Invibio, part of Victrex, establishes composite trauma manufacturing capacity in China
Invibio Biomaterial Solutions, part of Victrex plc, a British pioneer in the development of PEEK biomaterial solutions, have signed a manufacturing agreement with a medical device company, Paragon Medical, producers of high precision medical components and implants, to manufacture composite PEEK-OPTIMA™ Ultra-Reinforced medical trauma devices.
The launching ceremony of the project jointly created by Paragon and Victrex was held in Changzhou National High-tech Zone, Jiangsu province, China. In recent years, Changzhou High-tech Zone has focused on the development of industrial clusters of chemical preparations and biomedicine, high-end medical equipment and medical devices, and integrated carbon fiber and composite materials.
The manufacturing arrangement with Paragon Medical will support the scale up of high quality PEEK-OPTIMA™ ultra-reinforced composite fracture fixation devices, at a time when Invibio is seeing demand exceeding initial expectations.
“We currently manufacture Trauma plates from our UK facilities, but given the increase in demand since a US FDA regulatory approval last year, we have seen a 4-5 fold increase in demand. Paragon will help us to meet that demand as a contract manufacturer (the IP and know-how of development will remain with Victrex, Paragon will be a toll manufacturer)”, says Andrew Hanson, director of Investor Relations, Corporate Communications & ESG at Victrex.
Invibio has extensive experience in collaborating with customers in PEEK-OPTIMA™ Ultra-Reinforced part design and process development, with significant know-how and intellectual property (IP). During this time Invibio has developed novel materials and IP in relation to optimising the design and development of these parts and supporting customers with regulatory approval.
Providing scale, quality, confidence and manufacturing flexibility
The recent opening of the Invibio Leeds orthopedic product development centre in the UK has the potential to support an increase in the speed at which medical device companies can develop new PEEK-OPTIMA™ Ultra-Reinforced composite fracture fixation devices.
“Trauma is one of Victrex’s key mega-programmes, where we see significant growth opportunities over the years ahead and the opportunity to enhance patient outcomes. Clinical data on PEEK based trauma plates is already encouraging and initial demand is exceeding our expectations. We have invested over several years now, and bring a wealth of intellectual property in this area. Paragon Medical will help us support manufacturing scale up and they bring an excellent reputation as one of the world’s premier medical contract manufacturers. We are delighted to work with them to grow the composite trauma space and to make it easier for medical device companies to adopt this technology,” explains Jakob Sigurdsson, CEO of Victrex.
“With a broad operating footprint in Europe, China and America, Paragon Medical are an attractive company to work with, dealing with evolving supply chain strategies within the medical device industry.”
PEEK-OPTIMA™ Ultra-Reinforced composite device benefits
Patient risk factors affecting fracture healing such as diabetes, osteoporosis or obesity have increased significantly in recent years, which has in turn increased the challenges for traditional titanium plates and nails to successfully heal patients. The increased risk of delayed union or non-union may be reduced by utilising plates made from PEEK-OPTIMA™ Ultra-Reinforced materials due to their increased fatigue lifetime and the ability to tailor the stiffness of the device.
PEEK based medical devices have been implanted for over twenty years. The benefits of PEEK OPTIMA Ultra reinforced trauma plates such as increased fatigue lifetime, tailored stiffness and improved imaging are now being utilised to treat a more challenging patient population.
The potential to reduce revisions and accelerate healing make these solutions attractive to surgeons, patients and to payors.
