'Virtual Factory' Enhances Robustness and Time To Market of Medical Devices'Virtual Factory' Enhances Robustness and Time To Market of Medical Devices

A virtual manufacturing process for medical devices that integrates several software packages has been shown to improve a device’s robustness and reduce the time to market, as well as resulting in considerable cost savings.

Bill Torris, director of the Technical Design Center (TDC), North America, for Torekov, Sweden-based Nolato, was instrumental in developing the virtual factory, along with company employee Patrik Ingvarsson and the Global Nolato TDC.

The manufacturing firm helps its aerospace, medical, pharma, and automotive customers design and develop components and assemblies.

A presentation by Torris, “Virtual Factory: How Predictive Tolerance Analysis Can Improve Robustness and Reduce Time to Market of a Medical Device,” is scheduled for next month at the SPE/MPD MiniTec conference, as part of the MD&M West show in Anaheim, CA.

Torris explained the predictive tolerance analysis portion of the virtual factory to MD+DI.

What are the components of the predictive tolerance analysis?

Molding simulation software (Moldex3D) is used to simulate the manufacturing process of injection molding. Those results are then transferred to measurement software. The combination of these two different software programs, which weren’t designed to be used together, allows us to increase the manufacturing robustness of the product. It also allows us to increase the robustness of the mold during design and development. The process is used to derisk the components and ultimately the entire assembled device.

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This virtual approach is much faster and at a much lower cost than traditional physical design, build, assemble, and test numerous times over. Ultimately, though, the manufacturer will physically build and test a product incorporating the virtual factory, but without the iterations, for regulatory approval of the device.

Chart courtesy of Nolato

Is the virtual factory easy to incorporate into an existing workflow?

It depends where you are starting. If you are a corporation that has a fully mature design and development process, you are simply modifying those processes and procedures to include the new software tools and the way we do this virtually.

However, if a corporation does not have those prerequisite elements in place, it is quite difficult to establish a department that does design and development, whether using virtual or the older methods of actually building and testing a product.

What do you provide the client?

We furnish the client everything needed for the design history file (DHF), including the results of the multiple software packages that generated the more robust, derisked device.

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In the end, we will still build the product physically. We just want to do more of it virtually. Instead of three or four optimization loops in the real world of physical parts, our goal is for the first parts that we make to work, or a much easier optimization loop, which will get you into fully functional components and assemblies.

How can the virtual process improve the robustness of a medical device?

In the case of injection molding, it helps you design better tooling and better molding processes that then will produce more repeatable parts. Those parts then feed into the optimized assembly process. The virtual process leads to better part design—not just dimensionally, but strength of the components and assembly.

Chart courtesy of Nolato

How can the virtual process reduce the time to market of a medical device?

You can iterate much faster virtually through simulation than if you have to make a mold and then change that mold every time you want to change something in the manufacturing process. Our software allows for very quick changes in part design, material, or manufacturing processing.

Changes using a computer take only hours as opposed to days or weeks for physical changes. For simpler medical devices, the time to market has been reduced by roughly six months, whereas the time savings for complex medical devices could be a full year.

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Are certain medical devices more suitable for the virtual factory?

We found that devices produced at higher volumes tend to benefit more because you design for a more repeatable process and therefore a more robust product.

Will the virtual factory evolve further?

I expect that the software tools will become even more powerful and better at predicting the results. Eventually, one or two software packages will be able to handle all tasks from A to Z.