The project will support a workshop jointly sponsored by NSF, NIH and FDA focused on Computational Methods for Cardiovascular Device Design & Evaluation. This workshop will be held November 13 and 14 2007 in Bethesda, MD. A follow-up meeting will be held on September 30, 2008 in advance of the Biomedical Engineering Society Meeting in St. Louis. The purpose of this workshop is to lay important groundwork for the development of optimal computer modeling methods in medical device development. Experts from industry, academia and government will discuss issues in three key areas. (1) Document the best-practices and unmet needs in industry and academia related to modeling the cardiovascular system and predicting safety and efficacy of cardiovascular devices; (2) review best practices in other industries in simulation-based engineering sciences including verification and validation; (3) establish a strategy to promote the development, application and validation of computational methods for cardiovascular device design and evaluation identifying the roles of device companies, engineering software companies, academic institutions and government agencies.
To facilitate more effective medical device development, improved engineering analysis methods are needed to predict whether a proposed design will function properly and safely based on the intended function of the device and the anatomic and physiologic data gathered. Computer simulation methods could enable the virtual prototyping of medical devices in virtual patients with varying anatomy and physiology before conducting bench testing, animal testing and clinical trials. Such simulation tools could enable device designers to experience 'soft failure', or failure without consequences, which is critical to improving engineered products and reducing time-to-market and development costs.
A position paper will be written and submitted to Annals of Biomedical Engineering related to best-practices and unmet needs in industry and academia related to modeling the cardiovascular system and predicting safety and efficacy of cardiovascular devices. An additional white paper will be written for use by NIH and NSF. This white paper will present the consensus obtained by the workshop participants related to a strategy to promote the development, application and validation of computational methods for cardiovascular device design and evaluation. This paper will identify the roles of device companies, engineering software companies, academic institutions and government agencies. In addition, it will propose specific research topics with an emphasis on discovery sciences and translational research, and the means to enhance the competitiveness of U.S. medical device industry. Regulatory issues will also be considered.
