Rapid Fielding
“Many technologists believe that advantageous innovations will sell themselves. … Seldom is this the case,” wrote Dr. Everett Rogers in Diffusion of Innovation. For example, only 3–5 percent of U.S. government inventions become commercial successes, according to one estimate in the defense medical community. There are many reasons: user awareness, resistance, lack of test funds and no transition path to industry, just to mention a few.
Processes are needed to rapidly bridge the gap between a technology’s invention and use. In the Department of Defense, these processes reside in the Director of Defense Research and Engineering’s Office of the Deputy Under Secretary of Defense (Advanced Systems & Concepts). It’s not the only defense agency moving technology, but this office’s processes focus on war fighting needs, building partnerships to meet them, and working with the defense community to insert technologies into various stages of the acquisition system.
The result has been rapid fielding. The Office of Advanced Systems and Concepts is best known for transition of the Predator unmanned aerial vehicle, going from concept to operational system in 30 months. However, its processes also have led to rapidly fielding the IED-handling “Buffalo” vehicle, biometrics to identify personnel in insurgency areas, and munitions that limit collateral damage in urban areas. These processes provide rapid innovation and flexibility in defense in an era of uncertainty and irregular warfare.
These processes also facilitate rapid fielding of medical technologies that are critical to our warfighters’ well-being. The processes below are available to aid agencies and programs seeking to accelerate fielding:
• Joint Capability Technology Demonstrations: Formerly Advanced Concept Technology Demonstrations. JCTDs address joint, coalition and interagency capability gaps. Each JCTD forms a partnership with a technology provider and war fighting command, and demonstrates a prototype in one to three years. If successful, it transitions to an enduring capability. (See www.acq.osd.mil/jctd/)
• Defense Acquisition Challenge: Searches for mature, innovative U.S. technologies, typically from small and medium enterprises, meeting war fighting needs. Items are tested in about two years, with some finishing faster. Successful items follow acquisition plans. Such procurements enable and speed RDT&E and avoid other costs. (See www.acq.osd.mil/cto/).
• Foreign Comparative Testing: Searches for readily available foreign technologies not available in the United States and meeting war fighting needs. Items are tested in about two years, with some finishing sooner. Successful items follow an acquisition plan. On average, the program has cut fielding times by five to seven years. Procurement also avoids RDT&E and other costs. (See www.acq.osd.mil/cto/)
• Technology Transition Initiative: Identifies technologies meeting DoD goals and requirements and helps accelerate the technology’s transition to an operational capability by an average of 24 months. (See www.acq.osd.mil/ott/tti/.)
• Technology Transfer Program: Moves DoD technology to industry for production and from private industry to DoD use. (See www.acq.osd.mil/ott/techtransit/.) One tool is partnership intermediaries:
• DoD TechMatch: Makes known available DoD technologies, lab capabilities and R&D opportunities. (See www.dodtechmatch.com/.)
• FirstLink: Links DoD labs to companies commercializing technologies for first-responders. (See www.dodfirstlink.com/.)
• TechLink and T2 Bridge: Facilitate technology transfer agreements between defense labs and industry, to include cooperative research and development agreements and patent license agreements. (See www.techlinkcenter.org/.)
• SpringBoard: Facilitates technology transfer and focuses on future scientists and engineers.
The following medical technologies have been or are currently aided by these processes:
• Airmedical Power System: Presently, medical equipment for Aeromedical Evacuation patients uses aircraft power supplies and generators. A Hydrogen Fuel Cell Power System from Jadoo Power could move with medical equipment, reducing logistics footprints by as much as 140 pounds. Its hydrogen canisters are rechargeable, have low temperature and pressure, and are approved for commercial aircraft by the Department of Transportation. The system is being evaluated by the Defense Acquisition Challenge program and sponsored by the U.S. Air Force Air Mobility Command.
• Anthrax Immune Status Test: Rapidly determines whether an individual is fully immunized against anthrax. The kit detects IgG antibodies in blood or saliva samples, binds them to antigens and produces a signal in less than 20 minutes. It can determine the need for a booster, as well as for triage following bio-terror incident. The Naval Institute of Dental and Biomedical Research developed the test, and TechLink facilitated a patent license agreement with Oasis Diagnostics Corp. The test is being reviewed by the Food and Drug Administration and availability is expected in two years.
• Battlefield Medical Information System—Tactical: This handheld device is used by battlefield medical personnel to record, store and wirelessly transmit data on injured warfighters. It also has a diagnostic capability with reference materials and treatment aids. The U.S. Army deployed and tested the devices in Afghanistan, Iraq and post-Hurricane Katrina relief operations. It is integral to DoD’s electronic medical records system. The software was developed by the U.S. Army Telemedicine and Advanced Technology and Research Center. TechLink marketed the technology and facilitated a license agreement with Logica CMG. The device also is used by U.K. forces.
• Blood Clotting Technology: An injectable solution for non-compressible bleeding and severe cases of hemorrhaging, multiple injuries and internal bleeding. The product is shelf-stable and readily useable near front lines and in emergency medical vehicles. Walter Reed Army Institute of Research developed the technology, and TechLink facilitated a commercial evaluation license with ProFibrix B.V. to conduct additional R&D and prepare for regulatory review.
• Cognitive Performance Model: A watch-like device, called “Actigraph,” which is worn on the wrist and predicts a warfighter’s ability to perform. The device records motions and assesses data. It also selects sleep time for optimal performance and identifies potential psychological problems. Walter Reed Army Institute of Research developed the technology and TechLink facilitated a license agreement with Ambulatory Monitoring Inc. Actigraph’s entry into the market is imminent.
• Controlled Release of Active Agents in Microtubules: This initiative is developing a bandage with micro-encapsulated agents—such as clotting agents and drugs—that can be released on a controlled basis to aid healing. The microcapsules will be made of low-cost materials such as halloysite clay. To aid this development, TechLink facilitated a cooperative research and development agreement between the Naval Research Laboratory and a company developing multiple consumer and military applications. The bandage is in early development stages.
• Dengue Fever Diagnostic Test: Uses fluorescent DNA probes and primers to rapidly diagnose dengue fever infection. It also permits stereotype identification. The test is ready-to-use and comes in a field deployable kit, thus helping maintain warfighter health and epidemic prevention. The Walter Reed Army Institute of Research developed the technology. TechLink facilitated negotiations with companies, eventually enabling a patent license agreement with Access Bio Inc. Its entry into the market is imminent.
• Epidemic Outbreak Surveillance: This Advanced Concept Technology Demonstration provides a surveillance system that rapidly identifies and warns of infectious diseases so that commanders can take appropriate action. The system uses advanced diagnostics based on human genome research. A pilot system at Lackland Air Force Base supported surveillance of a serious outbreak of adenovirus in 2007. This initiative is the result of partnership with U.S. Joint Forces Command and U.S. Air Force Surgeon General.
• Field Expedient Bleeding Simulation System: Prepares Army medics for horrific wounds caused by gunshots and IED explosions. The system simulates concurrent wounds, from a venal nick to a pulsing arterial hemorrhage. The system can be fitted to mannequins or worn by personnel playing casualty roles. The system was invented by an Army medic, Sergeant Lynn Randall King. FirstLink enabled a license agreement with Skedco Inc., which specializes in emergency medical systems. The system is available through General Services Administration and sponsored by Army Medical Research and Materiel Command. U.S. Army and Army National Guard units have purchased the system.
• Forward Trauma Management Sets for Special Operations Forces: Presently, these forces do not have an organic forward resuscitative surgical capability when rapidly deployed to undeveloped theaters. North Coast Outfitters’ trauma management set could help fill this gap with a multipurpose, lightweight medical table with several modules: critical care, dental, oxygen concentrator, oxygen storage, X-ray/ultrasound, refrigerated blood storage and power generation. This gear is being evaluated under the Defense Acquisition Challenge program and is sponsored by U.S. Special Operations Command.
• Freeze-dried Blood Plasma: This technology freeze-dries blood plasma, making it more readily available for frontline battlefield use. It was developed by Walter Reed Army Institute of Research. TechLink facilitated a licensing agreement with Entegrion Inc., which is evaluating the technology for commercialization and transition potential.
• Healing Antibiotic-resistant Wounds: This initiative is developing compounds that can disrupt formation of a bacterial biofilm, which inhibits antibiotics in treatment of wound bacteria. Such treatment would enable use of a wide range of antibiotics at lower dosages. To enable the development of such treatment, TechLink facilitated a collaborative relationship between Armed Forces Institute of Regenerative Medicine, U.S. Army Institute for Surgical Research and Microbion BioSciences Corp.
• Hearing Pill: Protects against noise-induced hearing loss. It contains N-acetylcysteine, an amino acid, which synthesizes antioxidants, protecting cochlear inner ear hair cells. The pill works best when taken before noise exposures, but also may help reverse recent damage. The pill was invented at San Diego Navy Medical Center as another way to protect hearing besides mechanical means. It was transferred to American BioHealth Group with help from TechLink, which enabled a license agreement. Food and Drug Administration approval is needed for physicians to prescribe the pill. The Technology Transition Initiative is funding the requisite clinical trials.
• Hemorrhage Control (Celox Haemostatic Granules): Used when bandages have difficulty stopping bleeding from deep penetrating wounds. The absorbent granules are poured or injected into the wound. Red blood cells react to the chitosan-based granules and form a robust plug. Effective clotting is achieved within minutes of the application. It does not generate heat, is easy to irrigate from a wound, and works on anti-coagulated blood. To meet demand, MilTech trained and assisted SAM Medical Products staff in scheduling, inventory control and productivity.
• Hospital Emergency Assistance Tool (HEAT): Essentially, this tool models a hospital’s surge capacity in a given situation. It collects and analyzes data on a hospital’s preparedness for mass casualties. Specifically, the tool assesses readiness in such areas as facilities, logistics, clinical operations, patient tracking and communications. Its development was enabled by a cooperative research and development agreement, facilitated by TechLink between Navy Bureau of Medicine, and Crisis Simulations International LLC. The first test involves a simulated pandemic flu outbreak scenario with Penn State Hershey College of Medicine.
• Human Liver Cell Line: An artificial liver device used to treat liver trauma from abdominal injuries. It enables retention of normal liver cell functions, as well as production of reliable and stable cells that will grow and divide indefinitely. The device was developed by the U.S. Army component of the Armed Forces Research Institute of Medical Sciences-Walter Reed Army Institute of Research. TechLink enabled a commercial evaluation license with HepaLife Technologies Inc. for the purpose of testing functionality and tumorgenecity of cells.
• Improved Infection Prevention: This involves development and evaluation of “bismuth-thiol.” It is seen as key to developing a gel for wounds that may disrupt formation of bacterial biofilms, which have complicated wound treatment. Ultimately, the gel would reduce wound infections, recovery times, hospitalization, long-term impairment and mortality. TechLink facilitated a cooperative research and development agreement between the U.S. Army Institute of Surgical Research and Microbion BioSciences Corp. for the purpose of jointly conducting R&D and evaluation.
• Improved Performance Environmental Control System for Medevac Helicopters: May improve heating and cooling in HH-60 ambulance helicopters, compared to present environmental control system. Produced by Enviro Systems Inc., the system has 25 percent better cooling capacity, is smaller and lighter and is expected to need fewer overhauls. The system is being assessed under the Defense Acquisition Challenge program and sponsored by the U.S. Army’s Program Manager Utility Helicopters.
• Improved Wheelchair: This is an improved design for a gravitybased, anti-rollback, wheelchair brake, which provides safety benefits for veteran and civilian users. Further development and commercialization of this improved wheelchair is being done through a cooperative research and development agreement between the Army Medical Command, Medical Department Activities and Accessible Designs Inc. TechLink facilitated the agreement.
• Joint Medical Operations: This Advanced Concept Technology Demonstration resulted in a medical command and control system. It tracks patients within the medical system, as well as shows medical assets—blood, supplies, equipment, beds and staff. The information is displayed on a Joint Medical Workstation, which saw initial use in Iraq in 2003. The workstation is a key component in the Theater Medical Information Program. This initiative was the result of a partnership with the U.S. Pacific Command and U.S. Army Medical Research and Material Command.
• Joint Medical Distant Support and Evacuation: This 2009 Joint Capability Technology Demonstration seeks to provide battlefield medical units with a reachback capability to forward resuscitative care facilities. It will improve support for casualty triage and treatment, and will potentially include a telemedicine capability, as well as unmanned aerial systems delivering medical supplies to battlefield areas. This capability is expected to reduce risks associated with casualty evacuations. The capability is expected to be operational in 2011. This initiative is a partnership with the U.S. Special Operations Command, U.S. Army and U.S. Marine Corps.
• Lightweight Splint: A customizable, immobilizing splint that is easy to apply. It also can be modified for multiple injuries. The splint is made of ultra-lightweight medical-grade foam/ductilemetal laminate. It was developed by SAM Medical Products and is being used throughout DoD. MilTech is helping improve inventory management and supplier sustainability so the company can meet delivery schedules.
• Malaria Vaccine Tool: The previously mentioned artificial liver device, the human liver cell line, is being used in development of a malaria vaccine. TechLink facilitated the license with Sanaria Inc., which is developing the malaria vaccine.
• Medical Situation Awareness in Theater: This Advanced Concept Technology Demonstration will provide commands with a decision support tool for medical situations. It fuses medical data related to personnel and environment into actionable information displayed on a Web portal. The system will support U.S. and coalition forces. This initiative is the result of partnership with U.S. Pacific Command and the Office of the Assistant Secretary of Defense for Health Affairs.
• Mini Combat Trauma Patient Simulation System: A computerized mannequin, made by Medical Education Tech Inc. The simulator breathes, bleeds, blinks, urinates, tears, secretes fluid and produces heartbeats and lung and bowel sounds. Moreover, it simulates varying combat traumas and reacts to treatments. If correctly treated, the simulator’s condition improves. If incorrect, the condition worsens. The system is being used to train Army and Navy combat medical personnel bound for Afghanistan and Iraq. It was successfully evaluated under the Defense Acquisition Challenge program.
• Mobile Oxygen Ventilation and External Suction System: A mobile life-support system, with suction, ventilation and oxygen, produced by Thornhill Research Inc. of Canada. It may meet the Marine Corps’ need for transporting post-operative patients by air. The system may increase critical care safety and flexibility during transport. The system is being evaluated under the Foreign Comparative Testing program. The Army, Air Force, U.S. Special Operations Command and Department of Homeland Security are also interested in the system.
• Paromomycin for Treating Cutaneous Leishmaniasis: Made by TEVA Pharmaceuticals, Paromomycin is a topical treatment for a serious medical threat to warfighters deployed in Iraq and Afghanistan. Cutaneous leishmaniasis, or CL, typically presents itself as ulcerous skin lesions, developing weeks to months after an individual is bitten by an infected sand fly. In a recently completed clinical trial, Paromomycin proved to be over 90 percent effective in treating this disease. Paromomycin is being assessed under the Defense Acquisition Challenge program and is sponsored by the U.S. Army Medical Materiel Development Activity.
• Pelvic Fracture Treatment Belt: IEDs have caused “open book” pelvic fractures—a fracture in the pelvis’ middle—which are life-threatening because of internal bleeding. They are also difficult to treat. An Office of Naval Research study identified optimal pressure and where best applied to close open book fractures. SAM Medical Products used the results to develop the SAM Sling, with a buckle that “clicks” when proper pressure is reached. The sling is adjustable and fits all sizes. MilTech assisted the company with manufacturing and supply issues. SAM Sling is deployed and in use within DoD.
• Personal Oxygen Generators: These and air compressors are being qualified for mine–resistant, ambush-protected vehicle ambulance variants. Produced by Sequal Technologies and IGR Enterprises, they are safer than compressed oxygen in steel cylinders. Compressors weigh less than 20 pounds and reduce logistics, compared to 150-pound cylinders, which are shipped from the United States, refilled locally, or returned to the United States. Generators and compressors are being qualified under the Defense Acquisition Challenge program and sponsored by U.S. Army’s Medical Materiel Development Activity.
• Power-free Sterilization of Medical Devices: This technology uses chemical reactions to sterilize medical equipment and does not need external electrical power. Such a capability reduces cost and logistical support, and will allow users to sterilize medical devices in remote locations. Natick Soldier Center developed the technology and licensed it to ICA TriNova. MilTech is helping accelerate product design, which is being evaluated by Natick. The product is expected to be available for military use one year after Natick approval.
• Pseudofolliculitis Barbae Treatment for Enhanced Military Readiness, Safety and Personal Bearing: The Defense Acquisition Challenge program assessed the safety and efficacy of a treatment for Pseudofolliculitis barbae, called “ISWAP- 01,” produced by the ISW Group. This inflammatory skin disease affects appearance and the wearing of self-protection gear, such as gas masks. ISW-AP-01 successfully provided a self-medicating solution vice present laser treatment, and is sponsored by the Air Force Surgeon General.
• Rapid Tuberculosis Test: It is estimated that without a control effort this deadly disease will infect 1 billion people by 2020. This test assesses saliva to determine TB activity. It can be used in the field, requires no special training, and provides accurate results in 20 minutes—faster and cheaper than current methods involving trained personnel examining specimens under a microscope or analyzing chest X-rays. The test was developed by the Naval Institute for Dental and Biomedical Research. TechLink enabled a patent license agreement with Oasis Diagnostics Corp. Availability is anticipated in 2011.
• Red Blood Cell, Extended Life: This effort seeks to deploy a blood collection and storage system that will extend the life and functioning of red blood cells to at least eight weeks. This effort has involved the U.S. Army Medical Research and Material Command, the Food and Drug Administration and Hemerus Medical LLC. Recently initiated in vitro testing was funded with help from the Technology Transition Initiative.
• Scrub Typhus Assay: Scrub typhus is a debilitating and deadly tropical fever, endemic in the Asia-Pacific theater. This rapid testing kit uses a recombinant protein antigen to detect scrub typhus. The test was developed by the Navy Medical Research Center. TechLink facilitated a license agreement with Access Bio Inc., which is developing scrub typhus test kits for military and civilian use. These kits are being reviewed by the Food and Drug Administration. Availability is expected in about two years.
• Shockwave Therapy for Traumatic Wounds of the Extremities: Made by Tissue Regeneration Technologies Inc., this device uses painless acoustic pressures to treat traumatic soft tissue wounds and burns. Reportedly, it stimulates and accelerates healing. It is easy to use, with the applicator held near injured areas. The device is being assessed under the Defense Acquisition Challenge program and sponsored by the Walter Reed Army Medical Center. If successfully evaluated, it could be deployed to forward hospitals and treatment facilities.
• Special Medical Emergency Evacuation Device: Its acronym is SMEED. It was invented by Sergeant First Class Eric Smeed of the U.S. Army Institute of Surgical Research to lessen discomfort to burn victims. This lightweight, adjustable device attaches to evacuation litters and holds medical equipment needed for patient transport. It replaces the method of attaching equipment to patients. The device can be used in any DoD medical vehicle. TechMatch made the device known to industry. It was licensed to Impact Instrumentation Inc., which commercialized the device. DoD has purchased nearly 1,200 devices, which have been used in Afghanistan and Iraq.
• Stand-alone Patient Simulator: Made by Medical Education Tech Inc., this simulator results from spiral development of the mini combat trauma patient simulation system used to train combat medical personnel. This patient simulator is more robust and less expensive than its predecessor and does not require hook-ups to external power, compressed air, oxygen, nitrogen and carbon dioxide sources. The simulator is being assessed under the Defense Acquisition Challenge program and is sponsored by the Army Medical Simulation Center.
• Surveillance of Disease-carrying Insects: This is a remotecontrolled, solar-powered, field-deployable device that lures blood-feeding insects and detects the presence of diseases. The device can also identify specific insects by acoustic physiological patterns, such as wing beats and respiration. The device’s design and test protocol resulted from a cooperative research and development agreement between the Walter Reed Army Institute of Research and APTIV Inc. TechLink facilitated the agreement.
• Vaccine and Reagent Refrigeration System: AcuTemp’s field refrigerator for storing blood, plasma, vaccines and reagents. It is lighter and 20 times more reliable than current refrigerators, which have failed at a 90 percent rate within one to three months in the field. The system is being evaluated under the Defense Acquisition Challenge program and sponsored by the U.S. Marine Corps. If successfully evaluated, systems could support battalion aid stations, forward resuscitative surgery units, and shock trauma platoons. ♦