If your medical device is showing its age, if complaints, cost pressure, supplier obsolescence, or a competitor closing in are forcing the issue, the reshoring window is the right time to address Gen 2.
By: Habib Dawaliby with Mike Cordeiro contributing
Long-distance shipping and tariff uncertainty remain real supply chain considerations especially inclusive of medical devices. They are not going away any time soon. Momentum for reshoring medical device manufacturing back to the U.S. keeps building, driven by tariffs, the supply chain fragility exposed during the pandemic, and geopolitical tension.
But reshoring a medical device doesn't fully sever that dependence. Many raw materials, electronic components, and subassemblies may still be sourced internationally even when final assembly moves closer to the market. Moreover, reshoring alone leaves value on the table if it is the only move you consider or make for products ripe for Gen 2.
If your current device carries known, unresolved problems like complaints, an aging design, mounting manufacturing costs, supplier obsolescence, or competitive pressure that is eroding market share, this is the right time to couple reshoring with Gen 2. If none of that is true, reshore for the de-risking benefit and revisit Gen 2 when the product has matured enough to justify the investment. Do not force a Gen 2 onto a product that is not ready. That just trades one risk for another. What follows are three paths for reshoring a medical device and/or implementing its next generation.
Reshoring an unchanged device still requires site qualification, process validation at the new location, and supply base qualification. You gain shorter lead times, new measures of ‘security,’ and tighter control over quality issues simply by being closer to your own production line, but you have not touched the risk sitting inside the design itself.
Reshoring can improve materials, componentry, cost, freight, tariff exposure, transportation delays, and the day-to-day communication friction of managing a distant production line. What it does not solve is anything that lives in the design itself. An obsolete or single-sourced component is still obsolete and single-sourced wherever you build the device. A manufacturing process that is inherently complex is still complex. And a design that was never (or poorly) engineered for manufacturability carries that problem with it, regardless of geography. If your product is not ready for its next generation, but reshoring or near shoring is in your future, ensure to carefully evaluate your supply chain strategy and your product architecture together, not sequentially.
Related reading: De-Risking or "Tariff Proofing" Medical Device Materials and Components
Developing and launching Gen 2 alone at an already-qualified site requires new design and development work, updated risk management, human factors input, process validation and regulatory submission. You gain a fresh product without disrupting what already works. But the supply chain risk stays exactly where it started: the same tariff exposure, the same freight costs and risks, and the same potential for single-sourced components, just built into a newer device.
To repeat: medical devices showing their age or exhibiting technical limitations that need to be addressed now (including competitive pressure) are the prime candidates.
Combine reshoring with Gen 2, and a single technology transfer and validation cycle covers both moves at once. Design work including design for manufacturability (DFM) and process failure modes and effects analysis (PFMEA) reviews, quality system controls, supplier qualification against your new bill of materials, tooling and equipment IQ/OQ, pilot builds, and regulatory submissions can all happen once instead of twice.
Exactly how these activities sequence is product and device-class dependent; a Class II or III device class change carries different weight than a process tweak. Instead of qualifying suppliers against your old design and then requalifying months later against the new one, you qualify once, against the design you are actually going to build. That is also your best window to resolve strategic supplier issues and component obsolescence you were likely going to have to address eventually anyway.
Not everything doubles just because you are combining two moves, and not everything transfers just because you are doing them together. Manufacturing layout, cleanroom flow, assembly and packaging sequences, documentation, and ERP frameworks can carry over if there is no major process change. Operator training still needs to happen regardless. Tooling and fixturing carry over only when they are not product-specific, but a substantial Gen 2 change will likely require new tooling regardless of sequence or location.
Related reading: Building a Resilient Medical Device Supply Chain: Your Action Plan for Success
Executing reshoring and a Gen 2 launch typically pulls in a contract manufacturer, a design firm, engineering expertise, a regulatory consultant, and a quality consultant, each with its own contract, its own point of contact, and its own view of the project. For a large strategic move, managing this across multiple product lines; fragmentation adds its own cost. Every vendor handoff is a place where context gets lost, timelines slip, or ownership of a problem becomes unclear.
Consider the math, purely as illustration: if coordinating with a single vendor costs your project team roughly 30 to 60 minutes of communication and decision-making friction with every interaction, and you are working with five vendors instead of one, that friction compounds across the life of the project. Consolidating those vendors into a single, qualified, accountable partner with full lifecycle capability reduces overhead and gives you a single lever to pull if performance slips. Put another way, you are not just saving time on any one interaction; you are removing entire, time-consuming touchpoints from the project altogether.
Full lifecycle expertise, product development, manufacturing, regulatory, quality, and market assessment, in sync and under one roof, instead of scattered across separate vendors each optimizing its own piece. One relationship. One accountable partner. Fewer gaps. That is the case for treating Veranex as an integrated partner rather than another vendor in the mix.
If your device is showing its age, whether through customer complaints, market share loss, cost pressure, material scarcity, component obsolescence, or a competitor closing in, and you are considering or planning to reshore, do not sequence these as two separate projects. Combine them, and you absorb one disruption instead of two, one validation cycle instead of two, and one regulatory submission instead of two, coming out the other side with a more resilient supply chain and a current-generation product.
About the author: Habib Dawaliby is Veranex Director of Manufacturing Operations. Mike Cordeiro, Principal Electrical Engineer, contributed.
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