University of Leeds researcher Alejandro Frangi has received funding support from the Royal Academy of Engineering to develop a new approach to discover, develop and test new medical devices based on computational ‘in-silico’ trials.
During the in-silico approach, computer analysis will be leveraged to create medical devices from their conception and ensure optimum clinical outcomes through designs targeting a variety of patient groups.
This method is expected to offer an alternative to other innovation processes, which can sometimes result in medical technologies which do not work for all patients. This can require suspension of development, leading to high costs.
In in-silico testing, computer simulations will analyse how and when a device could fail, cause harm or become ineffective in certain populations.
The trials will involve virtual patient populations, dubbed virtual patient chimeras, representing the natural anatomical, physiological and biological variations present in real-life people.
Frangi said: “It is a huge waste of money with product development teams having to go back to the drawing board or even scrap a project.
“Similar problems exist in drug development with less than 10% of the drugs in various phases of clinical trials eventually ending up being marketed, either because they are proven to be ineffective or unsafe.”
Data from patient and tissue databases will be used to build these virtual chimeras.
As the technique is carried out long before in-human testing, it is expected to cause minimal harm to both animals and humans, compared with the existing process.
While the in-silico trials do not eliminate the need for real-life patient studies, they are expected to help identify and resolve any challenges before the device advances into clinical development.
Frangi added: “Computational medicine can bring about a complete shift in the way devices are conceived, developed, and ultimately tested for the market.”