“We’re manufacturing catheters, but currently we don’t have a reliable way to verify that our plasma treatment prior to coating is as effective as it could be.”

It should be no surprise that manufacturing in the medical device world carries with it a unique level of responsibility, as the final products directly affect the health and safety of the end user.

The comfort and safety of patients is directly related to the quality of products that come out of medical manufacturing operations. The FDA mandates these manufacturers to meet strict validation standards in order to sell their products.

So, when a manufacturer’s only option, until recently, is assuming their pre-adhesion processing was adequate, the outlook is cloudy, at best. There was a problem that needed to be solved to bring quality testing to life.

The Problem
PET tubing with PTFE coating (polytetrafluoroethylene, for our engineers) allows catheters to be placed into and removed from a patient with an extremely low level of friction that promotes comfort and safety in the patient.

The problem in this Surface Story starts on the manufacturing floor and stops at the ability to ship the product, and so ultimately determines the success of an entire division of medical device products.

Simply put, the manufacturer was looking for a way to validate that the plasma treatment being used to prepare their catheters for coating was preparing the surface effectively.

The Business Implications
Finding a solution meant they could provide highly specific, materials science-based audit data to the FDA, which would guarantee acceptance and confidence in to ship a safe and proven final product.

 

The Organizational Implications
The certainty and subsequent peace of mind in proving product quality had eluded this manufacturer for many years, through no fault of their own. This was an area of conversation that often caused tension and confusion both in the office and on the factory floor.

The company understood that being able to display the highest product quality would garner a unique competitive advantage through not just meeting FDA requirements, but by now knowing that their catheters were some of the safest, and highest quality tubes on the market.

 

The Cause & Effect
The round surface and small diameter of a catheter presented an obvious hurdle for obtaining any sort of surface-based information related to quality.

The physical form of the product itself limited the manufacturer from reaching their manufacturing goals and presented the question: How is it even possible to measure surface quality of our materials to gain an idea on how to evaluate the quality our process?

After years of unsuccessful methods, the customer ultimately relied on the assumption that simply treating the tubes with plasma in general, was enough to guarantee a satisfactory product. But judging by their struggles in recent years to prove quality to the FDA, and the constant fear of being audited and not having numerical proof, the effects of the problem were still present in their operation.

 

 

 

The Solution
Prior to discovering the Surface Analyst, and how they could use the instrument in tandem with a custom-designed fixture to stabilize the tube, methods of measuring surface quality on their small tubes were either incredibly misrepresentative and unreliable, or had proven cumbersome and ineffective.

Everything changed once the Surface Analyst was brought into the equation, and the analysis of their samples led to a few key business actions:

  • The lab was able to quantify the condition of the catheters immediately after extrusion, setting a baseline for quality for which effects of plasma treatment could be evaluated
  • Using in-house plasma treatment to replicate their process, we were able to optimize the level of treatment for this type of material and relay the results back to the customer for direct implementation into their process
  • The customer invested in Surface Analyst units in order for their factory floor operators to continually monitor and control all aspects of their material system

New life was given to their operation and the effects of efforts were seen across the organization, and in the bottom line.

 

The Results
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