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Perhaps unbeknownst to some, the U.S. Army, through its U.S. Army Medical Research and Materiel Command (USAMRMC), is a major contributor of funds and manpower to medical device development. And one of the people responsible for organizing its efforts in that sphere is William Howell, the first principal assistant for acquisition for USAMRMC. If device OEMs are interested in collaborating on a development project with the Army, or if they have a product that it could use, Howell is someone they need to know.
USAMRMC is the Army unit that determines what is required to meet the medical and health needs of U.S. soldiers. If the technology to address a need is available, USAMRMC purchases it. However, if such a technology is not available, it finds universities or companies with which to collaborate on development. It shepherds the products resulting through clinical trials and FDA approval, and then it purchases them for use on the battlefield and elsewhere. It enters into a variety of development contracts with firms and universities, most notably Cooperative Research and Development Agreements (CRADA). USAMRMC is headquartered at Fort Detrick in Frederick, MD.
Howell is one of the highest-ranking civilians in the Army and oversees USAMRMC's efforts from proof of concept through FDA approval and purchasing. He has served in various medical acquisition posts since 1987. Before that, he served as a logistician, both as a soldier in the Army and as a civilian. He spoke to MD&DI editor-in-chief Erik Swain in March.
Q: Can you describe the mission of USAMRMC?
A: USAMRMC serves as a life-cycle product acquisition command. We do front-to-back work, from basic science through development to fielding and procurement, of medical items used on the battlefield and needed to maintain troop health. For example, products include devices used in Army surgical hospitals for trauma cases and vaccines used to fight infectious diseases.
We do not manufacture anything. We search the marketplace for products or technologies that we need. If we can't find them, we look into developing them, or we partner with a company or university that is working in the area. We work with them to develop products and reach regulatory approval, and then buy the products back.
Q: What are your duties as principal assistant for acquisition?
A: The command is basically divided in half. The principal assistant for research and technology oversees basic science through proof of concept. I oversee the actions thereafter until procurement. In this phase, we transition the technology to a commercial entity, assist in advance development, work with the company through the FDA process, and procure the technology.
Q: How are USAMRMC's research and development activities structured?
A: There are four core research areas and two congressional pieces. The first research area is infection control, particularly as it relates to the Third World. If we are deployed to a Third World area and do not provide protective countermeasures, our soldiers will fall sick. The second is combat and trauma care, which is the most relevant to the medical device world. Many soldiers suffer battlefield trauma that is severe, with multiple wounds, and to a level not experienced at a community hospital. Plus, the treatment may have to be in austere conditions, even at the point of the battle at times. The third area is operational and environmental medicine. Soldiers undergo difficult jobs in tough environmental conditions. They may be cold. They may be under stress. They may be at high altitude. We find ways to optimize soldiers' performance on the battlefield in those conditions. The fourth area is chemical and biological. The primary focus is preventive vaccines or treatment products for those exposed to biological and chemical weapons.
Then there are two congressional set-aside programs that we have managed for about 15 years. The first is the Congressionally Directed Medical Research Program, or CDMRP. We manage more than $300 million worth of research protocols a year under this program. These protocols have been focused on the large disease groups, such as breast and prostate cancer. They mainly have a community-based benefit, so they don't fit as tightly with our mission. But they are relevant to military retirees, so in that way we do see some military benefit. The second is the Telemedicine and Advanced Technology Research Center, or TATRC. This set of congressionally directed efforts is primarily constituent based. In other cases, specific organizations, such as universities or small business, have gained congressional interest. We manage the contract and monitor the project with the entity. Because many of these projects are early in maturation, the principal assistant for research and technology plays a larger role in them than I do.
The projects of both congressional groups are one-year appropriations, and some may be funded for only one year. However, we are there from start to finish on projects in our four core areas. Projects must have dual [civilian and military] use. Many are prime candidates for introduction into the commercial marketplace.
Q: How do you decide which R&D activities to pursue?
A: For the core programs, we follow a risk-threat management process. What are we seeing on the battlefield that we aren't able to treat as well as we would like? How severe is the problem? When we look at proposals from companies and universities, we look for what value they would bring to the military. If a project has no value to us, we will not pursue it. For example, there are certain problems prevalent in [the military] that are not found frequently in the civilian population, such as posttraumatic stress disorder and traumatic brain injury. We will get involved because no one else has and because there is a bona fide military need. For the two set-aside programs, we do what Congress tells us. We specifically do not work in areas in which a large amount of civilian work is being completed. Rather, we go after the military niche areas where our research dollars make a difference.
Much of our drug and vaccine work is about discovery, but that's not the case with medical devices. [Device] projects often begin with a commercial prototype that we assist through development and into production.
Q: How does the CRADA system work? What other kinds of contracts with industry do you get involved in?
A: The joy of CRADAs is that both entities get to bring their capabilities to the table and figure out what is best for the development of a product or technology. The company or university may do the research, and then we work on the development together, or it could be structured another way. We also have a full range of contract options, from simple grants to fixed-price contracts. All actions are looked at as individual actions, and the contract agreement is made to match the effort. Our contracting activity, the U.S. Army Medical Research Acquisition Activity, assists us in determining what makes the most sense.
Q: What is USAMRMC's role with regard to clinical trials?
A: We are involved in several ways. On the disease side, we have laboratories with clinical sites in places like Thailand and Kenya, as well as joint labs with CDC in places like Mali and Uganda. We conduct trials for products that fight disease. We are able to develop protocols, conduct the trials, and complete the data management thereafter; it's a complete service. For trauma-care products, we can do the same at the Brooke Army Medical Center in San Antonio, TX, where we have an active research base and major trauma center collocated. In both instances, we see firsthand how a product works and how it might benefit our population. We can get a sense of how the product would work in the real world, how doctors would use it, and what effects we need to look for. Other times, we just provide the funds and others conduct the trial. For example, we are involved with a trial for an AIDS vaccine in Thailand, and the Ministry of Public Health is conducting it.
Q: What does USAMRMC do after the results are in?
A: It often comes down to the market value of the product. How much money can a commercial entity make? If the answer is a lot, a company will often take the product through to commercialization. If the answer is not much, then we may take it ourselves through the last steps of development to incentivize a commercial entity to take the product later. For example, when we worked on a hepatitis A vaccine, which was developed at the Walter Reed Army Institute of Research, we took it up through Phase I clinical trials. Our collaborator liked it so much that they swooped in and took it from there.
Q: How do you go about finding medical device companies with which to collaborate?
A: We do a lot of market research to see what is out there and who is working on which product lines. We attend conferences and have booths in all sorts of places, but the medical device market is difficult for us. The pharmaceutical and vaccine markets are made up almost entirely of big companies, and we know how to find them and who to talk to. The device industry has some larger companies, but also a lot of small ones, and getting to them is not easy. We are working with AdvaMed and others to reach out to them. From a procurement standpoint, however, we're doing well. We work with distributors like McKesson and Cardinal, who can keep us informed about what's available in the marketplace. Sometimes we find companies through unusual means. For example, a lobbyist came to us to tell us about a medical-grade oxygenation technology. He didn't even represent SeQual Technologies, the company that developed it, but he thought the firm had something we should know about. When we went to visit it, we learned that the company was working in the home-healthcare arena, but it had something that could be translated to the battlefield. We wouldn't otherwise have gotten a crack at that.
Many good ideas come from several directions, and it is very difficult to keep up. But the thing is, we are very much focused on the battlefield. Lots of people come to us with good ideas, but they don't understand what the battlefield looks like. They tell us about something that might work well at Johns Hopkins, but in actuality it may not work in the much poorer conditions of the battlefield. But we still want to have all those suggestions. Even if only one of 100 is of use, that's still one we did not have before.
Q: What should a medical device company do if it wants to collaborate with you but has no existing relationship with USAMRMC?
A: The best way is to identify the person in our service who is responsible for that area, and get in front of them. Or you can find us at conferences, or through AdvaMed. Also, there is a Web site for U.S. Army Military Research Acquisition Activity (www. usamraa.army.mil/pages/index.cfm). There is a “New Products & Ideas Submission” button on the left side of the Web page that allows you to give us some basic information on your product. Let us know what area your project is in, how mature it is, and how it might be of interest to battlefield medicine. That will be forwarded to a relevant representative within the command. Hopefully we will find something in it that is meaningful to us.
Q: How do products developed through USAMRMC go through the FDA approval process? Is there a special track for them? What is your role in this process?
A: We are just like everyone else. We do not have a special deal with FDA. Sometimes people assume we do because we are also part of the government. That is not the right thing to do politically or scientifically. We do have a good relationship with FDA and a good feel for what they want. At the early stage, we may be the submission holder, and then when we transition the product, the company may take it the rest of the way through FDA.
We do not like to use, and severely limit the use of, products without FDA clearance or approval. There have been a few products we have used that did not have FDA approval, but only under compassionate or truly unique risk situations, for which the soldier would be at severe risk of death unless we used [the unapproved product].
Q: Once a product is developed by USAMRMC, how does the technology transfer process work? At what point is it decided who will commercialize the product for civilian use?
A: If it's one of our ideas that we want out in the open marketplace, we may do a market survey early on to find a good fit with our technology to a company. It may take three to five years to do the research and development and take a product through FDA review, so we make long agreements. We also have to sort out the intellectual property issues. By the time we are ready to buy the product, everything will be in place.
There have been instances where we have worked on devices, and before we reached completion of the project, there were two or three other companies that had already entered the market. We may end up buying from them if their product turns out to be better. If that happens, so be it. Once we worked on a ruggedized x-ray system for six years, and two or three companies eventually beat us to market. In the end, that is a good thing, because our clinicians get the best product. Anytime we start work in an area and it becomes a competitive environment, we get a better-quality product regardless of whether we develop it ourselves. And sometimes we can get an enviable piece of a market that was not thought to be much of anything for decades.
Q: What are some of the more notable products developed through the USAMRMC process?
A: There is a wide variety. The most important of late is the chitosan bandage. Chitosan is derived from shrimp shells. It has an unparalleled clotting capacity and can defend against fungal infections. It has been very effective in stopping soldiers from bleeding to death on the battlefield. Also, a small group in Fort Detrick helped pilot a new digital image archiving and display system. That was a huge success and has been incorporated into civilian healthcare systems. It is now a multi-billion-dollar industry within large device firms.