Outsourcing for IVD Manufacturers
Contract manufacturing
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...
Challenges involved in technical transfer of assay manufacturing
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...
Introduction to Contract Manufacturing
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...
Manufacturing obstacles in IVD product development
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...
Finding success through the IVD product definition process
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...
Introduction to contract manufacturing
      Contract manufacturers such as Corgenix Inc. (Broomfield, CO) have established strong core competencies that help their clients bring their products to market quickly and with first-class quality. An exciting aspect of the IVD industry is that a company of any size can develop new products and technologies. Since many smaller IVD companies do not have the infrastructure to take these new products from innovation to finished product, a contract manufacturing...
Key considerations in biochemical outsourcing
              Figure 1. Liquid media manufacturing on an automated packaging line in SAFC's facility in Irvine, Scotland. IVD manufacturers usually employ one of two different types of biochemical outsourcing: purchasing raw materials for internal kit manufacture, and OEM/contract manufacturing by an outside source for external kit manufacture. This article will discuss global quality and supply-chain issues relevant to both sides of the...
Choosing an IVD contract manufacturer
    OUTSOURCING FOR IVD MANUFACTURERS       Figure 1. At Thermo Fisher Scientific's site in Middletown, VA, products are lyophilized under tight control ensuring robustness in the field. Outsourcing to a contract manufacturer is a practical and cost-effective option for many companies operating in the IVD industry. It addresses numerous challenges associated with bringing an IVD product to market, especially when companies face rising manufacturing costs...
Adding value to the product development cycle
    OUTSOURCING FOR IVD MANUFACTURERS       Figure 1. A strategic supply partner delivered this miniature in-line pump for a flow cytometry instrument after the OEM and supplier together determined that a full syringe pump was unnecessary. Aiming to be first to market with innovative products, a growing number of IVD equipment manufacturers wrestle with a critical question: that is, whether it is more profitable for original equipment manufacturers (OEMs)...
Introduction to contract manufacturing
      Contract manufacturers such as Baril Corp. (Haverhill, MA) use deep process expertise to enhance their clients abilities to innovate. (Photo courtesy Baril Corp.) Medical device and medical diagnostics companies have long been recognized as among the richest hotbeds of innovation. Many experts give at least some of the credit for the considerable rise in the number of medical technology patents issued in recent years—from 4178 in 1989 to 10,616 in 2006...