SUPPORTING THE FUTURE FORCE
with multiple companies and government laboratories, in addi- tion to several acquisition programs.”
“It is critical for us to maintain solid industry partners,” said Dawn Rosarius, USAMRDC’s principal assistant for acquisition. “Our labs and academic partners conduct the early research of candi- date technologies to reduce risk. With less risk, our PMs can then gain commercial industry partners to not only develop the capability we need for the warfighter, but also fund some of the development, sponsor FDA [U.S. Food and Drug Administra- tion] approval, and ensure a commercial market to lower our costs once FDA-approved.”
Within USAMRDC, other-transaction efforts focused specifically on prototypes are currently awarded through the aforementioned Medical Technology Enterprise Consortium (MTEC) program, which is a 501(c)(3) nonprofit corporation consisting of industry and academic organizations committed to developing medical tools that better manage, treat and rehabilitate those suffering from traumatic injuries on the battlefield. MTEC is organized and operated through Advanced Technology International via an award obtained through competitive solicitation in 2015. Since MTEC became fully operational in January 2016, USAMRDC has awarded 42 different prototyping projects through the consor- tium with $131 million in government funding, with private cost-sharing efforts kicking in an additional $24 million as of August 2019.
DEVELOPING NOVEL SOLUTIONS Leigh Anne Alexander can testify to the behind-the-scenes impact of other-transaction agreements. As deputy project manager for the USAMRDC’s Warfighter Expeditionary Medicine and Treat- ment Project Management Office, she has used the mechanism to try to help fill a high-priority capability gap via the continued
development of the Fast Onset Abdominal Management (FOAM) hemorrhage control device.
“We are trying to develop solutions that are not commercially available and very novel—solutions that industry wouldn’t other- wise invest in on their own,” said Alexander. “And so the ability to preconfigure the contracting agreement with options benefit- ing both sides was key.”
On the battlefield, certain types of injuries (and the eventual application of care to those areas) are naturally more complicated than others. While traumatic injuries to an arm or leg can be diagnosed relatively quickly and the resulting bleeding stanched with a tourniquet, traumatic injuries to the abdominal region— incidents of what is called noncompressible hemorrhage—require far more intricate care. As such, the FOAM device is designed to control severe intra-abdominal bleeding by delivering, into a Soldier’s abdominal cavity, a foaming agent that eventually expands and exerts pressure on internal organs and tissue, thereby stopping internal bleeding until the Soldier can be transported to a higher level of care. At that point, the injected compound can simply be washed away by the attending surgeon.
Te company behind the FOAM tool, Critical Innovations LLC was able to begin work on prototype delivery in just three to four months, using $600,000 in base other-transaction funding through the consortium. Further, the FDA granted the prod- uct its highly sought “breakthrough device” designation in an announcement in June. Alexander said the company is a full year ahead of schedule in terms of product development.
“Te approach that Critical Innovations took was fantastic because they were working with the end user in mind,” she said. “In the combat environment, you’ve got to think about the 18-year-old
A NEED FOR SPEED
Humacyte Inc., which developed the human acellular vessel, was able to accelerate the product by using other-transaction agreements issued through MTEC rather than going through a traditional Federal Acquisition Regulation-based contract. (Photo courtesy of Humacyte Inc.)
https://asc.ar my.mil
19
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
