| OEM Diagnostics Manufacturing |
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DiagnosticsImproved turn around time, data integrity and cost reduction are key benefits in automating the standard tests associated with the diagnostic industry. With trained staff and laboratory personnel being optimized for data analysis and management, more automation is necessary to keep up with the growing number of samples. Different laboratory sizes and throughput requirements create the need for flexible automation systems that bring Dynamic Devices platforms into the forefront of lab automation industry. OEM and Contract ManufacturingWith the ever increasing regulatory requirements of the clinical and in-vitro diagnostics (IVD) industries, Dynamic Devices works side by side as an original equipment manufacturer (OEM) with customers who may add value by adding on their chemistry test kits on our standard platforms or custom integrated systems. Customers, acting as a value added reseller, may configure our products to exactly fit their application. Our customers can utilize our standard products from the BioPharma market, our custom design group and our ability to integrate virtually any peripheral needed to fully automate an application, realizing reduced costs and the ability to implement the latest technologies. In our contract manufacturing business model, customers approach us with an application or design. We then help configure a system and quote the parts based on processes, labor, tooling, and material costs. Once a system prototype is delivered, customers may run the chemistries for proof of concept and to fine tune their assays. Once the chemistries are running reliably, we may then ‘lock down’ the configuration and finished the required regulatory documentation for the platform. At this point, customers may start the required FDA validation work of Premarket Notification (PMN) or 510(k). |

