About this Research Topic
Prior to be put on the market, the long-term safety, performance, and clinical benefits of a medical device should be demonstrated by the manufacturer. Although this evidence has traditionally been provided by means of in vivo or ex vivo testing, evidence in silico has recently started to be included in regulatory submissions as well. Nevertheless, a number of barriers still exists which contributes to preventing a more extensive adoption of in silico strategies for regulatory evaluation, such as the non-regulated choice of risks accounted for in the model, need of definition of the sufficient complexity of methodologies adopted, and the proof of credibility of the model employed.
The possibility of augmenting device testing by including in silico trials could not only significantly reduce the costs but could also allow to consider a wider spectrum of patients, clinical conditions, and device configurations, for example, in orthopedic or cardiovascular applications. In light of this, in silico methodologies, such as finite element analysis (FEA), computational fluid dynamics (CFD) or multibody simulation (MBS), will come to play a more significant role in the future. In this context, this research topic aims to include studies which, from different perspectives, bring methodologies and results fostering the development and the adoption of in silico strategies for regulatory purposes.
Objective: The primary goals of this research topic are twofold: to construct a comprehensive framework that encompasses the current state of the art, while identifying both strengths and weaknesses within the pipeline; and to contribute towards establishing standardized protocols for the adoption of in silico strategies in device testing, for regulatory purposes. Ultimately, this research topic aims to facilitate the successful introduction of innovative medical products into clinical practice.
We expect to receive original research articles presenting studies addressing the adoption of in silico methodologies for regulatory purposes, with particular attention to the reduction of in vitro evidence of safety and efficacy of a medical device.
Topics might be related, but not restricted to, the following fields:
Approaches and best practices for credibility assessment of computational models
Software and digital platforms to support manufacturers in the performance evaluation of medical products
Software and digital platforms to simulate the manufacturing process
Numerical strategies for design and validation of adaptable or patient-matched medical devices
Strategies for the generation of virtual cohorts to be employed in the in silico trials
Image analysis for non-invasive and non-destructive device assessment
The possibility of augmenting device testing by including in silico trials could not only significantly reduce the costs but could also allow to consider a wider spectrum of patients, clinical conditions, and device configurations, for example, in orthopedic or cardiovascular applications. In light of this, in silico methodologies, such as finite element analysis (FEA), computational fluid dynamics (CFD) or multibody simulation (MBS), will come to play a more significant role in the future. In this context, this research topic aims to include studies which, from different perspectives, bring methodologies and results fostering the development and the adoption of in silico strategies for regulatory purposes.
Objective: The primary goals of this research topic are twofold: to construct a comprehensive framework that encompasses the current state of the art, while identifying both strengths and weaknesses within the pipeline; and to contribute towards establishing standardized protocols for the adoption of in silico strategies in device testing, for regulatory purposes. Ultimately, this research topic aims to facilitate the successful introduction of innovative medical products into clinical practice.
We expect to receive original research articles presenting studies addressing the adoption of in silico methodologies for regulatory purposes, with particular attention to the reduction of in vitro evidence of safety and efficacy of a medical device.
Topics might be related, but not restricted to, the following fields:
Approaches and best practices for credibility assessment of computational models
Software and digital platforms to support manufacturers in the performance evaluation of medical products
Software and digital platforms to simulate the manufacturing process
Numerical strategies for design and validation of adaptable or patient-matched medical devices
Strategies for the generation of virtual cohorts to be employed in the in silico trials
Image analysis for non-invasive and non-destructive device assessment
Keywords: medical technologies, computational medicine, medical device testing, In silico strategies, Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), Multibody Simulation (MBS)
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
