10 Finalists Chosen for Supplier Innovation Challenge (Interface Catheter Solutions)

Name of Supplier 
Interface Catheter Solutions

Describe an innovation your company developed between 2012 and the present and its potential application in medical devices. 
The Auto-I 360 is an automated visual inspection system that performs visual defect and dimensional inspection for medical balloons. The system allows balloons to be inspected accurately to a predetermined, programmed specification in seconds eliminating the often encountered inspector-to-inspector variations within inspection.

By combining visual and dimensional inspection in one operation, the system significantly reduces inspection time and allows the user to perform other value-added tasks while the Auto-I is running. 

How does the innovation work? Please describe the technology.
The Auto-I contains a high-speed camera, telecentric lens and a lighting back-drop operated by custom software to measure the balloon outer diameter, length, cone length, cone angles, and tail diameter. It utilizes back lighting to locate and measure balloon visual defects such as gel spots, fisheyes and embedded material. It does this through taking pictures of the pressurized balloon being rotated and advanced via rotary air chucks, and classifying the various visual abnormalities with proprietary algorithms programmed into the software.

The user quickly connects each end of the balloon tail to the rotary air chucks and the system automatically pressurizes it to a programmed level with an integrated pressure regulator. When the inspector presses start button the linear drive advances the balloon while taking pictures until it reaches the end of the balloon. Once the end of the balloon is reached, it will rotate 60 degrees and traverse the length of the balloon again while snapping pictures.

It repeats this function a total of 6 times and displays the inspection results for the inspector to evaluate. All specifications, as well as visual abnormalities, are shown as pass or fail and are confirmed by the inspector before the next balloon is inspected. The Auto-I can store hundreds of balloon specifications that can easily be deployed for inspection of multiple balloon sizes throughout the day. At the end of each lot of balloons, an inspection report is generated showing each measurement, flagged defects, as well as average and standard deviation for each balloon dimension. The data can be printed or uploaded to the company’s network.

Describe how your innovation adds value for medical device OEMs. Can it make work processes more efficient, reduce costs, improve quality, or improve patient outcomes?

The most expensive component of balloon catheters is the balloon, and the most expensive process of the balloon is the inspection. The Auto-I 360 significantly decreases balloon inspection inconsistencies, as well as inspection time, while increasing labor utilization and generating accurate inspection data to assist companies with failure analysis and continuous improvement. The Auto-I was created to improve quality and reduce cost.

What distinguishes your product/service from those of competitors and what makes it unique in the market?

The Auto-I automates a process, which for the most part is done manually with inspectors holding up balloons at a specified distance and/or magnification to find defects.  

In many mature balloon catheter markets, there is strong pressure to reduce costs. The Auto-I offers a way to lower cost and improve quality. It’s not just a new product. It’s a new category of product that brings balloon inspection to an advanced level.