Our Customer’s Need: Economically Salvage Production Units Damaged during Manufacturing
A U.S.-based medical technology company (“XYZ”) needs the manufacturing process flexibility to economically salvage those device assembly units damaged during production. The problem occurs during gamma sterilization of its bag sets designed with integral tubing and traditional pinch clamps. The traditional pinch clamps polypropylene polymer is damaged by the harsh irradiation. XYZ’s management team’s goal is to modify the manufacturing process, by including an additional step at the end, replacing the damaged clamps with a better alternative,
XYZ's manufacturing department is losing a significant number of units to manufacturing failures. Its team needs a unique solution that fills the role of the traditional pinch clamp. Their device assembly and manufacturing process was already cleared in Europe and North America, so the replacement clamps needs to meet the same medical clearances. The new clamp needs to be capable of withstanding multiple sterilizations by gamma irradiation. The clamp also needs to provide complete flow cessation and withstand 100+ cycles of reuse.
Our Solution: The SidePinch Clamp
The solution was the CE Marked, side-load clamp, brand named, “SidePinch® Clamp.” Within 2 business days of its initial request, XYZ received SidePinch Clamps (SPCs) for performance testing. Documentation included SPC safety and reliability data, as well as critical technical and MSDS documentation, patent and clearance numbers (CE, FDA, Canadian) and advise of the correct sizing for the tubing durometer, O.D. and application. XYZ was able to test and confirm the SidePinch Clamp met or exceeded the safety and efficiency of the existing in-line clamps.
XYZ's manufacturing engineers received a component in the SPC that was easy to place on damaged assembly units’ extension tubing clamps significantly saving on salvage costs. The SPCs "quick-on/quick-off" design allowed damaged standard clamps to be easily swapped with SPCs at the end of the manufacturing process. And the clamp's highest quality medical-grade nylon accommodates the tough gamma sterilization method. XYZ also appreciated that the clamp is disposable and proven in clinical, in-home, ambulatory and lab applications. The SPC's standard medical red, white and dark blue colors allowed precise color matching with their standard pinch clamp units. Their choice was further verified with field reports of the clamp's user-friendly design and ease of replacement. Overall they felt they had received an “Outstanding Value” rating, given also the product's unique attributes, the pricing fell well within their required range.
The Side Pinch Clamp reduced XYZ's expenses and ended production delays. The SPC's clearance by the FDA, Canadian approval and CE Mark further enabled XYZ's effortless transition to the new component.
Our Customer’s Need: Fluid Flow Cessation
A patient with a feeding tube needs a user-friendly pinch clamp that could be easily added to his existing device without cutting the host tubing or disassembling the unit to replace the clamp.
His requirements include ready access, ease of installation and use, complete fluid flow cessation and clamp durability. A feeding catheter which he had been using did not have the appropriate flow cessation ability, partly due to standard pinch clamp over-use, fatigue...while the feeding tube still functioned, the clamp broke. He needed the ability to periodically change pinch clamps as required.
Our Solution: The SidePinch Clamp
Our service assistance, sampling and testing cooperatively with our customer, confirmed the proper SidePinch Clamp size and color. The assistant then filled the personal user order within 1 business day. Our end user customer appreciated receiving his SidePinch Clamp order quickly and in smaller manageable volumes.
Our customer found that the product was easy to place on his feeding tube. He found "quick-on/quick-off" design, various sizes and colors, the clamp's medical-grade nylon, durability and small volume availability perfect for his needs. He also appreciated that the clamp is disposable and proven in clinical, in-home, ambulatory and lab applications. His choice was further verified with field reports of the clamp's user-friendly design and ease of replacement.
Overall our customer said he had received an outstanding value, given the products’ unique attributes, and the price we more than reasonable. The SidePinch Clamp truly improved his quality of life.
