Discussions

Co-chairs Bienvenue and Clements moderated aspects of presentations and discussions. Four instances of particular note were (1) the discussion early on Day 2 when committee members explained their views relative to the presentations of Day 1 related to the future environment and its associated capability requirements; (2) the extended discussion late on Day 2 when the participants vigorously discussed two topics—the possible future DHA-Army medical R&D reorganization and improvements needed to prepare for the 2035 MDO environment; and (3) the committee discussion during the morning of Day 3 that led to (4) the final discussion by participants when major themes from the meeting were identified and addressed. All discussions are condensed into 10 main themes.

THEMES

Theme 1. Multi-Domain Operations and Battlefield Accessibility

Committee member Ann Salamone introduced the multi-domain operations and battlefield accessibility theme, emphasizing that innovative and disruptive technology must be developed to address potential 2035 conditions, such as lack of airspace control, degraded communications and electronic equipment, and inability and need to rapidly transport injured soldiers. This requires prioritizing investments toward highly flexible and adaptable medical capabilities. Training will also be essential for all unit personnel on the battlefield, not just the medic, and the role

of leadership and driving across-the-board training for all persons on the battlefield will be critical.

Colonel Deydre Teyhen noted that a critically important and undervalued point is maximizing human potential, so there needs to be a more purposeful way to balance that with other Army needs. There is considerable discussion about maximizing the potential of soldiers in terms of physical supremacy, cognitive dominance, and emotional resilience. Unfortunately, the requirements writers for these capability gaps typically represent the interests of combat-support hospitals and field medicine. Those requirements need to be written by a broader group. Considering the medical personnel as setting skin-in (soldier physiological) requirements, and the technology researchers as setting skin-out (soldier equipment) requirements, what thinking covers terms in the physical, cognitive, and emotional domains? What do those attributes mean? For example, the ability to make the right decision at the right time in the right place is very important. What is unique on today’s battlefield, and what will be true in multi-domain operations, is that a war of decision-making requires knowing whether that person confronting you, who is not in a uniform, is a combatant or just a friendly individual that happens to be out on the street. This is in addition to the fact that fighting will likely be in a social-media world where the errors in decision-making are out front quickly, unlike World War II where such decisions would never be known or would take weeks to be publicized. Now such errors could start their own revolution on social media. Thus, the 18-year old soldier who is merely trying to do the best and makes a decision during the fog of war actually could create a strategic consequence that changes the footprint and the outcome of that battle, or support from the local population. Multi-domain operations only amplify the need to enable young soldiers to make critical decisions better and faster. Committee member Ruzena Bajcsy noted that in underdeveloped countries, the battles are not only military versus military, but also within the environment of the local population, so it is necessary to take into account actions like helping the noncombatants.

Theme 2. Training and Technology

Committee member Robert Barish believed the issue of personal training cannot be overstated, and he urged caution about the allure of fancy technology, citing Mayhew’s Thomas-splint implementation in which he learned the real heroes were the stretcher bearers, not the technology itself. Barish was also struck by high initial battlefield mortality rates, which typically decrease over time as we learn more about significant injuries (the concept of the Walker Dip discussed by Holcomb), which only reinforces the importance of developing better interwar training.

Committee member Kent Kester echoed this caution, as human anatomy and physiology have not changed and there remain many basic problems to address. He also observed that history repeats itself, prompting the stopping and then restarting of countless programs. Some technologies may be of value, but knowledge products are just as important because not everything is a widget.

Salamone noted that the discussions explained what the United States and the Army medical R&D group should focus on, which appears to be a cyber-degraded environment by 2030-2035. Therefore, the need for using humans, rather than devices, to save lives was a key point. She also asserted that soldiers should be clinically capable of doing first-responder actions for their fellow soldiers.

Committee member Martín-Jose Sepúlveda conveyed an exceptional point that technology is not a solution, per se, and this had been recognized in industry for decades, as a tough lesson for computer and information technology companies to learn. The human being who comes to the table and employs the capability in an appropriate fashion to the appropriate problem will deliver an outcome of higher quality than technology alone can provide.

Michael Davis stated that technology and training need to be a partnership. If U.S. forces are potentially facing tens of thousands of casualties per 60 days against future threats, technology is needed to help one medic to respond to 20 to 40 casualties and help them have a chance of caring for that many patients. Davis pointed to modern hospital rooms, each with 10 to 20 technologies, as an example of innovations in the past 50 years.

Bajcsy noted the issue of how much technology is useful for the battlefield and for the medical personnel to be efficient and active. With the concern of no electricity or Internet available on MDO battlefields, she noted that the human body is an energy generator. She also mentioned body sensors, which do not consume much energy and can be turned off and on. She asked the participants not to completely ignore the important benefits of low-consumption energy devices.

Committee member Mary Ann Spott observed that given many great and innovative things to consider, there has to be a balance of technology and clinical care, without sacrificing the quality of care for advancing technology. She echoed Kester, pointing out that there are some fundamental things that still need to be fixed in order to advance to the future. For example, on a 2035 battlefield, military personnel might not have an Internet connection or means of communication. Thus, it is necessary to not only plan for those contingencies but continue related technology at the same time so as to not fall behind. In this connection, the training component and human capability are critical in knowing what can be accomplished under a range of conditions, such as needing to replace

or augment various types of equipment or personnel skills. A consistent amount of training is required for soldiers to adapt when technology is not available.

Ron Poropatich indicated that the right balance of technology and training needs to be based on a review of autonomous systems on the battlefield. The AFC AI task force is planning a series of training curricula bringing Army personnel (one-third each of officers, enlisted, and civilians) for AI training so that they promulgate the use of AI in their units when they return. It also is important to understand there is so much heterogeneity among the medical population where, for example, there might be a young doctor right out of training doing a procedure. Because there will always be training gaps, there will always be a role for autonomous systems. The entire medical robotics and autonomous systems programs within the medical community, along with AI programs in the AFC, are going to play heavily in this area, as will activities of the joint AI center, which is looking at this area not only from a medical perspective but from other perspectives, like weapon systems and preventive maintenance of aircraft, etc. Serious consideration should be given to technology being wrapped into autonomous systems, not just current robotics for doctors, but also autonomous systems that can help medical personnel on the ground. There is a need, irrespective of bandwidth in future conflicts, to determine a casualty’s status and how best to assess them—whether there are not just a couple casualties, but tens of thousands, or perhaps even more. Autonomous systems potentially could augment the lives of those being left attended to by hands-on personnel.

J. Fraser Glenn commented on technology development for knowledge products and tools to support training, especially on individual capabilities that are often lacking. Such requirements interact with the greater system and are a part of the technology development process to be considered. Engaging with end users to make sure that the concepts being worked on can actually be adopted and integrated into field care is key because there is no separate funding line for that activity. These deliberations have to be viewed through the lens of how the Army has things organized and how the lanes that must be navigated are defined.

Kester discussed the concept of assigning scientists, whether uniform or civilian, for short or longer terms, to places outside of the government for them to learn new skills, enhance collaborations, and improve connectivity with partner organizations. These assignments could be to an academic institution or private industry, although the latter could be more difficult depending on what is envisioned. This concept also applies to assignments overseas and partnerships with other countries supporting medical R&D priorities. Teyhen commented that her first question in an overseas town hall was, Why has the Army stopped sending its best and

brightest leaders to the field? She noted that it was an incredibly powerful question. Teyhen continued that great folks are still being sent overseas, but in years past, personnel could spend their whole careers within the medical family, and by the time they returned, they had accrued years of experience and were recognized internationally. Now, younger personnel are heading overseas with less name recognition and experience.

Kester commented there used to be good integration between international and U.S. laboratories overseas, with clear progression and tight collaboration. But he stated that some assignments became blocked by a view that less-quality personnel would staff those positions, and those personnel should be managed out. This comment also related to the upcoming theme on personnel, but the view was that it involves Army medical culture because those who staff the clinical mission and research are the people who do not deploy.

Bienvenue mentioned the importance of training and human capability, not just “widgets” and not merely for medical personnel, but for all on the battlefield. She emphasized the important speaker themes of competency versus capability.

Theme 3. Capability Requirements and Research Priorities

Clements commented on the continuity in speaker themes, countering Holcomb’s assertion of too much emphasis on preclinical research in DoD. He referred to Bertram’s presentation and Figure 3 (Drug Development Process and Timeline) with the uncertainty and cost of biologics, with the question of, Why don’t we just buy the other [developed] end? Clements believed those projects would not be attempted with overreliance on academia or industry. He argued that preclinical research is the foundation of what goes forward into the pipeline and that more clinical research is needed, but it is a zero-sum game in which one should not be sacrificed in favor of the other. Bajcsy, drawing from academic experience in robotics and robotics-adjacent sciences, agreed with Clements that preclinical research has to be balanced.

Regarding requirements, Kester noted for the future that he understood there will be no cessation of existing and new medical threats to the force—challenges that necessitate a strong Army medical R&D enterprise. He mentioned that Lane and Bertram spoke to the point that without a credible organization, one cannot address these threats.

Committee member Philip Spinella emphasized that prehospital health care is where the most lives will be saved because that is translatable to the battlefield. If prehospital activities are not being funded and carried out today, the people who need to learn them in the future will not have the training infrastructure and knowledge necessary to be effective.

Davis stated that there has been a pivot from a counterinsurgency focus to an adversary focus, which places an extraordinary challenge to Army medical R&D. Glenn commented that it is necessary to adapt to the future challenges as defined today, but knowing history, they will change. He reiterated that the charge to the panel suggested exploring whether an internal military laboratory system is needed to sustain capabilities for the future, like the MDO environment. Teyhen asserted that existing funds can be leveraged to get after those priorities. She discussed the congressionally directed medical research program (CDMRP), which has considerable dedicated funding from Congress and noted that it apparently reflects a desire to move away from the NIH funding model.

Salamone offered two takeaways that had not yet been discussed. One clear need was that the core capabilities within the worldwide Army medical R&D facilities must be strengthened to become more multidisciplinary. Salamone believed that forward thinking about current and future needs pointed to a multidisciplinary, sustained foundation for the Army’s medical R&D competency in order to have rapid and effective flexibility. She gave the example of COVID-19 where organizations had to turn on a dime to address it, a situation that could repeatedly occur in the future. To deal with such contingencies, multidisciplinary core competency experience in the Army will make a difference between survival and no survival in some cases.

Salamone’s second point was that the Army should supplement innovative and disruptive technology development to address the expected conditions of 2035 and beyond. She believed high and targeted investment in human, intellectual, and monetary terms will be necessary to develop the innovative and disruptive technologies to meet future warfighter needs.

Kester observed that with the progression of projects and programs, there is both the perception and reality that coherence is lacking, whether on an individual project basis, on larger projects, or driven by budgetary urgency. This hinders a consistent view across the enterprise on which the projects and programs are successful and which ones need closer scrutiny. A key question is whether a research organization can respond rapidly to unknown threats by leveraging existing technology personnel and expertise; there are instances where the response has worked well, in his judgment, because key people were willing to take the initiative. With that prospect as a given, progressing multiple projects in a meaningful way is difficult, especially where the funding is so limited that only salaries and maybe one or two small projects are covered. For example, deploying a novel vaccine will probably cost on the order of $0.8 billion to $1.0 billion. To enable top priorities to move forward, Kester suggested looking at available funding, the top three or four priorities, and researching those

areas rather than funding the universe. This approach contrasts with incremental progress on all programs. He summarized by saying that the requirements process is daunting and ripe for change, clearly with something more agile and less onerous. Spott was also struck by ideas that the research priorities are not aligned with the most important items in the funding lines.

BOARD member Jim Bagian commented on priorities and observed that a dislocation between what the people in the field believe they need and what people back in the research area are supporting. As with the Combat Trauma Care¹⁰ workshop, similar themes include the same lament that there is a gap in the field’s needs, measuring those needs, and tying those needs to what is in the research pipeline. Bagian suggested that kind of tie makes the research look more like applied research. He observed that the loss rate would be orders of magnitude better if recommendations were implemented. Studies looking at the medical responder equipment packs show a lack of required equipment, like tourniquets and nasopharyngeal airways. Bagian suggested some of the research ought to be on the social and technical factors preventing implementation. Advancing other technologies is extremely important; nevertheless, if the finish line cannot be crossed to full deployment readiness, maybe the economy is being stimulated; but it is surely not helping the warfighter.

Salamone emphasized the suggestion that scientists in laboratories also need to have a real-world relevance to what is happening on the battlefield so they are culturally aware of development needs and feel an obligation to develop products, technologies, and processes that will help on the battlefield.

Glenn noted that, historically, research funding (which DoD categorizes as 6.1 [Basic Research], 6.2 [Applied Research], and 6.3 [Advanced Technology Development]) was aligned to generate possible solutions or opportunities. The current threshold of such funding is not obtainable or justifiable unless a particular problem is identified, such as a vaccine. Glenn suggested that a good diagnostic would help point to a treatment, or maybe predict an outcome, either of which could be sufficient for the military need. Requirements discussions should occur in the context of opportunities to provide a solution to the real problem, and a “widget” is not necessarily a solution. The solution may be knowledge, a combination of technologies, or a combination of both. Unfortunately, program managers are asked to defend progress against requirements, not solutions.

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¹⁰ National Academies of Sciences, Engineering, and Medicine, 2020, Army Combat Trauma Care in 2035: Proceedings of a Workshop–in Brief, Washington, DC: The National Academies Press, https://doi.org/10.17226/25724.

Translational Research Requirements

Teyhen commented on the importance of translational research and metrics to assess how well the science gets into the field. An example was resilience research, standing up a research transition office to measure what things helped build resilience when applied to a unit. A field example was examining a host of malaria prevention techniques in Southeast Asia making sure that the solution set actually works. Teyhen outlined a solution-set failure example working with the Royal Cambodian armed forces. When they got a new set of treated uniforms, which were much nicer than their current set of uniforms, they did not actually wear those uniforms to the field; they kept them for parades and ceremonies. Potential solutions need to be tested not only in a laboratory setting but applied in a field setting to determine if they actually do work. It is incredibly powerful to understand how to come up with that family of countermeasures to really help prevent, for example, malaria. Teyhen provided another illustration where translational research is helpful, with tourniquets. If soldiers are not applying them properly or do not know when to apply them, they become just more weight in the rucksack. Translational research is different from training, so it is a slippery slope to emphasize training when resources could go to translational research to see how the average soldier applies the developed countermeasures and whether they have the intended effects.

Kester cited vaccine candidates as an example of an achievable translational strategy, with a number of products that have transitioned to general use over decades. However, mapping a translational strategy, and how it gets from point A to point B (jumping what is known as the “valley of death”), is an organizational challenge. Some vaccine examples referred to in the workshop require complicated doses and storage, which would make them non-translatable.

Barish supported the value of translational research, using the issuance of discharge instructions as an example. When instructions were issued a few minutes before discharge, follow-up at some homes indicated that these instructions might not even be found, which led to providers spending time with patients on these instructions several hours earlier.

Bagian discussed the translational risk-reward ratio, citing tourniquets as an example. Tourniquets are now used widely, but research on their use was delayed for more than 3 years. In setting requirements, one must ask, How sure do we have to be, and what risk are we willing to take relative to the risk of doing nothing? What is the value of that additional certainty brought by research, and what level of precision is really necessary in the near term and longer? That thinking is often not captured.

Theme 4. Acquisition and Acquisition Timelines

Teyhen asserted that the processes governing research execution have increased dramatically to demonstrate cost, schedule, and performance. Meeting milestones and deliverables and making sure capability-gaps are driving research instead of the investigators, which diffuses accountability for success.

Spinella urged clarity on where decision authority and scope of responsibilities will lie when it comes to funding specific programs. Davis mentioned innovative disruptive technologies and noted that the AFC understands the acquisition process is broken and that competition with China and Russia is hampered because they do not have the same roadblocks. He spoke about the need for leveraging industry and academia and independently validating very disruptive laboratories.

Clements noted that the “acquisition” theme title encompasses a number of the topics that were discussed by different speakers and that acquisition programs will develop in relation to priorities. He reflected on a comment that funding for medical research was almost a rounding error in the larger Army budget, and it was often seen as a place to retract funding if a medical research deliverable milestone had not been met. If true, Clements recommended the DARPA method Ling discussed of cutting that project loose and moving on (fail fast)—a model to be expanded across the whole R&D universe. Many things of great value to the military are not amenable to timelines, as with vaccines mentioned above, yet they are nonetheless worth pursuing. Infectious disease research also falls into this category. Leadership needs to have a greater appreciation for the time it takes to develop these kinds of technologies. Barish also urged patience; it may take 10 years to yield results, and one does not know what might be happening a decade from now; therefore, research investments are important.

Clements discussed return on investment, which is difficult to quantify for a project that takes 20 years. The United States may be on a faster timeline for the COVID-19 vaccine; however, the fastest vaccine ever developed took 4 years in the 1960s and usually takes 15 to 20 years to develop. A caution if one is looking at shortened timelines with mandatory deliverables. Many of the biologics discussed will never get developed, particularly if the pharmaceutical industry does not have a financial interest. Other factors cited were the need to create less dependence on resources received from other countries, either raw materials or finished products, and the need to match up research funding with DoD priorities, which are not always aligned with the relative importance of diseases (like diarrhea) in terms of the impacts on warfighters. Kester appreciated the depths of presentations on very difficult processes and funding mechanisms. He noted that the Army itself must be able to move forward

in a more agile and flexible manner because the world is changing in a revolutionary way, not an evolutionary way, which also applies to Army medical R&D.

Theme 5. Collaborations

Bienvenue reiterated a question from Kester, who asked, If we could blow up the whole system and start over again, would we not build it the way it is now built? What opportunities exist for change? Barish gave an Air Force example, which could be useful to the Army, which involved training 30 to 40 trauma teams that then go onto the battlefield with good results. Another Air Force example included a funded graduate medical education and a trauma fellowship.

Spinella discussed collaborations between military and research entities with industry and academia, noting that more extensive collaborations with academia and industry are needed to enhance core capabilities to match future medical infrastructure needs. Barriers to developing those collaborations need to be reduced to improve their working relationship with the military.

Spinella outlined contracting challenges and recalled that Quake indicated that his institute did not want to work with the military because of the barriers with contracting. Certain industries would take a year to develop a contract for dealing with the laboratories. It is necessary to assess which military laboratories can be augmented appropriately with outside support, and what capability does not exist within the military that these clever collaborative settings would provide. These collaborations from the military could bring value to these outside organizations. Spinella suggested that collaborations could provide a model not only for product development but also program development. The Wyss infrastructure could be used to facilitate the development of collaborative agreements. Success of the outside institutes has been mainly with a bottom-up approach, whereas the military approaches are usually top-down, so that difference would need to be reconciled within these collaborative groups.

Kester referred to Ling’s DARPA experience with innovative ways of developing and managing cutting-edge projects having high risk but potentially high payoff. Industry is trying that model, in some ways successfully, particularly those companies with a strong culture open to innovation. With collaborative space and partnerships, which provide an infrastructure for innovation, Kester noted that this innovative way of bringing people, technology, and missions together for mutual benefit might be possible. Kester continued that government, and sometimes industry, are complicated and move slowly. The Wyss Institute’s approach is worthy of exploration, because it facilitates a variety of performers,

considers an outcome that includes a defined collaborative place based in one of the laboratories, and can bring people and technologies together with defined goals and deliverables. Salamone noted challenges with funding and collaboration—negotiations and discussions can go on for years, and it can be difficult to execute decisions within the defined funding period.

Teyhen emphasized that military medical research is driven from a military-relevant problem that academia and industry are not currently investing in or investing at the speed needed. Another reason is a congressional requirement to fill a specific niche. AFC’s desire is to conduct research at the speed of relevance to provide a timely solution to warfighters. After looking at Army research efforts on an important medical issue, the question should be, Who could help answer that need faster? The search would logically include sister laboratories and services, multinational partners, academia, and industry. Teyhen reiterated that the need to find industry partners that can help on a specific question is a more effective strategy than broad, undefined partnership searches. Drugs for TBI was an example where team members that had different ways to look at that issue came together and moved quickly to two potential drugs at modest costs for several involved institutions, an incredibly successful outcome.

Mark Dertzbaugh stated that AFC is pressing the laboratories to identify innovations from external sources that could be evaluated for maturity and then transitioned to acquisition. Also, USAMRDC is establishing processes to allow it to systematically scan for the best technologies that meet customer needs. He asserted that the move under AFC is changing the model for conducting and planning research; in this new paradigm, there is competition with other priorities outside the medical community. He believed that this new arrangement indicates that some very difficult trade-offs are going to be discussed during the next several years. Kester noted that being small in the context of a large organization is a challenge and suggested that focusing on a technology scouting function that is aligned with the needs of projects could be valuable and help to facilitate partnerships.

Glenn discussed barriers in the culture to creating new approaches to collaboration. The current competitive culture has been seen as an impediment to adhering to the Federal Acquisition Regulations with grants and agreements. Knowing entities that can help the Army and reaching them could get the solutions moving a lot faster.

Industry and Academia versus Government Drivers

BOARD Director William Millonig discussed the following three paths introducing technology to government:

• Existing commercial solutions can be adapted for government use;
• Industry R&D budgets far exceed the government’s; therefore, adopt promising ideas and continue development; and
• The government must lead because industry has no incentive, business case, or investment.

The last technology path continued discussions on a requirements-related scenario introduced by Clements, where the Army (or the government in general) must lead, at a minimum, in basic research, because it does not exist in the commercial sector. Research funding levels have flipped from mostly government to mostly industry over the past 30 years, suggesting that industry will be driven by likely business cases and not necessarily the most important issues. However, Millonig noted there are areas where the Army must lead, and little mention of that was made during the workshop.

Committee member Clarion Johnson discussed a method of corporate tabletop exercises that uncover capability needs for which technology is not ready at this point, so management could be aware of future environments and needs; he gave telemedicine as an example. When current incidents signaled the need for it, management was ready for telemedicine and buy-in was immediate. Johnson gave another example of industry foundation money and French Army connections to help fight malaria death as a nongovernment foundation investment without a return on investment. Sepúlveda responded that business motivations include a host of reasons, not only revenue or extending products and services. Business investments can address important community and society issues in which they operate or issues of general social good. Businesses benefit from this investment type in terms of brand recognition or to obtain access into certain markets, old or new. The value is captured in the impact on what the businesses are doing, which are not immediate revenue-generating activities. Johnson gave the example of Exxon’s relationship with Oxford University scholarships for non-U.S. people to get a master’s degree in public health. They cannot be hired by Exxon Mobil when they finish; they go back to their respective countries or other activities, with no direct benefit to Exxon. Salamone gave the example of Shell Oil Company creating a new division on natural-based resources with the sole intent of decreasing climate temperature change by one and a half degrees. That scientific knowledge is being shared with many countries around the world. Bajcsy’s academic example was the development of an immersive environment showing real-time links between University of California, Berkeley, and University of Illinois at the beginning of Internet connectivity that now has grown into an immersive communication

environment; the lesson is patience. Barish gave the example of a University of Illinois Hospital and Health Sciences System corporate-university agreement involving deep innovation, working on augmented reality and virtual reality, which could help not only on future battlefields but also in the civilian world. Bienvenue agreed, supporting more agreements between the Army and universities to make sure that requirements are well understood on the university side and well integrated into the research programs of the universities.

Theme 6. Program Management

Bienvenue opened with the challenge of the Army as a big organization with similarities to large private-sector corporations. Successful companies are often on a much smaller scale, like Wyss and Biohub, and catalyze outstanding performance by operating with diverse talent, speed, agility, and brainstorming. Improvement was not just incremental but an evolutionary stage where at first the new approaches did not work very well, but leadership remained committed to creating the time and “space” to accomplish the transformation. Such organizations can bring special value to bureaucratic, rules-driven, top-down organizations.

Bienvenue suggested looking at program management from the perspective of those executing externally to the Army and government, as well as internal program management for efficiency. Both Bienvenue and Spott commented on the administrative burden on researchers, a known problem across many different agencies, as mentioned by Ling, Kaminski, Quake, and Ingber. Bienvenue used contracting and data agreements, which are particularly arduous, as barrier examples for industry and academia to partner with the government. Assessing the contract risk profile and adopting a level of risk can enable the work to get under way a little more rapidly and shorten the overall time to the solution. This approach entails looking holistically across all the different challenges for the academic and industry sides. Bienvenue continued, noting in academia, the lack of program management expertise was a particularly large challenge. From a DoD perspective, a requirement for program management beyond the lead faculty member would be a worthwhile approach. Bienvenue expressed the belief that the more faculty members take advantage of the program management resources provided by an institution, the better the outcome in terms of what is received from a university.

Kester agreed with Bienvenue regarding program management training, noting that project management is greater than its products, such as Gantt charts. Lack of effective management seems to be an accepted part of projects, perhaps because leadership concludes the project was just not working and doomed to failure. There are different models, but there

needs to be an accountability mechanism throughout the R&D organization for success and failure. Risk mitigation techniques, anticipating issues, and funding reprioritization are active management techniques. Kester recognized that the Army, NIH, and industry are all different organizations, but undisciplined execution is common (e.g., “Oh we got $350K this year. Well, okay, maybe we’ll get these assays done next month instead of this month.”) This attitude wastes taxpayer money, therefore, priorities should be identified and executed with a sense of urgency, even to the point of “can you go a little faster?” Certainly in the SARS-CoV-2 environment, acceleration is the watchword.

Teyhen agreed and recommended “Loonshots, How to Nurture the Crazy Ideas that Win Wars, Cure Disease, and Transform Industries,” by Safi Bahcall. The book’s concepts, she believed, align with workshop topics.

Theme 7. Information

Sepúlveda thought a glimpse of what the data and information underlying this medical research enterprise should look like will be exceptionally important with respect to the ways projects are financed and leaders are rewarded. However, any level of specificity for the myriad considerations, with respect to data and information, ranging from sources, types, collection, curation, processing, analytics, visualization, and distribution was not available. He recommended an event focused entirely on those subjects, would be an appropriate next step. Industry describes that step as segmenting, targeting, and positioning (STP) activity and articulates needs, assesses current statuses, identifies gaps and how they can be closed, and develops specific plans. STP activities establish processes, indicators, milestones, desired outcomes, and should be clearly resourced and funded. These are overall techniques to address the data and information subjects that permeate every aspect of what was discussed during this workshop. Spott added an important note that unless one has the documentation, one cannot collect the data, referring to Kotwal’s need for more pre-hospital data in order to continue combat trauma care studies. Regarding SARS-CoV-2 shifts, Spott commented on a need for data-registration capability, which would require pausing work on the combat trauma care registry and pivoting the platform to accept corona-virus data.

Bajcsy agreed with Sepúlveda that most speakers did not explicitly address information science and properly collecting and representing the information. Given the context of healthcare and privacy and cyber security needs, she asked how, is secure information collected and communicated on the battlefield? Existing technologies would have to be

incorporated and as data is collected, consistency is important so the right decision can be made at the right time. Sepúlveda agreed, noting cyber security, privacy, and consistency are important in extended discussions on data. Bajcsy offered an example of an implanted microchip needing a high level of security to protect critical organs like the lungs or heart, because the functioning of a microchip could be vulnerable to these types of threats, and with lethal results.

Sepúlveda observed data and information enterprise responsibilities have shifted from top level positions of chief information officers to chief data officers. Chief data officers manage operating systems, platforms, interoperability, usability, workflow integration, for the enterprise. The migration has been to incorporate team members at the right level with expertise on the data. Knowledge management is a systematic process built into the way people think and the way the enterprise operates to capture, store, and disseminate knowledge and continue to derive value so it is not lost. Bajcsy noted equipment or software obsolescence are continuing challenges the community must address.

Dertzbaugh commented on leveraging artificial intelligence and autonomous systems for medics to monitor and care for patients and monitor soldier performance. This requires a radical change to securing data rights and its storage. He speculated a cloud database containing data related to the Army enterprises, including medical data, would be possible. He believed that the challenge is no clear unifying vision or established architecture standard that would allow effective implementation. This would involve combining the operational needs with medical treatment facilities requirements to determine how the available information should be prioritized. He said it is important to look at the deliverables, as opposed to the mechanisms for solutions, which can be bright shiny objects. His suggestion was to outsource the information thinking and focus on what the organization can do well, leaving ownership of that infrastructure, maintenance, training, support, etc. elsewhere. Sepúlveda asserted that pricing models have shifted to what was just described and that one does not buy an application, platform, hardware, or software anymore; one buys a service.

On “big data”, Bajcsy commented that the data is useful if, and only if, the data is carefully collected and controlled and the experiments that collect the data are equally carefully designed. A fallacy of AI is that quality data exists. Once the control and design are there, then statistics can be applied to detect patterns. But one cannot predict anything that did not occur in the past. On outside companies that are providing platforms, Spott commented security considerations are a barrier; it can be very difficult to rewrite products to work on government systems.

Theme 8. Leadership

Bienvenue reiterated that ownership of the medical system should exist at all organization layers of DoD, up to the Joint Chiefs of Staff and Secretary of Defense levels. Everyone has a responsibility. Spinella agreed, echoing Lane’s assertion that the progress in implementing the DHB report recommendations can be attributed to a lack of leadership commitment. He reiterated that the 2016 National Academies report¹¹ recommendations for a national trauma health-care system align with the needs of this workshop, and he believed those recommendations should be re-visited, because very few of them were implemented over the past 4 years. Other participants also commented on leadership’s lack of accountability to implement the 2016 report, believing that this workshop is directly related and those recommendations should be leveraged and used.

Barish observed that workshop participants have seen an incredible diversity of Army research portfolios, which university presidents would be proud to put in their annual reports and be proud of what the Army accomplished. With respect to scientific literature, academic articles, and great journals that have come out of the military, those accomplishments in many fields document what happened on the battlefield. Those accomplishments have also changed the way civilian trauma orthopedics are handled, so there is much to be proud of. But there was not much evidence that the medical research mission had been sufficiently embraced by Army leadership. He wondered if this situation was due to a marketing issue in some way, even though medical research is now under a four-star general. Johnson agreed with the marketing point, noting that the Army has a solid past dealing with extreme situations and that experience has been published, so the Army is well positioned to go forward. He believed that how the Army is marketed in the complex terrain of government will make the difference, and he referred to the entrepreneurial spirit exhibited by Drs. Roy and Ling in earlier presentations. Kester also agreed. In light of the committee’s mandate for Army medical R&D, within the Army medical research community there has been a good understanding of the importance of the mission, both in terms of clinical care mission and, by extension, the deployment. Nevertheless, medical R&D organization integration within the larger Army was suboptimal; medical research ownership implies that attention must be placed on the importance of military R&D career-path assignments and effective talent management.

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¹¹ National Academies of Sciences, Engineering, and Medicine, 2016, A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury, Washington, DC: The National Academies Press, https://doi.org/10.17226/23511.

Sepúlveda described industry commitment that nearly 30 years ago brought forward the concept of health and wellness in the corporate environment. The top-level reaction was, What is that going to do for me today? and an examination of (1) how you can control health-benefits costs, because that is a part of labor costs; and (2) how you can fix the workplace from a safety standpoint to cut workers compensation costs. That led to creating a whole new science called health and productivity management, which involved discovering enterprise data on items like absenteeism, and the affected occupation groups at different pay scales. One could look at the cost of a person being out of work due to injury or illness and requiring someone else to receive overtime until the absent person returns (rarely at 100 percent). Similar to absenteeism, the costs of “presenteeism”—working while sick, often at a lower productivity level—also need to be quantified. The company chief financial officer would receive the economic data and was the most powerful advocate for changes, resulting in funds to address the root issues. Sepúlveda believed that there is an analogy here with Army medical R&D to collect relevant data and present the whole system-wide impact of what is being created through this novel research, particularly if it translates into practice in programs. Johnson agreed, reiterating the importance of metrics and return on investments, giving the comparison for research struggles to industry (like the near-miss step in the safety pyramid)—the more near-misses one has, eventually one’s output, “octane,” is higher.

Line Leadership

Bienvenue emphasized similarities with the combat trauma care workshop¹² results, particularly the focus on line leadership. Kester suggested that senior research leaders (flag rank and Pentagon level) need more accountability for research outcomes. Lack of accountability would not be accepted in industry. Kester noted that funding and the federal budget cycle is always at risk, and it is understood there are rarely top-line budget increases. Yet, a credible research organization needs an expectation of some degree of sustainable funding and project prioritization. He stressed that the medical R&D enterprise cannot be the bill payers for short-term gains elsewhere. He tied this situation to the management issue as well as to project leadership, such as senior medical clinical leaders, who would be held to account for problems in their area, and the same needs to be true for medical R&D leadership as well. Barish and Spott agreed. Barish

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¹² National Academies of Sciences, Engineering, and Medicine, 2020, Army Combat Trauma Care in 2035: Proceedings of a Workshop–in Brief, Washington, DC: The National Academies Press, https://doi.org/10.17226/25724.

noted instances where those leaders that took absolute responsibility had the best results on the battlefield. Line leaders needed to be responsible for battlefield medicine and accountable for prehospital deaths. Evidence of that was in the Special Forces (Kotwal) presentation, which was very significant.

Theme 9. Personnel

Clements discussed personnel challenges introduced by Lane and discussed by Kester and Teyhen. There is a need for careful evaluation of career paths and opportunities for medical research assignments, and successful research requires trained and committed investigators. Echoing General George Patton’s observation that wars are fought with weapons, but they are won by soldiers, Clements believed the best or newest technologies are not as important as the individual who has to execute the mission; and that is true in research just as on the battlefield. Comparing civilian to military researchers, he noted that civilian scientists have continuity of programs, specific missions, and accomplish critical mission-related objectives, whereas military personnel in those structures rotate frequently, without the same level of support as civilians, and have no clearly defined research path nor military operational specialty code for research. Clements observed that for some physicians in the military treatment facilities, the situation is even worse; their research is not supported by dedicated time or funds, and they are still expected to see a full patient load. There is no mechanism to evaluate or designate research achievements, so they are evaluated almost entirely on the quality of their patient care. Under such circumstances, he thought it remarkable that the research is done as well as it is.

Clements believed some of the most important medical R&D personnel are the military physician scientists who do research after deploying to the field. Their recent field experience sharpens their research focus and speeds delivery of solutions back to the field. Unfortunately, these are individual initiatives not attributable to overall command enthusiasm or support.

Kester recalled when the Army medical research laboratory system was able to afford high-performing people—military and civilian, world experts in certain areas. However, now research experience is not a requirement to lead a research organization, which impacts decisions and perceptions. To sustain the workforce, he believed the professional civilian and uniformed workforce needs clear priorities driving their research, as well as career paths that allow them to grow and remain challenged. Clements suggested looking at the various ways that individuals who support the Army research infrastructure progress; it was not through a designated career path.

Bajcsy did not see enough continuity in how young practitioners could be brought to the more intermediate levels and then on to the leadership functions. She noted that many medical doctors also have engineering degrees (Ph.D.s, etc.) and that multi-disciplinary view serves medical research programs well, because they have the skills to understand the good and bad of technology as it applies to the medical field. She suggested that such a program for enticing talent with this combination of medical and engineering education would be extremely profitable for Army purposes.

Theme 10. Defense Health Agency and Army Organization

Kester observed that the Army medical R&D enterprise is complex, fragmented, and a confederation of governance and piecemeal funding, which is antithetical to how a military organization organizes for unity of effort. The processes are overly bureaucratic, priorities are constantly shifting, and it is not at all suited to an agile research organization.

Sepúlveda said it was a learning experience for him to gain insight into the complicated nature of the medical enterprise, along with the complexity of integration and collaboration. The first day presentations reminded him of an academic medical center with its own silos driven by different funding mechanisms. He believed financial incentives must reinforce the collaborative efforts, not detract from them, if we are to tackle challenges from a process and outcomes standpoint.

Davis believed the Army medical infrastructure is in an “existential crisis.” The AFC, where Army medical R&D is now located, has the task of modernizing the Army to compete with China and Russia. The AFC portfolio includes missile defenses and next-generation fighting vehicles, and medical R&D becomes an afterthought. If medical R&D cannot show its relevance when solving the larger matters, the defunding of medical R&D to fund very expensive operational needs will result. Davis described a future battlefield with lack of air superiority, highly mobile weaponry, precision fire, directed energy, and challenged logistics and communications. Therefore, the medical R&D community has to convey how it helps achieve the goal of winning the nation’s wars, not simply saving lives. Those messages of relevance to the future battlefield can be understood and gain traction.

Teyhen commented on the benefits of moving medical R&D under AFC, the first time a four-star general has represented medical research. As a result, the priorities, capability gaps, and capabilities that medical research brings to the table gain added visibility, and thereby improve opportunities to contribute to problem solving.

Clements turned the discussion to issues associated with the DHA realignment; although it was not part of the scheduled agenda, the

realignment was identified in the process as an issue that needed further exploration. Bienvenue discussed how the Army R&D organization could relate to some of the greater organizational challenges and changes occurring in the U.S. military medical arena, in particular the DHA, whether DHA will be responsible for research, and moving forward, identifying where that authority lives. She solicited viewpoints into this topic because, if there is ultimately not going to be an Army medical R&D enterprise, then, she asked, How does the main thrust of this workshop continue? How does the enterprise interact with academia and industry? and Where does research fall within the new architectures looking forward? Kester noted the workshop had proceeded under the assumption that the Army medical infrastructure discussed is going to exist going forward, but if DHA takes over, that is a new world with tri-service implications for medical R&D.

In response, Dertzbaugh noted that the current National Defense Authorization Act (P.L. 116-92) language says that the move into DHA will be postponed until 2024; if that legislation becomes law, it delays the uncertainty of where Army medical R&D ends up and who it needs to align with. The benefit on the Army side is that it is now under a four-star general and receiving a lot more attention, raising overall awareness of how the medical enterprise fits. Lacking a better word, his suggestion was “uniformity” or “coordination” with a single jointness in medical R&D. But he explained that the challenge already alluded to is that right now it has been difficult for DHA to define a good government structure with which to accomplish a takeover.

CLOSING

Johnson remarked that in the corporate world, he sometimes had to search for honesty, but he felt the workshop presentations had consistent honesty, which gave him a sense of comfort. Salamone, referring to Johnson’s remarks, also admired the honesty of the conversations and presentations, with respect to scenarios as well as individual and leadership responsibilities, as foundational to providing good medical care with trained and clinically practiced personnel. The co-chairs and participants ended the workshop with rounds of thank-yous to everyone who participated in the workshop and acknowledged the excellent discussions over the past 3 days.

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