by Scott F. Walter, PHD
For anyone who has seen or evaluated a new medical product and wondered “why can’t we have this product in our sets, kits, and outfits?” or asked “how long will it take to field it?,” change is in the air!
The Department of Defense (DoD) last year enacted important changes to the Defense Acquisition System to improve its ability to rapidly develop prototypes, conduct early operational assessments, revise the design to optimize the desired effects, and expedite fielding to support the operational mission. These reforms will especially enhance the development of materials and technologies that have dual military and civilian applications, and are meant to facilitate the use of commercial processes in developing and fielding more effective and affordable capabilities. The reforms will significantly affect development and fielding of military medical products. At least 95 percent of those products have dual military and commercial applications.
Let’s look at how we got here. In the last couple of decades, the DoD and Congress implemented various reforms to the Defense Acquisition System to improve how the DoD develops and fields new capabilities to their operational mission as well as how to address existing problems better, optimize existing systems, and implement enhanced technologies. The initial launch of the DoD Instruction (DoDI) 5000 series for acquisition management in the early 2000s was heralded a success. It replaced the unaligned multi-Service approach to system development that was fraught with significant cost overruns, unsustainable systems that did not meet user requirements, and technologies that failed to transition to the Service members who needed them to execute the mission.
The initial version of DoDI 5000.02 essentially implemented dozens of best practices for managing projects and programs to avoid making mistakes. It required frequent, high-level in-progress reviews and centralized decision making. While the new instruction did reduce the number of failed DoD acquisition programs, the DoD still experienced program delays, cost overruns, and failures to deliver new capabilities in a timely fashion. Program managers noted the main issue was that the unintended objective to avoid mistakes significantly increased the number of reviews, required documentation, and over-administration of projects and programs. The new system unintentionally established a dichotomy of program managers and decision makers. The program managers had detailed knowledge of projects and programs but lacked decision authority. And the decision makers, who held decision authority, lacked detailed knowledge about the projects and programs and subsequently asked for more and more project and program information.
In subsequent revisions, the DoD addressed these issues by, for example, tailoring the administrative oversight to provide only what was needed to meet statutory and regulatory requirements. However, tailoring was largely ineffective because the decision authority for tailoring was not delegated and did not address the program manager–decision maker dichotomy that caused the problem. To be effective, the DoD acquisition system needed just enough oversight of projects and programs to ensure effective and adequate management while allowing enough flexibility so project and program managers could creatively take advantages of opportunities as they occurred. Basically, a “somewhere in the middle” approach was needed.
Over the last few years the various program offices and elements of the DoD acquisition community experimented with various processes for expediting development and fielding of new capabilities. Acquisition reforms initially focused on how to rapidly develop prototypes of new or enhanced technologies and then expeditiously field these capabilities. It was found that rapid prototyping must be coupled with early user assessments and feedback in an iterative process that applied lessons learned to revise user requirements after every iteration, and then repeated until the capability achieved the desired effect safely in the operational environments, conditions, and employments of the end-users. To incorporate acquisition reforms, multiple pathways or models for project and program management were developed so managers can make “pre-tailoring” decisions based on each project or program’s unique aspects.. The multi-model approach unveiled early last year was named the Adaptive Acquisition Framework (AAF), and it has six distinct pathways as detailed in the revised 2019 DoDI 5000.02 Operation of the Adaptive Acquisition Framework (AAF) (Figure 1).
Another outcome of the new acquisition reforms was establishment of the six tenets of the Defense Acquisition System to guide the management of programs and projects regardless of the pathway followed:
- Simplify acquisition policy
- Tailor acquisition approaches
- Empower program managers
- Conduct data-driven analysis
- Actively manage risk
- Emphasize sustainment
Each pathway has its own powerful effect of streamlining the acquisition system to reduce waste, improve throughput, reduce time required for fielding, improve affordability, and enhance the Warfighters’ capabilities to execute the operational mission. However, Ellen Lord, the Under Secretary of Defense for Acquisition and Sustainment and driving force behind the development of the AAF, said that the new policy’s heart is its delegation of decision authority to the program offices and empowerment of program managers. This enables program managers to pre-tailor acquisition approaches to the unique requirements of each program in order to deliver rapidly effective and cost affordable capabilities when and where needed.
The delegation of decision authority directly addressed the paralyzing dichotomy of knowledge and decision authority in previous iterations of the Defense Acquisition System. Also gone were the days of a single “one-size-fits all” model of acquisition management that applied the same acquisition pathway for overseeing the development of major weapon systems like aircraft carriers to the development of small projects or rapid fielding of urgently required capabilities. Another key aspect of these acquisition reforms is the requirement of active, continuous involvement by end-users to ensure that the project or program meets or exceeds their needs, from start to finish, and beyond with sustainment. Another important distinction is that everyone is encouraged to manage risk actively, not minimize risk, as mistakes should be expected and tolerated if they lead to improvements in processes, designs, and overall capabilities. After all, risks can be minimized and mistakes avoided by not taking any chances and by doing nothing.
Medical Product Uniqueness
Medical Product UniquenessRapid Development/Fielding: For medical product development, the Middle Tier of Acquisition (MTA) is the most appropriate pathway to use as it is designed to apply leading-edge commercial development processes and technologies to reduce developmental costs, encourage competition, maintain high reliability, ensure affordability, and retain availability. The MTA pathway supports, encourages, and executes rapid prototyping and rapid fielding of safe, effective, and affordable capabilities. These capabilities directly align with medical product development goals and objectives of quickly fielding safe and effective medical products to save lives, minimize/eliminate health effects of illnesses and injuries, improve health and readiness, and enhance/optimize human performance.
As established for rapid prototyping, MTA programs must field a prototype that can be demonstrated in an operational environment and ensure the operational capability meets end-user requirements within five years of an approved requirement. After acceptance by the end-users, MTA programs must begin production within 6 months and complete fielding, all within the 5-year period after a requirements document is approved. This accelerated cycle is ideal for fielding enhanced, advanced, and optimized medical products desperately needed by our Warfighters.
Reduced Duplicity: Manufacturers of medical products already follow commercial developmental practices created to ensure that products meet the stringent requirements of the Food and Drug Administration (FDA). As a regulatory organization, the FDA is unique in that it does not base its approval or certification of a medical product only on final testing results, but also evaluates the quality systems for manufacturing processes, the design history file that guided the development, the biocompatibility of the materials used, and much more. By following commercial developmental processes, companies are spared the redundancies of meeting military-unique acquisition development processes with which they may not be familiar, thereby saving funding, time, and personnel requirements.
Speed of Relevancy: The competition often is intense between medical product development firms to offer more-enhanced medical product in order to “corner the market. Innovations drive reductions in costs, size, weight, and power use while improving reliability and enhancing capabilities. Companies often re-invest their profits in developing new medical products. This drives innovation faster than the Joint Capabilities Integration and Development System (JCIDS) can generate Warfighter requirements documents such as a Capability Development Document (CDD).
As a result, Warfighters often ask to incorporate FDA-approved and commercially available advanced medical products into their sets, kits, and outfits, even when they do not have CDDs to support fielding. To address this, the MTA pathway exempts MTA-declared projects and programs from following JCIDS processes, and instead requires that the Services implement a truncated process for rapid establishing abridged capability development documents to support fielding. Each of the military Services already implemented unique processes to enable this streamlined approach. The Army, for example, uses an abbreviated CDD while the Air Force is using a Rapid Prototyping/Fielding requirements document to distinguish MTA projects and programs from major weapon system programs.
In accordance with MTA guidance, an abridged requirements document must be written and finalized within 6 months of declaring an operational need. In addition, the abridged requirements document can be easily revised after a project iteration to ensure it clearly identities the refined direction(s) to meet prioritized end-user requirements.
Larger Markets = Improved Affordability: Military use of medical products represents such a small market that companies must design medical products to sell to larger communities such as hospitals, clinics, emergency medical responders, and others external to the military market to be viable. Medical products designed only for military use often result in small sales. This drives up individual unit costs and essentially results in unaffordable medical products and an inability of companies to keep the product line open and the medical product available.
Conclusion
The MTA pathway represents a larger shift in culture and focus in the acquisition community to identify capabilities suitable for rapid prototyping and fielding, use of streamlined processes, delegated decision making, empowered program managers, and emphases on risk management as opposed to risk minimization. Because of the emphasis on utilizing commercial developmental processes, the MTA pathway is ideal for supporting medical product development, given there are both military and commercial applications of a vast majority of DoD medical products. The MTA process also is ideal for medical product development, given the need for rapid prototyping, development, and fielding for the competitive commercial markets as well as military users that urgently require the most effective medical products to complete their operational missions.
How to Get Started
As it is now a DoD instruction, the MTA pathway is one of many new acquisition tools available to Service program managers. Flexible requirements and other adaptable acquisition mechanisms enable medical program and project managers to leverage commercial practices, commercial innovation funding, advanced medical technologies, and novel medical products to enhance and support military medical operations and modernize the forces.
Learn all that you can about the MTA pathway, the abbreviated (flexible) requirements processes, the rapid prototyping and rapid fielding that lead to MTA, and the flexible contracting vehicles like Other Transaction Authority that enabled rapid prototyping and rapid fielding. Ask senior medical acquisition leaders and decision makers about using the MTA pathway, first as a prototype, then as a standard process, perfecting it while moving forward.
The 2013 interim DoDI 5000.02, noted that the Defense Acquisition System was meant to be updated and revised continually. The MTA pathway has moved us forward, and we are obligated to apply it for providing better, faster, and higher-quality materials, tools, technology, and capabilities to our Warfighters.
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WALTER is Director of Technology for the 59th Medical Wing, Science and Technology office. He received a Bachelor of Science degree in electrical engineering, a Master of Science in Public Health (Industrial Hygiene), and a PhD in Business Administration (Project Management). He retired in 2014 from active duty as a U.S. Air Force lieutenant colonel after 25 years of service. He is Level III certified in Systems Planning, Research, Development and Engineering and Level II in Program Management and is a licensed Professional Engineer in Florida. His research interests include new management models and relationships for project and program management to create dynamic, self-initiating, self-guided empowered teams for developing new and enhanced armed-forces medical capabilities. The views presented in this article are his own.
The author can be contacted at [emailprotected].
The views expressed in this article are those of the author alone and not the Department of Defense. Reproduction or reposting of articles from Defense Acquisition magazine should credit the authors and the magazine.
