Imagine you’re designing a cutting-edge medical device that might save many lives. You’ve got a brilliant concept, a solid engineering team, and a looming deadline. Now the million-dollar question: Should you test it in a lab or run it through a simulation?
Enter the age-old tango between in vitro (physical lab testing) and in silico (computer-based simulation). Both play essential roles in device development. The trick isn’t choosing one over the other. It’s knowing when to use which, and how to use both to your advantage.
What’s the Difference, Anyway?
- In vitro testing: Physical experiments conducted in a controlled environment using petri dishes, benchtop models, artificial tissue, or lab rats.
- In silico testing: Computer simulations that model real-world physics and biology to predict how a device behaves under a range of conditions.
Understanding when and how to use both in silico and in vitro testing is the key to unlocking the full potential of your medical device development. It’s not about using them equally or simultaneously, but about using them strategically.
When to Use In Silico Simulation
At AltaSim Technologies, we recognize that there’s no single perfect moment for in silico simulation; however, there are numerous points in the development process where it can accelerate progress and enhance results. During early design and concept testing, simulation enables you to quickly evaluate multiple iterations without wasting time or materials. For risk identification, virtual stress tests can reveal potential points of failure under extreme or unlikely conditions. Simulation also enables the exploration of complex scenarios, ranging from extreme temperatures to prolonged fatigue or anatomical variability, that would be difficult, dangerous, or costly to physically replicate. And when it comes to regulatory submissions, the FDA and other agencies are increasingly receptive to well-executed in silico data as a means to support, or in some cases, replace specific preclinical tests.
When to Use In Vitro Lab Testing
At AltaSim Technologies, we recognize that nothing replaces real-world testing when validating simulation models. Our COMSOL simulations are tailored to our clients’ exact specifications and deliver exceptionally accurate results; however, in vitro testing remains essential to confirm safety and performance. It is best to use in vitro testing to validate simulation models. Physical testing is crucial for verifying simulation accuracy, particularly when working with a new model or material. It is also called for to account for biological complexity. Human biology can be unpredictable, and specific responses, such as immune reactions or long-term tissue integration, still require direct observation. They are essential for preparing the final regulatory submission. Even with robust simulation data, regulators currently expect some degree of physical validation to complete the approval process.
The Smart Play: Integrating In Silico and In Vitro
At AltaSim Technologies, we perform the In Silico simulation, while you do the In Vitro testing. It is important to use both methods to provide an engineer with a complete assortment of data. We need feedback from the In Vitro test data to receive real-world insights that will inform our simulations. We use that feedback to guide our design decisions, test physical prototypes to validate the simulations, refine the simulations with real-world data, and use the validated model to explore additional use cases, scenarios, or design tweaks without restarting the In Vitro work.
This approach saves time, reduces costs, and produces stronger, more predictable results. By integrating in silico and in vitro testing, you can unlock the full potential of your medical device projects, resulting in faster development and improved patient outcomes.
How Companies Can Best Use These Tools
Start the simulation early. Waiting until the design is finalized to start simulation is like trying to use a GPS after missing your destination. As we collaborate with your engineers, we have time to steer the project rather than just perform checks. Think iteratively, not linearly. Don’t treat simulation and lab testing like separate phases. Instead, weave them together. Let each inform and improve the other. By starting the simulation early, you can take a proactive, strategic approach to your medical device development, identify potential issues early, and save time and resources.
Invest in Model Validation
Unvalidated models can mislead your team and your regulators. That’s why we suggest using in vitro testing strategically to demonstrate the reliability of your simulation. This validation process ensures that you can trust your simulation data, giving you the confidence to make real decisions.
Work with Partners Who Understand Both Worlds
Some vendors know simulation. Some know medical testing. You need a partner who understands how they work together. At AltaSim Technologies, we bridge this gap, ensuring that your simulation and lab testing efforts are not only complementary but also optimized for success.
How AltaSim Technologies Helps Clients Navigate the In Silico/In Vitro Balance
At AltaSim Technologies, we’re not choosing sides; we’re building bridges. We collaborate with your internal testing and regulatory teams to ensure that simulation and lab testing complement each other and meet FDA expectations. Our simulations are more than just colorful designs. They’re grounded in multi-physics, biology, and validated data, so you can trust them to guide real decisions. We optimize our testing strategy to minimize redundant physical testing, prevent costly surprises, and generate simulation data that withstands regulatory scrutiny. We accelerate time-to-market by using modeling to minimize prototyping cycles and focus on high-performance designs, without compromising quality. With our expertise in simulation and lab testing, you can navigate the in silico/in vitro balance with confidence.
Smarter Testing Starts with Strategy
The future of medical device development doesn’t belong to simulation or lab testing. It belongs to the teams that know how to choreograph both, reaping the benefits of faster growth, stronger designs, and better patient outcomes.
When in silico and in vitro work together, teams produce stronger designs, faster development, and better patient outcomes. At AltaSim Technologies, we help you create that harmony, every step of the way.