What is a Medical Device Contract Manufacturing Services Company?

lab with petri dishThere’s little doubt that the medical device manufacturing industry is expanding worldwide and contract manufacturing services a large part of it. Over the past several decades, the industry, and the contract manufacturing sector has met the challenges of ever-increasing demand and reshaped medical technology. There are near 5,800 companies employing over 350,000 people in the industry. Last year, the United States alone accounted for nearly half –45 percent of sales—of the $413 billion global market for medical devices. With the industry growth rate at 5 percent annually, projected sales by 2022 will be approaching $530 billion. As the global market for medical device manufacturers increases, so will the need for more companies and people in the industry. Expect the role of contract manufacturing to play an even greater part in the years ahead.

A Little Bit About Contract Manufacturing Services

Contract manufacturing is a form of outsourcing in which a company produces whole products or a single part a larger product. This is true in the medical device industry, as well. OEM (Original Equipment Manufacturer) of medical devices are companies that, in general, focus on a particular area of expertise, such as molding, assembly, or R&D design. Medical device contract manufacturing is the system by which a manufacturing company makes medical devices or components of medical devices that can be later sold by another company.

Medical device contract manufacturers often specialize in a certain process or task and can offer expertise from frequent practice of their manufacturing. Service or services for customers, clients, and inventors of medical devices include product concept and development, process validation and verification, production, or highly specialized manufacturing, packaging. They can even manage the supply and delivery to the end customer.

OEMs can also provide specialized facilities that are essential for the manufacturing of medical devices. On-site medical labs are necessary for all phases of production, from design to manufacturing. These labs afford engineers with the chance to validate and verify new products and allow for any design changes that may be necessitated as needed. Cleanrooms are also required to ensure the manufacture of medical devices is free of contaminants. A cleanroom utilizes advanced filters, specialized clothing, and even hermetically seals the workspace.

What is Medical Device Contract Manufacturing?

To be certain, the term “medical device” covers a broad range of products. They can be found in the operating room, labor and delivery, nursing homes, intensive care units, home health care, sleep labs, your local pharmacy, and many other places. Nevertheless, all medical devices sold in the U.S. are regulated by the FDA (Food and Drug Administration). By FDA definition a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body. The regulatory policy for these devices is strict and follows a three tiered classification system, i.e., Class I, II, and III.

When You Need an Experienced OEM Contract Manufacturer

As an OEM contract manufacturer, BMP Medical provides services for the medical device industry. Its area of specialty produces highly precise plastic consumables used in devices and diagnostic kits. BMP Medical will work with its customers through all phases of production. We offer state-of-the-art injection blow molding capabilities to produce an array of IVD & IV components, sample preparation devices, and lateral flow technologies. We can offer design consultation, engineering, drawing, R&D, tooling, mold development, computer automation, and statistical process control for mid-tier products. Our facility is equipped with a Class 8 clean room for manufacturing, packaging, and assembly needs.

As a single source provider, BMP is geared to meet all regulatory requirements for medical device engineering. Sterilization services, custom packaging, pad printing, DNase/RNase free manufacturing, and process validation services to support any complex product development cycle are all available to BMP’s customers. The company has established the most rigorous quality control standards possible; especially for Class 1 medical device approval and 510K filing specifications.

Finally, to meet the needs of our clients and customers, BMP offers manufacturing facilities in Massachusetts and Asia, we can service any complex project requirement worldwide. Our devices have assisted a wide variety of industries ranging from diagnostic, laboratory, and research to biomedical, clinical, medical, and pathology devices. BMP is both ISO 13485 and 9001:2008 compliant, and conforms to standards set by the FDA, cGMP, LPA, ANSI, AAMI, and SPE. This is why, as an OEM of medical devices, pharmaceutical and medical companies have looked to BMP Medical to manufacture their medical devices for over 30 years. If you have any questions, feel free to contact us!

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.


 

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

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