By Col. Matthew G. Clark, Dr. Renae Malek and Maj. Andrea Mountney
Disclaimer: The views expressed in this article reflect the views of the authors and do not purport to reflect the official views of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), United States Army, Department of Defense, or the U.S. Government.
The speed of innovation and development is a constant issue for the U.S. Department of Defense. Rapid acquisition is challenging when it’s unclear how to quickly achieve quality capabilities while streamlining programs. This is particularly difficult in the military, which organizational experts call a “coercive bureaucracy” that thrives on “oversight” (i.e., limited trust). This essay presents lessons learned over the last two years that illustrate ways to create an “enabling bureaucracy” that facilitates speed.
These methods resulted in greater readiness through two FDA-approved medical countermeasures, or MCMs, expanded use of an existing product, and a recently approved Middle Tier Acquisition effort for an opioid MCM. The newly approved MCMs of a new atropine autoinjector and the anticonvulsant midazolam are the first in 15 years for medical chemical defense, and the latter has even broader use affecting readiness. We learned that there are three core elements for streamlining: Listening through engagement, Leveraging opportunity, and Collaborating for speed and success. This “LLC” simplifies the “business” of effective acquisition streamlining.
Listening through Engagement
“Listening through engagement” created opportunity for streamlined product development. More involved than “active listening;” this involved dialogue (i.e., shared speaking and listening) between stakeholders, equities, organizations, and different nations. This was complex because each had different disciplines, cultures, subcultures, motives, and perception. Like in the military, we joke about the differences between and among the Services. Compound that with the numerous and often competing cultures of industry and different agencies. We engaged each openly and honestly, which also created challenges, but through challenge, transformational opportunities were created.
In short, Listening through engagement created opportunities for constructive change through an active process that created shared progress. We managed the contrast of creating spaces where teams could verbalize new ideas and take prudent risk, while also supporting an environment that pushed teams to find better business practices. This allowed the DOD 5000-series to move from being an immutable engineered template to the flexible guidance that it truly is.
Essentially, we witnessed that the engagement that created acceleration could only be achieved through trust. This meant that all engagements needed to demonstrate the qualities of character, competence, commitment, and reliability. We fought to avoid cynicism and autocracy, shared information openly, and even failed at times; those behaving contrary damaged our ability to progress quickly.
Obvious questions were “how should we engage” or “what could we do to create opportunities to engage?” Tools for effective engagement are standard practice. It started with a team vision, and creating a realistic plan to start dialogue—the details of the approach changed for different products but the vision did not. Once we had a vision and plan, only a strawman at times, it was broadly presented to stakeholders. Many pushed back, and that is where our team learned to listen closely rather than get upset.
Requests for information, tech watch, market surveys, and conferences all provided venues to engage industry and academia. Further, we used an Other Transaction Authority, or OTA, consortium as a target-rich environment. The key was that teams built the relationships that allowed for effective engagement and critical reviews of what was achievable. Interestingly, stakeholders sought challenges, particularly small businesses and academia—they loved hearing that something was impossible. These engagements provided the opportunity to learn about the reasonable art of the possible.
Additionally, beyond industry, our teams sought out rather than ran from detractors and engaged them in dialogue. In the Joint and Interagency medical space, that was usually requirements generators and the test and evaluation “authority” of the FDA, both of whom we engaged heavily. For each, our team frankly shared the biggest issues and goals while listening carefully for the elements that drive their “business.” This informed us about the energy that turned the flywheel of progress, which through this process, turned in our favor.
Lastly, we listened internally too. There was more than one group already supporting us who informed or resolved many of the issues we faced with streamlining; we only had to listen. Our people needed to be challenged, supported, and trusted to fully realize their potential; this one activity allowed us to make significant progress.
Leveraging Opportunity
Once teams developed momentum, how did they leverage additional opportunity? In our case, this involves drug and device development to FDA-approval and fielding.
We “Leveraged” both large and small pharmaceutical companies, start-ups, academics, and incubators for innovative ways to accelerate development. We sought solutions that have applicability outside of the military as an incentive because DOD requirements are dwarfed by the global civilian marketplace. The strategic use of Small Business Innovation Research programs and Cooperative Research and Development Agreements allowed us to mitigate risk and maximize test and evaluation of novel and existing technologies to deliver capabilities faster. Research and development collaborations with small businesses were generally more flexible than traditional defense contractors.
Developing MCMs is generally a 10-20 year process. There must be an understanding of technical, scientific, regulatory and customer requirements throughout the process. We communicated these elements through use of the Medical CBRN Defense Consortium, an OTA consortium where we leveraged broad Statements of Objectives and flexible contracting mechanisms for maximum industry participation.
Often the Fool’s Choice played out, where one is presented a dilemma, only a few options are seriously considered. The choice then becomes one or the other. However, more perspectives with diverse input created numerous viable alternatives, the choice then was not between two less desirable options, but was expanded to include solutions that leveraged unique partnerships between industry and government. Opening the aperture to see the complete picture and identify novel and innovative avenues became a means to find efficiencies to accelerate development not previously considered.
For us, the ultimate goal is decreased timelines and costs for the delivery of FDA-approved MCMs. This problem required new thoughts and processes between distinct organizations, each with its own reporting chain and funding. INFORMED (INteragency FORum for MEdical countermeasure Developers) is an interagency working group that engages the chemical MCM community in technical and scientific discussions, broaching topics that intersect both civilians and the military. The group helped us identify approaches for moving products through development pipelines. Participants include: the Medical Countermeasure Systems of JPEO-CBRND; Defense Threat Reduction Agency; U.S. Army Medical Research Institute of Chemical Defense; Edgewood Chemical Biological Center; National Institutes of Health (including CounterACT), Biomedical Advanced Research Development Authority, and the FDA. By leveraging interagency expertise we are successfully driving faster development through common understanding and consensus. This required pooling intellectual resources and promoting open, ongoing dialogue among U.S. labs, product sponsors, industry and academia experts, and regulatory scientists from the FDA.
We also leveraged international partners through data exchange agreements. Existing agreements allowed us to answer questions, avoid or reduce investment, and even conduct operational exercises through partners who dealt with similar challenges. Often the U.S. is seen as the only country investing, but we learned that this was a false assumption; we merely asked our international partners. This leverage is built upon quality relationships and it helped us avoid significant costs, eliminate research at various points, and develop concepts of use for urgent products where the requirements system was not agile enough to respond with a full concept of operations. At its crux, Leveraging opportunity was about finding shared purpose.
Collaborate to Speed and Succeed
As the final element of “LLC,” Collaboration in acquisition involved two or more groups working together towards a shared goal—delivering capability. Not to be confused with coordination, collaboration capitalized on strengths from across enterprises resulting in a synergistic and self-perpetuating output that was greater than the sum of individual components. While collaboration is a buzzword easily thrown into white papers and splattered across high-level briefings, its practical implementation was more challenging to realize.
Effective collaboration was more than roles and responsibilities outlined in a well-crafted memorandum or rigidly chartered meeting between organizations. Rather, our collaborations were flexible, dynamic, and organic where decision-making was decentralized to the lowest level possible. Institutional fiefdoms were dismantled; personal agendas were not tolerated; and obstructionist personalities were avoided or removed from the development process. This empowered the “sausage makers” to boldly, unapologetically, and most importantly rapidly react and adjust strategies and resources effectively. We found that the most productive collaborative teams were multidisciplinary cross-functional bodies that straddled government, industry, and users to bring the perspectives representative of all stakeholders—always working towards a shared goal.
Our high-functioning collaborative teams embraced the following characteristics: clear communication, diversity (including various perspectives), compromise, tolerance/trust, team-player mentality, reliability, and responsiveness. Conversations began with “how can we help?” or “what do you need from us?” and conflict resolutions revolved around principled negotiation to allow parties to reach agreement without jeopardizing relationships. Words like “me” and “mine” were replaced with “us” and “our,” and resources were proactively offered rather than reactively extracted.
Our two recent 2018 FDA-approved MCMs illustrate a “whole of government approach” in which the regulator and the regulated, including diverse users, found common ground through shared understanding and collaborative teams. Importantly, the DOD, Centers for Disease Control, BARDA, and FDA employed an innovative, collaborative and highly interactive approach that utilized working groups, emergency use authorizations and declarations, novel strategies, volunteer subject-matter experts from academia, and leveraged emerging legislative authorities (Public Law 115-92) to accelerate medical product development and provide capability at lightning speed. In the end, we delivered products to users significantly faster via an interim fielding capability at an accelerated timeline with reduced program costs.
Conclusion
For contrast, the LLC approach presented here intentionally offsets “coercive bureaucratic” behaviors that seemingly prevent rapid acquisition. Specifically, Listening through engagement countered uninformed, top-down, directives that were disconnected from how program management occurs at the tactical and operational level. Effectively Leveraging opportunities, relationships with other governmental agencies, available test and evaluation, and voluntary subject-matter experts, reduced costs by decreasing requirements to buy-down risk and it eliminated the need to fund all developmental activities. Lastly, listening through engagement and leveraging opportunity created the conditions for effective collaboration. Collaboration was the ultimate force multiplier in our limited resource environment. While competition has a place in some interactions, opportunities for collaboration between governments, agencies, and industry provided capability development synergy and speed.
In conclusion, we learned that the business of streamlining acquisition involves this “LLC.” Depending on the organization, community, or commodity, effective employment may require changes in thinking or culture. We learned that beginning locally and modelling what was required helped create an “enabling bureaucracy” in many ways. Listening through Engagement, Leveraging Opportunity, and Collaborating for Speed and Success seemingly was not easy for a competitive organization with a comparable mission. However, when adopted by participants and supported by leadership, these elements have generated the collaboration needed to benefit all and ultimately deliver capability faster. Our team’s performance over the last two years is a testament to these lessons.
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Col. Matthew G. Clark, PhD, PMP, is the Joint Product Manager for Chemical Defense Pharmaceuticals within Medical Countermeasure Systems at Fort Detrick, MD. The organization is in the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense. COL Clark is responsible for managing centralized research, development, acquisition, and integration of FDA-approved medical countermeasures against chemical, radiological, and nuclear threats. The products they develop are used by Joint, Interagency, and Multinational organizations. COL Clark has a Ph.D. in Behavioral Neuroscience from Rutgers University and a B.A. in Psychology from Coe College. He has extensive rapid and deliberate capability development experience in DOD Labs, Iraq, G-3/5/7 of the Army Staff, and USAMRMC and service at the U.S. Military Academy and the U.S. House of Representatives. He also has published on leader development and a host of military relevant topics, while also serving in nonprofit organizations serving the military and veteran community.
Dr. Renae Malek is currently the Acting Deputy Joint Product Manager of Chemical Defense Pharmaceuticals (CDP), a subordinate office to the Medical Countermeasure Systems Joint Project Management Office (MCS-JPMO) of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. She guides the daily operational activities for CDP, managing research, development and acquisition to achieve whole of government and joint integration of FDA-approved medical countermeasures against chemical, radiological, and nuclear threats to rapidly enhance readiness and increase capabilities. She holds a Ph.D. in Biomedical Pharmacology from SUNY Buffalo and a B.S. in Microbiology from SUNY Plattsburgh. She has a Certificate in Regulatory Compliance from Hood College and is Project Management Professional certified, Defense Acquisition University Level III certified in Science & Technology Management and DAU Level II certified in Program Management.
Maj. Andrea Mountney is the Assistant Joint Product Manager for Fielded Products and the Alternative Autoinjector support program within the Medical Countermeasure Systems Joint Project Management Office (MCS-JPMO) of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. She is responsible for lifecycle management of fielded countermeasures and project management of drug-device combination products used across the U.S. government. She holds a Ph.D. in Pharmacology from The Johns Hopkins School of Medicine and a B.S. in Biochemistry/Molecular Biology and Spanish from Ursinus College. MAJ Mountney holds her PMP and is Level III certified in Program Management and Science and Technology Management.
This article is an honorable mention in the 2018 Maj. Gen. Harold J. “Harry” Green Awards for Acquisition Writing competition. A special supplement featuring the winning entries is online now, and will accompany the print version of the April – June 2019 issue of Army AL&T magazine.
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