Air Force, Navy and Marine Corps. Part of our process is to form joint working groups with the other services. Together, we conduct market research and identify essential characteristics that will meet the medical needs of all our care providers. In this process, we reduce potential solu- tions to a few devices and then conduct rigorous testing to ensure that the final device will work in an austere environ- ment, in the field, onboard a ship or on an aircraft, depending on the mission. We prefer joint products because they enable us to save on procurement costs and overall life cycle sustainment costs. Joint products also ensure that our care providers train and practice on the same devices—which is extremely impor- tant on the battlefield because the first responder may not necessarily be from the same service as the patient.
We also determine our modernization priorities based on mission requirements and operational threats. Changes to the mission, such as a need for improved en- route care capabilities because of longer medical evacuations, may mean we need a new or different piece of equipment.
One recent example of modernization done right is the Portable Digital Radiog- raphy System (PDRS), which we began purchasing and fielding in 2017. Te PDRS is smaller, lighter, less expensive and more cybersecure than previously fielded systems.
Te PDRS replaces two aging devices, an X-ray generator and an accompanying computerized reader system. It combines these capabilities into a single, lightweight X-ray unit intended for use by deployed medical, special operations and mortuary affairs units. Te two older devices cost a total of $126,000. However, by combin- ing these systems into the PDRS, which costs about $69,000, the Army realizes
a savings of roughly $57,000 for each replaced set. Te PDRS weighs less than half of the systems it’s replacing—174 pounds, including shipping container weight, versus 437 pounds, making it easier to transport. To date, the Army has procured 106 of these units and, as it is a joint solution, the Navy and Marine Corps have procured 46.
Modernizing medical devices also means ensuring that they meet the most current DOD cybersecurity requirements. Many modern medical devices need to connect to military computer networks to operate properly. To ensure that medical devices purchased by the government do not introduce security vulnerabilities, each must pass a series of security certification checks.
Te PDRS was the first Army medical device to receive
the Defense Health
Agency’s authority to operate under the new Risk Management Framework, a process that took more than a year to complete. Te Risk Management Framework integrates security and risk management activities into the system development life cycle. Te risk-based approach to security control considers effectiveness, efficiency and constraints because of applicable laws, directives, executive orders, policies, standards or regulations. Achieving an authority to operate under the Risk Management Framework demonstrates that this device complies with all of the current cyberse- curity requirements, so users know that the device we are fielding is secure.
FASTER, FASTER One way we try to deliver the best solu- tions
in the most time-efficient—and
cost-efficient—way is to leverage private industry. If the private sector already has spent research and development dollars to design a solution that may meet Army
needs, we may be able to work with the company to modify the product and field a capability faster and for less money than if we had to start from scratch. Tis also helps USAMRMC invest its devel- opment dollars toward solutions that are specific or unique to the warfighter, such as a vaccine to protect military trainees from the adenovirus, a common cause of respiratory illness. Tere is no adenovirus vaccine available to the general public, but the military offers one to recruits, saving roughly 150,000 training days that would have been lost to illness.
To field solutions to the force more quickly, we also consider the best way to efficiently navigate U.S. Food and Drug Administration (FDA) regulations. In some cases, if the FDA agrees that a new piece of medical equipment is substan- tially equivalent to medical equipment already on the market, a manufacturer may not be required to submit premar- ket approval to the FDA and can market its equipment immediately. If that new equipment is not equivalent, the com- pany must submit a premarket approval to the FDA, a process that can take sev- eral months or even years, depending on the complexity of the product under review. Fortunately, USAMRMC pro- vides regulatory support to help Army medicine as well as our corporate part- ners navigate FDA clearance or approval.
CONCLUSION While USAMMA’s Medical Devices Modernization Directorate is still rela- tively new, our vision is to ensure that we provide today’s and tomorrow’s warfight- ers with the updated medical equipment they need to save lives and rapidly return troops to the mission. To that end, we have identified more than a dozen pieces of equipment that we plan to modernize within the next two years, including, in alphabetical order:
HTTPS: / /
ASC.ARMY.MIL
107
SCIENCE & TECHNOLOGY
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156 |
Page 157 |
Page 158 |
Page 159 |
Page 160 |
Page 161 |
Page 162 |
Page 163 |
Page 164 |
Page 165 |
Page 166 |
Page 167 |
Page 168
