WASHINGTON WRAP-UP
Critical Path Collaborations
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Schultz listed five collaborative medical device projects under the Critical Path Initiative:
1. Simulation-Based Engineering and Medical Imaging Technology for Cardiovascular and Peripheral Vascular Stenting Device Development. The project aims to develop anatomically and physiologically accurate adult and pediatric virtual circulatory systems. It will help assess the safety and effectiveness of new stent designs prior to fabrication, physical testing, animal testing, and human trials (with Stanford Biodesign).
2. Evaluation of Surrogate Outcomes for Cardiovascular Medical Device Trials in General and for Drug-Eluting Cardiac Stents Specifically. The goal is to develop a new statistical model for predicting the effectiveness of implanted cardiac stents. The system will measure and improve their long-term safety (with AdvaMed).
3. Analyze the Development of Biomarkers and Diagnostics and Their Application to Pharmacogenomics. The analysis will identify barriers to drug-diagnostic device codevelopment (with the University of California, San Francisco).
4. Compromised Health Models for Sensitive Patient Populations. The project will develop clinically relevant animal models to improve prediction of toxic effects of medical products on injured tissues in critically ill patients.
5. Fetal Risk Assessment Devices. The collaboration is intended to develop a new paradigm for evaluating fetal-monitoring devices to stimulate innovation in this field (with the National Institute of Child Health and Human Development).
