Thickness Measurement System Enables Rapid Design and Production for Direct Flow Engineers

Direct Flow Medical Inc. is using new measurement technology to better enable the design and manufacture of new cardiovascular products. The company is using OptiGauge technology from Rochester, N.Y.-based Lumetrics to design catheter and balloon products for its minimally invasive implant to treat patients with heart valve disease.

Founded in 2004, Direct Flow Medical is a privately held medical device company developing a next-generation, transcatheter aortic valve replacement device. The company is headquartered in Santa Rosa, Calif., has a manufacturing and technology facility in Lake Forest, Ca., and employs 75 people. The company’s unique implant design is not limited to aortic valve disease but is readily applicable to mitral and other heart valve anatomical sites.

“The OptiGauge allows us to understand our balloon manufacturing processes very clearly,” said Gordon Bishop, Direct Flow’s chief technology officer. “By obtaining precise, direct measurements of balloons upon line startup, we are able to make adjustments immediately and produce product that meet the design specifications from the beginning.”

The OptiGauge provides non-contact measurements at up to 200 samples per second and can measure objects as thin as 12 microns or as thick as 50 mm, according to Direct Flow. Advanced optical components allow for operation without continuous calibration. 

Prior to using the new system, engineers would have to wait for the lot to be built and then destructively test and analyze the balloon using a microscope. After implementing the OptiGauge, operations now have a 100 percent non-destructive method for measuring balloons.  

“OptiGauge has allowed us to achieve precise measurements with an added benefit of a reduced inspection cycle time,” said Andrew LaPlante, quality engineer.  “Today, I can inspect a balloon in five minutes and obtain much more data.  Additionally, all the operators find the system extremely easy to use, and we are investigating other uses within our product suite.”

Lumetrics engineers can take simple to complex fixturing into consideration to enable parts to be quickly scanned, categorized, and then passed or failed. The data can then be recorded and stored for full FDA compliance.

”Our goal is to enable our customers to rapidly produce safer products with more accurate, repeatable measurements” said John Hart, Lumetrics’ CEO. Lumetrics products are used primarily by manufacturers of medical devices, optics, flexible packaging, and industrial materials.