Many diagnostic device developers have experienced that heart-stopping moment: the final piece of the product puzzle doesn’t fit. For medical devices, a simple mismatch of discrete elements at the end of a development cycle can be catastrophic and require huge costs and long time frames to rectify.
Oftentimes, these issues arise from inefficient organization, a lack of foresight during development, minimal communication, and development silos. DCN Dx understands and proactively eliminates these problems through an integrated approach to point-of-use diagnostic product engineering.
Engineering Comprehensive Point-of-Use Diagnostic Solutions
Point-of-use diagnostic devices analyze glucose and cholesterol levels, perform electrolyte and enzyme analysis, and test for drugs of abuse, pregnancies, and infectious diseases. Point-of-use diagnostic devices are also used to test blood gases and cardiac markers and perform fecal occult blood tests. There are several advantages to doing the tests at the point of use, including quick results and faster implementation of therapy if needed.
Selecting the Right Point-of-Use Diagnostic Development Partner
When looking for a point-of-use diagnostic development partner, it’s important to ensure that they have the expertise and delivery record to tackle all aspects of development. Your diagnostic developer should understand the shifting regulatory landscape and be flexible enough to mold their clinical and engineering services to your application.
DCN Dx understands that the greatest concern of any diagnostic development is that the assay reliably solves the right problem and achieves FDA approval. However, DCN brings much more value to the development and leverages a unique combination of technical, regulatory, and business expertise to take your diagnostic device from concept to market success.
DCN Dx’s engineering services cover the design of mechanical systems, electronic equipment, software, optical systems, consumables/cartridges, and reader development. We also customize our base reader—the miniDxR for integration with lateral flow and point-of-care diagnostics, along with the design of lab-on-a-chip instruments, optical analyzers, PCR and isothermal systems.
DCN Dx is flexible enough to shape our development services around your project’s requirements. For example, we design diagnostics for high-throughput applications without compromising usability or performance. Our flexible services are modular, allowing you to select the clinical, engineering, or regulatory services you need to round out your diagnostic development. You can bring your point-of-use diagnostic device into the development cycle at any point—from feasibility, design, and development to clinical validation, regulatory submission, and product launch.
Say ‘Goodbye’ to Silos
Silos can lead to a loss of productivity, increased costs, and a lack of efficacy for point-of-use product development. This occurs when product, engineering, and manufacturing teams working on the same diagnostic device (or from different companies) function independently and communicate ineffectively, leading to continual readjustments that increase materials, costs, and labor while lowering productivity.
DCN Dx eliminates silos by integrating assay development, engineering, and manufacturing teams to prepare assays for use in cartridges and instruments from the conceptual phase. We serve as an all-in-one partner that provides centralized product development, eliminating the need to manage multiple developers for your diagnostic device.
Transparent Communication throughout Development
We understand the frustration of waiting for updates on your diagnostic development project. As an all-in-one development and manufacturing partner, DCN Dx serves as the single source of accountability for your point-of-use device. We keep you informed throughout the entire development chain, ensuring transparent communication and no uncertain forecasts or lead times.
An Efficient Approach to Development
From the outset, we “examine the seams” in the development of your point-of-use product, leveraging our expertise in assay, instrument, software, cartridge, and sample handling. Our integrated approach combines engineering, manufacturing, logistics, and clinical research, allowing us to navigate project milestones seamlessly through efficient communication channels, standardized design formats, and transfer protocols.
Reduced Risk for Point-of-Use Product Development
DCN Dx leverages over two decades of experience in lateral flow, flow-through, microfluidic, and other formats to de-risk your assay development projects and work efficiently towards milestones. Our integrated teams work together via standardized design formats and transfer protocols to ensure that every one of your requirements are satisfied from concept to commercialization.
Our product development lifecycle starts early by integrating the assay into the cartridge and instrument. Our unique end-to-end development capabilities allow us to identify and address interface problems before they become challenges. For example, clients often approach us with requirements for unique cartridge geometry. The lateral flow reader’s visual field of view must be matched to the relevant area of its cartridge. Our rapid customization options and engineering services allow us to create functional designs that proactively identify potential late-stage problems and optimize the final result.
DCN Dx’s integrated approach to point-of-use diagnostic product engineering ensures seamless IVD product development. By eliminating silos, streamlining communication, and leveraging our diverse expertise in engineering, manufacturing, logistics, clinical research, and regulatory management, we deliver innovative and reliable point-of-use diagnostic devices that make a difference in patient care.
Partner with DCN Dx for your next point-of-use diagnostic project and experience a transparent, efficient, and risk-free development process that will take your device from concept to market success. Together, we can revolutionize point-of-use diagnostics and make a lasting impact on the world of healthcare.
