Workshop on Computational Methods for Cardiovascular Device Design & Evaluation

该项目将支持一个由NSF、NIH和FDA联合主办的研讨会，重点是心血管装置设计和评估的计算方法。本次研讨会将于2007年11月13日至14日在马里兰州贝塞斯达举行。后续会议将于2008年9月30日在圣路易斯举行的生物医学工程学会会议之前举行。本次研讨会的目的是为医疗器械开发中最佳计算机建模方法的发展奠定重要的基础。来自工业界、学术界和政府的专家将在三个关键领域讨论问题。(1)记录与心血管系统建模和预测心血管装置的安全性和有效性相关的行业和学术界的最佳实践和未满足的需求；(2)回顾其他行业中基于仿真的工程科学的最佳实践，包括验证和验证；(3)制定战略，促进心血管装置设计与评估计算方法的发展、应用和验证，明确器械公司、工程软件公司、学术机构和政府机构的作用。为了促进更有效的医疗设备开发，需要改进的工程分析方法，以根据设备的预期功能和收集的解剖和生理数据来预测拟议的设计是否能够正确和安全地运行。计算机模拟方法可以在进行台架测试、动物测试和临床试验之前，在具有不同解剖和生理特征的虚拟患者中实现医疗设备的虚拟原型。这样的仿真工具可以使设备设计人员体验“软故障”，或者没有后果的故障，这对于改进工程产品、缩短上市时间和开发成本至关重要。将撰写一份立场文件，提交给《生物医学工程年鉴》，内容涉及与心血管系统建模和预测心血管装置的安全性和有效性相关的行业和学术界的最佳实践和未满足需求。另外将编写一份白皮书供NIH和NSF使用。本白皮书将介绍研讨会参与者就促进心血管装置设计和评估计算方法的发展、应用和验证的策略达成的共识。本文将确定设备公司、工程软件公司、学术机构和政府机构的角色。此外，它将提出具体的研究课题，重点是发现科学和转化研究，以及提高美国医疗器械行业竞争力的手段。监管问题也将被考虑。

0748725TaylorThe 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.