Genesis Medical Plastics engineered its calendaring technology to meet needs for small-size formats
CYPRESS, Texas—Genesis Medical Plastics is offering its own brand of PEEK film and thin sheet for fabricating intricate components of implantable medical devices. Genesis’s production technology yields quantities to support projects from testing through full production, the company said in a release.
Although implantable PEEK is widely used in medical devices, the vast majority of implant applications are produced by machining extruded rod and plate or by injection molding, according to Genesis. To fill the need for implantable PEEK film and thin sheet for device components, Genesis focused on engineering its own calendering technology.
The company’s capabilities are said to provide efficient sizes of film for laser cutting or stamping the small internal parts associated with defibrillators, pacemakers, and other bioelectronic devices.
“The decision to introduce Genesis PEEK film was driven by device manufacturers seeking a well-qualified commercial source,” said Genesis General Manager Stephen Kramer, in a statement. “Customers also needed small size formats, rather than large rolls common in film production. This led us to develop technology to calender yield-efficient sizes for precision parts in quantities suited to customers’ requirements.”
Genesis PEEK film and thin sheet, as well as the PEEK resin from which they are made, are reported to comply with ASTM F2026-17, an essential requirement for use in implantable devices. Genesis is ISO 13485:2016 certified and an FDA Class II medical device manufacturer, the company said.
Genesis film and sheet production width is 100mm (4 inches). Standard thicknesses range from 0.254mm (0.010 inch) to 1.106 mm (0.040 inch). Custom slit widths and made-to-order sizes are also available, the company said.
In addition to offering its new Genesis PEEK products, the company said it custom produces film and thin sheet for device manufacturers that prefer to supply their own implantable PEEK from Invibio and Evonik, and from Solvay under the Zeniva brand.
Processes offered by Genesis include extrusion of machinable rod and plate in a range of sizes, injection molding precision components, and CNC machining from prototypes to production quantities. The company said its production team has more than two decades of processing experience in medical grade plastics from polypropylene through PEEK.