Vascular Catheter Product Development Testing

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Vascular Catheter Product Development Testing

Vascular catheter development is an increasingly emergent area of medical device innovation. Society‘s desire is increasing for comprehensive non-invasive surgery procedures due to their gentle route into the patient’s body compared with other procedures such as open-heart surgery. Clever doctors and medical device engineers are creating new ideas every day for incremental improvements to these procedures and products. Most of these types of products are approved by the FDA via 510k, which means reasonable time-to-market and development costs. A vascular catheter typically consists of a luer manifold, several joints, and a wide variety of possible devices at the tip. Multiple-catheter kits may include an introducer, one or more guidewires, and one or more catheters; each of which must be tested comprehensively for 510k submission. Early in the product development process you will need a cost-effective, versatile test machine to assess the tubes and joints in your prototypes during early design iterations leading up to animal-based preclinical tests. Fast development of strong joint bonds is key to early project progress and effective animal labs. New catheters can have many different interesting devices on tip - anything from a balloon to a camera to a reamer. Researchers must tensile test any of these to ensure they will never be left behind in the body. Later in your testing program, ISO 10555 becomes important. It is the most common testing standard for vascular catheters. This FDA guidance document addresses all the essential mechanical characteristics of a typical vascular catheter including tensile strength, pressure, size, etc. A diligent catheter development engineer will also want to perform rigorous attribute testing to understand the true limits of the product design. For example, the tensile strength requirement in ISO 10555 is 15 N; but most vascular catheter assemblies are built to be able to handle about 75N or more. A low force rated universal test machine featuring long-travel is beneficial because it enables testing of an entire catheter or catheter assembly at once to save time. Our 220 Series Electromechanical Universal Test Machine serves applications at or below 5 kN (1125 lbs) with long-travel. Torque-ability is another important attribute of a well-designed vascular catheter. TestResources provides a full line of infinite-rotation torsional test machines including a 160 QTG machine that measure torque and windup. A typical 510k design validation test plan will include ISO 10555-based tensile tests of each element and joint on the product. Each of those tests must be performed to a 95% statistical confidence level which means about 30 tests per joint. That means many hours of testing if every test goes according to plan – more if not. Know your product strength, and ensure it is consistent unit to unit before you reach this point. Eliminating surprises in your formal design validation testing can result in the fastest time-to-market. A typical catheter has 3 to 6 joints. Therefore it is not unusual to complete 180 tensile tests in a formal design validation test for 510k submission. Additionally, there are also the tests of the comparable predicate device. Over 300 tensile tests are not an unusual quantity for formal validation testing. With that volume of testing, you may want to have fast on-fast off capability. TestResources can help with a full line of pneumatic grips, including pneumatic capstan grips. Capstan-style grips are the way to go for catheter testing. Our grips are designed to for precise tensile strength data. When testing with regular grips, you may come across the issue of stress concentrations at the edges. Regular grips can cause the specimen to break at a lower force than the true tensile strength. For precise tensile strength data, turn to capstan-style grips to test your tubes and wires. With a capstan grip, the specimen material is wrapped around the capstan cylinder before being clamped. The friction on the capstan surface reduces the tensile stress on the specimen to reduce the probability of breakage at the edge of the grip. View the tabs below to learn more about vascular catheter product development testing with TestResources. TestResources: your partner in intelligent, cost-effective vascular catheter product development testing