针对新项目的创新及协作式同步项目管理
Simulation is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process.
Developing increasingly complex medical devices requires increasingly capable tools for simulation and testing. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.
Simulation is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process.
Developing increasingly complex medical devices requires increasingly capable tools for simulation and testing. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.
Life sciences special report
The life sciences sector is experiencing an unprecedented change in the way new medical devices and pharmaceuticals are developed. Leading medical companies have realized that investing in modeling and simulation is critical, and have started integrating simulation into clinical trials and applying it to modernize their manufacturing processes. Ultimately, this results in better medicines, superior medical products, and significantly improved outcomes for patients. The articles in this special report highlight a few examples of this and cover a range of applications from medical device design to pharmaceutical manufacturing processes.
There has never been a greater opportunity to innovate in the design of medical devices, and to deal with the challenges of device development. Simulation is playing a critical role in identifying and preventing design-related failures, which continues to be the leading cause of device recalls. Simulation can increase product performance, safety and reliability, especially when performed early in the design cycle. And with the continuing rise in the cost of clinical trials, simulation-based product development, and virtual prototyping are increasingly being recognized by the US FDA as tools capable of supplementing experimental testing and clinical trials, and facilitating regulatory approval. Medical device developers can use simulation to generate digital evidence of product performance, an effort supported by FDA and regulatory agencies worldwide.
Engineers need tools that enable them to develop the most complete understanding of the complex processes occurring in the devices they design and troubleshoot, levels of understanding far beyond that provided by experiments or basic engineering principles. These tools should also allow engineers to explore the design space to understand the complex non-linear relationships between the relevant variables, then use the knowledge to inform trade-off decisions and provide insight into how products respond to the effects of variability, all while maintaining records of the simulation results and providing traceability between requirements and engineering data.
Explore the key areas of this solution.
Solutions for assessing the impact of variability from multiple interacting sources on product performance.
Predict product performance at every stage of the product development process--from system simulation to detailed multiphysics simulations of specific components and processes.
The platform for integrating simulation and test data into the broader, comprehensive database that comprises the "single source of truth" for your device.
Simulation holds the key to designing the next generation of implanted medical devices
使用计算机辅助工程 (CAE) 可以大大减轻工作负担,同时确保可靠性并改进医疗器械的设计。目前,工程仿真获得了世界各地的监管机构、制造商和供应商的广泛认可和采用。其中一个例子是由 FDA 举办的一场研讨会,其主题是通过血泵建模进行血液损害研究,以制定典范做法并促进仿真在器械设计中的使用。随着知...
一种全面的数字孪生,融合了病人的特定情况
了解仿真和设计探索如何能够帮助保持竞争优势并满足医疗器械开发中设计周期加快和风险管理的挑战。