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Developing Research and Medical Diagnostic Products

Medical Diagnostics

Innovation in Medical Diagnostic Device Development

Nevertheless, great care must be made when a diagnostic device is brought to market. It is an end result of a lengthy, multi-step process that includes material, time and financial investment—not only in research and development, design, and manufacturing, but the entire process of verification and validation, regulatory approval, and market placement that comprises each stage of the product life-cycle. From conception to finished commercial product, medical devices requires innovative engineers and product designers, experienced project managers, quality control experts, and substantial regulatory expertise to make that transition a successful one. A successful and quite common practice for companies, inventors and entrepreneurs to bring their device to market is through contracting Original Equipment Manufacturers (OEM) of medical devices. Contract manufacturing of medical devices is the system by which a manufacturing company makes medical devices or components of medical devices that are later sold by another company. Effective manufacturing systems can also offer areas of expertise in engineering, design, molding, assembly, and R&D, and range in capabilities from prototype to long production runs. Particularly with the medical device market, OEMs must provide specialized facilities for manufacturing such products, and have on-site medical labs for all stages of production, from concept to design to manufacturing. Labs give engineers the opportunity to validate and verify new products, plus allow for modification or change in design as needed.

How Can an OEM Contract Manufacturer Benefit Your Company?


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