Using Computational Modeling & Simulation Could Help Get Products to Patients FasterUsing Computational Modeling & Simulation Could Help Get Products to Patients Faster
Instead of benchtop testing & clinical trials, computational modeling & simulation may give engineers another opportunity to gather data for FDA submissions.
January 15, 2025

At a Glance
- Computational modeling & simulation is another tool in the engineer's testing toolbox, says MD&M West speaker Mark Burchnall.
- MD&M West will be held February 4-6, 2025.
- Burchnall, an engineer himself, helps firms with new product development, test method development, prototyping, & more.
Mark Burchnall, director of engineering at PSN Labs, will present "Optimizing Medical Device Development: Integrating Physical and Virtual Prototyping for Rapid Commercialization," at MD&M West 2025, in which he will showcase how best to use computational modeling & simulation (CM&S) to save companies time and money.
In a recent interview with Design News, Burchnall defined CM&S as the use of finite element analysis (FEA), computational fluid dynamics (CFD), or other numerical methods for design and development, as well as generating data for regulatory submittals.
“It’s not a new technique,” Burchnall said. “Finite element analysis and CFD have been around for decades. But FDA provided regulatory guidance a year ago and there's been a consensus standard since 2018 (ASME V&V40), and so in medical device design and development, it's starting to pick up steam.
“FDA’s rationale to supporting CM&S is very meaningful in that it saves time and gets products to patients faster to help them,” Burchnall continued, noting that it also reduces the use and exposure of animal testing and clinical trials. A third benefit is patient cost, because if manufacturers can deliver a product faster and cheaper, that translates into a less costly device for patients.
Burchnall spoke about some situations where it can be beneficial for companies to use CM&S. “Say you have a device that has been on the market for 20 years, but for some reason you need to change the material of a component,” he said. A material change would require verification testing and completion to assess whether that material change is suitable, he said.
“Modeling is particularly useful in these situations,” Burchnall explained. “If you have a substantial amount of historical data, you can model the current conditions of the device as it is on the market today. By validating that model against the historical data, you can then extend the use of the model to incorporate the new material properties,” he continued. “This allows you to assess whether the change impacts performance—for example, if the force to fire and material stiffness remains unchanged. In this case, those key factors are consistent. So, you can confidently use the model as your submittal, minimizing the need for extensive testing, which would otherwise be required for a larger verification program.”
Another case in which CM&S can be helpful, Burchnall said, is implants. “Sometimes implants may have multiple different configurations for different sizes for different patients,” he said. It can take months or even years to run tests to evaluate the reliability of the implant. “You could potentially use modeling to identify a worst-case condition out of all those different sizes and evaluate the test on just that worst-case condition,” he said.
Burchnall encouraged engineers, lifecycle engineers, and development engineers to attend his session, as well as project leads or directors that want to formulate strategy.
“Oftentimes, medical device engineers and verification engineers get pigeonholed into one approach to get through their verification testing or their validation,” Burchnall said. “And [CM&S] allows them another opportunity. Instead of just benchtop testing and clinical data, you now have this virtual option with computational modeling and simulation,” he said.
“I want [attendees] to take away from my session an awareness that there are other tools in your toolbox. And simulation is one of those tools,” Burchnall concluded.
Join Burchnall for his presentation, “Optimizing Medical Device Development: Integrating Physical and Virtual Prototyping for Rapid Commercialization,” on Tuesday, February 4, from 1:15 to 2 p.m., in Room 203AB, at MD&M West 2025.
About the Author
You May Also Like