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Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop
medical applications however, different guidelines prevail. For example, the regulatory process does not recognize the results of accelerated testing, a protocol that forms the basis for a large fraction of materials modeling. One near-term process improvement offered by attendees included standardizing procedures to enable a clear path to prove the efficacy of new materials.
The need for an easy path to make new materials available to product developers was also noted. Although this may seem trivial, workshop attendees pointed out that some new materials were not available for research because of a new interpretation of intellectual property laws. Improved communication is needed among materials developers and device designers to gain the most from all.
Finally, it was noted at the workshop that the regulatory governance of medical devices does not control their use outside the United States. Because the bulk of military combat takes place overseas, some discussion ensued as to whether the military needed to follow these approval protocols at all. Regardless of the letter of the law, the U.S. military has chosen to abide by U.S. guidelines, including operating with the informed consent of the soldier. However, the demands of battlefield care can provide the opportunity to gain valuable clinical trial information in the field. Many workshop attendees felt that a recognized path for using field trials to prove efficacy would be very useful.
MEASURES OF SUCCESS
Throughout the meeting, workshop participants discussed the outcomes of their efforts to develop and implement new materials for military medicine. Success in the implementation of these suggested goals was linked in the breakout sessions to a number of benefits for the nation's defense, as follows:
Preserving fighting strength—improving soldier health and well-being could result from improved battlefield diagnostics and care that would keep soldiers at their best and could also allow wounded soldiers in the field to complete their mission. It would result as well from successful tissue engineering technologies that could heal more serious wounds quickly and allow a soldier to return to duty.
Improving the benefit of medical spending—new materials and processing technologies can reduce the cost of medical care and therefore stretch the funding available and provide better care.
Transferring cutting-edge technologies developed for the military to civilian medical practice—in many ways, military needs are the most demanding. Success in transitioning technology to field use can push new technologies into other applications. This will require the involvement of new partners, including civilian practitioners and the reimbursement industry.
Strengthening the biomedical technology industry—by creating and nurturing a critical mass of innovative researchers and product developers, the growth and impacts of biomaterials technology could multiply accordingly.
Improving troop morale and public perception—confidence that medical technology can save lives in the field and can repair the damage from severe battlefield wounds is important to many soldiers as well as to their families and the general public.
The following performance metrics were suggested by workshop participants the accelerate the availability of biomaterials and related products developed for military applications:
In the near term, make field clinical trials for new battlefield products routine.
In the mid-term, establish a transition path to move existing new biomaterials into military applications.