Genesis Medical Plastics has developed production-scale calendering to convert medical-grade and implantable PEEK into thin sheet and film. Genesis is featuring the new capability at the co-located Plastec West and Medical Design & Manufacturing (MD&M) West event in Anaheim, CA, this month.
PEEK has seen exceptional growth in medical device applications, according to Genesis. Valued at $582 million in 2021, it is projected to reach a 7.8% compound annual growth rate through 2030, according to a report from Prescient & Strategic Intelligence. Implantable PEEK is available to device manufacturers from polymer producers under restrictive conditions: Device manufacturers either process the polymer in-house or align with a medical polymer conversion specialist, such as Genesis, for production.
Thus far, implantable PEEK-based components have been primarily produced via injection molding or machining of stock shapes. The lack of commercially available implant-grade PEEK film and thin sheet has hampered advances in medical device technology, according to Genesis.
"Our investments in calendering for medical PEEK came in response to customers' requests,” explained Stephen Kramer, General Manager. “Starting with FDA F2026-certified PEEK resin and hitting the necessary targets for reliable production with consistent thicknesses, physical properties, and overall quality led us to engineer our own production equipment and process control systems.”
Genesis' calendering operation converts implantable PEEK into thicknesses from 0.1 to 1.0 mm in rolls, spools of strip, and custom-sized sheets. The film can be laser-cut or stamped into intricate configurations for implantable bio-electronic applications, including connectors and components for defibrillators and pacemakers.
"Genesis is a project-based conversion service for customers' medical polymer formulations,” said Kramer. “Our mindset is about adapting or developing technology to deliver whatever customers need for their medical devices. With film calendering, we saw the development challenge as an opportunity to help our customers bring the proven benefits of implantable PEEK to more applications.”
Based in Cypress, TX, Genesis Medical Plastics is certified to ISO 13485:2016 and registered with FDA as a Class II medical device manufacturer. It recently added calendering medical PEEK film to its capabilities, which also include extrusion of machinable rod and plate, injection molding, and CNC machining from prototype to production quantities.
Genesis Medical Plastics is exhibiting in booth 1082 at Plastec West/MD&M West at the Anaheim Convention Center in Anaheim, CA. The event runs from Feb. 7 to 9.
