Reshoring your medical device manufacturing operation is no easy feat.
It requires technical expertise, resources, and dedication.
If—after weighing the pros and cons of reshoring—you’ve decided to continue down that pathway, you need to know what’s required to effectively pull off a reshore initiative.
In this blog post, we’ll talk about what it takes to reshore manufacturing successfully by highlighting three foundational factors that have influenced reshore initiatives in the past.
Factor #1: A robust quality management system.
For your device to be marketable, your manufacturing operations must meet governmental regulations and requirements.
To comply with governmental regulations, you need to have a quality management system (“QMS”) in place that ensures quality practices are implemented, followed, and maintained.
By properly defining the strategies and procedures for moving your manufacturing equipment and processes, a robust QMS can help you mitigate some of the major risks associated with a manufacturing transfer—the last thing you want is for your reshoring initiative to cause your manufacturing operations to become non-compliant.
With products that fall under the FDA’s jurisdiction, manufacturers must perform—among many other tasks—“installation qualification” to (according to the FDA):
“[A]ssure that the equipment has been properly installed, meets the device manufacturer’s specifications and requirements for it, and is capable of operating in the range required for the process being validated.”
Though this is typically performed as a pre-production activity, there is another situation where an installation qualification must be performed: when equipment is moved.
Beyond something as obvious as installation qualification, even a subtle change in environment humidity can impact an operation like injection molding—which could force you to have to redevelop and validate your process.
If your QMS does not cover scenarios like these or provide the processes and procedures for making a proper transfer, your manufacturing operations may produce bad parts and fall out of compliance.
Factor #2: Technical expertise.
Transferring the manufacturing of a product from one facility to another can be extremely difficult.
This difficulty is compounded when the transfer involves moving across continents and countries.
Though a robust QMS can help a great deal, you need the technical expertise to actually execute the transfer properly—you need to have people who actually know how to perform an installation qualification, redevelop a process, and run a proper validation.
If you do not have people with the knowledge and experience necessary to transfer a manufacturing line, you may end up spending a lot more time and money on your reshore than you expected.
However, having the expertise to perform a transfer is only one component of the equation.
Depending on the complexity of your manufacturing processes, you may have trouble finding qualified employees to perform the work.
As you may recall from our post about the advantages and disadvantages of reshoring, one of the biggest problems US manufacturers face is a dearth of skilled labor.
So, before you begin down the pathway of reshoring, be sure you have the technical expertise to oversee the transfer and a workforce with the skills necessary to build your product.
Factor #3: A good partner.
In 2019, the global medical device manufacturing outsourcing market was estimated at $104.5 billion.
Given the fact that the global medical device market is valued somewhere around $425 billion, we can surmise that a good chunk of medical devices are manufactured by out-of-house partners.
When undertaking a reshore initiative, having a good partner can be extremely advantageous.
First, if your manufacturing partner has a presence in the US (like ATL), the transfer can be much easier as they won’t need to build a facility or workforce from the ground up.
Second, with manufacturing partners who are well-versed in transferring production lines across continents and borders, chances are, their QMS has been built-up to handle these types of requests.
Finally, given that the manufacturing of the product will be performed by the partner, they can help lighten the load of the technical expertise requirements laid out above.
Partners who have helped others undertake similar initiatives—who know the intricacies of transferring manufacturing operations—can help guide you down the reshoring pathway.
Reshoring your medical device manufacturing can be a challenging, resource-intensive undertaking.
However, if you consider and build-around the three factors mentioned in this post, you can put yourself in a better position to succeed.
To learn more about reshoring, download our free ebook.