Medical device manufacturing is a serious business. It’s a business that directly affects a person’s health and well-being. When a product operates so intimately with a human life, there is no room for failures. The final product must be reliable and top-of-the-line to address patients’ needs harmlessly and seamlessly. Thus, process monitoring and quality control are pivotal to manufacturing an ideal product.
A medical tubing manufacturer specializing in catheters needed to implement more effective process monitoring for their coating process. This tubing, made from PET (Polyethylene terephthalate) is used to administer fluids and gases or to drain fluids from a body cavity, vessel, or duct. Therefore, the tubing must be flexible, inert, and highly lubricious in order to enter the human body harmlessly and efficiently.
To achieve lubriciousness, the manufacturer coated the PET tubing with PTFE (polytetrafluoroethylene) coating. Plasma treatment was used as a way to prepare the tube’s surface prior to coating. However, the manufacturer had no in-line method of verifying the effects of the plasma treatment on the surface.
The closest solution they had to verifying the plasma treatment was dyne inks, but, because dyne inks are destructive to the part and hazards to its users, it was limited to the laboratory for research and development only. This was not a feasible method for the factory floor. Dyne is also highly subjective and not quantifiable—leaving inconsistencies in product quality.
The manufacturer desired a process to verify and monitor their plasma treatment on the factory floor and eliminate the use of dyne inks. Without an in-line surface cleanliness gauge, the manufacturer could not guarantee their product and risked failures in the field.
A sales engineer from BTG Labs visited the company and demonstrated how the Surface Analyst is a non-destructive, objective, and quantifiable instrument that can easily be used on the actual part for measurements right on the factory floor. BTG Labs even offers a specially made catheter inspection kit to hold different sized catheters and other medical tubing in place during measurements.
Using the Surface Analyst, the company was able to measure every tube to verify plasma treatment. They could guarantee that every part was ready to hold the coating evenly, preventing failures. Furthermore, as the Surface Analyst records and saves every measurement, the manufacturer was able to collect data for audits and research and development.
When manufacturing a product that directly affects a person, excellence is crucial. There is no room for failure. With more precise process monitoring and in-line quality control through the Surface Analyst, the manufacturer now has confidence that their product will work seamlessly and easily to address patients’ needs.
Ensuring a bond will hold is the most important component of adhesion. At times, a successful bond could change a life.
A revolutionary prosthetics company knew that their unique and innovative product was changing lives, so there was no tolerance for failures. As the need for prosthetics continues to grow, companies must build a product that is as strong as the human body. It must withstand stresses of weight baring, pivoting, uneven surfaces, etc., but also must be comfortable and lightweight. They produce a prosthetic that mimics the human form. The product must withstand the stresses of everyday life, to enhance the lives of amputees. Prosthetics are meant to catalyze, not hinder an individual’s physical ability. The expectations of this product are extremely high and there is no room for error or failures.
This manufacturer needed a way to verify the bonds of their dissimilar materials which included carbon fiber and titanium. Bonding was necessary as traditional fasteners would not be able to withstand the varying stresses of a prosthetic. In preparation to bond, the manufacturers sanded and solvent wiped the material. Verifying this surface treatment would be the key to a successful and reliable bond. The manufacturer came across the challenge of finding an accurate and precise way to verify this surface preparation process on a complex shaped, 3D material.
When the company recruited the Surface Analyst, they found just this. The instrument provided an accurate, precise way to measure their complex surfaces prior to bonding. This quantifiable, accurate process helps the manufacturer confidently make a revolutionizing product that significantly helps amputees live their lives comfortably.