Why Made in the USA Counts in Biomedical Device Manufacturing

In the medical device industry, patient safety is directly connected to the supply chain. Dynamic socioeconomic and regulatory factors influence domestic and international supply networks. The global supply chain holds impressive economic power, but it also carries a complex burden of risk.

Some US biomedical companies import and sell internationally sourced replacement parts, while others obtain components from overseas manufacturers, then assemble parts stateside. Many of them are responsible businesses, but they can never eliminate the complicated risks associated with the global supply chain.

For this reason, starting with US manufacturers when searching for a strategic 3rd-party biomedical device partner makes sense. Here’s why:

US Manufacturers Control Product Decisions

A product legally falls under the "Made in the USA" description when "all, or virtually all" parts, processing, and labor originate in the United States. Most Americans associate "Made in the USA" with secure US job creation and good quality due to American manufacturing standards that exceed those in other parts of the world.

Starting with "Made in the USA" means that a potential 3rd-party partner knows all of the specifics about production processes, materials, suppliers, and controls than companies who source parts or components globally. However, in the 3rd-party biomedical space, the level of quality isn’t necessarily the same with every US manufacturer.

Patient Safety Over Cutting Corners

The FDA subjects OEMs to rigorous quality control standards in manufacturing. However, the FDA does not currently regulate 3rd-party repair services, which includes US 3rd-party companies who sell replacement parts for FDA-approved OEM devices.

The FDA’s 2018 review of 3rd-party repair safety and subsequent 2021 guidance may pave the way for future regulatory changes. At this time, however, nothing prevents 3rd-party companies from using inferior materials and cutting corners in production--the same issue that compromises overseas manufacturing in some parts of the world.

A values-driven US manufacturer understands that human lives depend on the reliability and safety of their products. Their business model prioritizes patient-centered values, and sees ROI and cost-savings as supportive of, but secondary to, the goal of exceptional patient care.

“The Value of Thorough Reverse Engineering”

Most overseas companies do well at replicating OEM products, quickly fabricating and shipping parts that will fit properly and do what they're supposed to do. However, the materials and construction of these parts might not match the quality of the OEM devices.

Rather than copying, a quality-focused 3rd-party company approaches design with the same care and attention to detail as the OEM. A multistep reverse engineering process ensures that the part not only functions but is also structurally sound.

Robust supply-chain vetting

Third-party companies who source entirely in the US can thoroughly vet all suppliers, allowing them to make targeted decisions throughout the production cycle. This includes choosing design tools, selecting types of steel for molds, contracting an independent testing lab, and purchasing the machinery involved in full-scale production.

Voluntary certifications and precision quality control

The most important hallmark of a values-driven US medical device manufacturer is participation in voluntary quality standards programs. Look for the following voluntary programs:

• FDA facility registration: Third-party parts manufacturers who voluntarily register must maintain all FDA safety and quality manufacturing standards. The FDA may inspect the facility at any time. Although 3rd-party parts aren't subject to FDA clearance, the agency may initiate a facility inspection in response to consumer complaints, product failure, or if the facility didn't pass a previous inspection.
• ISO 13485 Certification: The International Organization for Standardization offers this quality management system certification. It requires rigorous documentation of quality controls based on internationally recognized standards for medical devices.

Some US companies integrate additional quality controls to add extra insurance against product anomalies and human error. A quality-focused manufacturer will allow potential and current healthcare partners to observe the quality management system as well as full production runs. A trusted strategic partner also commits to standing by the health system in product failures or adverse patient events.

US Manufacturing Standards in Action

Partnering with a US manufacturer who invests substantially in quality control provides significant advantages. Some recent real-world examples illustrate those benefits: 

Preventing potentially fatal infusion errors

In recent years, there have been complaints of cracks in the Carefusion 8100 Bezel Plastic. Concerns were raised about potentially fatal infusion errors due to this cracking which was later attributed to a resin that was susceptible to common hospital cleaners. In February of 2021 the FDA and several other US sellers issued a recall of the parts.

When reverse engineering this replacement part, Elite Biomedical Solutions had elected to use a material that was superior in strength and chemical resistance to the material that was being used by the OEM and other suppliers. Because of this safety based resin choice Elite’s trusted partners’ avoided the risks, costs, labor, and asset downtime associated with a Class 1 recall.

Keeping Hospital Equipment Running in the COVID-19 Pandemic

When low stockpiles and export bans tied overseas suppliers' hands, US device production continued virtually uninterrupted, with minimal cost increases. US-built parts kept devices running, so thousands of COVID-19 patients and other hospitalized individuals stayed safe in the worst months of the crisis. A strategic partner should have a clear strategy for future global emergencies that affect the supply chain.

Partnering to Uphold Patient Safety

Biomedical equipment will continue to evolve with the changing health needs of the American population. At the same time, increasingly complex data streams will power intricately connected biomedical solutions. Equipment procurers need partners who can help them navigate the expanding world of medical technology.

An experienced, dedicated US manufacturing partner has a comprehensive understanding of leading-edge biomedical innovation. From digital design to minor hardware changes, a 3rd-party strategic partner will help you upgrade your asset inventory to deliver state-of-the-art, patient-centered care.

Elite Biomedical Solutions welcomes the opportunity to forge robust relationships with new partners.