Validation is a critical process to keep patients and end users safe. Proper documentation of tooling maintenance and repairs, adjustments to process and part design will help facilitate a successful and efficient validation process. [Photo courtesy of Beacon MedTech Solutions]
Reshoring medical devices — moving production back to the United States — requires strategic and complex navigation.
John Banks and Richard Landry, Beacon MedTech Solutions
Reshoring is a topic of conversation with almost every biopharma, life sciences and medical company currently outsourcing production of thermoplastic or silicone parts, products and assemblies to overseas molders.
Just look at the numbers. The Reshoring Initiative released data showing that reshoring and foreign direct investments are projected to drive an additional 350,000 U.S jobs in 2022, a record high.
The reasons for this growth are numerous. Companies may be experiencing issues with quality from current suppliers, capacity issues against fluctuating demand or timeline delays due to supply chain complications. No matter the reason, today’s medical device, equipment and product manufacturers can reap a number of benefits when transferring tools to a domestic contract manufacturing partner. Still, the decision to reshore is a strategic and complex one, with many issues that must be balanced as you maneuver the process.
In making the decision to move production back to the United States, one of your primary goals should be to ensure a smooth transition. Whether you’re transferring your work to a contract development and manufacturing organization (CDMO) or managing the transition to a captive facility, explore these three considerations to successfully navigate your reshoring initiative.
Reshoring programs can take many shapes, from one-tool transfers to full equipment transfer. No matter the scope of your reshoring initiative, a strong supply chain and engaged team are critical to ensuring success at every stage of the process. [Photo courtesy of Beacon MedTech Solutions]
1: Your existing tools can’t always be salvaged.
An early consideration of the reshoring process should be the state of your tooling. Ideally, you would be able to seamlessly collaborate with your overseas partner to ship tooling back to the U.S., make minor repairs, and start injection molding parts. In reality, it’s often more complex.
For legacy parts, tooling has likely been repaired and modified over the years to ensure volumes continue to be met. However, during the reshoring process, some companies may find that they haven’t been maintained well. Others may find a lack of maintenance or repair documentation, or missing part drawings, 3D files or other design mechanics. In both situations, your program may require entirely new tooling to ensure compliance or produce the quality and volumes you need.
As you begin your reshoring initiative, managing expectations about the state of your tooling will help you identify the right steps for your team while building a strong foundation for ongoing production.
2: Preparation for the validation process can expose potential risks.
As a medical device, product or equipment manufacturer, you have likely experienced the critical FDA validation process to get your product to market while keeping patients and end users safe. As with any move to a new supplier, make sure you prepare the documentation and data you need to ensure a smooth process, no matter who will be molding or assembling your parts.
If transferring production to a contract development and manufacturing organization, that team will be critical in supporting you through the process, identifying the potential downfalls through the validation process, especially if your tooling evaluation exposes potential risks.
Quality management teams will use part drawings, tool designs, specs and more to uncover areas in need of attention prior to validation. Whether the tool needs to be modified to meet design documentation, new documentation is needed, or entirely new tools must be built, a CDMO can ensure ongoing quality against your exacting standards.
Whether your tools are in excellent shape or need work, engaging your team to prepare for validation will help accelerate your timeline and drive efficiency throughout the process.
3: You may need to say goodbye to part of your current supply chain.
A known advantage of reshoring is the ability to gain greater control over your supply chain and improve collaboration with companies closer to home. The move to a domestic supplier for ongoing production of your thermoplastic and LSR components and assemblies may also require reconstruction of your supply chain, both from a geographic and a risk perspective.
Your bill of materials (BOM) — the raw materials, sub-assemblies, sub-components, parts and quantities needed to manufacture an end product — provides an excellent blueprint for this reconstruction. When moving part production closer to your facility, it just isn’t feasible or logical to maintain your same partners overseas. Whether you choose a vertically integrated CDMO who can manage more of the BOM or choose to manage those relationships individually, reconstructing your value chain can drive sustainable program success long-term with thoughtful and careful vetting of your partners.
Though a total shake-up may seem unnecessary, the move may also help you gain more control amid rising raw material costs, freight and transportation costs, wages, energy costs and more, now and in the future. A 2020 McKinsey Global Report found that companies can now expect supply chain disruptions lasting for at least one month every 3.7 years. With trusted suppliers closer to home, you can help lessen the long-term effects of these recurring disruptions, like issues with quality, on-time delivery and ultimately, your brand reputation.
Take the step to evaluate your supply chain
The decision to reshore production can factor in many other things: financial benefits, brand value, customer loyalty and more. Whatever your reshoring decision, now is the time to ensure you have a smart, stable supply chain to help you accomplish your short- and long-term goals.
John Banks is assembly operations manager at Beacon MedTech Solutions. [Photo courtesy of Beacon MedTech Solutions]
If you are a captive molder seeking partners for materials, sub-components and assemblies, or you are seeking a contract manufacturing organization to manage your programs, take steps today to establish your goals, evaluate the performance of your supply chain and guarantee lasting success.
John Banks, assembly operations manager at Beacon MedTech Solutions, oversees the manufacturing operations of all products in the Life Sciences portfolio to ensure on-time delivery and quality standards compliant to ISO 13485, ISO 9001 and cGMP. He brings 10-plus years of experience in both technical and leadership roles within the medical device and biopharma industries to help companies accelerate success in the market.
Richard Landry is director of operations at Beacon MedTech Solutions. [Photo courtesy of Beacon MedTech Solutions]
Richard Landry, director of operations at Beacon MedTech Solutions, applies decades of plastic injection molding and contract manufacturing expertise to oversee all manufacturing operations. Working with a cross-functional team, Landry elevates customer programs through particular expertise in engineering and operations management, with an emphasis on quality, training and continuous improvement.
The opinions expressed in this post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.