How do we obtain FDA validation on our medical tubing when there’s no way to show quality in a measurable and specific way?
A question all too commonly faced in the medical device industry, with the answer meaning acceptance of the product and the ability to sell without risking legal implications, and more importantly, the lives of patients.
The new year brings new focus on solving business problems, many that have been present for years. Our focus this year, will be highlighting the stories of real customers who’ve gone on their own journey to discovering how the Surface Analyst can give new life to businesses seeking to answer these key questions.
So, let’s have a look at the unique challenge faced by a medical tubing manufacturer when dealing with catheters, and how we helped them in their customer journey on the way to FDA validation.
Having previously been using dyne inks, the manufacturer had only a subjective and interpretive solution to gauging the quality of their PTFE coating.
Furthermore, the cumbersome nature of dyne left a huge need for a factory floor solution that could quickly, easily, and accurately measure tubing in-line during production.
How can a manufacturer that desires to produce a product at scale rely on a method of quality testing that leaves the door open for “good enough,” in an industry where failure, means lives at risk?
A different solution was needed.
Our sales team successfully demonstrated, with the use of a custom-made fixture to hold the medical tubing in place, how the Surface Analyst could answer that question.
The company was then able to verify the plasma treatment used on the factory floor was properly preparing the tubes to be coated with PTFE.
Peace of mind, FDA Validation according to ISO Regulations, and the ability to tell customers that their product holds a certain degree of quality, proven, by the Surface Analyst.
So, with that being said, what processes are YOU struggling to quantify?
What impact would gaining new awareness and insight into YOUR key processes have on your business?
These are important questions to any business heading into the new year, and ones that we can help get you on your way to solving.