The demand for medical devices is growing worldwide due to the ageing population in Western nations and improvements in healthcare services in developing regions. One area for expansion is more user-friendly medical equipment for home use, to minimise hospitalisation of the older population. Innovation is essential to provide the optimum patient care and materials are a key part of any new product. AMI is pleased to announce the programme for the Medical Device Polymers 2011 conference at Cologne, Germany. This event provides a forum to debate the latest developments in medical devices, materials and manufacturing.
The conference kicks off with an overview of current demands and issues in orthopaedics from the leading company, Stryker. These are very high specification applications using high performance plastics like PEEK, as supplied by Invibio. Researchers are looking beyond the conventional range of plastics: St Jude Medical has reviewed the challenges and advantages of developing polymers in-house for the medical device market. The Regenerative Medicine division of University College London is examining the use of nanocomposites in cardiovascular grafts, and the Fraunhofer Institute for Applied Polymer Research is looking at biomaterials for regenerative medicine, implants, diagnostics, drug delivery and wound care. Smith and Nephew is leading innovation in new wound care products and selecting suitable polymers. One key area of research is novel electrical implants, extending the range from cardiac pacemakers into neurostimulators: Boston Scientific is looking at the range of polymer materials and requirements. Safety is the primary concern in this industry, so all new developments are heavily regulated and thoroughly tested before entering the clinical markets. NAMSA has looked at the use of the standard ISO-10993 in material selection. LyondellBasell has been reviewing the criteria for pharma applications and their use in risk management in plastics in healthcare. Additives and colourants are subject to legislation in plastics in this industry to avoid leaching and extractable chemicals that could harm patients: Clariant International masterbatch division is looking at the options for colouring medical polymers. The IBF Institute for Blood Research carries out haemocompatibility testing.
Plasticisers have long been the subject of debate in the medical industry: there is a recent study on leaching from endotracheal tubes in newborns conducted at the University of Pisa, and on the use of betacyclodextrin as an alternative by Dr Susan George at the Victoria Royal Infirmary. Another hot topic at the moment is bisphenol A and the European Commission including the European Food Safety Authority has recently re-examined the risk assessment. Hospitals are a very hostile environment for materials, with harsh sterilization technology and chemicals: the human body is similar and implants have to be able to survive attack from the many different cellular, chemical and physical elements. Some of the top global polymer suppliers have specific products for this marketplace including SABIC, Solvay Advanced Polymers, Evonik Degussa and Eastman Chemical. Anaswar in Sweden provides support on selecting appropriate testing for medical polymers, depending on the application.