Office of the Secretary Of Defense (osd) Deputy Director of Defense Research & Engineering Deputy Under Secretary of Defense



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Office of the Secretary Of Defense (OSD)

Deputy Director of Defense Research & Engineering

Deputy Under Secretary of Defense (Science & Technology)

Small Business Innovation Research (SBIR)

FY2009.3 Program Description




Introduction
The Deputy Under Secretary of Defense (Science & Technology) SBIR Program is sponsoring the Defense Health Program Biomedical Technology theme in this solicitation.
The Army, Navy, and Air Force are participating in the OSD SBIR Program on this solicitation.  The service laboratories act as our OSD Agent in the management and execution of the contracts with small businesses.  The service laboratories, often referred to as a DoD Component acting on behalf of the OSD, invite small business firms to submit proposals under this Small Business Innovation Research (SBIR) Program solicitation. In order to participate in the OSD SBIR Program this year, all potential proposers should register on the DoD SBIR Web site as soon as you can, and should follow the instruction for electronic submittal of proposals. It is required that all bidders submit their proposal cover sheet, company commercialization report and their firm’s technical and cost proposal form electronically through the DoD SBIR/STTR Proposal Submission Web site at http://www.dodsbir.net/submission. If you experience problems submitting your proposal, call the help desk (toll free) at 1-866-724-7457. You must include a Company Commercialization Report as part of each proposal you submit; however, it does not count against the proposal page limit of 25 pages. Please note that improper handling of this form may result in the proposal being substantially delayed. Information provided may have a direct impact on the review of the proposal. The DoD SBIR Proposal Submission Web site allows your company to come in any time (prior to the proposal submission deadline) to edit your Cover Sheets, Technical and Cost Proposal and Company Commercialization Report.
We WILL NOT accept any proposals that are not submitted through the on-line submission site. The submission site does not limit the overall file size for each electronic proposal, there is only a 25-page limit. However, file uploads may take a great deal of time depending on your file size and your internet server connection speed. If you wish to upload a very large file, it is highly recommended that you submit prior to the deadline submittal date, as the last day is heavily trafficked. You are responsible for performing a virus check on each technical proposal file to be uploaded electronically. The detection of a virus on any submission may be cause for the rejection of the proposal. We will not accept e-mail submissions.
Firms with strong research and development capabilities in science or engineering in any of the topic areas described in this section and with the ability to commercialize the results are encouraged to participate. Subject to availability of funds, the DUSD(S&T) SBIR Program will support high quality research and development proposals of innovative concepts to solve the listed defense-related scientific or engineering problems, especially those concepts that also have high potential for commercialization in the private sector. Objectives of the DUSD(S&T) SBIR Program include stimulating technological innovation, strengthening the role of small business in meeting DoD research and development needs, fostering and encouraging participation by minority and disadvantaged persons in technological innovation, and increasing the commercial application of DoD-supported research and development results. The guidelines presented in the solicitation incorporate and exploit the flexibility of the SBA Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to DoD and the private sector.

Description of the OSD SBIR Three Phase Program

Phase I is to determine, insofar as possible, the scientific or technical merit and feasibility of ideas submitted under the SBIR Program and will typically be one half-person year effort over a period not to exceed six months, with a dollar value up to $100,000. We plan to fund 3 Phase I contracts, on average, and down-select to one Phase II contract per topic. This is assuming that the proposals are sufficient in quality to fund this many. Proposals should concentrate on that research and development which will significantly contribute to proving the scientific and technical feasibility of the proposed effort, the successful completion of which is a prerequisite for further DoD support in Phase II. The measure of Phase I success includes technical performance toward the topic objectives and evaluations of the extent to which Phase II results would have the potential to yield a product or process of continuing importance to DoD and the private sector, in accordance with Section 4.3.


Subsequent Phase II awards will be made to firms on the basis of results from the Phase I effort and the scientific and technical merit of the Phase II proposal in addressing the goals and objectives described in the topic. Phase II awards will typically cover 2 to 5 person-years of effort over a period generally not to exceed 24 months (subject to negotiation). Phase II is the principal research and development effort and is expected to produce a well defined deliverable prototype or process. A more comprehensive proposal will be required for Phase II.
Under Phase III, the DoD may award non-SBIR funded follow-on contracts for products or processes, which meet the Component mission needs. This solicitation is designed, in part, to encourage the conversion of federally sponsored research and development innovation into private sector applications. The small business is expected to use non-federal capital to pursue private sector applications of the research and development.
This solicitation is for Phase I proposals only. Any proposal submitted under prior SBIR solicitations will not be considered under this solicitation; however, offerors who were not awarded a contract in response to a particular topic under prior SBIR solicitations are free to update or modify and submit the same or modified proposal if it is responsive to any of the topics listed in this section.
For Phase II, no separate solicitation will be issued and no unsolicited proposals will be accepted. Only those firms that were awarded Phase I contracts, and have successfully completed their Phase I efforts, will be invited to submit a Phase II proposal. Invitations to submit Phase II proposals will be released at or before the end of the Phase I period of performance. The decision to invite a Phase II proposal will be made based upon the success of the Phase I contract to meet the technical goals of the topic, as well as the overall merit based upon the criteria in section 4.3. DoD is not obligated to make any awards under Phase I, II, or III. DoD is not responsible for any money expended by the proposer before award of any contract. For specifics regarding the evaluation and award of Phase I or II contracts, please read the front section of this solicitation very carefully. Every Phase II proposal will be reviewed for overall merit based upon the criteria in section 4.3 of this solicitation, repeated below:
a. The soundness, technical merit, and innovation of the proposed approach and its incremental progress toward topic or subtopic solution.

b. The qualifications of the proposed principal/key investigators, supporting staff, and consultants. Qualifications include not only the ability to perform the research and development but also the ability to commercialize the results.



c. The potential for commercial (defense and private sector) application and the benefits expected to accrue from this commercialization.
In addition, the OSD SBIR Program has a Phase II Plus 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 Plus allows for an existing Phase II OSD SBIR contract to be extended for up to one year per Phase II Plus application, to perform additional research and development. Phase II Plus matching funds will be provided on a one-for-one basis up to a maximum $500,000 of SBIR funds. All Phase II Plus 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 Plus contract modification. The funds provided by the DoD acquisition program or a non-SBIR/non-STTR government program must be obligated on the OSD Phase II contract as a modification prior to or concurrent with the OSD SBIR funds. Private sector funds must be deemed an “outside investor” which may include such entities as another company, or an investor. It does not include the owners or family members, or affiliates of the small business (13 CFR 121.103).
The Fast Track provisions in section 4.0 of this solicitation apply as follows. Under the Fast Track policy, SBIR projects that attract matching cash from an outside investor for their Phase II effort have an opportunity to receive interim funding between Phases I and II, to be evaluated for Phase II under an expedited process, and to be selected for Phase II award provided they meet or exceed the technical thresholds and have met their Phase I technical goals, as discussed Section 4.5. Under the Fast Track Program, a company submits a Fast Track application, including statement of work and cost estimate, within 120 to 180 days of the award of a Phase I contract (see the Fast Track Application Form on www.dodsbir.net/submission). Also submitted at this time is a commitment of third party funding for Phase II. Subsequently, the company must submit its Phase I Final Report and its Phase II proposal no later than 210 days after the effective date of Phase I, and must certify, within 45 days of being selected for Phase II award, that all matching funds have been transferred to the company. For projects that qualify for the Fast Track (as discussed in Section 4.5), DoD will evaluate the Phase II proposals in an expedited manner in accordance with the above criteria, and may select these proposals for Phase II award provided: (1) they meet or exceed selection criteria (a) and (b) above and (2) the project has substantially met its Phase I technical goals (and assuming budgetary and other programmatic factors are met, as discussed in Section 4.1). Fast Track proposals, having attracted matching cash from an outside investor, presumptively meet criterion (c). However, selection and award of a Fast Track proposal is not mandated and DoD retains the discretion not to select or fund any Fast Track proposal.
Follow-On Funding
In addition to supporting scientific and engineering research and development, another important goal of the program is conversion of DoD-supported research and development into commercial (both Defense and Private Sector) products. Proposers are encouraged to obtain a contingent commitment for follow-on funding prior to Phase II where it is felt that the research and development has commercialization potential in either a Defense system or the private sector. Proposers who feel that their research and development have the potential to meet Defense system objectives or private sector market needs are encouraged to obtain either non-SBIR DoD follow-on funding or non-federal follow-on funding, for Phase III to pursue commercialization development. The commitment should be obtained during the course of Phase I performance, or early in the Phase II performance. This commitment may be contingent upon the DoD supported development meeting some specific technical objectives in Phase II which if met, would justify funding to pursue further development for commercial (either Defense related or private sector) purposes in Phase III. The recipient will be permitted to obtain commercial rights to any invention made in either Phase I or Phase II, subject to the patent policies stated elsewhere in this solicitation.
Contact with DoD
General informational questions pertaining to proposal instructions contained in this solicitation should be directed to the topic authors and point of contact identified in the topic description section. Proposals should be electronically submitted. Oral communications with DoD personnel regarding the technical content of this solicitation during the pre-solicitation phase are allowed, however, proposal evaluation is conducted only on the written submittal. Oral communications during the pre-solicitation period should be considered informal, and will not be factored into the selection for award of contracts. Oral communications subsequent to the pre-solicitation period, during the Phase I proposal preparation periods are prohibited for reasons of competitive fairness. Refer to the front section of the solicitation for the exact dates.
Proposal Submission
Proposals shall be submitted in response to a specific topic identified in the following topic description sections. The topics listed are the only topics for which proposals will be accepted. Scientific and technical information assistance may be requested by using the SBIR/STTR Interactive Technical Information System (SITIS).
It is required that all bidders submit their proposal cover sheet, company commercialization report and their firm’s technical and cost proposal form electronically through the DoD SBIR/STTR Proposal Submission Web site at http://www.dodsbir.net/submission. If you experience problems submitting your proposal, call the help desk (toll free) at 866-724-7457. You must include a Company Commercialization Report as part of each proposal you submit; however, it does not count against the proposal page limit of 25 pages. Please note that improper handling of this form may result in the proposal being substantially delayed. Information provided may have a direct impact on the review of the proposal. The proposal submission Web site allows your company to come in any time (prior to the proposal submission deadline) to edit your Cover Sheets, Technical and Cost Proposal and Company Commercialization Report. We WILL NOT accept any proposals which are not submitted through the on-line submission site. The submission site does not limit the overall file size for each electronic proposal, only the number of pages is limited. However, file uploads may take a great deal of time depending on your file size and your internet server connection speed. You are responsible for performing a virus check on each technical proposal file to be uploaded electronically. The detection of a virus on any submission may be cause for the rejection of the proposal. We will not accept e-mail submissions.
The following pages contain a summary of the technology focus area, which is followed by the topics.
Defense Health Program Biomedical Technology Focus Area
The Department of Defense is aggressively pursuing unified Force Health Protection and Deployment Health strategies to protect Service members and their families from health hazards associated with military service. Toward that end, DoD is undertaking technology development programs that save lives and promote healthy individuals, units and communities while improving both force morale and warfighting capabilities.
The operational force is exposed to health threats throughout the operational continuum, from CONUS fixed facilities (garrison, base, ashore) through deployment, employment, and redeployment. DoD is developing policy and procedures to assess occupational and environmental health threats for all locations.
When Force Health Protection capabilities are fully implemented, commanders will have a more complete view of potential health threats. Integration of assessments from health databases and other assessments from intelligence (e.g., about land mines, directed enemy fire, fratricide) and safety (e.g., about injuries, vehicle accidents, explosives, aviation mishaps) will provide a framework for identifying future medical technology capabilities necessary for Force Health Protection.
Ensuring the health of the force encompasses several key capabilities:

  • To mobilize, deploy and sustain medical and health support for any operation requiring military services;

  • To maintain and project the continuum of healthcare resources required to provide for the health of the force;

  • To operate in conjunction with beneficiary healthcare; and

  • To develop training systems which provide realistic rehearsal of emergency medical and surgical procedures and unit-level medical operations.

  • These capabilities comprise an integrated and focused approach to protect and sustain DoD’s most important resource—its Service members and their families—throughout the entire length of service commitment.

The Office of the Secretary of Defense believes that the small-business community can be effective in developing new technology-based approaches to needs in force health protection. Three broad capability areas of particular interest are tools and techniques for near real-time surveillance of the health threats and health status of the Force, for epidemiology research, and for delivery of health education and training. These are described in more detail below:




  • Health Surveillance Planning and Decision Support Tools: Tailorable and targeted software applications that are integrated into the Military Health System’s backbone of installed information systems are the essential enabling technology for surveillance. Applications in the areas of decision support tools, data and knowledge management, information visualization technologies including geospatial tools, and artificial intelligence-based appliqués for essential analyses are needed. It is expected that the applications would produce a comprehensive system of risk based assessments, predictions, and courses-of-action utilizing epidemiological, intelligence, environmental exposure, and health information concerning deployed forces. The applications should also allow for predictive modeling of medical readiness scaleable from individuals to the aggregated Force, given such data streams as reported real and somatic symptoms.




  • New Methods to Monitor Health Status and Clinical Laboratory Data: Monitoring of health status during deployments is necessary to determine etiologic factors of deployment related health change. Data and information analysis tools are needed to collect and harmonize disparate data and information sources and to provide health status surveillance pre- or post-injury to medical information consumers within and outside of military medical channels. Health monitoring should be for a limited set of indicators, and should yield an unambiguous interpretation of health status. Projects are required to have a strong biological basis and be sensitive to changes in health status based on either real-time measurements from warfighters in an operational environment, clinical laboratory data sources, and/or recorded in-patient or out-patient or trauma registry data.




  • Medical Training and Learning Tools: Developing and maintaining skills among the personnel of the Military Health System is an important aspect of deployment health. Advanced distributed learning, simulation-based training and other computer-based training technology should enable all health-care personnel to plan, respond and manage the future medical missions, and should assist medical professionals to maintain clinical knowledge and skills. Tools that can be extended to use by the general military population for proactive preventive medicine are desirable. Tools should be based on existing medical and allied health knowledge, should be universally accessible, should allow for unlimited practice, and should be SCORM-compliant in content and in delivery modalities.


OSD SBIR 093 Topic Index

The Defense Health Program Biomedical Technology topics are:


OSD09-H06 Neuromonitoring of Traumatic Brain/blast Injury

OSD09-H07 Evidence-Based Evaluation Process for Traumatic Brain Injuries and Co-morbid

Psychological Disorders in Service Members

OSD09-H08 Early Detection of Mild Traumatic Brain Injury

OSD09-H09 Actively Compliant Parallel End-Effector Mechanism for Medical Interventions

OSD09-H10 Natural Polymers for Cranio-facial Tissue Engineering

OSD09-H11 Bioreactors for Tissue Reconstruction

OSD09-H12 APPLICATION OF SEMANTIC WEB TECHNOLOGIES TO ALERT PROVIDERS

REGARDING POLY-PHARMACY ISSUES IN TRAUMATIC BRAIN INJURY (TBI)

AND/OR POST-TRAUMATIC STRESS DISORDER (PTSD) MILITARY PATIENTS

OSD09-H13 Aeromedical Stabilization and Evacuation of Traumatic Brain and Spine Injuries: A

Novel System for Patient Transport

OSD09-H14 Virtual Evacuation Vehicles for Training Medics (VEV-TM)

OSD09-H15 Non-Contact Monitor for Patients with Sleep Disorder

OSD09-H16 Medical Capability Simulator Interface Tool for OneSAF

OSD09-H17 Novel Biomaterials for Complex Tissue Repair and Reconstructive Surgery of Traumatic

Injuries

OSD09-H18 Remote Monitoring and Diagnosis of Warfighters at Risk for PTSD

OSD09-H19 Development of a universal method for diagnostic sample inactivation, extraction and

enrichment of pathogens in arthropod hosts of military importance.

OSD09-H20 Development of a hand-held, field-deployable multiplex assay for the detection of

Chikungunya Virus (CHIKV), West Nile Virus (WNV), and Dengue Virus in

mosquitoes.

OSD09-H21 Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major

and L. Infantum in Sand Flies

OSD09-H22 Treatment of mTBI Balance Dysfuntion via Multimodal Biofeedback

OSD09-H23 Advancements in Retinal Imaging for Diagnosis of Mild Traumatic Brain Injury

OSD09-H24 Toxicity Sensor for Food



OSD09-H25 Remote Diagnostic Access and Automated Proactive Medical Equipment Monitoring in

support of Hospital of the Future Initiatives

OSD09-H26 Novel Methods to Monitor Health Status and Clinical Laboratory Data: Portable

Acquisition, Assessment, and Reporting of Middle Ear Function and Hearing

OSD09-H27 Development and commercialization of a tent trap for the surveillance and control of

disease-carrying flies
OSD SBIR 093 Topic Descriptions

OSD09-H06 TITLE: Neuromonitoring of Traumatic Brain/blast Injury


TECHNOLOGY AREAS: Biomedical
OBJECTIVE: Design and build an inexpensive, portable brain monitor/alarm for deployment on the battlefield, for use during transport of wounded soldiers, and for use in the neurosurgery ICU. The non-invasive device will monitor brain function continuously while unattended to detect and alert medical personnel of developing pathologic brain conditions such as edema, vasospasm, and increased intracranial pressure, which can cause secondary brain damage. The monitor should detect changes in cerebral blood flow (CBF) autoregulation (AR) (Strandgaard and Paulson, 1984), and activate an alarm when CBF AR has reached its lower limit and when failure of neuronal synaptic transmission occurs as a consequence of severe CBF decrease (Symon et al, 1986).

DESCRIPTION: The brain monitor will apply existing technology: EEG and Rheoencephalography (REG) (Moskalenko, 1980; Jenkner, 1986; Anonymous 1997; Grimnes and Martinsen, 2008). The brain monitor will 1) detect the lower limit of cerebral blood flow autoregulation (Bodo et al -1, 2005; 2007; Czosnyka et al, 1997; Anonymous 2; and 2) detect failure of neuronal synaptic transmission (defined as a 2 second isoelectric EEG period (Prior, 1973, Bodo et al 2001). The brain monitor will have sufficient memory (minimum 80 GB) to store both the EEG and REG analog signals during transport of wounded soldiers and in the neurosurgery ICU. These records can later be stored and connected to the DoD computer-based electronic health record (CHCS II, AHLTA).




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