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.
Better communication

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

BMP Medical should be your next plastics manufacturing partnerServices Offered:

  • Class 7 Assembly
  • Clean Room Manufacturing (Class 8)
  • Clean Room Packaging and Assembly (Class8)
  • Custom Two-Shot Molding
  • Custom Assembly & Packaging
  • Custom Injection Blow Molding (IBM)
  • Custom Injection Molding
  • Custom Insert Molding
  • DNase- and RNase-free manufacturing
  • FDA Registered Facility
  • Pad Printing
  • Product Design & Development Services
  • R&D Tooling
  • Sterilization Services

It is time to bring design, development and manufacturing back to the United States. Get to know BMP Medical today.

Archives

Categories

Plastic Products Catalog

BMP Medical is a quality manufacturer of plastic consumables and plastic products for research and medical diagnostic laboratories. Our products are manufactured to the highest quality standards. We offer a wide selection of products sold through the world’s premier laboratory distributors.

Non-Sterile and Sterile Centrifuge Bottles

  • Available with standard caps for low-speed work and sealing caps for high-speed applications
  • Caps have a built-in gripper to facilitate removal from the rotor
  • Extra thick walls for durability-resistant to most chemicals
  • Wide mouth design makes filling and decanting easier

These precision molded centrifuge bottles are available in polycarbonate or polypropylene. For low speed applications the bottles provide excellent value for large volume/large batch centrifugation procedures. For high-speed work, the easy-to-use Noryl® (Noryl® is a registered trademark of General Electric Company) sealing caps with silicone O-rings enable leak-free processing at high centrifugal forces over long durations. Bottles must be filled to 80% of capacity.

Centrifuge bottles may be autoclaved at 121ºC at 15 psi for 20 minutes. Caps should be placed on the bottles without engaging the threads. Bottles are qualified to the rated g-forces using Sorvall® (Sorvall® is a registered trademark of Kendro Laboratory Products) and Fiberlite® (Fiberlite® is a registered trademark of Piramoon Technologies Inc.) high-speed rotors, tested at 20ºC, with bottles filled to 80% of capacity.

Failure to use the correct rotor cushion or adapter will shorten the life of the bottle and may prevent achievement of the maximum rated RCF and/or bottle failure.

Prolonged autoclaving and reuse may cause stress cracks, crazing or bottle discoloration.

centrifuge bottle

Sterile Centrifuge
Bottles 


 

centrifuge bottle

Non-sterile
Centrifuge Bottles

Cytology Funnels Category

BMP Medical Cytology Funnels for the Shandon CytoSpin® Centrifuge BMP Medical Cytology Funnels are the functional equivalent of the Thermo Shandon CytoFunnel®. Fully compatible with the Shandon CytoSpin Centrifuge, BMP Medical Cytology Funnels can be used to deposit a thin layer of cells in a clearly defined area of a microscope slide. The filter card absorbs any excess fluid. Operation is identical to those supplied by Shandon and easy-to-follow instructions are included in each pack. All products sold in case quantities only.


Disposable Cytology Funnel Clips

Disposable Cytology Funnel Clips

 

metal cytology funnel clip

Metal Cytology
Funnel Clips


Double Cytology Funnels

Double Cytology Funnels


Single Cytology Funnels

Single Cytology Funnels

Hemodrop Blood Dispenser

The Hemodrop is designed to reduce the risk of exposure to bloodborne pathogens in the Hematology laboratory. To prepare a manual differential smear, a drop of blood needs to be dispensed onto a glass slide from the specimen tube. Simply puncture the rubber stopper with the Hemodrop, and then invert and press gently onto the slide. A single drop of blood will be dispensed and the slide is ready. No more removing the stopper and manually putting a drop on the slide to test blood.

 

hemodrop

Hemodrop

Multipurpose Containers

These high-quality non-graduated lab containers are designed for the collection, transport, and storage of specimens and samples. Tight fitting lids prevent leaks and odors. Ideal for storing biologically hazardous samples for terminal autoclaving before disposal. Molded from various materials. The stackable containers are resistant to freezing and boiling.

centrifuge

Translucent Multipurpose
Containers

Polypropylene Beakers

Resistant to most commonly used laboratory reagents, including a variety of strong acids, bases, and organic solvents, these high quality polypropylene beakers are the premier choice for scientific laboratory applications. All beakers are transparent for clear content visibility and graduated for easily estimating volumes. Molded-in pouring spouts, and a rolled lip, for a dripless working environment. Autoclavable to 121ºC ( 248ºF).


centrifuge

Polypropylene Beaker

Specimen Collection

For specimen collection and transport, this system provides disposable products for the convenient collection, delivery, and testing of urine specimens. A plastic cup is provided for specimen collection and the pressure sensitive patient identification labels have ample writing space. The lightweight transport rack is small and easy to carry yet provides space for up to 20 tubes with labels and caps. The tubes are made of sturdy polystyrene and are safe for centrifuging. The flared top permits the use of a midget urinometer ensuring a tight cap fit. 

centrifuge

Specimen
Collection Kit

centrifuge

Commode Specimen
Collection Systems


urine container

24 Hour Urine Containers


urine container

24 Hour Urine Containers with Spout

Tissue & Ultra Tissue Grinders

We offer two lines of tissue grinders for the clinical lab and research lab. The standard product is all plastic and is designed to grind softer tissues such as liver and spleen. The Ultra tissue grinder line has a vitrified tip and is designed for tougher material such as muscle or bone. Both lines are delivered sterile sealed Tyvek® (Tyvek® is a registered trademark of DuPont) package.

tissue grinder

Tissue Grinders


ultra tissue grinder

Ultra Tissue
Grinders

Urine Sedimentation System

BMP Medical, a manufacturer of diagnostic products, has a full line of urinalysis disposables. We offer the components separately, or in various kit sizes and configurations. The line is built around our 10-chambered Decislide which is made out of optically clear acrylic. It can take 10 individual samples on the same slide eliminating the need for a new slide for each sample.

 

Urine Sedimentation

Urine Sedimentation
System