Response to Article Regarding Reshoring Medical Device Components

Due to a combination of the effects of the pandemic and geopolitical tension globally, there is a strong trend for reshoring manufacturing, especially with medical device components.  Medical devices can be critical and having a predictable supply chain may outweigh the savings of producing offshore, at least in the current environment.

An article by MDO Contributors Network described 3 things to consider when deciding to re-shore medical device production to ensure a smooth process.

Three considerations for reshoring your medical device components and assemblies

October 4, 2022 By MDO Contributors Network

1: Your existing tools can’t always be salvaged.

While the ideal transition would be to take existing tools overseas, ship them to an onshore facility and flip the switch to begin production in the U.S., things rarely go that smoothly.  The article mentions several of those reasons including the possibilities that the tools were either inefficient or not well-maintained.  They may have been customized for overseas production, but specifications may be different here in the U.S.  In addition, there may be a need for updated drawings, design mechanics or other quality control issues.

ETI has the ability to evaluate your tool and customize or repair to ensure smooth production.  If needed, a new tool will be recommended to improve efficiency and quality of the parts. Our team will work with you to provide the best solution for your needs.

As the article mentions, it is important to manage expectations and consider this an opportunity to improve the tooling efficiency.  ETI can evaluate and provide flexible tooling options to consider.

2: Preparation for the validation process can expose potential risks.

The team at ETI will ensure that all of the quality control measures are in place.  We are ISO 9001 and ISO 13485 certified with a separate clean room for production of silicone parts for medical devices.  Our quality control team will ensure that all procedures and documents are done properly to fulfill any quality validation requirements supporting the ISO 13485 certification.

3: You may need to say goodbye to part of your current supply chain.

The Covid-19 pandemic exposed the risks of utilizing just-in-time manufacturing with multiple supply chain vendors collaborating overseas.  In fact, any portion of the production supply chain currently being utilized offshore may have to be evaluated for replacement.  This exchange will bring all of the materials onshore and ensure access to materials and vendors that would not be feasible if any more lockdowns commence in the near future.

With the wealth of experience and connections available, ETI can help to source new vendors and assist with everything from tooling to accessing materials for your silicone and rubber parts.


ETI can become your onshore partner to bring your medical device production back to the U.S. Doing so will ensure quality production of your silicone parts and offers a more reliable supply chain in this uncertain global business environment.  While ETI focuses on small to medium-sized parts of up to 12 inches, we can evaluate your project of any size or make a referral as needed.

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