What to Look for When Choosing a Medical Device Contract Manufacturer

Two professionals brainstorming with laptopsWhen companies, developers, and inventors seek contract manufacturing services for their medical devices, selecting the right medical service OEM (Original Equipment Manufacturer) is vital for the overall success of their new product. With all the levels of complexities, shapes, sizes, demands, and varying technologies for medical devices on today’s market, the medical device contract manufacturing services company is in a prime position to fill an ever-expanding niche in the medical device manufacturing sector. The strict regulatory environment combined with rigorous international standards, place a high demand for companies that can provide regulatory expertise and fulfill a project from product design and development to testing, validation and verification, manufacturing, and delivery to the marketplace.

A medical device contract manufacturing company is a comprehensive medical device manufacturer that supplies a range of services which covers the entire lifecycle of a product. Clients or companies may need some or all of these services for their product. Nevertheless, medical device OEMs bring to any project a wealth of experience, insight, management, and expertise in a variety of fields that can ensure the success of your product on the market, and do so cost-effectively. Teams of engineers, designers, and regulatory experts work with clients from the design of a new product at its inception to development, validation, and verification, medical device manufacturing, and assembly, final packaging to supply chain management. Depending on the needs of your medical device, medical contract OEM’s will have tooling and machining, or medical injection molding available for the manufacturing of the device.

Saving Time and Money without Sacrificing Quality

One of the main services provided by medical device OEMs is overall cost-effectiveness and time and money saved for their clients. Integrated, cross-disciplinary project teams are in place to make sure the process of design, development, compliance, and manufacturing and consumer markets is streamlined. For example, by working together, design and manufacturing teams effectively standardize procedures and proactively identify, communicate, anticipate, and solve problems. Experienced design engineers monitor trends in emerging technologies, and have a comprehensive understanding of the FDA regulatory and submission process from start-up through performance and validation. Experienced manufacturing teams will likewise meet regulatory requirements in a high volume production environment. They have the capability to produce higher-quality products to meet end-user satisfaction and safety. In total, integrated medical device OEMs are designed to save both time and money.

Following Industry Standards Ensure Success

Managing the manufacturing processes of a medical device or component requires legal expertise, knowledge of the FDA regulatory environment and a robust compliance program to ensure your product’s timely delivery and success. This is another important service provided by a medical device OEM. Inventors, start-up companies, or novices should not underestimate FDA regulations and compliance to them. Class I, II, and III medical devices have different compliance protocols. Choosing the medical device OEM service company will depend on your product’s FDA medical device classification. Some may only handle Class I, II, or III medical device manufacturing. In that regard, knowing what classification your device is and choosing an OEM that exclusively handles that classification can bring a greater degree of experience and expertise to the project.

Identifying Medical Device Contract Manufacturing Expertise

That expertise is needed. The process of regulatory compliance is all-encompassing. Thorough patent research must be conducted. The study of competitive patents or finding patent opportunities for any device is an essential first step. Medical device OEM’s can then seamlessly prepare for FDA inspections, meticulous recordkeeping, audits, and have quality control protocols in place. The medical manufacturer’s responsibility is to be up to speed on current FDA regulations as they relate and pertain to a particular device or product. Compliance with regulatory and quality control, and accompanying legal expertise, are an absolute must that will span the entire lifecycle of the product.

A Partner From Design to Market

From inception to launch, a medical device contract manufacturing services company can provide clients with insight and opportunities for the success of their product. Engineering and manufacturing teams bring decades of combined experience and expertise for their clients. Capable of managing production and consulting throughout the entire process allows all parties to address opportunities for improvements when or if they present themselves. Such contributions can meet the toughest development challenges of your medical device from administering regulatory compliance issues to preapproved materials and processes in manufacturing. In the end, it all adds up to savings and successful delivery of your product to market.

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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
Specimen Collection Kit
   
centrifuge
Commode Specimen Collection Systems
 

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