Taking innovations through to successful, cost-effective medical device manufacturing

The global economy has taken a hit in the past few years and there is additional uncertainty in the US market surrounding the impact of healthcare reforms. This is putting cost pressure on all links in the medical device supply chain and it is critical that quality is not compromised for short-term gains, and that innovation continues. AMI is holding its annual conference on Medical Grade Polymers 2012 in September in Boston. This event focuses on the practical aspects of taking innovations through to successful, cost-effective medical device manufacturing. Polymer materials experts meet with designers and device manufacturers to debate the optimum solutions for the healthcare industry. The conference kicks off with a key note address from Dr. Jeffrey Karp, Professor at Harvard Medical School, Brigham & Women’s Hospital, on platform technologies for the upcoming generation of therapeutics. The medical industry is tightly controlled for patient safety, and rightly so. The FDA will be present at the conference delivering a paper on the use of polymers in medical devices from the US Government regulatory perspective. The situation in Europe will be reviewed by BSI Americas. Designers need to understand the benefits and range of performance of polymer materials. Manufacturers like SMC regularly advise on practical aspects governing material selection. Exponent has conducted failure analysis on medical devices, which can inform and improve the future material choice. Mass spectrometry is a useful quality control measure and Johnson & Johnson has investigated practical uses. With outsourcing, from design to manufacture, it is best to “look before you leap” – Winovia will be giving some best practice guidelines at the Medical Grade Polymers conference. Improving quality of life is leading to exciting innovations in implant technology. Custom designed, patient-specific implants can be made by the laser sintering process from high performance plastics like PEKK from Oxford Performance Materials. Porous and surface-modified forms of PEEK are under investigation for use in musculoskeletal applications at Biovera. A new photodynamic polymer has been tested for orthopaedic implants by Illuminoss Medical. Soft tissue can be harder to mimic: the Cambridge Polymer Group has been involved in the design of materials for these situations. Infection is a serious issue in the healthcare environment and there is extensive research into avoiding the major issues: Sterling Biomedical has developed and tested chronic antimicrobial catheters. SSB Technology has looked at manufacturing of cannulae beyond conventional injection molding. Husky Injection Molding Systems focuses on improving the whole plastics process to reduce variability and in doing so to cut waste in manufacturing. The range of polymers available includes biodegradable and resorbable plastics. Boston Scientific has been using biodegradable plastics as stent coatings, while Cordis, Johnson & Johnson has been using resorbable materials for drug delivery. Polyurethanes from Lubrizol Life Science Polymers are in use in wound care. There are radio-opaque additives with FDA approval like those from POLYONE/NEU, and RTP Company has prepared plastics compounds for use as metal replacement.