Company insight
few of the applications that utilise single- use tube sets.
Selecting tubing is important because the tubing must be durable, resistant to chemicals (internal and external of the tubing), compatible with the connectors that will be used and not prone to any kinks that might occur as the tubing is bent in different positions. If the connections to the tubing will be barbs, tubing should be selected to ensure a secure connection to the barb but allow for easy assembly in production. If you have the right tubing selected for performance and flow, the selection of the appropriate barb to go into the tubing on the connector side is the next step. If the connectors will be bonded in, then the tubing selected must be of a bondable material.
Whether bond-in or barbed, tubing connectors are selected based on the application. Most of the time, a tube set will have an end connection on both ends of the tubing. For example, in an ophthalmic surgery application, one end of the tubing might be a luer connection to the panel of the machine, while the other end is a customised connector to connect to the surgical instrument. In an IV tube set, one end of the connection could be a bag spike to an IV bag, while the other end is a luer to connect to a needle to the patient.
There are many different connectors that may be selected within the tube set to complete the application and full performance of the medical device. Flow control connections are often selected based on the application. Flow control connections could be check valves, filters, drip chambers and flow restrictors. External to the tubing, tube clamps can be used to control or stop flow in the tube set. Often, the connectors are chosen based on their performance characteristics to the specification, but in most cases there are multiple options for connectors from multiple sources. Potentially more important than the internal medical device tubing and connectors is that the external tubing and connectors should be ordered from a reliable source to ensure assurance of supply so that delivery issues with components is minimised. To summarise, the four significant criteria in selecting tubing and components are performance in
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the application, reliable delivery and assurance of supply, quality of the component, and competitive pricing based on expected annual volumes. Working with various suppliers of tubing and components is an important part of the design process. Some suppliers are the manufacturers of the components, where others are not. If the market for the medical device is a high-volume supply of components, then working directly with the manufacturer is a good solution. These companies usually have minimum volume requirements and lead times that must be considered. In most medical applications, it is important to choose a manufacturer that performs their plastic moulding in a cleanroom environment. It is beneficial to work with a
distributor/supplier who can supply all the necessary components that are needed on the tube set. Rather than working with a variety of suppliers, the designer and buyer can work with one company to deliver all the connectors needed. Qosina is the most well-known company in this category, and in some cases, Qosina owns the component mould and design. Qosina carries thousands of stock components and will sell in small volumes, as they specialise in down-packaging performed in a 1,700ft2
ISO-8 class 100,000 cleanroom. There are multiple factors that should be evaluated when choosing suppliers for the internal or external tube set parts: ■
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confirmation if supplier maintains a quantity management system review of supplier processes for
Selecting tubing is crucial in ensuring that, amongst other things, it does not kink if the tubing is bent. component quality issues or replacement
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moulding and packaging the components or tubing in a cleanroom environment
ability to provide samples for prototypes with reasonable minimum order quantities
ability to provide drawings (preferably 3D) for all components
ability to provide all material specifications to satisfy regulatory standards whether the standards are US or international
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confirmation of supplier lead times on the parts specified and alignment with project needs
review volume pricing to determine best possible prices based on annual blanket orders
confirmation of part availability with no plans to obsolete the part you have specified
Choosing the right tubing and components for your medical device design can seem like a simple activity, but attention to the details as described in this article will help ensure the device is successful in the market with minimal supporting design changes after product release. The most crucial criteria is to select components that perform the best in the design for the intended application, but keep in mind that the vendor supplying the component can have a major impact on the lasting success of the medical device. ●
www.qosina.com Medical Device Developments /
www.nsmedicaldevices.com
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