60 In-Silico Modelling in the Development of Novel Devices in Thoracic and Abdominal Surgery: A Systematic Review Free

Surgical innovation has made significant leaps in recent years, but the adoption of novel devices has lagged due to prolonged efficacy and safety assessment through randomised controlled trials. In-silico modelling may provide a solution, utilising computational simulations to develop and improve surgical devices. This systematic review aimed to evaluate the current use of in-silico modelling for devices utilised in thoracic and abdominal surgery.

Studies in the last five years were searched in PubMed databases (Jan 2019 - Aug 2024). Specified inclusion criteria included original studies using mathematical/computational modelling to investigate thoracic/abdominal surgical devices which are invasive in nature.

Of 2968 studies derived from the search strategy, 42 were included in the final analysis and categorised by surgical specialty: general surgery (n=4); hepato-pancreato-biliary (n=2); vascular (n=5); paediatric (n=9); and cardiothoracic (n=22). Three core themes were identified: proof of concept (n=19), device improvement (n=22), and in-silico clinical trials (ISCTs) with simulated human patients (n=1). Most studies were at IDEAL stage 0 (pre-clinical) and 19 studies validated in-silico results with in-vitro/ in-vivo data.

In future, in-silico modelling could replace components of pre-clinical in-vitro and in-vivo testing of surgical devices. Applications include generating efficacy data for novel devices in the pre-clinical stage, modelling minority patient demographics or rare diseases, and developing/repurposing existing devices to reduce complications. Standardised core outcomes and credibility frameworks will minimise inter-study heterogeneity in methodologies and reporting of results. Global collaboration will help bring in-silico modelling to the forefront of surgical device research.