What is Computational Fluid Dynamics (CFD) in medical device development? Uses, limitations & pitfalls

17 Oct 2011 13min read

Team Discussion

Multiple authors

When determining the performance boundaries of a design, or even if just looking at the feasibility of a concept, a certain level of analysis needs to take place. When it comes to a fluid handling device, which in the medical world could be anything from a pen injector to a blood analysis machine, the triangle of physical testing, ‘heavy’ analysis (in the form of Computational Fluid Dynamics or CFD), plus mathematical modelling, can be a very powerful analytical combination. However, it is essential to understand both the benefits and limitations of CFD and the other tools at your disposal.

What is Computational Fluid Dynamics?

Computational Fluid Dynamics (CFD) is a powerful tool for simulating fluid flows and related physics in a virtual environment and can be of great benefit to the development of medical devices. But creating effective CFD simulations can be a challenging business.

CFD models can help you test the effects of a number of design changes without having to prototype and test all the variations in reality. By comparing a real-world test to the CFD and math models, you can validate the accuracy of those models, and from there run a series of virtual experiments.

Uses for CFD modelling

With Computational Fluid Dynamics, you can also determine the critical parameters, dimensions and geometries, by altering them in the CFD model and observing the effects. This can help real-world experiment design, by helping you decide which parameters to experiment with, and which aren’t important to the performance of your fluid system. You can then run these experiments in the virtual world first, to see if they are likely to teach you anything. Taguchi style experiments reveal a great deal about a design with minimal testing, maximising the learning-to-cost ratio; CFD can help you determine which parameters to put into your Taguchi experiment.

However, you do not have to commit to modelling the entire fluid system in CFD. By taking bite-size chunks of the system, maybe just modelling the area of particular interest (such as a specific orifice or chamber), you can learn all that is needed. Math modelling can then be used to model the rest of the system. Keep a track on CFD modelling, and know when to stop; this will probably be driven by budget, but know when your results are ‘good enough’, and do not get stuck in analysis paralysis.

Understanding the limitations of CFD

Before embarking on CFD, it is important to know what to expect from it, and whether it could help you or not. Too many assumptions in the CFD modelling may invalidate the results, and it is possible to spend a lot of time and money fully modelling an entire system, without learning anything useful about the design.

Also ensure that you understand the limitations of CFD. For example, if the fluid is not well understood then you will get inaccurate predictions from the CFD model.

A good relationship with a CFD service provider can help ensure success. CFD experts can advise on how well a system can be modelled, and which elements of a system to focus on – in other words, how best to spend your money. The provider can also highlight what to expect from the CFD analysis, and what it can be used for.

5 common CFD analysis pitfalls

1. Neglecting verification

All math models, CFD simulations included, are approximations of the real world and it is important to accept that there will always be some level of error associated with CFD results. But that doesn’t mean the results can’t be useful. We just need to verify the predictions with some carefully planned experiments before we can assess and confirm their usefulness, and understand the possible limitations of CFD.

Verification of CFD is essential for checking it is providing a sufficiently accurate approximation of the real world to inform design decisions. Without this, CFD is just a bunch of complicated maths solved over many hours by high-powered computers that happens to be meaningless as an engineering tool.

Despite this, the temptation to rely on Computational Fluid Dynamics without verification can remain strong. After all, isn’t a key advantage of CFD supposed to be that it can take the place of experimental testing and thereby save valuable time and resources? Well yes, the number of prototypes and tests can be reduced using CFD, but testing shouldn’t be neglected all together. Take the example of the 2010 Virgin Racing F1 Team, who took the ambitious but ultimately flawed decision to design their F1 car using solely CFD. Considerable time and money was inevitably saved by avoiding verification with wind tunnel testing, but unfortunately the performance of the final product spoke for itself. Two seasons completed and zero points scored.

Simulation and physical testing inherently complement each other and so shouldn’t be viewed as competition. The insight gained from CFD analysis can maximise the reward from testing by helping to explain prototype performance and by identifying key parameters for the effective design of experiments. The results from testing can then maximise the reward from CFD by verifying the simulation approach and exposing inaccuracies. By applying the right combination of both techniques, a seriously streamlined process for device development can be achieved.

2. Desperately seeking complexity

Fluid dynamics are inherently complex, as will be familiar to anyone who has marvelled at the curling and twisting of smoke rising from a campfire, or wondered at the structures created by milk mixing in a morning coffee (it can’t just be me?). But attempting to capture all of these details using CFD modelling can quickly cause a simulation to become overly burdened by complexity. Computational time suddenly extends into weeks, simulation robustness falls off a cliff and the use of CFD becomes an impractical encumbrance.

The tight budgets and times scales in medical device development demand lean and flexible simulations, and it is a skill of the CFD engineer to make pertinent assumptions and approximations that limit simulation complexity.

This approach is especially relevant in the use of CFD for DPI (dry powder inhaler) development. The finer details of the physics of powder aerosolisation and deagglomeration within DPIs is still not fully understood, and CFD that attempts to simulate all of the processes involved remains in the realm of academic research. Employing such a simulation during device development slows the process, takes weeks to churn out heaps of data that is already out of date before it is calculated and is generally not recommended.

A simpler simulation, such as the flow of air through an important section of the concept geometry, is the starting point to quickly gain a good understanding of device characteristics. This enables fast investigation of large-scale design changes and efficient guidance towards a solid baseline design for the device. Simulation complexity can then be added in a step-wise fashion if required for accuracy when fine-tuning the design and optimising performance. This may involve extending the airflow simulation to the complete device, for example, or tracking discrete dose particles as they travel through the device and then simulating the delivery of a complete powder bolus — but only if this extra complexity adds value.

Of course, leveraging the latest in computing power can increase the levels of CFD complexity that are practical during a project. Processor speeds may be reaching a plateau, but we can now turn to parallel computing for increased performance. Most commercial Computational Fluid Dynamics codes include sophisticated algorithms to efficiently divide a simulation up across multiple processors, and a relatively small investment in high-spec hardware can yield high rewards in CFD effectiveness.

3. Treating CFD as a Black Box

Commercial CFD software has come a long way since it first appeared in the early 1980s, and development continues at a beguiling pace. Much of this work concerns the commendable improvement of CFD accessibility for the engineering community through automated processes and enhanced user interfaces. But with this comes a dangerous tendency to treat CFD as a black box; define the inputs, press the big green “default settings” button and accept the automated results.

This incurs a significant risk of falling foul of the ‘garbage in- garbage out’ scenario common in computer science. This problem is exacerbated with CFD because solving the relevant fluid dynamics equations is often non-trivial, and so there is no guarantee the software will achieve a valid set of solutions. Even with a perfect set of non-garbage inputs to the black box you can still end up with garbage out.

With little experience of CFD or fluid mechanics, it is possible to produce results with CFD software that appear convincing but have little resemblance to reality, which can be very misleading for the project team. The ultimate goal of CFD software — to consistently produce meaningful results from fully automated processes — remains something for the future.

CFD is most definitely not an iPhone (it is supplied with an extensive set of user manuals) and it is important to take time to understand the processes under the hood of CFD software and how these can affect results. This, coupled with a sound knowledge of fluid mechanics, is essential for appropriate interpretation of simulation predictions.

4. Curing rather than preventing

In the world of healthcare, we know that prevention is better than cure, but when it comes to the use of Computational Fluid Dynamics for device development, this is sometimes forgotten. It is true that CFD can be a very powerful tool for diagnosing and curing problems with device functionality, but it is even more effective when used to prevent problems arising in the first place. A recent study of engineering simulation strategies employed across a range of industries found a very clear conclusion that “using simulation to gain better insight into product behaviour from the very beginning of the design process is a key differentiator of success”1.

This success is partly due to the ever-increasing cost of design changes as a device progresses through development. Using CFD to help predict and prevent problems in the initial concept stages may appear unnecessary if prototypes are performing well, but it is far more cost-effective than attempting to fix design problems discovered when at high-volume manufacture.

But implementing simulation early isn’t just about reducing costs, it is more about achieving better devices through improved understanding. A device can be thoroughly tested and proved to work consistently, but if there are gaps in our understanding of how the device works, then there is always a risk that it is not optimised and that problems may be encountered further down the line. Simulating early helps mitigate this risk, and the resulting improved understanding can inspire innovative new routes for development at a point when taking new routes is still possible. CFD limitations become more apparent when it is left until late in the development process, as this can seriously compromise its ability to benefit device performance.

5. Thinking you can survive without it

Scepticism towards CFD modelling is sometimes present in medical device development, possibly resulting from the pitfalls I’ve been discussing. It can be healthy to treat results with a critical eye, and this helps prevent mistakes, but if it causes simulation to be discarded altogether, this can be a bigger mistake still.

Engineers often take inspiration from nature, and inspiration for simulation can be found in the theory of evolution. The ability to simulate is believed to play a significant role in evolution by natural selection, as noted by biologist Richard Dawkins: “[Organisms] that can simulate the future are one jump ahead of [organisms] who can only learn on the basis of overt trial and error. The trouble with overt trial is that it takes time and energy. The trouble with overt error is that it is often fatal.”2

This sums up the benefits of simulation succinctly. It can achieve a competitive advantage by saving time and resources and by providing the knowledge to develop superior devices with lower risks of failure. If we’re only interested in developing the very best medical devices we can, then we need to make full use of simulation tools when appropriate.

Getting the most from Computational Fluid Dynamics in your medical device development

Widespread acceptance of the benefits of engineering simulation for device development is reflected in the fact that the FDA recently published guidelines for including computational studies in medical device submissions3. This is a welcomed and comprehensive document that clearly describes the components of a successful study to ensure it contributes valid scientific evidence; a check-list for simulation effectiveness. CFD has firmly established itself in the device developer’s toolbox. However, as I’ve highlighted, merely ‘doing some CFD’ isn’t enough. If this valuable tool isn’t used correctly, it can have significant consequences for device success.

CFD is a powerful tool that can save weeks of time in the lab and can teach you about the critical parameters of your system. However, there are myriad limitations of Computational Fluid Dynamics, and it can be costly. You have to make a decision as to whether a full – or even a partial – understanding of the system is critical enough to warrant spending the time, effort and money on CFD. Working on your own medical device development? Visit our engineering page to find out how we apply leading tools such as CFD to de-risk your project and speed up your time to market.

References
1. Houlihan, D., Jordan, The Impact of Strategic Simulation on Product Profitability. Aberdeen Group (2010)
2. Dawkins, R., The Selfish Gene. Oxford Paperbacks, 2nd Revised Edition (1989)
3. Reporting of Computational Modeling Studies in Medical Device Submissions. Draft Guidance for Industry, FDA (2014)

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