Simulation of Medical Devices

Simulation of Medical Devices & Topology Optimization

Before we discuss various aspects of simulation for medical devices, let us understand both the terms first.

Engineering Simulation
Simulation, in the engineering context refers to the use of computer models and mathematical algorithms to predict and analyze the behaviour and performance of a product in various operating conditions and scenarios. Simulation allows designers and engineers to test and evaluate the performance of a product without the need for physical prototypes, which can save time and money in the product development process. Simulation is an indispensible tool today for product development, and can be used in different engineering domains like structural analysis, fluid dynamics, thermal analysis, electromagnetics and across different industrial verticals like automotive, aerospace, machinery industry, marine, etc.

Simulation allows engineers to evaluate different 'what if?' scenarios, so that they can identify any potential design flaws before even building a prototype. If a company has many different ideas about developing a product, simulation helps the design team narrow down on design choices. Thanks to ample computing power, it is now possible to evaluate numerous variations of a design in relatively less time. Traditional physical testing requires a whole lot of time even to reach the prototyping stage, a luxury that companies today simply cannot afford. Simulation has therefore proven to be a boon for progressive manufacturers.

Here are the benefits of simulation in a nutshell:

•  It enables faster product development
• It benefits machine learning and model training, as it enables the accumulation of useful data for training a machine-learning model
• Possible to evaluate complicated and rare situations involving extreme conditions which are difficult to test in a real environment and with real equipment

Medical Devices
As per the explanation by WHO, "A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose." Medical devices can range from simple tools like scalpels and syringes, to more complex devices such as pacemakers, MRI machines, and surgical robots. A point to note is that while medical devices are slightly different from medical equipment, the two terms are sometimes used interchangeably.
It is impossible for the medical and healthcare fields to do without medical devices. Again, as per WHO, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. Medical devices have permeated all aspects of the medical field; they are used not only in medical clinics or hospitals, they are used at the common person's homes as well.

Simulating Medical Devices
Simulation of medical devices refers to the process of using computer-based models or physical prototypes to mimic the behavior of a medical device in a realistic environment. As mentioned above, the purpose of simulation is to develop a product fast. Simulation of medical devices is undertaken to test and evaluate the performance, safety, and effectiveness of a medical device before it is brought to market or used in clinical settings.

Medical device simulation can be used to:

• Test the design and functionality of a device in various scenarios
• Evaluate the impact of environmental factors on the device's performance
• Predict how the device will perform in real-world conditions
• Assess the safety of the device in different usage scenarios
• Optimize the design and functionality of a device to improve its performance and user experience
• Train healthcare professionals on how to use the device effectively and safely.

Simulation can be done using software programs or physical models, depending on the type of device being tested and the complexity of the simulations needed. But in general, manufacturing companies today rely on software as the primary source of simulation.

Software to Simulate Medical Devices
With so many medical devices in the market, there is a stiff competition between manufacturers of such devices to introduce better versions at the earliest. There are quite a few simulation software available today to facilitate these companies develop newer and improved medical devices. The specific method used to simulate a medical device depends on the type of device being tested and the goals of the simulation. Some common methods include:

• Finite Element Analysis (FEA): FEA is a method that uses mathematical models to simulate the behavior of a medical device under different conditions. It is often used to test the strength and durability of implantable devices and surgical instruments.
• Computational Fluid Dynamics (CFD): CFD is a method that uses mathematical models to simulate the behavior of fluids and gases in and around a medical device. It is often used to test the performance of diagnostic devices and implantable devices such as stents.
• Physical prototyping: Physical prototyping involves creating a physical model of a medical device using materials such as plastics or metals. It is often used to test the usability and ergonomics of a device and to identify any potential safety issues.
• Virtual reality (VR) and augmented reality (AR): VR and AR technologies can be used to create realistic simulations of medical procedures and device use. They can be used to train healthcare professionals on how to use a device safely and effectively.

Simulation is an important tool for medical device development, testing, and training, and can help ensure that devices are safe and effective before they are used in clinical settings.

Topology optimization
Topology optimization is a design process that uses advanced computer algorithms to determine the optimal material distribution within a given design space. It is essentially a numerical method that maximizes the performance and efficiency of the design by removing redundant material from areas that do not need to carry significant loads to reduce weight. The result is a design that is often lighter, stronger, and more cost-effective than traditional designs. Coupled with additive manufacturing (AM), also called 3D printing, it can provide new pathways to light-weighting by enabling the use of new materials and unconventional shapes such as lattice structures. Altair is one of the few reputed companies that offer high class simulation software which when combined with topological optimization software makes medical devices lighter. HyperWorks, MotionSolve™, HyperMesh™, Inspire Mold, OptiStruct™, SimLab™ all provide a variety of simulation and / or topology optimization tools that can be used for many engineering applications, including the simulation of medical devices.

To summarize, simulation is a powerful tool for product designers and engineers, allowing them to evaluate and optimize the performance of a product before it is built, leading to more efficient and effective product development processes. Manufacturers of medical devices need to make use of simulation software to develop better quality of devices in a shorter time period.