The Food and Drug Administration has partnered with the Biomedical Engineering Society over the past three years to provide a forum to discuss and disseminate findings related to computational simulations and modeling in medical devices. The 2017 meeting focused on advancement of translational science, through the innovation cycle. This included presentation and critical discussion of studies addressing each of the steps in the translation of a medical device to the patient, as listed below.
The Ideation track addressed the inception of a new device or therapy, and/or the translation of an idea to reality. Ideation includes concept generation, customer needs, disease modeling, and technology scouting. Pre-clinical studies focus on the early work performed to prepare for evaluation in human subjects. Preclinical topics may include animal studies, animal to human transfer function, model validation, and test development. Product development encompasses the translation of early concepts to products ready for use, including predictive modeling, business modeling, robust design, and pre-submission communication with regulators.
Clinical studies center around the generation of evidence that demonstrates that a product is suited for use in humans, e.g. virtual patients, simulation as therapy, clinical study design, and statistical modeling. Market release and post-market studies follow products into the field and highlight the challenges and advances that occur during this process, i.e. regulatory marketing approval, post-market surveillance, failure analysis, and product recall.
This Research Topic will include contributions based on abstracts submitted to the conference as well as additional studies in the area of modeling and simulations in medical devices.
The Food and Drug Administration has partnered with the Biomedical Engineering Society over the past three years to provide a forum to discuss and disseminate findings related to computational simulations and modeling in medical devices. The 2017 meeting focused on advancement of translational science, through the innovation cycle. This included presentation and critical discussion of studies addressing each of the steps in the translation of a medical device to the patient, as listed below.
The Ideation track addressed the inception of a new device or therapy, and/or the translation of an idea to reality. Ideation includes concept generation, customer needs, disease modeling, and technology scouting. Pre-clinical studies focus on the early work performed to prepare for evaluation in human subjects. Preclinical topics may include animal studies, animal to human transfer function, model validation, and test development. Product development encompasses the translation of early concepts to products ready for use, including predictive modeling, business modeling, robust design, and pre-submission communication with regulators.
Clinical studies center around the generation of evidence that demonstrates that a product is suited for use in humans, e.g. virtual patients, simulation as therapy, clinical study design, and statistical modeling. Market release and post-market studies follow products into the field and highlight the challenges and advances that occur during this process, i.e. regulatory marketing approval, post-market surveillance, failure analysis, and product recall.
This Research Topic will include contributions based on abstracts submitted to the conference as well as additional studies in the area of modeling and simulations in medical devices.