Outsourcing for IVD Manufacturers
Contract manufacturing is generally defined as the production of goods or services by one company under the label or brand name of another company. Contract manufacturers (CMs) may provide such services to several organizations based on customer (or CM-generated) designs, formulas, and/or specifications. Contract manufacturing is a form of outsourcing. Companies that use contract manufacturers range in size from one to several thousand employees. CMs are usually hired to perform specialized...
Table 1. Capillary flow times for Hi-Flow Plus membranes. *The range is for all measured values on a roll and represents ±3∂. The acceptable range for the mean is ±10% of the target.   Selecting, evaluating, and sourcing critical raw materials is a strategic step in the development and production of diagnostic kits. This is also a strategic task for company management, because an IVD company always must optimize its return...
  Shopping for parts, components, services, and new technologies at the Clinical Lab Expo next week? You're in luck. Here's just a tiny sampling of what will be on display there. Isolation Miniature Valves Solenoid-operated valves use a flexible diaphragm to isolate the solenoid actuation mechanism from the fluid path. When the valve is energized, the solenoid retracts an armature that is attached to a flexible diaphragm. In a normally closed valve, this raises the diaphragm, allowing...
The Clinical Lab Expo will feature new science and technology in every area of clinical diagnostics, automation, information systems, point of care, OEM, and biotech. Roughly 750 organizations will occupy about 2000 booths. According to Clinical Lab Expo's Website, "You will see more products in every clinical lab discipline than at any other show." Find What You Need The Clinical Lab Expo will have special sections for special products. Visit the special sections for point-of-...
Automatic sampling systems allow for efficient storage and handling of a diverse range of clinical samples. Clinical patient samples are an essential but often overlooked tool in numerous clinical and medical applications. In the IVD industry, they are widely used during the various stages of test kit development, including marker discovery, field trials, product validation, and preparation for regulatory approval. They are essential to ensure the scientific relevance and specificity...
Contract manufacturers are described on FDA’s Web site as companies that “manufacture a finished device to another establishment’s specifications.”1 More than 1500 companies at more than 14,000 locations are currently registered with FDA as contract manufacturers.2 In addition to these companies, many other unregistered firms are also contract manufacturing nonregulated products and offering contract sterilization, repackaging, relabeling, remanufacturing, and...
Many factors have contributed to IVD companies relying increasingly on outsourcing of their assay manufacturing. The number of applications for rapid IVD technologies has grown. In addition to traditional human clinical testing, IVDs are also being used in veterinary, food and beverage, pharmaceutical, and environmental testing. Chronic disease management and the aging population are also driving the demand for both existing and new home-use and point-of-care clinical tests. Figure 1. A...
Regardless of whether a product has been established in the IVD market, its production volumes can vary from month to month and year to year. A supplier’s priority is to ensure that it can be manufactured on time, in the required amount, and with the highest quality, while remaining cost effective at all times. The IVD industry is increasingly relying on contract manufacturers. For a number of reasons, many companies are not equipped to manage the demands of an ever-growing industry. For...
With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more efficiently is mounting. To reduce costs and shorten product development cycles, some OEMs and start-up companies have been turning to contract instrument developers and manufacturers for their guidance and relevant experience to overcome common development challenges. As partners to major OEMs and start-ups, contract manufacturers can offer insights on the technical trends affecting...
The successful development of new IVD products depends on first establishing the right product definition. The product definition serves as a guide for the development project. It should contain an optimal product concept and a comprehensive list of requirements that help designers make choices throughout the development project and that allow marketers to understand what benefits the product will deliver and how it will fit into the market.   The product definition...