For medical device manufacturers, reshoring plans have been part of the discussion for years. Now, many are putting them into action and hitting familiar capacity challenges along the way.
New research from MedTech Dive and JR Automation shows why scaling is easier said than done. While 90% of manufacturers say increasing capacity is critically or very important to their competitive position, four in 10 have already paused or delayed investment due to uncertainty around which solution or approach to choose.
Most manufacturers don’t want to build new operations on outdated systems and processes. That leaves them with crucial decisions to make, often with a high degree of risk and reward.
Mick Trompen, Chief Engineer of Life Sciences at JR Automation, recently explained what’s behind this shift.
“The COVID pandemic was a big trigger. We were dependent on products made overseas, and then suddenly we needed to build machines in days to scale up domestic production. It was very… [reactive], and no one wants to be in that position again,” said Trompen. “The push to reshore is also regulatory and quality-driven. As devices become more advanced, and part of the competitive advantage, manufacturers want to be more protective of that technology and their IP.”
These factors may explain why manufacturers want production closer to home. But once they make that decision, an entirely different set of questions begins.
What should the new manufacturing environment look like?
Reshoring doesn’t mean taking an established overseas model and reproducing it domestically. According to Trompen, “It’s not going to be the same machines, computers, people, MES, or enterprise systems. Instead, it’s building from ground zero.”
This rebuilding process starts with the physical facility, deciding whether new construction or retrofitting makes the most sense, and extends to equipment and infrastructure.
Integration will likely be a core concern. The research shows the number one barrier to optimizing manufacturing operations is integration, cited by 47%. A reshoring initiative provides the opportunity to proactively address this leading barrier by focusing on how equipment, software, and data infrastructure work together from the start.
Leaders also need to consider what those systems will eventually support. AI is a major part of that equation: 84% say AI will be critically or very important to how they adapt and scale manufacturing over the next three to five years.
As AI and advanced analytics become increasingly important to operations, it makes sense to ensure the systems established during reshoring can support that vision long term.
How can we rethink manufacturability?
Even if a process is proven overseas, reshoring presents the opportunity to take a fresh look at design for manufacturing, including areas like automation, standardization, and modularity.
“When advanced devices first entered the market, the long-term potential wasn’t always considered. For example, can this device deliver more than one drug? Can we design it in a way that standardizes something simple like a spring? Can we use the same mechanics to avoid bottlenecks in our supply chain? Reshoring provides a perfect opportunity to explore those efficiencies and improve overall capacity,” said Trompen.
That means smart decisions made during the reshoring process can improve manufacturability now while supporting greater capacity for future products as well.
How will we staff the new operation?
Reshoring initiatives may compound existing staffing challenges: 42% say inadequate staffing is a barrier to optimization, the second-most-cited barrier.
One way to address staffing is to think beyond the number of hires, focusing instead on improving the roles people play alongside automation.
“Often, the answer becomes reallocating people into more technical positions. The person who might have been snapping two parts together or applying adhesive can now transition to quality inspection of the device, teaching robots, or maybe become part of the maintenance team,” said Trompen. Automation and workforce strategy should go hand in hand, especially during reshoring. Manufacturers can make informed decisions by evaluating what technical capabilities the new environment will require, which processes still need manual intervention, and where automation fits into the full picture.
Reshoring is one part of a larger strategy
Reshoring is far more than putting a new facility on domestic land. Every decision — from infrastructure and technology to automation and people — shapes what the new operation can deliver and at what cost.
“The ROI calculation can also include benefits that aren't captured by simply comparing domestic and overseas production costs,” said Trompen. “For example, if poor quality was coming in from overseas, does bringing production closer offset that cost? Does greater automation improve consistency and therefore patient safety, which is always the number one priority? Having production in your own backyard can provide greater control over all these factors.”
Reshoring is also part of a broader leap in capacity in medical device manufacturing today. The findings shared in this article are one piece of that picture, with the broader story detailed in a new report from MedTech Dive and JR Automation. Based on a survey of 125 manufacturing decision-makers, the research reveals what’s challenging manufacturers most, where they’re headed, and what it will take to get there.
Explore how JR Automation can help you solve your capacity challenges and get ready to scale for what comes next. Visit www.jrautomation.com/industries/life-sciences.
