Transforming FDA Approaches: The Role of In-Silico Data, Multiscale Modeling, and Generative AI in Medical Device Product Development

Plenary Room

Oral Presentation

Information

Session chaired by Heidi Sernoff

Description:

The session will explore the concept of 'In Silico' clinical trials (ISCT) and demonstrate the unique integration of AI methodologies with computational modeling. Medical device development has already employed modeling and simulation for product development and early-stage product testing. The latest advances now allow for continued operations in virtual environments throughout the clinical trial stage. This includes generating virtual patient cohorts for treatment arms and synthetic patients for control arms, offering an innovative approach to trial design, and streamlining the assessment of novel treatments.

CDM Competency Framework Topic(s)

AI & Cognitive TechRegulations & Standards

Learning Outcomes

Future of Medical Device Development and Regulation: Explore the latest advancements and future trends in medical device development and regulatory processes influenced by AI and computational modelingUnderstanding Computational Modeling and Generative AI in Clinical Trials: Learn how these technologies are revolutionizing medical device development and clinical researchInsights into 'In Silico' Clinical Trials (ISCT): Gain knowledge about the latest application of ISCT in medical device development, including creating virtual patient cohorts

Level

Intermediate

Target Audience

Data ScientistsData EngineersDigital Health and Innovation