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  • Writer's pictureElite Precision Plastics

Made in the USA: Why Biotechs Should Choose a U.S.-Based Plastics Manufacturer

For biotech and medical device companies, patient safety and overall business success hinges on high quality product components, including top-tier plastic components. Increasingly, that means seeking out elements that are “Made in the USA” — a designation that, according to the U.S. Food & Drug Administration (FDA), means that “all or virtually all” parts of the product are created in the U.S.


Across multiple industries, American-made products are associated with vigorous oversight and quality control — but those features are even more important in the healthcare and biotech spaces. Particularly when it comes to precise plastic components, U.S.-based manufacturing can ensure easier access, shorter lead times, and supply chain reliability — all of which offer significant advantages to cutting-edge healthcare and biomedical companies.

Advantages of Partnering with a U.S. Plastics Manufacturer

Overseas manufacturing is often associated with lower costs — but there’s more to the story. USA-based plastic component manufacturing offers many benefits that ultimately result in high-quality, cost-effective products.

Enhanced access and communication

A “Made in the USA” designation means having easy and timely access to the manufacturer, without the challenges of language barriers and time zone differences.


In addition to easier communication, geographic proximity also facilitates site visits and audits. With an overseas partner, you may have limited or no chances to tour the facility, and site audits crucial for transparency and strong partnerships.

Shorter lead times

With faster shipping speeds and efficient communication, U.S. manufacturers can provide significantly shorter lead times when delivering new orders. This enables businesses to respond quickly to changing market demands, trends, and customer preferences — which can give them an advantage in the competitive healthcare and biotech market.

Consistent quality

Overseas manufacturing is known for unpredictable quality due to varying regulatory standards. Without that oversight, foreign-made plastic components may fail to meet companies’ strict standards in terms of tolerances, materials, or quality control processes.


“Something we’ve seen is missing resin additives,” says Nate Schlauch, Director of Manufacturing at Elite Precision Plastics. “Whether it's a UV protectant, a flame retardant, or extra strengtheners — it's tough for the average person to recognize when a part doesn’t have the right materials, but those additives are necessary for a good product.”


Products manufactured stateside, however, are subject to FDA regulations and good manufacturing practices. These regulations and requirements outline guidelines for a manufacturer’s quality management system (QMS), manufacturing facility, production process, worker safety, and quality assurance. The FDA regularly audits U.S. facilities to ensure that guidance is followed correctly and consistently.


In addition, manufacturers’ suppliers must also maintain strict quality control, which ensures the integrity of the individual elements used to create plastic products, such as resins or steel for molds.

Cost efficiency

Based on cost alone, using an overseas manufacturer might seem more financially beneficial than a domestic partner. But the initial product price tag can be deceptive.


“You can go after a low piece-price,” says Justin Heileman, Chief Strategy Officer at Elite Precision Plastics. “But how much is it to ship to the United States? How frequent are those shipments? Are there any tariffs? There’s ease of mind with a U.S. manufacturer, knowing you have parts available without hidden fees.”


A number of factors can elevate the cost of overseas manufacturing, including longer lead times, shipping fees, shipping delays, and needing to store stock due to bulk shipments. Then, add rising labor costs in countries such as China, and you may end up paying nearly the same price for an overseas-made product as you would have paid for an American-made component.


Alternatively, U.S.-based manufacturers can tailor production runs and shipment frequency to meet the client’s individual needs and storage capacity so the right amount of product is available exactly when it's needed.

Supply chain reliability

The global supply chain inherently operates with a level of unpredictability, with factors such as the shifting geopolitical climate, trade disputes, and rail freight disruptions continually creating unexpected disruptions.


While disruptions can occur in any supply chain, domestic vendors can more easily communicate with the contract manufacturer and their suppliers, which can help all stakeholders reduce delays or plan ahead when they’re unavoidable.


For healthcare and biomedical device companies, choosing a U.S.-based plastics manufacturer offers a higher degree of transparency, consistency, and quality — all of which can contribute to the success and resilience of your business, as well the safety and well-being of the patients who rely on your products.


Elite Precision Plastics is a proud USA plastic injection molding manufacturer specializing in high-quality, tight-tolerance manufacturing. Contact us to learn more about our manufacturing services.



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