. The idea is the human body is the main sensor and we seek to simulate ways to electronically read the changes through the use of conductive fibers. Previous work has described using conductive fibers for antenna [4] and the potential for reading signals from the human body [5]. The research should consider unique environments such as submersion in salt water, humid, and dry environments. The effort should use an innovative approach to implement a simulator to provide a what-if assessment of current technologies for e-textiles to determine which are capable of detecting electrical signals emanating from the body without contact. Different conductive fibers are expected to receive different signals. The simulator should be extensible to model new fiber technologies as they become available. The assessments will determine size and power budgets for various technologies, along with their projected reductions. The simulations will be based on the conductive fiber combat uniform prototypes built by the Natick Soldier Research Development and Engineering Center [1].
PHASE I: Phase I will consist of a simulation using sensor materials to detect weak EMFs, possibly operating in the Nano-Tesla range. This work will build on using conductive fibers as possible sensors. That is, if a conductive fiber is vulnerable to EMI, use this vulnerability as a sensor. In particular those designs that are not used because of susceptibility to EMI will be explored as potential sensors. The simulation will help to refine how sensors, to include fibers as sensors, could be used within combat situations. It will test sensors at the technology level, specifically examining the signal processing requirements to include the sensor’s frequency range, power requirements, and size. The simulation will also use a history of past technical advances to predict future size reductions. That is, as the size of the sensor decreases, the resulting EMI detection capabilities will be analyzed. The expected results should point to technologies for detecting signals resulting from changes to the human body. These could be determined by contrasting the set of signals received before the event to those following the event. Success is determined if a difference can be computable.
The second part of Phase I will establish a baseline for human generated EMF frequencies and field strengths. That is, identifying what set of signals are available than can be detected by various conductive fibers. In so doing, the simulator should be able to simulate using multiple conductive fiber technologies to receive different signals. In general, there are numerous man-made and other interference signals. Shielded enclosures such as those typically used to eliminate or suppress communication signals in support of TEMPEST reduction could be used to improve fidelity. A shielded enclosure or other innovative approach could be used to attenuate ambient noise and allow for accurate EMF measurements from various locations adjacent to the human subject. Various injuries and stress to the human body will be simulated to ascertain the best algorithms for determining the root causes.
Specific questions to be answered in this phase are:
• What is the best approach for isolating human generated EMFs from background noise;
• What is(are) the best fiber as sensor technology(ies);
• How will the sensors transmit information through an e-textile data bus;
• Should the sensor include Digital Signal Processing circuity; and
• What are the limitations for EMF sensors in e-textiles?