By Sean Fenske, Editor-in-Chief

IVD testing has been a crucial part of providing healthcare for some time, but the COVID-19 pandemic really put a spotlight on just how important it can be. As such, manufacturers are increasing the development of tests for a variety of diseases and conditions. Since accuracy is critical to the value of these diagnostics, using the right supply partners and reliable components is vital.

One important aspect of IVD solutions is ensuring the controlled flow of fluids necessary for the success of these devices. A potential pain point for this transfer is at the connection between two elements of the system, such as tubing and an analyzer. The connector used at this interface must be easy to use, ergonomic, ensure a tight fit, and not impede flow, while requiring precision as well.

To help further explain just how important the connector selection process can be for an IVD system, Brendan Simmonds, Product Manager – Medical Solutions at CPC (Colder Products Company), responded to several questions on the topic. In the following Q&A, he speaks about the IVD market, important design considerations, and anticipated technology advancements.

Sean Fenske: Overall, what are you seeing happening with the IVD space? Is it growing? What’s driving the growth?

Brendan Simmonds: IVD is growing, and the growth in personalized medicine, for example, is having an effect. BioPhorum, a UK-based industry association, says effective IVD offerings are essential to personalized medicine because “medicinal developments need a companion diagnostic test alongside it to ensure that the medication is applied where it can have the greatest benefit.” So, diagnostics are crucial to precision medicine progress and success.

An aging population and associated increasing disease states also mean more testing. Analyzers must handle more throughput while maintaining both precision and closed-system designs to protect the integrity of the processes. Some of these analyzers are running thousands of tests each day, so it’s easy to see the demands placed on equipment with the growing need for diagnostic tests.

Fenske: What’s CPC’s involvement with the IVD space? What types of components or services are necessary from your company?

Simmonds: In IVD analyzers and equipment, CPC makes connectors that connect the tubing through which a range of fluids flow. Operators encounter connectors in multiple places: in internal fluid lines, when loading bulk fluids into the equipment, when cleaning the equipment, and more. Connectors can significantly impact everyday use. That’s why we’re focused on addressing the performance issues that are most important to IVD equipment manufacturers and operators.

For example, with a higher demand for diagnostics comes a drive for greater efficiency and throughput in labs. Automation helps process more tests, so manufacturers’ equipment must handle automation while capturing valuable data at the same time. CPC’s radio frequency identification (RFID)-enabled connectors not only connect tubing throughout IVD equipment but also transfer data like product shelf-life information, system settings and protocols, usage rate, and much more from integrated tags within the coupler to the reader.

Clinical labs expect more functionality from their diagnostic equipment without dramatically increasing the machine footprint. Fluidics components are shrinking to fit more confined spaces, but fluid management performance cannot be negatively affected by smaller flow paths and more twists and turns in tubing. To address the evolving needs for these complex systems, CPC offers a wide range of product sizes, materials, lumens, and terminations like hose barbs and panel mounts.

Not surprisingly, accuracy is still the most important factor for IVD equipment. To support both high accuracy and throughput, the components within analyzers must be durable and compatible with specialty chemicals.

Fenske: What should IVD companies be thinking about when it comes fluid handling? Where do they most often need your help?

Simmonds: Diagnostic processes like immunoassay/clinical chemistry, hematology, and flow cytometry and histology handle a significant amount of fluid flow. Tubing and connector selections can affect the speed, efficiency, and accuracy of IVD equipment, so IVD equipment manufacturers look to us to help them effectively manage fluid types, flow paths, and rates.

When it comes to compatibility with fluid types, diagnostic equipment components need to withstand exposure to a variety of fluids, from patient media to buffers and reagents to cleaning solutions.

Thorough chemical compatibility testing helps: 1) reduce or eliminate the risk of components breaking down over time due to chemical degradation; and 2) support the selection of components that will withstand the typical throughput of a clinical laboratory.

Flow pathways and rates are another significant operational factor for IVD equipment. As manufacturers seek to have more compact footprints, flow pathways have become tighter, with smaller-diameter tubing and more turns. Components must not impede the desired flow rates, so we offer a range of product sizes and materials to address these evolving market needs.

Also, the components in a fluid pathway matter. Two connectors of the same size might deliver significantly different flow rates with different viscosity solutions, so diagnostic equipment companies should closely evaluate the options appropriate for their media so they can achieve the flow rates they want.

User experience is important, too. Components also must be easy for technicians to handle as necessary. With connectors, design elements like color coding or keying to help avoid misconnections, low force-to-connect, audible “clicks” that signal connection, and break-away latches all can contribute to an improved user experience and more streamlined equipment operation and maintenance. Even seemingly simple design elements like thumb latches help field service technicians achieve faster maintenance and operation procedures.

Fenske: What key technological advancements will shape the IVD market in the future?

Simmonds: Technology has enabled the market to shift from manual processes to fully automated processing. To support this move, couplers are becoming more advanced, too.

CPC offers connectors that integrate sensors and radio frequency identification (RFID) technology directly into the coupler. These sensing technologies can detect when fluid levels are low or too high, or alert operators to refill reservoirs. Sensing capabilities can also confirm when connections have been made and track flow rates, temperature, and pressure.

The integrated RFID tags/readers also transfer data such as the shelf life of consumables and program settings used to calibrate equipment. The connectors can be programmed to detect the use of unknown or knockoff consumables, shutting down the system if necessary.

These technologies continue to evolve, allowing IVD equipment manufacturers the capabilities to do more in existing or smaller footprints. Even non-RFID connector solutions can help in more compact equipment. For example, our multi-tube connectors connect multiple fluid lines in a streamlined way; there are numerous options from which to choose.

Fenske: What are your early recommendations or best practices for companies developing an IVD solution to help them avoid fluid handling issues later in the process?

Simmonds: To optimize performance, we’ve found that connecting the IVD equipment makers’ design engineers with our engineers early in product development is very helpful.

Sometimes, equipment makers think about connectors later in their design stages. But as we’ve discussed, connectors can impact flow pathways and rates, operators’ ease of use, and automation and data capture capabilities, while increasing efficiency and saving costs in the long run.

By thinking about these critical performance factors early in the design process, IVD equipment makers can deliver more robust solutions out of the gate. Also, a collaborative process with fluid management experts may influence the overall equipment design in ways that may not have been part of the original plans but make the final product more robust.

Connector technologies today offer so much more to enhance equipment performance than just connecting tubing. Knowing the available options early on and incorporating connectors that yield top performance benefits helps manufacturers differentiate themselves from competitors while simplifying use for operators. And ultimately, anything we can do to improve efficiency and throughput, or support testing integrity, is a win for labs and the patients they serve.

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