By the Simulation Team at 42T
This computational technique allows engineers to simulate and analyse the physical behaviour of products under various conditions ‘in silico’ helping to ensure their ultimate safety, efficacy, and reliability.
Clare Castle, Senior Consultant at 42T, says: "Simulation tools have become even more powerful in recent years as technology and processing power have moved forward. This has only expanded their use cases.
Not only has it made it possible to model more complex properties and scenarios, it also means that models that might previously have been too lengthy or expensive to run can now be simulated quickly and easily.
We can incorporate these tools earlier in the development process or analyse a greater number of design iterations, making the product development process quicker and more cost effective.”
Here we have broken down four common reasons to use multiphysics simulation in medical device development:
Simulation enables precise optimisation of medical device designs by allowing engineers to test multiple design iterations quickly. This leads to the creation of devices that are both effective and efficient, ensuring optimal performance, patient outcomes and cost.
For example, by simulating real-world conditions, FEA helps identify potential failure points and stress concentrations in medical device components. This proactive approach enhances the safety and reliability of the devices, reducing the risk of malfunction during clinical use.
Simulation provides a detailed analysis of how medical devices will perform under various operational conditions, such as different loadings, pressures, and temperatures, that the team might not be able to reproduce in physical testing. This comprehensive performance insight ensures that devices will function as intended at the extremes of their specification.
Simulation helps in identifying and addressing potential design flaws early in the development process. Key areas of concern such as thermal and mechanical stresses, fluid behaviour, and efficiency or performance, can be analysed while the design is still at concept stage. By detecting problems before physical prototyping, engineers can make necessary adjustments, preventing costly design changes later in the development cycle.
Simulation can reduce the need for physical prototypes, which can be costly and time-consuming to produce. Virtual multiphysics simulations allow for extensive testing and modifications in the digital realm, significantly cutting down on development costs and time-to-market.
By allowing for rapid prototyping and testing of new ideas, simulation accelerates the innovation process. Engineers can explore novel designs and materials without the constraints of traditional manufacturing, leading to faster development of cutting-edge medical technologies.
For example, FEA allows for the simulation of different materials under various loads and environmental conditions. This capability helps in selecting the most appropriate materials for medical devices, ensuring they meet the necessary strength, durability, and biocompatibility requirements. Teams looking to improve sustainability of their product range could quickly evaluate the feasibility and implications of changing to a lower-footprint material and prioritise development effort on where the biggest improvements are possible.
Above: simulation can be used to compare alternative designs of key components
Regulatory bodies like the FDA and EU Notified Bodies require extensive testing to ensure the safety and efficacy of medical devices. Simulation data can be used as evidence of verification of device performance under various conditions, aiding in regulatory approvals and compliance.
Sharing the data with potential customers can help prove the clinical benefits of the device, influencing Key Opinion Leaders (KOLs) and empowering them to make evidence-based recommendations.
Simulation can provide particular benefits when designing and certifying products with many design variants. With the rise of 3d printing across a wide range of industries, custom medical devices can be tailored to individual patient anatomy and needs. A full suite of prototypes for extensive destructive testing could make developing custom devices unviable, meaning patients wouldn’t benefit from these powerful technologies. By accurately modelling patient-specific designs, a validated simulation model ensures these custom devices perform effectively and safely under expected load conditions.
42T is able to bring deep expertise in applying advanced multiphysics simulation techniques, enabling accurate and efficient analysis of complex medical device designs.
We have access to state-of-the-art software on powerful hardware, and a team of experienced simulation engineers, which might be cost-prohibitive for individual companies to acquire and maintain independently.
Our simulation experts work within multidisciplinary project teams in which communication is fast and efficient, enabling rapid and effective design iteration based on the results.
Sarah Knight, Head of Healthcare Technology, says, “Engaging with consultants like 42T allows medical device companies to optimise their design and testing processes without the need for extensive in-house resources, leading to cost savings in prototyping and development.
We are also able to provide comprehensive documentation and performance data that support regulatory submissions, helping medical device companies achieve compliance with stringent industry standards more effectively.”
As leading product development consultants, the 42T team is committed to pioneering healthcare advances through our expertise in solving complex technical challenges for medical device manufacturers. Contact us to explore how we could support your team.
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If you would like to find out more, please contact Sarah:
answers@42T.com | +44 (0)1480 302700 | Sarah Knight | LinkedIn
Sarah is a chartered engineer (IMechE). She holds an honours degree in Biomedical Engineering and a Master’s degree in Mechanical Engineering from Cambridge University.
She is also an experienced project manager with particular expertise in medical device development and has guided products through all stages of development from innovative concepts to detailed design, regulatory approval, and troubleshooting in manufacture.