Steps for Successfully Developing and Designing In Vitro Diagnostic Products

For over 30 years, BMP Medical has produced components for in vitro diagnostic medical devices testing.  In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, detect, treat, or prevent disease, or a disease that is a consequence of a previous health condition, i.e., its sequelae.

Such products are intended for use in the collection, preparation, and examination of tissue or blood samples taken from the human body. IVD can also be used to identify patients who are likely to benefit from specific treatments or therapies through next-generation sequencing tests. This method scans a person’s DNA to detect genomic variations. Devices include general purpose lab equipment, reagents, or test kits that may include monoclonal antibody technology. 

Medical Diagnostics | in vitro diagnostic medical devices

An IVD, as with any medical device, must go through a series of tests to receive FDA approval before the product can be brought to market. The product development, design, and delivery cycle can be grueling to the uninitiated. To successfully develop and design IVD products, assembling an experienced team can ensure timely delivery of the device. This may comprise inventors, engineers, scientists, compliance experts, and an OEM (Original Equipment Manufacturer).  Once assembled, follow 3 crucial steps in ensuring your products’ design for manufacturability elements that will result in timely, compliant, efficient production and delivery schedule.

Customer and Client Needs

When considering any type of IVD medical device design, it’s important that it meets the needs of its end users. Getting feedback and gaining perspective along the way can mean the difference between success or failure of any product. Determine how users want to interact with the product, what their preferences are, and whether it will perform a desired function. By conducting such field research, companies can avoid costly product redesign and avoid weak market acceptance upon launch. Identifying desired features and intended functions of an IVD from all parties, from marketing to regulatory control, from safety to design personnel, will ensure success. Include your OEM during the design process by involving their compliance experts, production staff, and quality control personnel.

Simulation Modeling

A computer-based simulation model can be of great assistance in observing interactions and anticipating conflicts in product design. Simulation modeling will ensure your device functions efficiently and as intended. The program can prioritize features such as operational performance, process technology, and resolve other problematic or unforeseen complexities or even costs. It can reveal design challenges, where they exist, and how to adjust or correct them.

Choosing the Right OEM Reduces Time and Costs

Your goal is to successfully introduce your IVD medical device on the marketplace as soon as possible. To do so your IVD must be compliant. IVDs are subject to the approval of regulatory authority. FDA classifies IVD products into Class I, II, or III according to the level of regulatory control that is necessary to assure safety and effectiveness. The classification of an IVD medical device determines the appropriate premarket process. There is no compromise on this process. However, the right OEM for your product will be able to save time and costs through greater efficiency. An experienced OEM can bring off-the-shelf (OTS) solutions to adapt to a customer’s needs. All the necessary components to manufacture are already in place. Modules for newly designed diagnostic instruments may interoperate with existing system components. Some OTS solutions may be scalable or flexible to integrate in verified prior applications to apply to your device. An experienced medical device OEM has had a long time to develop OTS solutions that may adapt to your device and meet compliance in a timely and efficient manner.

Over the years, BMP Medical has worked with many clients to develop very intricate designs and features that set them apart from other IVD products on the market. We work closely with our customers to provide support for the design and the ability to manufacture their product. Our success rests on what we know since it’s what we do.

For more information, please contact us today!

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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