“We’re manufacturing catheters, but currently we don’t have a reliable way to prove to the FDA that our plasma treatment process is effective and in control”
It's no surprise that manufacturing in the medical world carries with it a unique level of responsibility.
The comfort and safety of patients is directly related to the quality of products that come out of medical manufacturing operations, and the FDA mandates manufacturers meet strict validation standards in order to sell their products.
So when a manufacturer's only option is assuming their process is adequate, the outlook is cloudy at best...
Your Problem Is Something We've Seen Before
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.
The manufacturer was looking for a way to validate that the plasma treatment being used to prepare their catheters was working effectively to prepare the surface for coating.
Get specific with your process
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.
Peace of mind for making products that affect patients
The certainty and 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 on the market.
Understand Your Unique Application Hurdles
The round surface and small diameter of a catheter presented an obvious hurdle for obtaining any sort of surface-derived measurement.
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, the effects of the problem were still present in their operation.
Everything changed once the Surface Analyst was brought into the equation, and with the help of a custom fixture, the analysis of their samples led to a few key business actions:
Setting a new baseline number for quality for which effects of plasma treatment could be evaluated
Optimization of plasma treatment levels for this type of material
Ability 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.
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