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!