Because of their utility, medical professionals commonly use catheters for a variety of applications and procedures. Consequently, billions of individual catheter products are necessary for good patient care outcomes. Experts predict that the demand for catheter products will increase by 4% - 5% every year for the next ten years and this growth will reach billions by 2025.
These products include Central Venous Catheters (CVC), Epidural Catheters, Hemodialysis Catheters, Pacemaker Lead Catheters, and Gastrostomy Tubes (G-Tubes). How catheter manufacturers will handle the expected rise in product demand is unclear. Smart manufacturers are preparing now to take advantage of future market opportunities.
Some are preparing by scrutinising how they are leveraging fluid dispensing solutions. Fluid dispensing systems allow manufacturers to control the amount and placement of fluid on a substrate for catheter bonding. This technology allows for a smooth transition from manual to semi-automated to fully automated manufacturing processes. In this way, organisations can implement dispensing automation solutions in a stepwise manner as market conditions dictate.
What is Catheter Bonding?
Catheter design typically requires that manufacturers bond a tip, balloon, connector, and often a handle for the product. The main shaft of many catheter designs requires gluing a guide wire shaft to it. Quality control is important for catheter bonding because of FDA regulations and the costly validation process.
Every device must meet regulatory agency requirements. Additionally, it should have reliable parts, strong bonded components, and a smooth exterior. This is important for easy positioning inside the patient's body.
95% of catheters use a bonding process along the length of the catheter. Manufacturers must make important decisions about the volume of glue used to provide the appropriate amounts of bond strength. Bonding is a critical function because a catheter failure inside the patient's body can adversely impact his health.
If a catheter product is faulty, it can lead to scrutiny, investigation by the FDA, lawsuits, and damage to reputation.
From patient’s standpoint, poorly bonded catheter components can become detached, or leak. This can cause complications ranging from infection that require more surgical procedures to significant harm to internal organs. A catheter with compromised bonds increases the risk for the patient. In the worst case, it can cause life threatening injuries.
Fluid Used
Over the years catheter manufacturers have used fluids like cyanoacrylates and solvents to bond components. Today, people prefer UV-cure adhesives because they change colour when cured. UV cure adhesives offer manufacturers a visual confirmation that the adhesive has completely cured. In addition, UV-cure adhesives deliver faster cure times and very accurate fluid dispense placement on substrates.
Application Requirements
Manufacturers need to apply a consistent amount of UV-cure adhesive to certain parts of the catheter and tube. This is vital for CVC, Epidural Catheters, Hemodialysis Catheters, Pacemaker Lead Catheters, and G-Tube applications. Fluid dispensing enables producers to reliably manufacture catheters within required specifications.
The catheters need to pass FDA tests. Catheters must be strong, secure, and flexible. The devices must be able to withstand sterilisation and insertion into the patient's body. Lastly, catheters must pass rigorous internal and regulatory tests.
Fluid Dispensing Solutions
Nordson EFD has various fluid dispensing solutions for catheter bonding tailored to customer needs and manufacturing processes.
Manual Processes
Nordson recommends the UltimusPlus I or UltimusPlus II fluid dispenser for catheter manufacturers who use a manual/operator-based fluid dispensing process. This solution offers several advantages, principally that the solution is an entry point investment and is operator-based. The UltimusPlus products enable a more controlled dispensing solution that is easy to operate.
In addition, the UltimusPlus solution offers reduced guesswork and decreases fluid waste. Organisations benefit from less rework and rejects when they improve upon their existing manual methods.
The fluid dispensing system is lightweight and easy to operate, lessening operator fatigue. It is also versatile because it can be used for manual and automated applications. It scales with production requirements.
Also, these fluid dispensing solutions enable users to download dispense logs. The controller records information about the dispense cycle. This includes pressure, vacuum, time settings, and the start and end dates and times of these actions.
These features enable the medical device company the opportunity to record and download dispense data, such as dispense time, dispense pressure, and vacuum applied. Each dispense record identifies the dispense program used and is date/time stamped so the team can easily identify which production batch the dispense information is related to. You can save the information as a CSV file. This file can be used to find patterns in production and detect any problems that may affect quality.
Semi-Automated
Nordson recommends a semi-automated solution for organisations producing fewer than 300,000 catheter units. The primary benefit of semi-automated fluid dispensing technology is that it offers faster, higher yield operations. This mid-value investment is operator-based, but the machine offers improved control, accuracy and repeatability for higher volume, precision-oriented manufacturing.
Nordson recommends using the UltimusPlus Series dispensers and the PICO Pµlse XP jet valve and PICO Toµch XP controller for semi-automated fluid dispensing catheter bonding applications. Robots and gantry systems automate tasks and individuals can use them alone or add them to assembly lines with conveyors.
These dispensing automation solutions offer improved process control with reliable and repeatable fluid dispensing. True three-dimensional motion control allows easy programming of dots, lines, circles, arcs, and compound arcs.
Organisations can save time and improve efficiency by programming and monitoring dispenser settings from a PLC or computer. The UltimusPlus dispenser uses Ethernet compatibility with NX protocol via TCP/IP to integrate with Smart Factory controls.
Custom Automation (Machine Builder Applications)
Catheter manufacturers making 300,000-500,000 units per year at <$30 each should think about using custom automation. This high-value investment offers a turnkey solution that extends multi-process assembly capabilities to manufacturers. A customised, fully automated fluid dispensing solution enables catheter manufacturers to leverage quality assurance processes like pick and place, testing, pull testing, etc.
The principal benefit of a fully automated fluid dispensing solution is reduced process time for high-production volume applications. The improved product quality, coupled with the rapid setup and programming capabilities, enable catheter manufacturers to seek and fulfil new manufacturing opportunities.
Impact (Why Fluid Dispensing Matters)
Catheter manufacturing and catheter bonding applications are on the precipice of a great opportunity. At the same time, the industry faces substantial challenges. On one hand, the market for catheter products is strong, and getting stronger. However, meeting the demand for CVC, Epidural Catheter, Hemodialysis Catheter, Pacemaker Lead Catheter, and G-Tube products is becoming increasingly difficult.
Choosing the right fluid for catheter bonding is important for efficiency and meeting market demands. Fluid dispensing, whether done by hand, partially automated, or fully automated, helps maintain catheter quality and consistency. The manufacturing efficiencies available reduce waste and improve uptime, while providing strong traceability features. In summary, finding the right way to dispense fluid can help protect your catheter manufacturing business in the future.
Conclusion
Catheter manufacturers must balance the need for high volume demand with meeting demanding regulatory requirements. To succeed, manufacturers need to securely attach parts to the catheter shaft as the demand for catheter products increases.
Using fluid dispensing solutions helps catheter manufacturers take advantage of the growing market and increase their production capacity. The technology enables both manual and automated processes, ensuring high-quality catheters in the market.
Over the next decade, healthcare providers will need millions of catheters for a variety of patient care applications. A strong fluid dispensing capability affords manufacturers the speed, quality, and flexibility needed for catheter bonding applications.
This article first appeared on Nordson’s website.
