By Sean Fenske, Editor-in-Chief

The past several years have left medical device manufacturers reevaluating their supply chains. Whether seeking to transfer work to suppliers closer to where their manufacturing is established, identifying new suppliers with which to work, or determining other ways to save time and money, companies are searching for answers. Suppliers who can provide will get noticed.

Custom enclosure manufacturing is a capability most medical device manufacturers require, regardless of their specific application area or technology. Sensitive products and instrumentation need protective housings to ensure they remain functional and safe while being used in the rigorous clinical environment. Having a regional (or nearshore) supplier who understands this necessity can assist medical device makers seeking an alternative or new provider.

In response to the interest in nearshoring within the medical device space, Mark Rauenzahn, CEO of The Producto Group, responded to a number of questions about his company’s new facility in Mexicali, Mexico. In the following Q&A about one of the organization’s companies—ThermoFab—he talks about the reasons for opening the new location, what it means for customers (both new and established), and how he sees the location assisting with medtech manufacturing needs.

Sean Fenske: You just announced you’re opening a new facility in Mexico. What led to this decision?

Mark Rauenzahn: The reasoning behind this was two-fold. First, we reviewed our supply chain, as we source quite a bit from China. Like many in the industry, we’ve seen the potential challenges of this strategy, given logistics issues as well as the geopolitical environment. As a result, we decided it was time to explore nearshoring options.

Then, following customer due diligence, we noted many of our customers were located on the East Coast, relatively close to our Massachusetts facility. However, to better serve our West Coast clients, we were seeking options to open a facility there as well. We wanted to provide them with a nearshoring option that would be more convenient for them.

We consulted with a Baja California medtech group and identified Mexicali as a fantastic option for our new location. In speaking with several customers about the facility, we’ve received positive feedback. This will also make us the only medical device thermoformer in Mexico, which is an important capability to bring to the country.

Fenske: Will the new facility be an extension of the company’s capabilities or will it also offer new services?

Rauenzahn: It’s really both. As I mentioned, this 50,000-square-foot facility is being opened to better serve customers in the West Coast region. But, we are also equipping it with other capabilities. In addition to the custom thermoforming and injection molding services our clients require for their medical device enclosure needs, we are providing reaction injection molding [RIM] as well.

While ThermoFab views these as complementary capabilities, many companies have a preference between them. In other situations, the company may have already selected one method for a specific design and are now locked into using one method over the other. As such, we decided it would be best to be able to provide either capability to them.

In addition, we will also add 3D printing technologies to enable tooling to be fabricated using these machines. That capability will be added to the array of other services we already provide—CNC plastic machining; complete assembly lines; finishing, paint, and pad printing; and tool maintenance.

Really, it’s about providing what our customers need, where they need it, and using the process they prefer. To that end, we’ll be providing similar additive manufacturing services at our Massachusetts location as well.

Fenske: How will the new opening impact the services you are currently providing?

Rauenzahn: The move to Mexico will enhance our ability to partner with customers and deliver products faster, more efficiently, and with greater reliability by leveraging advanced technology and expanded capacity. Ultimately, we anticipate this new facility will enable us to double the size of our operations.

The 50,000-square-foot facility in Mexico will open mid-2025 and be fully operational by the end of Q3 2025. While the transfer of production will take place over six months, our current customers will not experience any delays as we’ve already worked to ensure sufficient supply through the process.

In addition, we expect to see a substantial reduction in lead times as a result of this facility coming online. Currently, our lead times are approximately 13 weeks. Following the entire process, we anticipate lead times closer to eight weeks.

Fenske: What are the types of technologies for which you are providing custom enclosures?

Rauenzahn: We’re addressing needs across a wide array of medical devices. We’re not focused on a specific type of device or size. Our enclosures are being used for everything from handheld devices and single-use components to medical carts, diagnostic and lab equipment, x-ray machines, and surgical robots. We’re experienced in meeting the high-precision needs of this industry.

Fenske: How do you respond to new potential customers who are looking for nearshoring options to address their own supply chain challenges?

Rauenzahn: Clearly, this facility demonstrates we understand there’s a need and it’s only going to continue. That’s why we ensured it would enable us to not only better serve our current customers but also grow alongside them as well as aid new clients.

ThermoFab can collaborate with companies to facilitate the seamless transfer of mold tooling from China or other parts of the world to our Mexico facility through our tooling transfer program, ensuring a smooth transition that simplifies logistics and reduces production costs.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Rauenzahn: Just to reiterate the point, our Mexico location will be the only one in the country to provide medical device thermoforming at an ISO 13485-certified facility. So under that one roof, we’ll be able to supply enclosures leveraging thermoforming, injection molding, or reaction injection molding, up to 1,000 tons. That’s a pretty unique proposition for the industry and we’re proud to be able to offer it.

In addition, this expansion underscores our company’s commitment to investing in advanced technologies to ensure we continue to meet the most stringent customer requirements and enhance the overall experience they have with us.

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