Physicians and device designers want medical solutions that are cost-efficient and safe for end-users. Ron Denoo, global director - research and market development at Quadrant, tells Medical Device Developments about the benefits of polymer-based materials.
Ron Denoo: Quadrant has been making polymers for a variety of applications for more than 70 years. We are accustomed to supplying high-performance industries where purity, performance and cost are critical. We have been the global leader in implant-grade UHMWPE [ultra-high molecular-weight polyethylene] for orthopaedic implants since its development half a century ago, and we continue to lead the way in new polymer grades specifically designed for life science applications.
The number-one concern of patients and physicians is safety. The materials must be biocompatible in their raw form and must be handled in a way that ensures they stay like that up to the point of use. Beyond that, physicians and device designers want options that will allow them to maximise performance while controlling cost. Mechanical requirements can vary greatly depending on the intended use. For example, single-use devices don't need to survive multiple sterilisation cycles in the way a reusable instrument does. Implantable devices don't see multiple sterilisation cycles, but they are expected to last in vivo for several decades.
Customers are also looking for ways to reduce cost, as public and private healthcare systems around the world continue to consolidate their buying power and put price pressure on device companies. Cost savings are not always in the form of a lower upfront cost but factors such as life-cycle cost, procedure-time reduction and equipment reliability are also considered.
In many cases, our polymers can offer lower weight, lower cost, more design flexibility and enhanced performance compared with more traditional materials. For example, we have materials in our portfolio that have a higher strength-to-weight ratio than titanium, aluminium or stainless steel, which is a surprise to many of the engineers that we deal with. Polymers can also give you a flexibility on colour and design that you don't have with metals. Using coloured polymers allows a practitioner to quickly identify a particular instrument, saving time and minimising errors. Polymers are also translucent under X-rays, so they really help improve precision when positioning an instrument during surgery, for example.
We have three distinct product families for life science applications: implantable polymers, life science grades (LSG) and single-use devices. Our implantable materials, Chirulen and Extrulen, are designed for long-term implantation in orthopaedic applications. The LSG portfolio offers a range of durable, sterilisable materials for instruments, medical treatment equipment, laboratory equipment and other safety-critical devices that are biocompatible (according to ISO 10993 and USP Class VI). LSG products are fully lot-traceable and produced in ISO 13485-compliant facilities to ensure cleanliness and product safety. We also produce devices that are intended for single-use in our Class 100,000 clean room.
The benefit of working with Quadrant is that we offer a wide variety of polymer and processing options to meet any cost, volume or performance requirement. Our LSG materials are all pre-certified so designers can have confidence in them. A last-minute failure of a device to meet biocompatibility requirements can cost a medical device company valuable time to market and sales revenue, as they delay a product launch and search for a new solution. Our broad portfolio also allows us to work with our customers to select the option that represents the best value for the application, considering all aspects of performance, quantity, lead time and cost. A medical company's reputation depends in part on its suppliers' ability to consistently produce a quality product over the lifetime of the device. You can't really put a price on that type of security.