How engineering simulation technology is revolutionising cardiovascular research

The challenges are substantial: how do we accurately model an organ that beats approximately 100,000 times a day?

How can we predict the impact of interventions without risking patient safety? And crucially, how do we accelerate the development of life-saving treatments for the millions affected by cardiovascular conditions worldwide?

As we face these challenges, innovative technologies and cutting-edge research are becoming essential to unlocking fresh solutions for the patients and transforming the future of cardiovascular care.

The heart of the challenge

The human heart is a marvel of biology, beating approximately 100,000 times a day, 40 million times a year, and a staggering three billion times in an average lifetime. This intricate organ functions through a precisely orchestrated dance of chambers, valves, arteries, and veins that work in harmony to sustain life.

At its core, healthy cardiac function depends on the seamless translation of electrical impulses into mechanical action, a process which is known as excitation contraction coupling.

When disease or injuries disrupt this delicate system, whether through damaged muscle tissue, compromised blood vessels, or other pathologies, the consequences cascade throughout the body, often with devastating effects. 

For researchers and clinicians, the challenge has always been observation without interference. Traditional methodologies provide limited windows into cardiac function, particularly when attempting to measure dynamic processes occurring inside a beating heart.

This constraint has historically slowed innovation and limited understanding of complex cardiovascular pathologies.

The power of in silico solutions

In response to these challenges, computational modelling and simulation offers a non-invasive approach to cardiovascular research, one that not only provides a realistic alternative to traditional methods but also compliments them. By creating virtual patient specific models that replicate heart function, researchers can observe previously unmeasurable parameters and gather insights that would be impossible to obtain through conventional studies alone. 

A core advantage of in silico modelling, a computer simulation of biological processes, is that it enables researchers to conduct experiments more rapidly and cost effectively than traditional in vitro, ex vivo or in vivo studies, with zero risk to human subjects.

Another benefit is that these digital representations allow scientists to develop deeper understanding of fundamental cardiac physiology and disease progression.

Today’s advanced simulation platforms can create detailed models incorporating blood flow dynamics, tissue mechanics, and complex electrophysiological behaviour. These comprehensive models capture the intricate details of cardiac function, from structural stresses to muscle fibre orientation, and can account for surrounding anatomical features like the fluid-filled pericardial sac that encases the heart.

Regulatory acceptance and patient safety

A significant milestone in cardiovascular innovation came in 2017 when the FDA began accepting computational modelling and simulation (CM&S) evidence in regulatory submissions for medical devices; the same year the European MDR (Medical Device Regulations) opened the door to in silico evidence for non-clinical studies. This recognition was further solidified in November 2023 with guidance specifically addressing the integration of CM&S with real-world evidence.

This regulatory evolution addresses a critical inefficiency in cardiovascular device development. The traditional pathway from initial concept to an approved cardiovascular device is fraught with inefficiencies and patient risk. Of the medical devices that don’t make it through the regulatory approval process, 52% of first-in-human technologies expose patients to interventions that will not progress to the next stage in the product life cycle.

Similarly, 24% of pivotal human studies expose patients to interventions that don’t advance. Most concerning, 41% of patients in trials are exposed to devices that remain investigational and never reach market approval. 

By incorporating digital evidence into the regulatory process, manufacturers can now demonstrate safety and efficacy through computational methods before involving human subjects, significantly reducing unnecessary patient exposure to experimental interventions. 

The future of cardiovascular innovation

Looking to the future, we can expect to see further improvements in cardiovascular simulation that accurately reflect individual patient physiology using personalised models, possibly connected with the real patient. These “digital twins” will enable clinicians to test treatment strategies virtually, before implementing them physically, while also facilitating the creation of diverse virtual patient cohorts to establish safety and efficacy evidence through in silico clinical trial.

As computational capabilities continue to expand and simulation methodologies become increasingly refined, we can anticipate further breakthroughs in cardiovascular research and treatment. These technologies enable innovation while maintaining rigorous quality standards, fundamentally transforming how cardiovascular interventions are developed and implemented for the sake of the patient.

From early-stage design to regulatory submission, simulation technologies are reshaping every aspect of cardiovascular research and development. By providing unprecedented insight into cardiac function, these technologies are establishing entirely new approaches to understanding, diagnosing, and treating heart disease.

In this critical healthcare domain where precision directly impacts human lives, engineering simulation technology isn’t simply enhancing existing practices but fundamentally transforming approaches to one of medicine’s most persistent challenges, offering renewed hope to millions facing cardiovascular disease worldwide.