Office of the Secretary Of Defense (OSD)
Defense Health Program (DHP)
Small Business Innovation Research (SBIR)
Introduction
The OSD Defense Health Program SBIR Program, in coordination with the Director of Defense Research & Engineering (Research Directorate) is sponsoring topics in the Biomedical technology theme in this solicitation.
The Army 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.
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 $150,000. 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 are evaluated using the Phase I evaluation criteria, in accordance with paragraph 4.2 of the DoD Solicitation Preface. 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), with a dollar value up to $1,000,000. 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, may 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 just 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; however, to obtain answers to technical questions during the formal Solicitation period, please visit http://www.dodsbir.net/sitis. 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. (This applies to both Phase I and Phase II proposal 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 areas, 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.
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, skills, and certifications. 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.
Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD): TBI and PTSD are important priorities for casualty care in the DoD Medical Health System. Improved understanding of the etiology, identification, assessment, and treatment of TBI and PTSD is essential to force health protection.
For PTSD, research is needed to close gaps in knowledge about; 1) the epidemiology of PTSD, including the incidence, factors important in susceptibility and recovery and its impact on the function of the patient, families and caregivers; 2) basic neurobiology and genetic factors associated with PTSD; 3) prevention of PTSD, including development of methodologies for screening, detection, and diagnosis.
For TBI, research is needed to increase knowledge about the mechanism of injury in both closed and open head injury and to develop assessment methodologies for understanding the field epidemiology and blast physics related to brain injury, outcome metrics for the treatment and clinical management of all severity levels of TBI, neuroprotection and repair strategies, and effective approaches to rehabilitation/reintegration.
Tools or other products with commercial potential and systems that help to address these gaps in monitoring and assessing can substantially advance the DoD program to prevent and treat TBI and PTSD.
Acute and Rehabilitative Management of Traumatic Extremity and Eye Injury: With the successful implementation of body armor, extremity injuries have grown in its contribution to morbidity and mortality in the combat casualty. Eye injuries are also commonly associated with blast as well, with both direct damage to the eye and damage to the optic nerve and visual cortex playing a role. As a result, improved methodologies are sought in both the acute and rehabilitation phases of the clinical management of extremity and eye injuries, particularly as a result of blast. Technologies directed at repairing/restoring nerve, muscle and tendon damage that may occur as a direct result of the traumatic injury or due to secondary mechanisms of damage such as compartment syndrome are of interest as are improvements in rehabilitative strategies for recovery of normal limb function. Improvements in limb prosthetic devices are also sought.
OSD-DHP SBIR 10.3 Topic Index
The Defense Health Program Biomedical Technology topics are:
OSD10-H01 Advanced Blood Simulant for Simulation Based Medical Trauma Training
OSD10-H02 Non-Invasive Detection, Differentiation, Diagnosis and Treatment of Balance Pathologies
OSD10-H03 Spatiotemporally Controlled Delivery System that Promotes Functional Tissue Regeneration
OSD10-H04 Technologies for Treating Cartilage Tissue Loss Following Traumatic Injury
OSD10-H05 Deployable Automated Analgesia and Anesthesia System
OSD10-H06 Development and Integration of Next Generation Haptics into Medical Simulators
OSD10-H07 Deployed First Responder Course of Action (COA) Evaluation and After Action Review (AAR) Tools
OSD10-H08 Medical Gaming
OSD10-H09 Synthetic Tissue Trainer
OSD SBIR 10.3 Topic Descriptions
OSD10-H01 TITLE: Advanced Blood Simulant for Simulation Based Medical Trauma Training
TECHNOLOGY AREAS: Materials/Processes, Biomedical
ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition, USAMRMC
OBKECTIVE: Develop an advanced blood simulant for medical trauma training that approximates real blood in viscous and clotting/coagulation properties to advance the ability for medical simulators to conduct hemorrhage control training on a large scale as would be seen in a stricken warrior. Example: a simulant that can be used to portray bleeding from a simulated soldier's gunshot or shrapnel wound from which 1-2 Liters of simulated blood may flow in a given encounter.
Gaps: Current commercial alternatives are basically dyed water and do not share the correct thickness of blood nor the viscous properties of blood nor are any commercial products capable of caking/clotting in presence of a clotting agent of simulated clotting agent like a quick-clot bandage. Current training is done with live animals and real blood. Animal blood products represent an excessive biological risk for training. A suitable advanced simulant will help foster non-animal alternatives for medical trauma training and allow for realistic hemorrhage training that cannot be performed now in the military or commerical space.
DESCRIPTION: Of the nine critical medical procedures for combat casualty care that have been identified by the DoD, four involve bleeding and require extensive use of live animals in pre-deployment trauma skills training. Current simulation technology has yet to realistically reproduce bleeding for training hemostasis and use of hemostatic agents, tourniquet application, venous cut-downs and amputation & salvage of amputated limbs. Additionally, use of animal blood is biohazardous. The development of a safe blood simulant with similar viscous and clotting properties to animal blood will be an important enabling technology for advancement of simulators into the realm of bleeding and gross hemorrhage medical managment and may lead to reduced live animal use.
PHASE I: Determine the clinical and technical requirements for this development and produce a demonstrable proof of concept prototype and comprehensive report. The concept simulant must:
- Be non-biological
- Have viscous and tactile properties similar to actual blood
- Demonstrate realistic flow through both small and large diameter vessels
- Clots or coagulates in presence of actual or simulated clotting products so as to aid in training for use of hemostatic agents
- Can be used for both grossly exsanguinating and oozing presentations
- Is inexpensive
- Is easy to clean for quick recycling of the simulation.
PHASE II: Develop and test the prototype to meet all of the project’s stated goals from Phase I including an advanced blood simulant product. This includes development of suitable simulator tissue models and mechanisms to realistically portray gross hemorrhage, oozing hemorrhage and clotting with use of actual or simulant hemostatic agents. Phase II includes testing of the product in a realistic training setting and submission for publication of the study results.
PHASE III: Phase III will commercialize the advanced blood simulant for end-user sale in both the military and private sector markets for commercially available devices.
REFERENCES:
1. Foster, Robert E. et al. Final report of the Use of Live Animals in Medical Education and Training Joint Analysis Team. Office of the Director of Defense research and Engineering Research Directorate, Biosystems. DoD unclassified publication, 2009.
2. Kelly JF, Ritenour AE, et al. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008 Feb;64(2 Suppl):S21-6; discussion S26-7.
KEYWORDS: Medical Simulation, simulator, medical training, blood, hemorrhage, amputation, hemostatic agent, tourniquet, trauma
OSD10-H02 TITLE: Non-Invasive Detection, Differentiation, Diagnosis and Treatment of Balance Pathologies
TECHNOLOGY AREAS: Biomedical
ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition, USAMRMC
OBJECTIVE: To develop innovative technology for detecting and treating balance pathology secondary to concussion or mild traumatic brain injury (MTBI). The technology will assess visual-vestibular reflexes, orientation sensations, susceptibility to visual or motion-induced sickness, and visual targeting behavior.
DESCRIPTION: Problem: The vestibo-cochlear labyrinth is highly sensitive to pressure and acceleration. As a result, disequilibrium is one of the most common outcomes of mild traumatic brain injury (MTBI), concussion, vestibular disease, or age-related sensory degradation (Luxon, in Baloh & Halmagyi, Eds., 1996). A recent report indicates that vestibular pathology occurs among 90% of military personnel with acute MTBI (Balaban & Hoffer, 2009). Previous studies had listed headache as the most common symptom of MTBI, due to a lack of sensitive measures of vestibular or balance pathology. This SBIR seeks to address the need for more sensitive vestibular and balance tests to quantify deficits associated with MTBI, to differentiate central and peripheral deficits, and to distinguish blast versus concussion deficits.
Balance and spatial orientation are maintained via the coordination of multiple afferent and efferent systems. Balance problems following MTBI are due to injury of one or more of these systems, including the vestibular system, visual system, somatosensory system, musculoskeletal system, and/or or central nervous system. The injuries and interactions among these systems can be subtle and complex, requiring special tools to differentiate the site(s) of injury and sources and characteristics of functional disability. This SBIR topic seeks to deliver a non-invasive multimodal technology to aid clinicians with these diagnostic needs. This SBIR topic will provide a non-invasive tool to assist caregivers in identifying the source(s) of injury (and thus where to focus treatment), while at the same time providing a technique to monitor the progress of recovery. The vestibular end organ, which is stimulated by acceleration, is really a “system of systems” since it reflexively stabilizes and interacts dynamically with the visual and auditory sensory systems as well as the postural control system. The medical specialists (ENT (Ear, Nose & Throat)/ neurootologist / “dizzy doc”/vestibular rehabilitation physiotherapists) responsible for identifying the source(s) of balance dysfunction are in need of sensitive, objective, diagnostic tools to identify subtle deficits in the sensory systems involved or in the interaction between these systems occurring in the brain. The injuries and interactions among these systems can be subtle and complex, requiring special tools to differentiate the site(s) of injury and sources and characteristics of functional disability. This SBIR topic seeks to deliver a non-invasive multimodal technology to aid clinicians with these diagnostic needs.
Desired Solution: Innovative technology is needed to improve the assessment of visual-vestibular functioning and vestibular or sensorimotor deficits associated with mild Traumatic Brain Injury (MTBI) or other disease or age-related effects. Good coordination of balance, spatial orientation perceptions, hand-eye skills, and visual targeting performance are all critical to military operations. The technology will assess visual-vestibular reflexes, orientation sensations (e.g., tilt perception, visual targeting, visual dependency, vection illusions), and susceptibility to visual or motion-induced sickness. Treatment has been identified as a capability of this SBIR technology as well, since the envisioned assessment device will allow controlled multi-axis body positioning and thereby serve as a treatment for Benign Postural Positional Vertigo (BPPV), the most common treatable complaint in the general population of balance patients. Treatment will also involve habituation or desensitization of the sensory stimuli associated with the device and the noxious effects certain stimuli have on patients prior to their achievement of full adaptation and compensation. The development of a tool with highly repeatable, consistent stimuli will permit the delivery of tests to create evidence-based medical diagnosis and treatment of MTBI.
PHASE I: Identify the most innovative and effective approach to meet the solicitation requirements. Develop a plan for development and integration of all technology components. Finish all relevant computer simulations and detailed analysis of predicted performance. Deliver a complete design which meets solicitation and relevant safety requirements. The technology should be capable of providing various combinations of vestibular and whole-field visual stimulation in multiple head-centered axes simultaneously. The technology should permit the rapid assessment of gaze reflexes (e.g., vestibulo-ocular reflexes, optokinetic, visual-vestibular), orientation sensations (e.g., vection, subjective vertical, after-rotation), and motion discomfort associated with visual or motion-induced sickness.
PHASE II: Assemble, test and deliver the fully-functional system defined in Phase I design. Demonstrate the technology to the technical points of contact and complete successful integration at the Army customer’s site. The functional prototype should be capable of being used to examine patients experiencing vestibular/balance deficits, especially those due to TBI, concussion, or blast.
PHASE III: Develop or transition the prototype technology into a viable product for sale in the military or private sector markets. The potential markets for commercialization include the government (NASA, DoD, VA) and industry (e.g., hospitals and other commercial medical or aerospace agencies). Applied transition applications include vestibular assessment and treatment, spatial disorientation training, and motion sickness assessment and desensitization.
The military medical laboratories will be the first to evaluate this device for potential as a clinical tool in the diagnosis and treatment of various categories of patients with balance dysfunction. If successful, an office-scaled version will be needed in moderately large numbers for tertiary treatment centers in both the military and civilian communities (estimate of at least 300 units). Although MTBI is the driving force for this military device development, the civilian community has at least two orders of magnitude greater patient demand for diagnosis/treatment of concussions related to sports and accidents.
This proposed device, although designed and specified as a medical diagnostics/treatment tool, has significant potential as a basic 6.1 research device to examine interaction between sensory systems, and if equipped with auditory and tactile displays, could be use to design improved man-machine interfaces. As the population ages, and the Baby Boomers insist on maintaining an active life style, there will be greater demand to diagnose and treat balance disorders. Falls are currently the number one cause of accidental death in the elderly. The demand for this device or a version of this device will significantly increase in 5 to 10 years.
REFERENCES:
1) Balaban, C., & Hoffer, M.E. (2009). Mild traumatic brain injury: Vestibular consequences. Retrieved 5 Oct 09 from www.dcoe.health.mil/Content/Navigation/Documents/Balaban.pdf.
2) Luxon, L. M. Posttraumatic vertigo. In R. W. Baloh, & G. M. Halmagyi., Eds. (1996). Disorders of the Vestibular System. pp. 381-395. New York: Oxford Press.
KEYWORDS: traumatic brain injury (TBI), concussion, vestibular, balance, fall(-s; -ing), postur(-e; -al).
OSD10-H03 TITLE: Spatiotemporally Controlled Delivery System that Promotes Functional Tissue Regeneration
TECHNOLOGY AREAS: Biomedical
OBJECTIVE: Develop and test an advanced topical delivery system that promotes the regeneration of damaged or degenerated tissues. The delivery system should be biocompatible and tunable to provide spatiotemporal control of the presentation of appropriate biological factors (e.g. cells, proteins, small molecules) in vivo. Integrated within the project should be the validation of the delivery system in appropriate tissue injury or degeneration animal models, enabling the quantitative evaluation of the system’s ability to restore tissue structure and function.
DESCRIPTION: There is a substantial clinical need for regenerative therapies that effectively restore function to damaged tissues. Injured or degenerated musculoskeletal tissues, for example, represent the most common cause of pain and disability worldwide (1). For many tissues, autograft remains the clinical standard despite the limited volume available, associated patient morbidity and the resulting non-functional tissue. Therapeutic strategies can be broadly categorized as targeting tissue replacement or tissue regeneration. Replacement strategies have involved culturing cells seeded into porous biomaterial scaffolds within dynamic bioreactor systems to create fully-formed tissues in vitro that must then be integrated with host tissue following implantation.
An alternative therapeutic strategy is to deliver progenitor cells or key biomolecular signals that augment or stimulate endogenous repair mechanisms. This regenerative strategy has been successfully demonstrated clinically in bone using high doses of osteoinductive proteins loaded onto simple collagen sponge matrices (2). However, concerns and complications associated with the rapid release of high doses of proteins have motivated recent investigation into sustained delivery strategies that may provide efficacy at lower doses. In addition to release kinetics, the spatial presentation of exogenously delivered signals can strongly influence the resulting regenerative response (3).
Advanced topical delivery systems that provide spatiotemporal release or presentation of biological factors are thus needed that effectively promote the health of damaged or degenerated tissues. Examples Delivery strategies should be engineered to preserve the viability and functionality of topically delivered biologics and provide controlled retention and release. Delivery technologies should be concurrent with surgical procedures and promote tissue regeneration.
Phase I: Identify a delivery system that is biocompatible and can be engineered to provide spatiotemporal controlled delivery of a biologic for tissue regeneration. There are several factors that must be considered when designing a delivery system including: toxicity of the degraded byproducts, degradation mechanism (e.g. hydrolytic, enzymatic), efficiency of loading, preservation of bioactivity/viability, and controllability of release rate and dose. FDA approval pathway during developmental stages should be defined.
PHASE II: Test the efficacy of the delivery system in vivo in an animal model and determine the biodistribution of the delivered biologic. The safety (i.e. toxicity and immunogenicity) of each combination of delivery system and biologic should be determined. Outcome measures should include quantitative measures of tissue function, and comparisons should be made to current clinical standards. In addition, treatment should be designed to be used during clinical/surgical procedures.
PHASE III: The most promising delivery systems will be analyzed using additional in vitro assays and tested in clinically relevant large animal models. The overall program will provide a tunable delivery system that can be effectively commercialized for both civilian and military trauma care and/or treatment of tissue degenerative conditions.
REFERENCES:
1. Woolf AD, Pfleger B, 2003, Burden of major musculoskeletal conditions. Bull World Health Organ 81(9):646-56.
2. Swiontkowski MF, Aro HT, Donell S, Esterhai JL, Goulet J, Jones A, Kregor PJ, Nordsletten L, Paiement G, Patel A, 2006, Recombinant human bone morphogenetic protein-2 in open tibial fractures. A subgroup analysis of data combined from two prospective randomized studies. J Bone Joint Surg Am 88(6):1258-65.
3. Guldberg RE, 2009, Spatiotemporal Delivery Strategies for Promoting Musculoskeletal Tissue Regeneration. Journal of Bone and Mineral Research, 24(9):1507-11.
KEYWORDS: Functional tissue regeneration, Spatiotemporal delivery, Biomaterials
OSD10-H04 TITLE: Technologies for Treating Cartilage Tissue Loss Following Traumatic Injury
TECHNOLOGY AREAS: Biomedical
ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition, USAMRMC
OBJECTIVE: Develop technologies for treating and regenerating cartilage tissue following traumatic injury.
DESCRIPTION: Traumatic injuries to soft tissues, such as experienced in military conflicts, frequently involve loss of significant volumes of tissue, muscle, cartilage and bone in craniofacial areas and limb extremities (1). Due to the loss and limited supply of suitable replacement tissue (2), there is a critical need for technologies that can be used to treat focal defects and limit further degeneration of the adjacent tissues.
While more than half of injuries being sustained by our soldiers in the Iraq and Afghanistan conflicts are to the extremities, more than 25% are to the oral and maxillofacial structures (3,4). These are particularly problematic, not only because of loss of function and resulting poor nutrition and overall health, but because of the severe psychological problems resulting from impaired physiognomy. Scar formation can exacerbate loss of function and reduce the chances of achieving a cosmetically acceptable result.
Materials used to reconstruct craniofacial cartilage following traumatic injury must not only restore structure and function but must elicit little if any scar formation. Current technologies can restore function but they do not yet successfully integrate with host cartilage to the extent needed. Moreover, success using autologous chondrocytes is variable and in most instances fibrocartilage results. Craniofacial cartilages are elastic in that they contain elastin; thus, strategies that are effective for articulating cartilages may not be optimal for the ear and nose. It is important to develop stem cell therapies that minimize scar and result in cartilage formation. Lastly, engineered cartilage must maintain structural integrity when implanted in the translational phase; a major barrier in the development of tissue engineered cartilage has been deformation of cartilage implants from wound contracture when implanted.
Biomaterials that have physical properties similar to the lost tissues provide an important option, but the interface with the existing tissues is often less than ideal and can lead to further degeneration, an outcome frequently seen when treating focal defects in articular cartilage. Prosthetic devices are limited by the need to devise attachment mechanisms that permit function as well as form. These issues are particularly problematic for treatment of facial defects, including the articulating surfaces of the temporomandibular joint, nasal cartilage and ear cartilage, as well as tracheal defects.
Technologies are needed that can address the need for repair or regeneration of focal defects in the craniomaxillofacial cartilages (TMJ, ear, nose) and trachea, as well as of articulating joints in the extremities, including small joints of the hand and foot. Approaches using biomaterials, tissue engineering, or cell therapy alone or in combination should be considered. The goal is functional restoration of the cartilage with little or no degeneration of existing cartilage. For craniofacial defect repair, consideration to surgical technique, limiting potential for scar formation is of importance. In addition, a plan for FDA approval should be outlined.
PHASE I: Develop a cell-based therapy and/or a device that can be used to repair focal defects in cartilages in the head, trachea or small joints. Demonstrate that this system results in cartilage repair or replacement in vitro.
PHASE II: Demonstrate the effectiveness of the therapy or device in vivo using a relevant animal model to repair focal defects in cartilages in the head, trachea or small joints. In addition to efficacy, verify both safety (e.g., toxicity and immunogenicity) as well as quality of repair or replacement based on histology and biomechanics.
PHASE III: Demonstrate the ability of the therapy or device to repair focal cartilage defects in the head, trachea or small joint in an appropriate a large animal model(s). The overall program will result in a cell-based therapy and/or technology that repairs or replaces cartilage tissue lost to focal injuries, restoring form and function limiting further tissue degeneration.
REFERENCES:
1. Boyce RG, Nuss DW, Kluka EA. The use of autogenous fat, fascia, and nonvascularized muscle grafts in the head and neck. Otolaryngologic Clinics of North America 1994; 27(1):39-68.
2. Mischkowski RA, Domingos-Hadamitzky CMD, Siessegger MMDDDS, et al. Donor-Site Morbidity of Ear Cartilage Autografts. Plastic & Reconstructive Surgery 2008; 121(1):79-87.
3. Masini BD, Waterman SM, Wenke JC, Owens BD, Hsu JR, Ficke JR, 2009, Resource utilization and disability outcome assessment of combat casualties from operation Iraqi freedom and operation enduring freedom. J Orthop Trauma 23:261-266.
4. Owens BD, Kragh JF, Wenke JC, Macaitis J, Wade CE, Holcomb JB, 2008, Combat wounds in operation Iraqi freedom and operation enduring freedom. J Trauma Injury, Infection, and Critical Care 64:295-299.
KEYWORDS: Tissue engineering; Cell therapy; Biomaterials; Craniofacial cartilage; Temporomandibular joint; Trachea
OSD10-H05 TITLE: Deployable Automated Analgesia and Anesthesia System
TECHNOLOGY AREAS: Biomedical
OBJECTIVE: To develop a deployable automated analgesia and anesthesia system that improves pain control and sedation of injured warfighters across roles of care.
DESCRIPTION: Drugs such as narcotics, propofol, and S-ketamine need to be administered when, where, and at the doses they are needed. Unfortunately, the therapeutic window for many analgesics and anesthetics is narrow and even expert use is routinely associated with uncontrolled pain from underdosing or hemodynamic and respiratory compromise from overdosing. Automated analgesic and anesthetic infusion could dramatically improve pain control and sedation of injured warfighters. A deployable closed-loop system would be a medical force multiplier that significantly improves care, safety and outcomes. Improved treatment of acute pain and stress also could decrease the incidence and severity of post traumatic stress disorder (PTSD).
A major obstacle that has blocked clinical use of target controlled infusion anesthesia (TCIA) has been the lack of a sensor that can detect the administered drug in blood or exhaled breath in a clinically relevant manner. Drug detection in combination with relevant physiologic monitors and control algorithms could overcome regulatory hurdles and permit widespread implementation.
Synergism between multiple medications, complementary technologies (eg, integrated pain/psychological assessment tools, noise cancelling headphones) and alternative therapies (eg, biofeedback, music, and games) could further augment treatment of pain and stress in the injured warfighter.
PHASE I: An interdisciplinary team will conduct a detailed design and feasibility study to define a deployable automated analgesia and anesthesia system. The proposed platform should include relevant drug(s), drug sensor (serum or exhaled gas), control algorithm and a simple control/communication interface. Physiologic monitors, pain/psychological assessment tools, complementary technologies, and alternative therapies should be included as necessary to augment safety and treatment. A proof-of-concept device will be designed. The device should improve analgesia and/or anesthesia beyond the level of treatment provided by currently fielded devices (ie, ambIT patient controlled anesthesia and manually bolused/continuously infused intravenous anesthetic agents). The device should interface with current and planned military en route care, life support, and electronic health systems. Design should allow use in military operational environments, vehicles, and facilities. Drug(s) dosing, detection and control as well as device weight, size, power requirements, ruggedness, single/lifetime operational use, and cost of production will permit assessment of utility and feasibility of prototype device fabrication in Phase II. Phase I deliverables include a detailed plan for design, fabrication, and experimental evaluation of the prototype system within Phase II.
PHASE II: Based on the detailed design from Phase I, a prototype deployable automated analgesia and anesthesia will be fabricated. The performance of the prototype will be quantitatively tested and characterized in an appropriate animal model. Initial clinical testing to meet military and FDA requirements will begin.
PHASE III: In this phase, detailed market analysis, application selection and commercialization will occur. Additional testing to meet military and FDA requirements will be completed and clearances obtained. The successful system will be presented to the appropriate Army and DoD acquisition authorities for consideration of initiation of technology insertion into the Military Healthcare System. Additional funding may be provided by DoD sources but the awardee must also look towards other government or civilian funding sources to continue the process of translation and commercialization. A deployable automated analgesia and anesthesia system will improve analgesia and sedation of injured warfighters across roles of care.
REFERENCES:
1. Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology 2006;104(4): 686-95.
2. Pambianco DJ, Pruitt RE, Hardi R, Weinstein ML, Bray WC, Kodali VP, Vargo JJ, Schubert T. A computer-assisted personalized sedation system to administer propofol versus standard-of-care sedation for colonoscopy and esophagogastroduodenoscopy: a 1,000 subject randomized, controlled, multicenter, pivotal trial. Gastroenterology 2008; 135:294.
3. Bourgoin A, Albanèse J, Léone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13.
4. Manberg PJ, Vozella CM, Kelley SD. Regulatory Challenges Facing Closed-Loop Anesthetic Drug Infusion Device. Clinical Pharmacology & Therapeutics 2008; 84 (1): 166–169.
5. Takita A, Masui K, Kazama T. On-line monitoring of end-tidal propofol concentration in anesthetized patients. Anesthesiology 2007; 106: 659-64.
6. ambIT in the Military (http://www.ambitpump.com/section/ambit-in-the-military)
7. Holbrook TL, Galarneau MR, Dye JL, Quinn K, Dougherty, AL. Morphine Use after Combat Injury in Iraq and PostTraumatic Stress Disorder. N Engl J Med 2010; 362:110‐7.
KEYWORDS: Automation, Patient Controlled Sedation, Totally Intravenous Anesthesia (TIVA), Target Controlled Infusion Anesthesia (TCIA), Opioid, Ketamine, Propofol, Pain, Post Traumatic Stress Disorder (PTSD)
OSD10-H06 TITLE: Development and Integration of Next Generation Haptics into Medical Simulators
TECHNOLOGY AREAS: Biomedical
OBJECTIVE: To develop and commercialize the next generation prototypes and products using haptic technologies as components of medical simulators and potentially other related applications. These prototypes and/or products need better delineation of different tissue properties, e.g. discernable delineation between tissues such as fat, connective tissue, muscle, tendon, bone that can be applied onto / imbedded into mannequins and better sensing technologies in mannequin-and / or virtual reality based simulators. Successful efforts will increase the sensitivity of two point proprioception, better delineate between tissue properties that span the range of living tissue, e.g., fat, connective tissue, tendons, sheaths, smooth muscle, striated muscle, cartilage, and boneto name a few. Additionally, this prototype should have the sense of “slickness and stickiness” that tissue fluids exhibit. Submission of data from an independent source (another organization) is preferred in addition to the organizations own internal studies which are to be included in the outcomes.
DESCRIPTION: Haptics is the study of the sense of touch in humans and machines. Some within the medical community believe haptics is a much needed modality for the gamut of learners to learn, demonstrate and master skills and procedures. Some students learn by visuals, some by auditory inputs, and still others through touch. There are results which demonstrated that the introduction of haptics within medical simulators has benefitted the learning curve of the student, while some others have demonstrated that haptics is either a distraction or may provide inappropriate feedback to the learner [1, 2, 3, 4]. In addition, some aspects of the sensory of touch seem to be absent, e.g., range of warmth to the touch. Living sensory receptors, e.g., Merkel’s disk, Meissner’s corpuscle, Ruffini’s corpuscle, Pacinian corpuscle, hair receptors, and trans-membrane proteins provide some many ways humans can sense touch, pressure, and temperature, that it is not wonder that humans have not been able to reproduce this sense of touch mechanically, especially in a robust interface device, based on an open architecture design, and cost effectively. The lack of consensus among experts in the field regarding the effectiveness – or even appropriateness –of haptics suggests a need for continued research. It is not ethical to train novices with inappropriate inputs and it may put the safety and outcome of the patient at risk.
The following performance metrics / outcomes should be met (in no particular order) in a consistent, reproducible, and robust matter. The prototype / product will:
• allow for two point proprioception – preferably detecting two points that are less than 0.6 mm apart when being detected by one finger
• distinguish between different tissue properties spanning the range from fat to bone and several tissues that are distinguished in between. (We prefer capability to clearly distinguish at a minimum 5 distinct tissue properties).
• sense the presence of fluids / fluid properties, e.g. slickness, congealing blood.
• distinguish variations in temperature within a +/- 6.5 F of 98.6 F ( ~+/- 3.0 C of 37 C): NOTE, some literature has 98.2 F / 36.8 C as normal: the emphasis is on having a range.
• elicit muscular fasciculation (muscle spasms / seizures)
• have different textures that span the range of tissue properties from fat to bone and also have receptors that detect minute differences in both amount and type(s) of forces (compression, shear, and torsion) and can also delineate, measure, and report these components both accurately and consistently.
• be ergonomically compatible with the typical instruments that a surgeon, interventionist, and other healthcare professionals use and span the range between physical examination (fingers), through needles / catheters to surgical instruments (trocars, laparoscopic instruments, robotics).
• provide a report(s) of findings / results - will be done comparing the prototype to tissue. Compare various metrics such as stretch, puncture (curved needle and/or IV needle), as well as frictional characteristics (fluid, fat, muscle).
PHASE I: Prepare a feasibility plan for development of the components of the sense of touch into a “system” or “interface”. By the end of Phase I, a proof of concept will be completed and ready for presentation. Phase I final report with the preliminary generated results and anticipated design requirements are also necessary; predicted system requirements would be beneficial in the report.
PHASE II: Develop and demonstrate a functional working prototype of the potential system, interface, or physical tissue materials. Develop / report plans for scalability to a potential commercialize entity as well as design and prototype / product specifications for the anticipated commercialize entity.
Additionally, Phase II will provide data from an independent evaluation of the prototype -- especially of the potential capabilities and the content that the system, interface, and/or tissue materials are intending to replicate. Evaluation by military personnel (minimum of two independent evaluations) and report of evaluation of product is necessary. A final report of the evaluation study is required, including the data and outcomes, as well as submission of abstract to peer review type journal and/or public forum such as a conference.
PHASE III: Fully robust, ergonomic, cost-effective, manufactured commercialize product. Manufacturing capabilities and scale up plans provided. Test results on robustness, shipping, electrical safety testing, accuracy, consistency, and comparability to current existing methodologies are required. Specifications of manufactured product as well as manufacturing process need to be prepared and finalized.
REFERENCES:
1) Caroline G. L. Cao, Mi Zhou, Daniel B. Jones and Steven D. Schwaitzberg, Can Surgeons Think and Operate with Haptics at the Same Time? Journal of Gastrointestinal Surgery Volume 11, Number 11 / November, 2007, Received: 11 May 2007. Accepted: 24 July 2007. Published online: 21 August 2007. Poster presented at DDW/SSAT May 20–24, 2007, Washington, DC.
2) Louise Moody, Alan Waterworth, John G. Arthur, Avril D. McCarthy, Peter J. Harley and Rod H. Smallwood, Beyond the visuals: tactile augmentation and sensory enhancement in an arthroscopy simulator, Virtual Reality1359-4338 (Print) 1434-9957 (Online) Volume 13, Number 1 / March, 2009 59-68, Received: 16 February 2006 Accepted: 9 September 2008 Published online: 4 November 2008
3) Lukas A. Batteu, Alan Liu, J.B. Antoine Maintz, Yogendra Bhasin, Mark W. Bowyer, A Study on the Perception of Haptics in Surgical Simulation, Lecture Notes in Computer Science, Volume 3078/2004 185-192
4) Sanne M.B.I. Botden, Jack J. Jakimowicz, What is going on in augmented reality simulation in laparoscopic surgery? Surg Endosc. 2009 August; 23(8): 1693–1700.
KEYWORDS: Haptics, Force-feedback, Touch, Medical, Simulation, Simulator
OSD10-H07 TITLE: Deployed First Responder Course of Action (COA) Evaluation and After Action Review (AAR) Tools
TECHNOLOGY AREAS: Biomedical, Human Systems
OBJECTIVE: The objective of this topic is to develop a tool that fuses information from a variety of mediums/agencies during humanitarian support operations, allowing rapid development, evaluation, and execution of courses of action (COAs) and provide performance feedback in the form of AAR for training and live operations.
DESCRIPTION: Lessons from both the Hurricane Katrina relief effort as well as the observations from the Haitian earthquake humanitarian support show the tough challenges faced by humanitarian agencies to work together, seamlessly sharing limited resources and changing information (i.e. logistical details, accessible transportation corridors, and details on when and where supplies and support infrastructure are located, updates from in-the-field first responders, etc.) while accomplishing their individual and common objectives. While individual agencies might be well trained and equipped, interoperability with other agencies is difficult for several reasons: these humanitarian agencies are responding to situations where time is a limited commodity and lives of many people are at stake; there is a delegate balance that must be achieved by collaborating with resources and information to develop unified COAs throughout the operations, and there are limited opportunities to train together and improve the process for developing the most appropriate COAs prior to these catastrophic events. The limiting factors for these difficulties are twofold: 1) the technologies utilized by each agency are not necessarily interoperable, making knowledge sharing for optimal COA development difficult and 2) a technology does not exist that can provide performance feedback of COA development and implementation during real-time and training exercises. This effort will develop an innovative technology that can ingest and fuse the information from the various agencies and sources together in a clear and concise method utilizing advanced visualization techniques such as: two and three dimensional displays, virtual terrain boards, and common operating pictures (COPs) as examples, for rapid COA development, evaluation, and execution by Watch Commanders. The technology to be developed will integrate the decision support tools and systems already in existence not designed to work together and are used by the various agencies that respond during these relief efforts. This tool must be capable of not only ingesting but also injecting appropriate information back to the appropriate persons or agencies in order to execute the COA objectives once a plan has been developed, evaluated, and selected. Furthermore, this tool will provide dual use by incorporating an After Action Review (AAR) feedback and assessment capability for teams to evaluate and discuss mission execution. This tool will facilitate improved knowledge sharing, COA decision making, and development of novel COA models for future mission preparedness in interoperable contexts.
PHASE I: Will result in a proof-of-concept technology demonstration using 2 sample scenarios which shows the capabilities of each component and model of the system. Phase I will also result in a detailed analysis of current and past humanitarian operations COA related issues, difficulties, and lessons learned.
PHASE II: Will build upon Phase I to fully develop, refine, test and evaluate the high fidelity visualization component and method for ingesting the information from several agencies and sources of information. This will include the models and methods used to collect, analyze, and provide decision support for COA development, selection, and execution as well as the real-time updates based on new information. Phase II will fully integrate the AAR portion and performance monitoring piece into the overall system.
PHASE III DUAL USE COMMERCIALIZATION: The effort will supply a capability for first responders and humanitarian agencies to be used not only in real-time operations but also as a training tool to provide a performance feedback capability that currently does not exist. Potential users could be from a number of agencies (military and civilian) that must receive and analyze large amounts of information while planning and executing a plan or COA.
REFERENCES:
1. Bisantz, A., Pfautz, J., Stone, R., Roth, E., Daniels, G., & Fouse, A. (2006). Assessment of Color Variables for Displaying Meta-Information on Maps. In Proceedings of Human Factors and Ergonomics Society 50th Annual Meeting. San Francisco, California.
2. Eggleston, R. G. & Whitaker, R. D. (2002). Work-Centered Support Systems Design: Using Organization Frames to Reduce Work Complexity. In Proceedings of Human Factors and Ergonomics Society 46th Annual Meeting, (pp. 265-269). Santa Monica, CA: Human Factors and Ergonomics Society.
3. Means, B., Salas, E., Crandall, B. & Jacobs, T. O. (1993). Training decision makers for the real world. In G. Klein, J. Orasanu, R. Calderwood, & C. E. Zsambok (Eds.), Decision making in action: Models and methods (pp. 306-326). Norwood, NJ: Ablex.
4. Salas, E., Bowers, C. A., & Cannon-Bowers, J. A. (1995). Team processes, training, and performance. Military Psychology, 7, 53-139.
5. Wellens, A.R. (1993). Group situational awareness and distributed decision making: from military to civilian applications. In N.J. Castellan, Jr. (Ed.), Individual and Group decision making.
6. Additional Q&A from TPOC in response to FAQs, uploaded in SITIS 8/12/10.
KEYWORDS: Humanitarian Training, Decision Support Training, Rapid COA Development, COA Evaluation, COA Execution, Performance Feedback Monitoring, AAR, Assessment, Information Fusing
OSD10-H08 TITLE: Medical Gaming
TECHNOLOGY AREAS: Biomedical, Human Systems
OBJECTIVE: To develop a web-based serious medical game that covers point of injury, medical transport to field hospital or Theater Hospital, critical care air transport to level 1 trauma hospital in theater or CONUS.
DESCRIPTION: A web-based serious medical game is important for future medical training of all corps. It serves as a realistic platform for learning and enables individuals to manage difficult medical cases prior to actual patient care. Serious medical gaming will incorporate existing clinical practice guidelines and will teach cognitive skills or serve as refresher training.
The gaming system should have the capability to integrate with overarching virtual medical training world, but not require it to operate. Serious medical game should be web-based. The virtual environment should be reconfigurable to all environments of military medical training: Expeditionary Medical Support (EMEDS) or Air Force Theater Hospital, Field Hospital (Forward Surgical Team), Critical Care Air Transport Team (CCATT), Aeromedical Evacuation (AE), pre-hospital and hospital care, etc. The game should have seamless transition between all virtual environments and medical care. It needs to have the latest Shareable Content Object Reference Model (SCORM) compliance. User and patient avatars should be able to move between environments within the game. User avatars should be able to monitor patient avatar physiology status and intervene. Patient avatar physiology status will be tracked at all times and recorded for performance metrics. Performance feedback and recommendations will be tracked, archived and given to the user after completion of the game. System administrators will be able to change virtual environments, patient avatars and scenarios easily to add new medical requirements and performance metrics to individual medical scenarios. This gaming system will be able to fully integrate with the virtual medical training world that will be developed for the AFMS Medical Modeling & Simulation program and will meet all DoD Information Assurance Certification and Accreditation Process (DIACAP) and Information Management/Information Technology (IM/IT) security requirements.
PHASE I: Provide a detailed concept with early prototype of medical gaming software that provides training from point-of-injury throughout continuum of care. Demonstration of the applicability to all fields of military medical training including EMEDS, CCATT, AE, pre-hospital and hospital care, etc through a developed medical scenario. Performance metrics and standardized medical instruction embedded into medical game.
PHASE II: Further development of prototype from Phase I based on results. Demonstrate, test, validate, and refine the developed medical game. Work toward implementation to entire Air Force Medical Service via accessibility online and integrate with developed AFMS virtual environment for ease of use. Design from Phase I should be finalized during Phase II.
PHASE III Commercialization: Multiple players and team training can take place in the virtual environment by accessing the fully developed medical game. Multiple medical scenarios available for various medical training procedures. The medical game can be implemented DoD-wide and utilized by all services for gain of medical knowledge by exercising cognitive skills and team training. There is a need for geographically isolated teams to interact and train together virtually from remote locations prior to deployment.
REFERENCES:
1. “Serious Games.” Federal Computer Week. 16 April 2007. 31 May 2010 <http://fcw.com/Articles/2007/04/16/Serious-games.aspx?Page=3&p=1>
2. Stone, Robert. “Serious Gaming – Virtual Reality’s Saviour?” 31 May 2010 <http://www.seriousaboutgames.com/.../Stone%20Keynote%20Paper.pdf>
KEYWORDS: KEYWORDS: medical game, EMEDS, CCATT, AE, SCORM, DIACAP
OSD10-H09 TITLE: Synthetic Tissue Trainer
TECHNOLOGY AREAS: Biomedical, Human Systems
OBJECTIVE: To develop a stand-alone synthetic tissue trainer to substitute for live animal tissue training.
DESCRIPTION: The Air Force Medical Modeling & Simulation Program has a need for a stand-alone synthetic tissue trainer that is a comparable replacement for live tissue and can replicate live tissue and tissue-tool surgery. The synthetic tissue model will have the functional characteristics of biological systems and will have similar characteristics as live tissue to include skin, fascia, arteries, veins, and organs. Synthetic tissue will also be organized to simulate normal human anatomy. In addition, the tissue will be able to simulate massive hemorrhage. The system should support tissue-tool surgery using the same surgical equipment as live tissue (scalpel, sutures, retractors, bovie). The system will also support surgery and other invasive procedures that may include but will not be limited to: Suturing, penetrating injuries of major organs, arterial and venous injuries, fasciotomy, massive intrathoracic and intraabdominal hemorrhage, cricothyroidotomy, chest tubes, central lines, venous cut down, orthopedic surgery, cardiovascular surgery, burns and debridement of soft tissue wounds, tendon/nerve repair, genital trauma repair, alimentary tract surgery, abdominal surgery, thoracic surgery, vascular surgery, head trauma surgery, oral/mandibular surgery, and neurosurgery.
The system should be able to simulate physiological parameters of blood pressure, respiration, pulse, etc. Finally, the synthetic tissue trainer must be mass producible allowing for the training of multiple individuals. Replacement parts should be obtained quickly and at reduced cost. The system will also have reusable components.
PHASE I: Identify and define various invasive procedures that can be trained on enhanced synthetic tissue. Early prototype should simulate normal human anatomy and massive hemorrhage for live tissue models. Investigate processes for developing cost efficient synthetic tissue models.
PHASE II: Develop, demonstrate, and validate early prototype of synthetic tissue. Must simulate realistic biological function of proposed tissue. Construct and demonstrate the operation of the prototype and refine any inaccuracies through extensive review with medical subject matter experts (SMEs). Develop processes for production and ensure quality control.
PHASE III Commercialization: Military medical personnel will be able to perform invasive procedures utilizing simulated synthetic tissue that replicates biological function. Once all complex invasive procedures are developed synthetically, the goal is to replace live animal training. This not only is an advantage for all DoD personnel, but also can be utilized throughout medical industry in civilian medicine as well. Provide practical implementation across medical industry that will sustain medical training in the absence of utilization of live tissue and even perhaps enhance training with readily available supply of synthetic tissue.
REFERENCES:
1. Sakezles, Christopher. “Synthetic Human Tissue Models Can Reduce the Cost of Device Development.” Medical Device Technology 20 Jan-Feb 2009.
2. Torkington, J., Smith, SGT, Rees, BI, Darzi, A. “The role of simulation in surgical training.” Ann R Coll Surg Engl 82 2000: 88-94.
KEYWORDS: Synthetic tissue trainer, live tissue, biological system, tissue-tool surgery, human anatomy, physiological parameters