DEFENSE HEALTH AGENCY
18.B Small Business Technology Transfer (STTR) Program
Proposal Submission Instructions
The Defense Health Agency (DHA) STTR Program seeks small businesses with strong research and development capabilities to pursue and commercialize medical technologies.
Broad Agency Announcement (BAA), topic, and general questions regarding the 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
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
The DHA Program participates in three DoD STTR BAAs each year. Proposals not conforming to the terms of this BAA will not be considered. Only Government personnel will evaluate proposals
PHASE I PROPOSAL SUBMISSION
Follow the instructions in the DoD Program BAA for program requirements and proposal submission instructions.
STTR Phase I Proposals have four Volumes: Proposal Cover Sheets, Technical Volume, Cost Volume and Company Commercialization Report.A new Volume 5, Supporting Documents, is optional and is available for proposers to include additional files and documents which are not required in the Technical Volume.The Technical Volume has a 20-page limitincluding: 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.
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 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.Please refer to the DoD Instructions, section 4.2.f to view a “Model Agreement for the Allocation of Rights”.
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. Submission instructions are typically sent toward the end of month five of the phase I contract. The awardees will receive a Phase II window notification via email with details on when, how and where to submit their Phase II proposal.
Small businesses submitting a Phase II Proposal must use the DoD STTR electronic proposal submission system ( 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. A new Volume 5, Supporting Documents, is optional and is available for proposers to include additional files and documents which are not required in the Technical Volume. 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-STTR government program or eligible 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
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 precede. 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 18.B Topic Index
DHA18B-001 / Cervical Spine Health Improvement ProductsDHA - 1
DHA STTR 18.B Topic Descriptions
DHA18B-001 / TITLE: Cervical Spine Health Improvement ProductsTECHNOLOGY AREA(S): Biomedical
OBJECTIVE: Obtain a medical materiel solution that non-invasively collects cervical spine data to include position, velocity and acceleration; medical device output provides objective (pain independent) metrics for surveillance, risk assessment and measurement of intervention outcomes. Resulting solution will directly address Fleet requirements for improved surveillance and same-day evaluation of musculoskeletal injuries, specifically those of the cervical spine.
DESCRIPTION: Neck pain and cervical spine injury are mission degraders across the spectrum of military personnel, and a source of increased cost in terms of preventative actions, healthcare treatment and negative impact on productivity. While important work has been done describing the complex mechanisms of action in catastrophic injuries to the neck or extreme loading (i.e., high G-forces combined with heavy helmets), much more needs to be done in the field of longitudinal measurement over the course of a career, in order to better inform both clinicians and patients of changes in function prior to the point of serious injury. Likewise, occupational measurement tools are currently insufficient to provide accurate risk assessments in real-time environments.
The current standard for cervical spine impairment assessment is Range of Motion (ROM). While providing critical information, ROM and postural information do not accurately model dynamic motion, either for normal or abnormal neck conditions. In addition, many studies rely on subjective measures, such as a questionnaire, that relies on pain as a metric. Pain as a subjective symptom is highly variable and confounded by many factors not related to the disorder. Existing Commercial, off the Shelf (COTS) sensors and software are currently capable of not only measuring positional data, but also velocity, acceleration and rotation in all axes of motion. However, these same sensors capture motion data, but provide no tools to interpret this data as a useful output for clinicians or occupational health specialists.
To date, many modeling efforts have been developed that provide valid information regarding the mechanical properties of the cervical spine [1, 2]. When adapted for clinical or field use, these models may be effective for both prevention and treatment of cervical spine musculoskeletal injuries MSIs.
The final requested product will use COTS inertial measurement unit (IMU) sensors to collect positional data on upright subjects in a neutral cervical posture, as well as flexion, extension, lateral movements and rotations of the neck and head. Velocity and acceleration data will be recorded as well. The device should include software that analyzes and interprets the kinematic data to provide output that can be used in both occupational and clinical settings. The anticipated device should beuser-friendly, provide an expedient measurement technique (under ten minutes), and be able to be used with existing work garments. Portability between test environments is critical. Similar devices for lumbar spine have already been commercialized [3].
PHASE I: Phase I will focus on concept design and feasibility testing of a technology solution that can be used to measure neck kinematics in industrial settings. There are three physical barriers to success that must be cleared in Phase I: proof that the performer can develop a data acquisition platform capable of collecting and analyzing the required data; design and early manufacture of an appropriate mounting platform for sensor placement; and acquisition and testing of COTS sensors to obtain the necessary data. Performance goals include the following:
1. Defining the necessary data needed to provide accurate and high fidelity results;
2. Development of a data acquisition platform capable of collecting data either wirelessly, or capturing data stored on a sensor for use in environments where wireless data transmission is not possible;
3. Development of a mounting platform for the sensors that can be quickly and reliably placed on human subjects of varying heights and body shapes, over light work clothing and designed for low complexity and ease-of-use.
4. Acquiring and testing appropriate COTS sensors for feasibility of requested data acquisition;
5. Physical and software modification(s) of sensors as needed to reduce or eliminate the effect of sensor drift, communicate appropriately with other sensors or data acquisition platform, and for use with a dedicated mounting platform.
Human subject testing is not requested or expected for Phase I.
PHASE II: The sensors, mounting platform and data acquisition platform developed in Phase I will be employed to produce a functioning prototype that combines hardware and software to quantify kinematic measurements on human subjects. The second goal of Phase II is to collect and analyze data to develop algorithms capable of defining existing cervical function, injury risk and sincerity of effort.
Measurements with human subjects should be validated with existing “gold-standard” equipment that can accurately define human motion, such as optoelectronic motion capture (Mo-Cap) systems. This validation equipment, which is typically bulky and not easy to transport, should not be considered as part of the deliverable device. Furthermore, while general population data acquisition is appropriate for initial database development, it is suggested that the STTR awardees attempt to obtain data from military populations early in the process, to ensure that our unique demographic population is accurately modeled for the required outputs. In either case, prototype testing may be requested through Federal laboratories, which could provide both MOCAP capability and access to military subjects. While testing would be conditional to Federal entity fund availability, no additional cost would be requested from successful proposal entities.
Performance goals for Phase II include the following:
1. Final draft of test protocol submitted to Contract Officer Representative(s) (CORs) and appropriate administrative personnel, submission of IRB documentation to appropriate oversight boards, and recruitment of human subjects for data acquisition provided IRB approvals;
2. Refinement of sensors, mounting platform and data acquisition platform as needed to satisfy the stated objective;
3. Define required objectives for field testing, and developing test protocols for field data acquisition;
4. Define required objectives for clinical testing, and develop test protocols for clinical data acquisition;
5. Define prototype fabrication requirements for scalable manufacturing efforts;
6. Define storage and/or shipping requirements for possible shipboard deployment;
PHASE III DUAL USE APPLICATIONS: The vision for this device is to have a portable, easy-to-use tool that provides reliable, valid and objective kinematic assessments for warfighters in operational work settings, as well as a tool for clinical use. Potential customers include Navy Medical Logistics Command (NAVMEDLOGCOM) or US Army Medical Materiel Agency (USAMMA). In the hands of an occupational specialist, the device would be able to assess injury risk across all industrial environments, providing empirical data to reduce neck injuries and assess prevention strategies. In the hands of a clinical team, the same measurement tool would be able to identify severity of any kinematic abnormality; monitor improvement over time; assist with treatment outcome evaluation and provide valid return to work metrics. In both cases the device should have the ability to discern sincerity of effort, which will be extremely valuable in the realm of disability claims, especially if longitudinal monitoring of the service member is routinely performed.