A cloud-based platform for seamless digital testing of cardiac medical devices and drugs
Résumé
The advantages of in silico approaches based on computational modelling and simulation (CM&S) are clear: they can help reduce development costs, shorten timelines, improve early predictions of safety and efficacy, identify potential failures before reaching human trials and promote personalised solutions. High-resolution biological data, together with advances in computational power and artificial intelligence, are gradually overcoming the complexity of modelling the human body and enabling more accurate predictions. However, a significant unmet need remains: the lack of accessible, trustworthy, validated in silico models that are robust enough for regulatory adoption. The requirements for technical computational skills and the need for extensive verification, validation and credibility assessment, along with substantial investment in software licences and hardware infrastructure, have considerably limited their adoption among large pharmaceutical and medical device companies, or offered as dedicated consulting services, while remaining an insurmountable challenge for small and medium-sized enterprises.
Domaines
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