Future Hydrogen Production and Use: Letter Report (BEES)

Science-Based Assessment: Accelerating Product Development of Combination Medical Devices (NMAB)

The Food and Drug Administration (FDA) has established testing centers for assessment of three categories of medical products; devices, biologics, and drugs. Increasingly, however, medical products are appearing that are combinations of more than one of those categories. The FDA is just beginning to develop procedures for evaluating such combination products, which pose new challenges for assessing efficacy and safety. The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is an NRC activity that brings together relevant parties to discuss R&D, applications, and regulation of biomedical materials and devices. In 2003, BEMA held a workshop to discuss science-based assessment for evaluation of combination products. This report and accompanying CD present abstracts and viewgraphs of the talks given at that workshop. The workshop focused on three specific types of combination products: orthopedic repair using morphogenetic protein, drug-eluting stents, and cell-matrix cartilage implants. In addition, context-setting discussions of science-based assessment and experimental design were presented at the workshop.

Capturing the Full Power of Biomaterials for Military Medicine: Report of a Workshop (BMED, NMAB)

Recent results in biomaterials R&D suggest that there are exceptional opportunities for these emerging materials in military medicine. To facilitate this possibility, the National Research Council convened a workshop at the request of the Department of Defense to help create a technology development roadmap to enhance military R&D into biomaterials technology. The workshop focused primarily on identifying useful near- and mid-term applications of biomaterials including wound care, tissue engineering, drug delivery, and physiological sensors and diagnostics. This report presents a summary of the workshop. It provides a review of biomaterials and their importance to military medicine, the roadmap, and a discussion of ways to enable biomaterials development. Several important outcomes of successful capture of potential benefits of these materials are also discussed.

The Owner's Role in Project Risk Management (BICE)

Effective risk management is essential for the success of large projects built and operated by the Department of Energy (DOE), particularly for the one-of-a-kind projects that characterize much of its mission. To enhance DOE’s efforts in this area, the department asked the NRC to prepare a summary of the most effective risk management practices used by leading owner organizations. This report presents the results of that study. The report provides DOE’s project managers with a basic understanding of both the project owner’s risk management role and effective oversight of those risk management activities delegated to contractors. It presents a discussion of the steps in the risk management process, the elements of a proactive approach, and tools that can be used for risk management of one-of-a-kind projects.