CREATING SUCCESS OUT OF NECESSITY


base consists of 26 depots, arsenals and ammunition plants that manufacture and reset Army equipment.


Many government organizations have 3D printers used in the additive manu- facturing of parts or tool applications throughout DOD. Te DOD organic industrial base also uses additive manu- facturing to support prototyping and the sustainment of military components for aviation and other vital military systems. Tere has been a recent emphasis within the government to use additive manufac- turing to maintain the readiness of our military systems, but never before had full-scale production of medical prod- ucts been part of that equation.


Te public health emergency suddenly placed the ability to secure medical supplies at the fore of a different type of battle and prompted an entirely new way of thinking. Tere were skilled and dedi- cated workers across DOD at government facilities, but none had experience manu- facturing a medical device. Nevertheless, they were eager to help. Organizations like the U.S. Army Tank-automotive and Armaments Command’s (TACOM) Rock Island Arsenal started asking how they could use their extensive manufacturing capabilities to produce medical devices and who could point them in the right direction. Ultimately, they were pointed in the direction of Fort Detrick, Mary- land, and USAMMDA.


ANSWERING THE CALL One Tuesday evening last April, during a phone call with Dr. Ana-Claire Meyer, the senior clinical adviser in USAMRDC’s Office of the Principal Assistant for Acquisition, Meyer mentioned fielding calls from teams across DOD requesting advice as they worked to respond to urgent supply shortages in hand sanitizer, PPE and sample collection kits for COVID-19


78 Army AL&T Magazine Winter 2021


testing. She recognized that the DOD organic industrial base needed guidance on how to navigate the regulatory hurdles and meet the rapidly changing FDA guid- ance to mitigate critical shortages during the public health emergency.


In a single weekend, she had worked closely with the Naval Air (NAVAIR)


them through the regulatory and medical product development process, and make sure that their items are safe, effective and compliant.”


By combining our forces, DOD was able to organically manufacture and supply a medical product—for the first time ever.


Systems Command and TACOM to provide face coverings urgently needed across the fleet to enable full compliance with FDA regulations, which are not service- or military-specific. To implement these processes across DOD, she knew she needed assistance.


She thought our team at the Warfighter Expeditionary Medicine and Treatment Project Management Office may be able to help organize the effort across the enterprise.


“We have teams across the DOD with all of these great manufacturing capa- bilities that want to help in the COVID effort, but none of them have experience with medical,” she said. “We really need a team at USAMRDC that can help guide


Our team fully understands what it takes to develop and produce an FDA-approved medical item. Not only is the process long, it is also quite complicated. As its name might suggest, the Food and Drug Administration regulates not only food, but also drugs, biologics, vaccines and medical devices to protect public health. Te agency ensures the safety, efficacy and quality of these products. Our team at Fort Detrick was ready and eager to help, and it took just one phone call to pull the right players together.


Within a few days, the Additive Manu- facturing Working Group was born. Te primary intent of the working group is to expedite the delivery of medical prod- ucts in short supply during the pandemic through two approaches:


• Using the DOD organic industrial base to manufacture medical materiel.


• Ensuring the quality and compliance of medical materiel procurements from alternative suppliers in the face of criti- cal supply shortages.


Led by USAMMDA’s Warfighter Expedi- tionary Medicine and Treatment Project Management Office, the working group sought to help produce not only face masks, but also 3D-printed nasal swabs, face shields, protective barrier enclosures and N95 respirator masks.


Comprising 24 professionals across the USAMRDC enterprise with program- matic, regulatory, agreements, clinical, legal and intellectual property expertise, the working group has been a force multi- plier for DOD. To date, it has streamlined


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  |  Page 169  |  Page 170  |  Page 171  |  Page 172  |  Page 173  |  Page 174  |  Page 175  |  Page 176