What Is “In Silico” and How Does It Benefit Medical Device Engineering?
The medical device industry is a fast-paced world in which companies cannot afford to make missteps or fall behind. Med device developers who, in the past, have dominated the market are now faced with startups and tech companies entering the field.
Innovations, such as in silico clinical trials, can offer game-changing opportunities for companies to get ahead by reducing regulatory costs, managing risks, and reducing time-to-market.
In this blog post, we’ll provide a definition of the term “in silico,” explain how it fits into medical device engineering and hear predictions from subject matter experts on how it will be involved in the evolution of the healthcare sector.
What is In Silico?
To put it simply, the term ‘in silico’ refers to an experiment that is performed on either a computer or through a computer simulation. The term is related to the more commonly known terms “in vivo” and “in vitro.”
More specifically, according to The University of Sheffield’s Insigneo Institute, in silico medicine (also known as ‘computational medicine’) indicates modeling and simulation technologies that directly contribute to the prevention, diagnosis, prognosis, treatment planning & execution, or management of the disease. In silico methods complement traditional in vivo approaches (working with animals and human beings) and in vitro testing (working in a lab).
How Does It Benefit Medical Device Engineering
Though in silico can complement in vivo and in vitro testing, modeling and simulation can benefit medical device products by offering fast development and safe ways to test the safety and efficacy of a medical device.
Through in silico trials, manufacturers can understand the operating conditions that their devices will work for, thus building creditability, and ensuring that when they are ready to go to a patient, that preparations for safety, accuracy, regulations, and policies are in place.
According to Ansys, “the use of computational modeling (i.e., simulation or in silico trials) is being used more often in the design of medical devices. These simulations accelerate innovation and provide comprehensive evidence of long-term safety. However, in spite of the benefits of simulation, the utilization of computational modeling as evidence in regulatory submissions is lagging. With the introduction of regulatory pathways for in silico testing of medical devices, we can expect to see simulation as an increasing trend in the regulatory side of the healthcare industry.”
The Computer Modeling Evolution
In an example of how in silico can speed up the development, Thierry Marchal, Program Director for Healthcare Solutions at Ansys, writes in this recent post on our blog, “the dramatic COVID pandemic has amplified a trend that appeared a decade ago – progressively calling for the adoption and deployment of in silico medicine. Stormed with the COVID pandemic, the world could not wait for 10 to 15 years to get a new vaccine fully tested and approved using a traditional approach.”
He continues to share, “as medical innovation will be essential soon, this evolution cannot be slowed down by an extremely long and costly regulatory approval process: a digitalization of drug and medical device approval, including in silico (clinical) trial is another major trend that we are observing.”
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Global Standardization of In Silico Trials
There are great efforts from companies working toward making in silico testing the global standard. For example, Ansys is working towards streamlining credibility assessment for healthcare in silico testing through education and awareness.
Measures like standardization play a large part toward standardizing in silico. In this blog, Dr. Marc Horner, Lead Healthcare Specialist at Ansys, shares that The American Society of Mechanical Engineers (ASME) standard on the V&V of medical devices completes the regulatory pathway for computational modeling. “The ASME V&V 40 subcommittee is now working to educate the community about the standard and its best practices. This education is being done through industry days, training sessions, examples, and new work items.”
Additionally, organizations like the In Silico World Project are working to lower the barriers to a universal adoption of in silico trials. Their vision is a future where medical products, thanks to the use of modeling and simulation, are developed much faster and with the highest possible safety standards.
The In Silico World Project, in partnership with the Avicenna Alliance, are actively working toward this goal with efforts such as the Good Simulation Practice (GSP) Task Force, which was created as a community and sounding board for future simulation standardization efforts.
The Evolution of and Future of In Silico Experimentation
As in silico methods evolve and become more rapidly adopted by the medical device engineering and healthcare industries, it can help solve some of the scientific, methodological, ethical, regulatory, and financial issues related to the development of medicinal products to benefit patients.
As predicted by Dr. Liesbet Geris, Research Professor in Biomechanics and Computational Tissue Engineering at the University of Liège and KU Leuven in Belgium. “Very soon, I believe it will be considered unethical to fail to use in silico methods for biomedical research.”
“Given the enormous benefits of the in silico approach, and the increasing accuracy of modeling and simulation tools, there will be a reduced need to incorporate humans or animals into our experiments,” Geris explains. “We will be able to move faster, more confidently, and more cost-effectively toward research discoveries by using advanced simulation tools than we would using traditional in vitro and in vivo approaches.”
According to Geris, one of the primary benefits of in silico experimentation is the ability to create customized models that reflect a specific patient. “Every human body is distinct in its geometry, movements, and behaviors,” notes Geris. “By creating a patient-specific simulation, we can predict how a proposed treatment plan will work not just in a generalized way, but in some cases also for a specific person. This is a revolutionary concept that has the potential to fundamentally change the way we treat patients in a medical setting.”
To learn more about in silico, read this blog post: “Overview of the Regulatory Pathway for In Silico Testing of Medical Devices”