Reshoring medical device manufacturing in the United States

Over the past several years, the United States has seen a growing demand for reshoring medical device and component manufacturing. The past year has done much to prove that reshoring manufacturing is even more critical than we ever thought. With businesses quickly pivoting and supply chains being pushed like never before, there is a greater need for companies to better control many aspects of their medical devices and components, such as design, development, manufacturing, and assembly.

Key Factors to choosing a medical device manufacturing partner
When choosing a U.S.-based medical device and component manufacturing partner, several key factors determine the right fit for your product and business, such as quality control/quality assurance (QMS), the complexity of the product, IP protection, better supply chain management, lower shipping costs, mitigation of risk, avoidance of unanticipated import challenges and taxes, better communication, lower travel and communication costs, greater market appeal, and more jobs for the U.S. economy.
medical device manufacturing

Things to consider with selecting a medical device contract manufacturer
Medical device manufacturing • Quality control/quality assurance (QMS)
Quality control and quality assurance are paramount in medical device design, development, and manufacturing. An important first step is being able to visit the contract manufacturing company that you’re considering partnering with. Virtual tours are another good option. It is crucial to understand the detailed quality control and quality assurance tactics that will be put into place to deliver a flawless, well-documented finished product throughout each stage of the design, development, and manufacturing process.

Both quality control and quality assurance fall under QMS. Making sure your medical device manufacturing partner is embracing real-time data QMS procedures will help with evolving compliance and regulations requirements. Finding out what robust QMS they have in place is important, and it is imperative to mitigate risk at every stage of your product lifestyle. Several certifications and accredited programs, including MedAccred, FDA-compliant, ISO-certified, and adherence to cGMP practices, should be taken under consideration to mitigate risk.

Complexity of product
It is vital to find a design, development, and manufacturing medical device contract manufacturing partner that has the proper equipment, technology, and expertise, and is capable of meeting your production levels throughout the entire product life cycle while maintaining outstanding production of high-quality throughput. Very important also is asking the right questions and developing a cohesive understanding as to what resources would be readily available to deliver a high-quality medical device or component on time, on budget, and on schedule.

Medical device manufacturing • IP Protection for your innovations
Protecting your medical device is an important action that should be considered at the inception of the development cycle. The medical device industry is a crowded space with a lot of pending patents and registered designs. You must engage with a patent attorney early on and obtain a signed NDA with any manufacturing company you engage in discussions with. Many OEMs have expressed some concerns around IP protection when working with an international medical device manufacturer.

Medical device manufacturing • Better supply chain management
Consider the resources needed to manage a global supply chain from a sourcing and logistics standpoint when selecting a medical device manufacturing partnership. These additional internal resources should be calculated into your overall project cost. How will a global supply chain affect your lead time? Could unexpected shipping delays affect your product deliverable dates?

Unanticipated import challenges and taxes
China has seen seeing rising labor rates over the past several years and has also experienced importing challenges that delay delivery times. China is also hampered by additional shipping costs, uncertainty around tariffs, and rising taxes. Many U.S.-based manufacturers have been able to bridge the cost-efficiency gap with investments in automation, technology, and enhanced operational programs, all with a keen eye on delivering a higher-quality product.

Mitigating risk
Greater regulatory requirements have put more importance on mitigating risk in order to deliver safer and more effective medical devices. Companies have put greater emphasis on developing a risk management plan that analyzes, evaluates, controls, and monitors risks. Does your potential medical device manufacturer have a robust QMS? Do they hold the needed certifications? How will audits be performed? Does your potential manufacturing vendor have a crisis response plan that ensures manufacturing continuity?

Better communication, less travel, and lower communication costs
Working with a medical device manufacturing vendor in the same hemisphere that can respond to production changes in a time-sensitive and responsive manner is an added advantage. Even in our digital age, human interaction is a vital component to delivering great customer service.

Over the past seven years, more and more OEMs are returning their medical device design, development, manufacturing, and assembly work to the United States, which provides greater market appeal and adds jobs to the U.S. economy.
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Why BMP Medical should be your next plastics manufacturing partner
Located within the United States, BMP Medical provides plastic contract manufacturing services to leading medical device and diagnostic OEMs in need of injection molding, injection blow, two-shot, and insert molding. BMP Medical’s 80,000 sq. ft. facility is located in Sterling, Massachusetts. We foster strong trust-driven relationships to develop inventive solutions tailored to customers and end-user needs. From concept through commercialization, BMP offers in-depth problem-solving backed by deep industry knowledge and operational excellence. BMP Medical is a global contract manufacturer servicing the Medical Device and Medical Diagnostic markets in all areas, including, but not limited to, IVD, IV access, sample-preparation devices, and lateral-flow technologies. Headquartered in Sterling, Massachusetts, BMP Medical can service our partner requirements on a worldwide basis.

Certifications: ISO13485:2016; FDA registration #1220502; ISO Class 8 injection molding; ISO Class 8 assembly & packaging; 21 CFR 820 Quality System Regulation; FDA registered; MedAccred Certified

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