Engineering Simulation: A Promising Tool for Securing Regulatory Approvals - White Paper

Computational modeling and simulation (CM&S) is now widely used as a part of healthcare product and process development activities. By simulating the performance of healthcare devices and therapies in a low-risk, cost-effective virtual environment, the development process can be accomplished much faster and more cost-effectively. To date, CM&S technology has been largely ignored during the equally important and very costly regulatory approval process. Yet its acceptance for securing regulatory approvals is increasing, as more government agencies and other stakeholders are seeing its benefits. The United States Congress, the US Food & Drug Administration (FDA) and the European Parliament have all publicly recognized the value engineering simulation can add during the process of demonstrating product performance and gaining approvals. Today a number of healthcare companies and technology providers are joining forces within the Avicenna Alliance to accelerate the pace of adoption. With so many doors open, the failure to use engineering simulation as part of the regulatory approval process not only misses a major opportunity, but also wastes precious resources.