As regulatory frameworks evolve and digital health technologies advance, in silico methods like modeling, simulation, and virtual clinical trials are increasingly positioned to transform cardiovascular device development. In silico clinical trials for cardiovascular devices are high on the list of priorities for regulators such as FDA. Still, despite clear advantages, many medtech teams remain hesitant.
Not because the technology doesn’t work, but because persistent myths continue to create hesitation. Adopting new approaches can feel risky, especially when public success stories are limited.
In the report “In Silico Technologies: A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-Regulated Products” published by Reagan-Udall Foundation, the authors discuss some of the most common myths.
Myth #1: Regulators don’t accept modeled evidence, and the submission processes for in silico trials are unclear
The assumption that modeled evidence isn’t accepted by regulatory bodies remains one of the most common beliefs in medtech.
In reality, both the FDA and EMA support the use of in silico clinical trial data as part of regulatory submissions, particularly in high-impact areas like cardiovascular implants. These models can simulate blood flow dynamics, anatomical variability, and device-tissue interaction—providing meaningful safety and performance data without the need for early-stage animal or bench testing.
FDA is advocating for use of In Silico Methods and their multiple Guidance documents provide clear pathways to include simulation-based evidence. For devices like stents and valves, this means virtual testing can supplement or even reduce bench and animal testing, helping teams reach approval faster. Regulatory bodies have already published examples of how companies are successfully using these models to support innovation.
You can see this in action in our Tricuspid Valve Replacement use-case, where digital twins and simulations were used to virtually replicate benchtop testing of an aortic valve, enabling performance evaluation under realistic physiological conditions without physical prototypes.
Myth #2: The ROI isn’t worth it, and in silico trials are just an extra cost
A major misconception is that in silico simulations for cardiovascular device testing are too costly or resource-intensive to be practical for small or mid-sized medtech teams.
In silico modeling actually reduces both development time and cost—especially in cardiovascular R&D, where devices often require multiple design iterations and extensive physical testing due to patient diversity, blood flow complexity, and anatomical variability.
For example, with virtual testing, teams can:
- Simulate heart valve implantation across 100+ patient anatomies
- Predict flow characteristics of different stent designs under dynamic conditions
- Assess fit and performance across demographic subgroups and body types
These kinds of insights are often impossible or extremely expensive to gather using traditional methods alone. And when models are reused across different product lines or studies, they continue delivering value long after their initial use.
With user-friendly platforms like v-Patients, there’s no need to hire a simulation team. Anyone from your R&D or product team can get up to speed quickly, with expert support available as needed.
See how simulation accelerated early development in our Cardiac Catheter Design Optimization case, where digital twins were used to simulate cardiac catheter navigation through diverse patient anatomies, allowing the design team to identify stress points and optimize performance before physical testing.
Myth #3: In Silico Tools Are Only Useful for Early-Stage Prototyping
While simulations are incredibly useful in the concept and design phase, their value goes far beyond that. In silico methods can and should be integrated throughout the cardiovascular device lifecycle.
They support:
- Design optimization: Simulate anatomical fit and flow before prototyping
- Regulatory strategy: Provide additional performance evidence
- Market expansion: Ensure devices fit anatomies in new populations, such as pediatric or Asian cohorts
- Post-market surveillance: Model how devices may perform under varied or long-term conditions
Instead of being a single-use tool, simulation becomes a continuous advantage—connecting R&D, clinical, regulatory, and marketing teams through shared insights.
In our Aortic Valve Benchtop Testing in Silico project, digital patient twins were used to simulate tricuspid valve implantation across varied anatomies, helping clinicians assess fit, plan procedures, and reduce reliance on early animal testing.
Conclusion: The Real Risk Is Not Adopting In Silico Methods
For companies developing cardiovascular devices, digital patient twins and in silico clinical trials are no longer future-facing ideas, they’re becoming a standard of innovation. The technology is ready. The regulatory frameworks are in place. The ROI has already been demonstrated.
What’s holding many companies back isn’t technical, it’s mindset and hesitation. FDA and other regulatory bodies have shown that computer modelling and virtual patients are of priority. In silico methods will soon become the standard, and the sooner medical device developers adopt them, the more benefits they will have.
If you’re ready to explore how simulation can enhance your cardiovascular pipeline, send us a message.
And if you would like to read more about In Silico Technologies and about these myths, read the full report here: In Silico Technologies: A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-Regulated Products
