Interview with Mike Callahan of Invibio
BY JOHN MCCORMICK, JUNE 14, 2005
Today we are publishing our recent interview with Mike Callahan Managing Director of Invibio, ltd. Many of you know Invibio as a principal supplier of PEEK polymer to the industry an increasingly important material used in orthopedic applications.
Q: How did PEEK polymers emerge as a key biomaterial?
A: Historically few polymeric biomaterials have been available for long-term implantation (particularly those approved for long-term implantation by their manufacturers) for a myriad of reasons. We identified the market's need for a structural polymeric biomaterial for long-term implantation and therefore designed, developed, extensively tested and manufactured PEEK-OPTIMA (R) polymer specifically to meet this need.
Since its introduction to the medical market, Invibio grades of PEEK polymers have gained the confidence and acceptance of the medical community as a highly reliable biomaterial. Their combination of strength, stiffness and toughness, along with the ability to be repeatedly sterilized without the degradation of their mechanical properties, make these materials some of the most versatile biomaterials available and ideal for the manufacturing of short-term and long-term implantable medical device applications.
In addition, PEEK has superior chemical resistance, ideal imaging properties, and a modulus that can be tailored to closely match that of natural bone, which reduces stress concentrations that are transferred to the bone, limiting stress shielding.
Q: Are there PEEK applications besides spine?
A: Invibio's PEEK polymers are used in a variety of markets. Because of its versatility, PEEK-OPTIMA polymer is utilized in nearly every application area for long-term implants. These include Cranio-Maxillofacial (CMF) applications such as various cranial devices; cardiovascular applications, such as heart valves and intracardiac pumps; various orthopaedic applications including trauma fixation; arthroscopy devices like suture anchors and interference screws; and dental applications such as permanent dentures, bridges, abutments and healing caps.
PEEK-CLASSIX (TM) polymer has been routinely used in the development of catheters, surgical instruments, analytical equipment, blood management and drug delivery systems.
Q: A lot of people wonder how you emerged as the market leader in PEEK. Do you have special intellectual property related to PEEK?
A: Invibio believes that we must deliver more than a material, but rather a comprehensive biomaterial solution. Invibio makes meaningful contributions from inception to marketing. This starts with extensive technical capabilities to support initial development requirements with device manufacturers. Furthermore we offer security of supply and 'no change' agreements for the assured long-term supply of PEEK-OPTIMA polymer. This guarantees its specification and production methods for an agreed period of time.
Our quality is critical and therefore we embrace all principles of Good Manufacturing Practice in relation to the manufacturing of PEEK-OPTIMA unfilled granular, compounds and rod and plate stock. We operate in compliance with ISO 9000 and ISO 13485, offer complete batch and raw material traceability, utilize accredited independent laboratory testing and offer packaging in double-lined, tamper evident drums suitable for clean-room production.
Importantly, Invibio also supports device manufacturers during the regulatory process with extensive documentation, FDA Device Masterfiles and a knowledgeable regulatory support team to accelerate device approvals thereby reducing time to market.
Q: What other biomaterials do you develop besides PEEK?
A: Invibio develops PEEK polymer based biomaterials, including PEEK-OPTIMA and PEEK-CLASSIX polymers.
PEEK-OPTIMA polymer is used in the development of implantable medical devices having blood or tissue contact for more than 30 days. Formulated to meet the most exacting in-vivo criteria, PEEK-OPTIMA is a safe, biocompatible and stable polymer, available in a range of forms that offer virtually unlimited design solutions. PEEK-CLASSIX polymer is a high performance, biocompatible thermoplastic used in the development of medical device applications requiring blood or tissue contact of less than 30 days.
Invibio also develops derivative technologies such as EndoLign(TM), a new composite product manufactured with continuous carbon fiber in a PEEK-OPTIMA polymer matrix. This fiber reinforcement significantly enhances the mechanical properties of the polymer. EndoLign's mechanical properties are comparable to those of metallic materials such as Co-Cr, titanium, alloys and stainless steel. Because of its high strength, EndoLign can be used for load bearing applications such as translaminar pins and bone plates.
Additional areas of biomaterial development include tribology, bioactivity and joining technologies.
Q: How do you collaborate with OEMs in their product development process?
A: Invibio collaborates with OEMs in several ways. Many companies leverage Invibio's technology team to provide expertise on the application development process. OEMs may not have the research and development resources or manufacturing expertise, so they often rely on Invibio's technology team to provide insight on the materials and manufacturing methods needed to develop superior applications.
Invibio prides itself on helping clients develop the best possible solutions, and then getting those solutions to market quickly. Bringing a new medical application to market can be a time intensive and expensive process. Many OEMs rely on Invibio's products and technical expertise to reduce product development time and costs associated with regulatory approvals.
Some companies simply offer biomaterials for manufacturing, but Invibio is much more than just a biomaterials provider. Invibio collaborates with OEMs from conception to market launch, offering expertise and insight to ensure OEMs achieve their application goals as quickly as possible.
Q: And how do you work the supply chain mechanics with OEMs once manufacturing begins?
A: This usually depends on the OEM involved because each OEM has a unique set of requirements. Invibio's extensive resources and expertise can be tailored to meet the requirements of the individual OEM.
Q: We saw that you will be at the MedTec conference in China this September. Do you see China emerging as a manufacturing hub for orthopedic implants or materials?
A: China is a rapidly growing market that cannot and should not be ignored. Invibio is actively developing opportunities in this area within the orthopaedic market and beyond. For example, the Japanese Ministry of Health, Labour and Welfare has recently approved an arthroscopy device which utilizes PEEK-OPTIMA polymer.
Q: Thank you for your time Mike!
A: You are very welcome.
