Medical Device Link.

Originally Published EMDM November/December 2004

Technology News

Designed to measure lubricious coating performance on medical devices, the FTS 5000 simplifies the creation, modification, and storage of test protocols.

Pinch testing is one standard method for evaluating low-friction coatings on catheters and guidewires. Its drawback for many manufacturers has been the need to design and build appropriate testing equipment. Harland Medical Systems (Eden Prairie, MN, USA) has developed a tabletop instrument that simply and rapidly creates, runs, and analyzes friction tests.

The FTS 5000 friction test system is designed to measure lubricious coating performance on catheters, guidewires, pacing leads, and other devices that contact vascular tissue. It integrates a number of user-friendly features.

Built-in software simplifies creating, modifying, and storing the test protocols that are run on product samples. Once a sample has been placed in the unit’s collet, the operator selects or creates a protocol and moves the transport mechanism to the desired start point. The system does the rest. Results are displayed in real time in graph and table formats.

The FTS 5000 has an 850-mHz single-board computer and a 10.4-in. colour touch screen. Test protocols can be imported from remote devices as well as exported. The system can also be integrated into a local-area network.

The firm also recently introduced the PCX coating station that combines dip coating and curing functions in a compact unit. Coating fluids are contained in discrete disposable reservoirs that are assigned to specific devices. This setup ensures strict quality control and reduces waste.

To increase productivity, the station includes dual loading docks. While a batch is being processed, the operator can load or unload a second batch.

The system’s modular construction enables users to select the appropriate size and degree of automation needed for their application.

Harland Medical Systems was formed a little more than two years ago to respond to a perceived need among device OEMs producing coated products. Vice president of sales and marketing Drew Summerville used to work at Eden Prairie–based surface treatment firm SurModics. “While [I was] at SurModics, [the staff] had difficulty finding resources for device manufacturers that were ready to start manufacturing a coated product,” says Summerville. “This is the gap that Harland Medical fills. We understand the various coating chemistries and what is required to apply them reliably and productively in a manufacturing setting.”

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