By Mr. Doug Wright, Medical Devices ModernizationApril 4, 2018
The Army's modernization strategy has one focus: Make Soldiers and units more lethal to win our nation's wars and come home safely. Lethality is important, but so is survival. That's why medical equipment modernization is just as critical as the modernization of other Army resources.
The way the Army delivers medical care on the battlefield is dramatically different than it was 100 years ago, or even 10 years ago. Every war or conflict offers lessons that improve lifesaving medical care on the front lines, which is why the survival rate for injured warfighters is higher than it has ever been.
At the U.S. Army Medical Materiel Agency (USAMMA), a subordinate organization of the U.S. Army Medical Research and Materiel Command (USAMRMC), we work to design, develop, deliver and sustain new medical capabilities to further strengthen Soldier survivability.
But what about the capabilities we already have? As an organization we knew that we needed to make sure we were providing the most up-to-date medical materiel solutions. So, in November 2017, USAMMA stood up the Medical Devices Modernization Directorate, a new program management office solely focused on medical device modernization. It is a small but robust office of product managers, maintenance experts and logisticians who, in collaboration with the rest of USAMMA, chart the "life expectancy" of our fielded medical devices and create strategies to replace and modernize them. While medical materiel modernization was not a new mission for USAMMA, reorganizing to create a new team focused entirely on this effort will allow us to provide better life cycle management of our inventory of fielded medical devices within the Army.
Army clinicians and medics often see or hear about a new medical device or capability available to civilian medical personnel and wonder: Why don't we have that? The answer to this question isn't simple. and, fFrankly, there are often many reasons why a medical device used in a hospital stateside will not work in a field environment.
However, in some cases, the answer is that you we don't have it--yet. We are continually watching the market, too, and completing regular analysis to identify commercial off-the-shelf products that improve medical capabilities and reduce our logistical footprint. These items may be more easily maintained on the unit level, or they could be more cost-effective. Our aim is to buy and field medical devices that are smaller and lighter than current versions, in order to ease the shipping and transportation burden.
Other critical reasons for why we must modernizeation include changes to current practice or modification to clinical practice guidelines. When we identify that fielded medical equipment no longer meets current standards of care, we modernize. An example of this would beis the video- assisted laryngoscope, a tool that helps health care providers intubate patients to re-establish breathing. When we have evidence of technology that could significantly improve the standard of care--while being practical for use in deployed settings--we modernize.
Technical refresh is another primary driver of medical materiel modernization. When we find that we have items in our inventory that we can't procure, maintain or sustain anymore, or are nearing obsolescence, we must replace the existing capability. This is actually one of the more complicated parts of modernizatingmodernization ofon of medical equipment, because medical technology is very fast-moving. .
If we procure a specific device from a company, there is no guarantee that the same make and model will be procurable five years later, which has second- and third-order effects on maintenance and purchase of repair parts. When this happens, we often must modernize that fielded capability by competitively procuring a comparable device that meets all of the essential characteristics of the requirement.
Where possible, when we modernize we also seek to find a joint solution when we modernize that can be used by not only the Army but also the 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 solutions to a few devices and then conduct rigorous testing to ensure that the final device will work in an austere environment, 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 important when addressing casualties 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 differentce piece of equipment.
One recent example of modernization done right is the Portable Digital Radiography System (PDRS), which we began purchasing and fielding in 2017. The PDRS is smaller, lighter, less expensive and more cybersecure than previously fielded systems.
The 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. The two older devices cost a total of $126,000. However, by combining these systems into the PDRS, which costs about $69,000, the Army realizes a savings of roughly $57,000 for each replaced set. The 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.
The 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. The Risk Management Framework integrates security and risk management activities into the system development life cycle. The 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 cybersecurity requirements, so users know that the device we are fielding is secure.
One way we try to deliver the best solutions 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 quicker faster and for less moneycost than if we had to start from scratch. This also helps USAMRMC invest its development dollars toward solutions that are specific or unique to the warfighter, such as a vaccine to protect military trainees from the aAdenovirus, a common cause of respiratory illness. There is no aAdenovirus 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 substantially equivalent to medical equipment already on the market, a manufacturer may not be required to submit premarket approval to the FDA and can market its equipment immediately. If that new equipment is not equivalent, the company must submit a premarket approval to the FDA, a process that can take several months or even years, depending on the complexity of the product under review. Fortunately, USAMRMC provides regulatory support to help Army medicine as well as our corporate partners navigate FDA clearance or approval.
While USAMMA's Medical Devices Modernization Directorate is still relatively new, our vision is to ensure that we provide today's and tomorrow's warfighters 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, (listed in alphabetical order):
• Chromatographic Gas Mass Spectrometer
• CT Scanner for Field Use
• Field Portable Suction Apparatus
• High Capacity, Radiographic and Fluoroscopic X-Ray Apparatus
• Human Ultrasound Diagnostic System
• Infusion Pump Analyzer
• Medical Oxygen Generation System
• Ophthalmic Diathermy Apparatus/Vitrectomy System
• Pneumatic Tourniquet System
• Programmable Surgical Suction Apparatus
• Surgical Binocular Microscope
• Ultrasonic Ocular Scanner
• Veterinary Ultrasound Diagnostic System
• Video Assist Laryngoscope Set
Superior weapons are important. But we can't win without lethal manpower, and that means keeping Soldiers alive to fight another day.
For more information, contact USAMMA at email@example.com.
This article will be published in the April -- June 2018 Army AL&T magazine.