Pre-Clinical Evaluations and Clinical Investigations. Strategizing Towards Efficiency and New Approaches Including in Silico Methods

Description: Pre-clinical evaluations and clinical investigations are generally the most cost-intensive parts of designing a new medical device and bringing it to the market. Therefore, designing an efficient regulatory-clinical strategy is key. The definition of endpoints is important from a regulatory compliance perspective, but also from a cost perspective. Identifying the right data points is crucial. The session will address how endpoints, sample size and follow-up can be derived from the regulatory-clinical strategy and how this can be used for an efficient clinical study design.

As a new approach, in silico methods (computational modeling and simulation) are playing an increasingly important role in the research, development, and evaluation of innovative medical devices. Correspondingly, this session will further introduce the application of such methods as a selected example. In silico methods can serve as a basis for scientific proof of the safety and performance of medical devices, in addition to the conventional animal model, the in vitro model ("bench"), and clinical investigations. This may include computational modeling to simulate a medical device and/or a patient for testing, evaluation of medical device performance using a virtual cohort (in silico clinical trials), or computational modeling implemented in medical device software. Such in silico methods must be adequately considered in regulatory submissions or in the conformity assessment procedure of medical devices. Correspondingly, it will be discussed during the session how conceptual aspects of in silico methods for medical devices can be integrated while maintaining regulatory compliance.