By Mr. Jeffrey M Soares (Army Medicine)April 25, 2018
In the world of Army Acquisition, some of those involved believe the road to product development is often quite bumpy. However, if you ask Kathleen Berst, Deputy for Acquisition at the U.S. Army Medical Materiel Development Activity at Fort Detrick, Maryland, she will tell you -- rather adamantly, in fact -- that the current acquisition process is a very flexible one that can accommodate any of those bumps.
"When many people hear the word 'acquisition,' they usually have a negative concept attached to it," said Berst. "Actually, this is truly a system with a lot of flexibility that allows us to be smart investors of government dollars -- to help us increase our chances of getting much-needed products to our Service Members as quickly as possible."
Briefly defined, Army Acquisition means precisely what one might think: it is the process of developing and acquiring products or services necessary for our military forces. Although the system was developed originally for items such as tanks, planes, weapons and other types of defense equipment, USAMMDA currently tailors this process to the unique aspects of military medical products and devices.
Although the acquisition process can take quite a bit of time from initial concept to fielding of the product, the USAMMDA team handles this task in expert fashion -- especially since it means savings lives on the battlefield and at home. Some items fielded or currently in development include blood products and vaccines, such as those for malaria and adenovirus, an aluminum rail system to convert a standard litter to an operating table anywhere, and a permanent vascular graft solution to salvage traumatized limbs.
As a subordinate command of the U.S. Army Medical Research and Materiel Command, under the direction of the U.S. Army Medical Command, USAMMDA's primary mission is to protect and preserve Warfighters throughout the world, and it stands as the premiere developer of world-class military medical capabilities. Therefore, the organization must work within the parameters of the Department of Defense's established acquisition process to realize the development and delivery of numerous items critical to the health and safety of our nation's military forces.
Col. John Ryan Bailey, USAMMDA commander, acknowledges the challenges within the current acquisition process, but he also realizes that the experience and knowledge his team brings to the table remains an important factor in the organization's achievements.
"The key to our success are the individuals assigned to USAMMDA, both military and civilian, who are acquisition professionals," said Bailey. "Many are certified as Defense Acquisition Workforce Program Managers, which only helps us to execute our acquisition mission in an effective and efficient manner."
Focusing on the Pathway
Berst certainly knows the acquisition arena quite well, having been involved in various aspects of medical acquisition for nearly two decades. Her role at USAMMDA is to ensure project managers and product managers have everything they need to remain successful in executing their respective programs. Typically, this will involve funding, personnel and various technical resources, among other things, for programs that include medical support systems, pharmaceutical systems, neurotrauma and psychological health, and tissue injury and regenerative medicine.
"Everything we do at USAMMDA is in direct support of the acquisition process," said Berst.
Not surprisingly, this point is supported by USAMRMC's Civilian Deputy Principal Assistant for Acquisition, Dawn Rosarius, who also serves as MEDCOM's Acquisition Career Management Advocate. In this role, Rosarius represents more than 820 Army Acquisition Workforce professionals to help ensure that each meets the established workforce requirements while also providing guidance regarding education, continuous learning points and various opportunities for career growth in the field.
"In Army Medical Acquisition, USAMMDA is one of the key organizations in moving products and solutions forward to our military," said Rosarius. "The group owns the majority of the project management teams for the USAMRMC -- they are extremely well-versed in the advanced development process and know this lane better than anyone else in the DOD."
As USAMMDA's higher headquarters, the USAMRMC manages and maintains the regulations established for the DOD's acquisition process, and Rosarius detailed the strengths of the command's guidance.
"The USAMRMC is a 'Lifecycle Management Command' [involved from early discovery of a product to final fielding and support], and this is a big factor in our success across the board," she said. "We involve our science and technology partners early in the development process, along with the experts on our integrated product teams. By synching the two together, we have a greater opportunity to find the best solution for our Warfighters."
"We are also making great strides in streamlining our acquisition processes, and we hope to start by cutting down our contracting timelines by about six months -- which often feels like a lifetime to our military forces in the field," she added. "When our Warfighters are asking for something they need to continue the fight, we must do all we can to get these products to them as quickly as possible."
Berst identified some challenging areas in the process that can be time-consuming and may hinder the expedited development of critical products. However, as she recently returned from a temporary duty assignment for the Army, she was able to convey a bit of positive news on this topic.
"I was very fortunate to be involved in the Army Futures Command Task Force, which is looking at new ways of accelerating leap-ahead technologies for our troops, and also hoping to speed up the overall timeline -- and cost -- between concept of need and delivery of solution," she said.
"It was an exceptional opportunity to learn from other Army groups, to see how other 'pieces' of the Army do business, and I left there feeling very blessed to be part of the Army Medical acquisition space -- we do a great job of utilizing the flexibilities that exist in the system within our lifecycle command," she continued. "In many ways, the concept they are hoping to realize for this new 'Futures Command' is very much what the USAMRMC is already doing in the medical space."
Forging Successful Partnerships
While USAMMDA does its part in the advanced development of critical products moving through the acquisition pipeline, it relies heavily on commercial partners in industry to complete this important task. As Berst explains, the organization looks for unique opportunities to partner with companies who already may have a technology that has a civilian market and is militarily relevant, but not necessarily military-specific.
"Everything we do is driven by a requirement," she said. "However, our requirement is probably not the only driver of our industry partner's development effort -- so the question we ask ourselves is, 'How do we integrate our requirement with the industry partner's strategy to deliver a commercially viable product that is sustainable and meets the military's need?'"
Berst highlighted the similarities between the DOD's business model and that of typical companies today.
"We both look at the same factors: How much will this cost? What is the need for this? What is the market? How long will it take to develop? What's the programmatic risk?" -- The bottom line is that it's an investment decision," she said.
She explained that, working within a relatively small budget, the Army must remain very diligent in its investment decisions, so it is always looking for partners with the greatest chances for success. The DOD simply cannot create a militarily unique product that leaves us as the only customer, as this would create the difficult scenario of having to solely sustain the product indefinitely.
However, when it comes to partnerships, those across the command may be just as important as the commercial ones established outside of the military for the advancement of critical products. Dr. Lawrence Lightner, project manager of USAMMDA's Pharmaceutical Systems Project Management Office, provides insight regarding this topic.
"As an advanced development command, USAMMDA has access to and the availability of multiple contracts and sites to conduct the pivotal testing of vital Army medical products," said Lightner. "For instance, with infectious diseases that are endemic in other countries of the world, we have command assets that include labs in Thailand and Kenya that have developed field sites to conduct clinical testing of products."
"Our DOD partners in these labs overseas are regionally focused and have access to populations that are directly affected by diseases we are trying to eliminate, so these locations remain extremely important with regard to product effectiveness testing," he continued. "The expertise available at these OCONUS [outside of the continental United States] laboratories is often not available in many pharmaceutical companies."
As mentioned by Lightner, contracting plays a major role in the acquisition process. He explained that a government contract provides a flexible mechanism for utilizing DOD funds to assist industry partners in a variety of areas. However, the Cooperative Research and Development Agreement, or CRADA, is a very important tool as well.
"The CRADA essentially affords the DOD a 'seat at the table' in contributing to decisions made by the industry partner," said Lightner. "Under a CRADA, the industry partner may provide funding to the DOD for specific activities, while the DOD can provide other material items to the industry partner for the advanced development process."
The result of this type of partnership is usually a win--win scenario: the industry partner ends up with a commercially profitable product that the DOD may purchase, generally at a reduced cost, for use throughout its military forces.
Again, the DOD cannot, nor does it wish to, solely sustain a militarily unique product for the sake of its Warfighters throughout the world. Simply put, it would not be a sound investment. Although some exceptions to this rule exist for products that are a DOD operational priority but have no civilian market, these cases are rare.
Despite being an effective system with modest flexibility, the Army's acquisition process still presents numerous challenges along the pipeline. Berst quickly lists three items that present problems to the USAMMDA team.
"For all of the requirements we have, and the gaps we're trying to fill, we have a relatively small budget to work with," she said. "This is the main reason we must be very selective in both our partnerships and our investments. We always seek out industry partners with the greatest chances for success, and an ability to contribute towards the product, especially because they are the ones who will profit from it in end.
"Also, we have a difficult time attracting and maintaining qualified personnel, because many who work at USAMMDA could earn more in the private sector -- but they choose USAMMDA because of our great mission.
"And related to this," she continued, "many of our staff may get frustrated at times with some current government processes that could use improvement. Our personnel are typically highly motivated go-getters who have a hard time dealing with some government processes that take longer than expected to complete. However, these processes were created for the right reasons, to ensure that everyone is a good steward of taxpayer dollars."
To move through the acquisition system more efficiently, the USAMRMC utilizes its "Decision Gate" process with each and every product that enters the pipeline.
Said Berst, "Decision Gate is the way the command has tailored the DOD acquisition process to acknowledge the unique aspects of the U.S. FDA-regulated products we develop, so we can avoid any artificial starts and stops in the program."
With event-driven milestones along the way, Decision Gate allows successful products to move along the development pathway. These milestones serve as "Go/No-Go" decision points to help weed out poor choices, ultimately saving resources for more fruitful efforts that can produce stronger products in the end.
As Lightner puts it, "Decision Gate provides a governance structure for the development of products from the tech base all the way up to fielding -- it makes the acquisition process stronger and more effective."
The Road Ahead
As we progress further into the 21st century, advancements in medical products and devices certainly will be seen, and our military forces will continue to request these in support of their mission. However, the development, production and fielding of these critical items will most likely be tempered by the Army Acquisition process of the future. The great strides made by those involved today will help to lessen the burden of those involved tomorrow.
And Rosarius clearly understands the impact of this.
"The Army realizes the importance of streamlining the current acquisition process, and it hopes to cut down the timeline from two years to six months," she said. "One of our ultimate goals is to provide solutions to the Warfighter much faster."
"When you have a two- to three-year process just to get a requirement approved, and technology is turning over every six to 18 months, the great risk is that the technology will become obsolete before it is even implemented," she continued. "That's another challenge for medical acquisition -- new sensors, new apps, new devices, new technology -- and we're doing our best to make things happen for quick-turn solutions."
"Streamlining for success" is a mantra used often by Rosarius, and she knows that USAMMDA is doing its part in helping to make this happen as quickly as possible, because the organization clearly realizes that our nation's safety and welfare depend on this.
"Effectively transitioning products, ironing out logistics issues, fielding items more quickly -- these are the things USAMMDA continues to work on so that we can ensure that everything is in place to move a product forward for the Warfighter in the shortest timeframe," said Rosarius. "And we need to create checklists to remind people of these critical functions every time."
Yes, the acquisition process may provide challenges to the expedited development of products, but as Berst reiterates, it also provides a system of checks and balances to ensure we field safe, effective, timely, affordable and sustainable solutions to our Service Members.
"Acquisition is just the business process the Army uses to make sound investment decisions at key milestones along the way, and everyone in industry does the same exact thing," said Berst. "The difference is that we look at the outcome for our Warfighters, rather than the monetary profit -- the 'profit' for us lies in saving and restoring as many lives as we can, and you certainly can't put a dollar amount on that."