Nice interview and article from the Dimensions Magazine about the Avicenna Alliance and about the role played by computer modeling and simulation in regulatory approval.
Engineering simulation has been used for decades to develop healthcare devices. Today, simulation is increasingly being leveraged to demonstrate product performance during the regulatory approval process — where it can significantly reduce time and costs.
While all product development processes are rigorous, time-consuming and resource-intensive, this is especially true in the healthcare industry — where devices have the potential to impact the well-being of millions of patients. For decades, engineering simulation has helped reduce the time, cost and risk involved in designing these devices. By engineering and testing patient solutions in a virtual design space, healthcare companies can propel products to the launch phase much faster, and with a higher degree of confidence that they will perform as expected in the real world. By building 3D models of products and the human body in a virtual design environment, healthcare product developers can test and verify performance, using simulation and digital exploration to make modifications quickly and easily. Simulation is much faster, more cost-effective and less invasive than building and testing physical prototypes. However, product development is only the first step in launching innovative healthcare devices — which must next undergo a lengthy process to secure regulatory approvals from government agencies. Historically, simulation has been largely ignored during this phase. However, healthcare companies and regulatory agencies alike are now recognizing that, because it can replicate and demonstrate the way devices will actually perform under real-world conditions, simulation is critical to support the regulatory approval process. Called in silico clinical trials, this approach is rapidly gaining ground. The United States Congress, the U.S. Food and Drug Administration (FDA) and the European Parliament are now urging healthcare companies to explore its potential. In 2016, the FDA released a document detailing exactly how simulation results should be submitted as part of the regulatory approval process. In early 2017, the European Parliament approved text stressing that any simulation results submitted within the framework of a regulatory approval process must be considered...
You can read the full article here
