 Arthur Erdman “The Emergence of Regulatory Science, High-‐Speed Computation and New User Interfaces in Development and Approval of Medical Devices” Medical devices are fundamental to effective health care. From pacemakers to catheter delivery systems to replacement heart valves, medical devices impact patient care in both routine and life critical settings. Innovation in this field can have a direct positive impact on health outcomes. Despite the overall success of these devices, both mechanical and tissue based devices fail over time, sometimes within months to several years. Currently, introduction of new medical devices require extensive and expensive product cycles that usually include animal and clinical trials. The FDA dictates these processes to assure safety and efficacy of all medical devices. Competitive pressures often force initiation of animal trials without sufficient understanding of parameter selections based on bench tests and other preliminary analysis. In turn this may lead to suboptimal results due to the lack of sufficient insight about the true impact of design decisions upon actual device success. This seminar will suggest that these limitations can be reduced through advancements in simulation-based medical device design and manufacture including CAD and FEA. The new thrust at the FDA is the application of Regulatory Science to the entire regulatory process including computationally based virtual prototyping. The future may also include patient-specific physiologic simulations that provide high-resolution data based on anatomic models derived from MRI and CT imaging and tissue testing. The device/tissue interaction results can be visualized at the medical device designer’s workbench using a large-format stereoscopic display and new user interfaces. Since the designer is interested in comparing the impact of particular design decisions, visual analytics techniques optimized for data comparison are used to explore high-dimensional datasets from 10’s to 100’s of simulation runs. This is a path towards personalized medicine. The vision is the development of an integrated simulation-based environment, from personalized anatomical data to the design, optimization and manufacturing of a medical device. When: Thursday 2/28/13 4:10 PM Where: 1005 GBSF |
