MEDICAL DEVICES
KEY ADVANTAGES
Of in silico experimentation
FDA
The FDA recognizes Computational Modeling and Simulations (CM&S) as valid evidence in device submissions — if credibility is demonstrated. Their 2023 guide outlines how to ensure models are trustworthy and science-based.
At IN SILICO STEM, we align with this framework to deliver credible simulations that support Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), Premarket Notifications (510(k)s), and De Novo classification requests.
Faster access
to market
Investment
attraction
Evalute safety and effectiveness
Regulatory
compliance
Reduce animal and clinical trials
Evaluating a medical device during its development stages is a complex and demanding process aimed at generating solid evidence of its efficacy and safety. Traditionally, clinical and in vivo studies have been used for this purpose; however, testing the vast parameter space through these types of studies poses several challenges, ranging from high costs and long execution times to ethical and legal dilemmas.
Unlike traditional methods, in silico experimentation allows for the rapid, safe, and cost-effective exploration of a wide range of complex scenarios. It also enables the generation of data to support decision-making related to device design, performance, and safety—especially in the early stages of development.
In addition, simulation can be integrated at multiple stages of the medical device development cycle: from initial concept, design, and optimization, to verification, validation, and regulatory approval processes.
PROJECTS
At IN SILICO, we have extensive experience in using multiphysics models to improve the design, performance, and safety of medical devices.
At In Silico STEM, we conduct in silico device testing and in silico clinical trials of ablation devices and techniques such as RFA, PFA, laser, cryoablation, among others. These simulations make it possible to analyze the progression of tissue damage. Based on this information, treatment protocols can be optimized, safety thresholds evaluated, and risk factors identified — all contributing to the development of safer and more effective therapies.the text to include your own content. Adjust the font, size or scale to customize the style.