Catheters & Endoscopes
Noninvasive surgery is one of the fastest growing areas of medical science. Doctors are using the “cath lab” more often in lieu of traditional surgery, in favor of the reduced risk and shorter recovery times. Increasing demand for noninvasive options has driven rapid growth in the development of catheter and endoscope-based medical devices. Innovative medical procedure proposals and incremental technology improvements are driving hundreds of new 510k submissions to the FDA each year. Submissions to the FDA must include comprehensive test results on the new proposed product and an existing comparable product. TestResources engineers can provide the guidance and quality testing equipment needed for FDA approval.
510k is the way to go for FDA approval of most new noninvasive surgery medical devices
Noninvasive surgical options include a vast array of products including vascular catheters, guidewires, urinary catheters, IV kits, endoscopes and syringes. Most of these products are FDA Class II or III which involve some risk to the patient and require premarket notification. The majority of new product ideas are incremental improvements to an existing medical procedure, which means there is an existing predicate device. This means FDA approval involves premarket notification via 510k submission. 510k’s provide a convenient path for product developers while avoiding the need for expensive and time consuming human clinical trials. Rigorous laboratory testing is still required, aimed at thoroughly comparing the proposed new product with the predicate device in terms of both safety and efficacy.
Catheter and endoscope products are becoming increasingly complex as doctors and product developers seek to accomplish more complex procedures from outside the body. Such products typically consist of wires, tubes, joints, luers, and a wide variety of intricate devices. Each product validation testing plan involves rigorous testing to ensure each joint and element of the product will perform its function and stay intact as it goes into and out of the body. Every product has a unique testing plan catered to the particular risks to safety and efficacy of the device.
Make a Design Validation Testing Plan
The FDA prefers to see testing data that is based on relevant published testing standards. To learn more, contact a TestResources application engineer today. For noninvasive surgery products, the tests often involve tension and torque. We can provide testing equipment designed to fit your individual product’s needs.
Can you stay on your product development timeline? Yes you can.
Laboratory testing should be considered a priority in your product development plan. In the early stages of the development process design verification tests ensure that your prototypes will perform well in upcoming animal studies. Although you may not know exactly what you need in testing equipment, a versatile machine can eliminate time and frustration when frequent changes occur as you arrive at your final design. Complex products require numerous tests because each joint and connection must be tested individually. You will need to test several units of the new device and the predicate device, with good test repeatability, to achieve a high statistical confidence level in all of your test results. Initial submissions to the FDA must contain quality test results or they will request more testing, which means more time-to-market – time you don’t have.
TestResources test equipment is designed for versatility and reliability. It will enable you to do whatever you need to do to test your prototypes early; and it has the reliability to perform consistently and repeatably in your formal validation testing.
Don’t forget about packaging
Most noninvasive surgery products are sterile-packaged. That means you also need a good packaging design; and you need to test your packaging to show it maintains sterility through the transportation process. TestResources can help with sterile package seal testing in both your package design validation activity as well as in production control.
A reliable manufacturing process is key to consistent product quality. It is also wise to plan for a reliable and repeatable manufacturing process to ensure the product is consistent unit to unit in every way. TestResources has experience with IQ’s, OQ’s and PQ’s; and can help you integrate our test machines in your validated manufacturing process.
Medical device product development engineers and managers face many challenges. With limited product development funding, timelines are never long enough. You need test equipment which is cost-effective, versatile, and reliable. Call TestResources. We understand your world and can help you.
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