AMI’s Medical Grade Polymers 2015 conference on plastics and elastomer materials for medical devices, drug delivery, implants and surgical instruments, takes place September 15-16, 2015 in the beautiful city of Boston, MA.
The medical device market is expanding worldwide, providing vital health technology to the growing population and enabling a much higher quality of life through new advances. These developments include custom-made personalised devices, such as 3D-printed artificial bone implants and tissue scaffolds, and combination devices providing drugs and functions in the same piece of equipment. At the other end of the scale, bulk cheap devices such as syringes and fluid delivery bags and tubing are reaching much wider markets with advances in healthcare in developing nations. Polymers offer a cost-effective, accurate mass manufacturing option. For example, Solvay Specialty Polymers has illustrated how to replace metals with plastics in products such as surgical retractors.
Medical Grade Polymers 2015 kicks off with a review by Mark Moyer (formerly at Smith & Nephew, now with the Center for Advanced Medical Learning at USF), of how to innovate, sort out the regulatory compliance and get a new product into the healthcare market as quickly as possible. The molder, Cequr, will follow this with an outline of manufacturing trends and market challenges for innovation. The scale of the legal liabilities in this industry has deterred some of the larger materials companies from participating fully: the law firm Keller and Heckman will give a critical outline of the key issues for material suppliers in the medical marketplace.
Manufacturing costs are being driven down by fierce market competition; it is vital to find the most efficient production technology and best components to build a viable future for the medical device industry without cutting corners. Raumedic has focused on the design requirements and manufacturability of medical tubing for stent and balloon delivery systems, while Mack Molding has discovered several ways to cut production costs and UFP Technologies produces a number of medical foams and films used in wound care.
Massachusetts Materials Research has looked at material selection from the perspectives of manufacturing, use and interaction. Durability and life-time expectancy are highest in the orthopaedic sector: DePuy Synthes has studied the use of antioxidant-stabilised UHMWPE in implants. Visibility on X-rays is important, particularly in some investigative procedures and PolyOne has developed translucent radio-opaque compounds. Lubrizol provides flexible thermoplastic polyurethane materials for medical applications. Cambridge Polymer Group will review the difficult process of introducing new materials to this market.
Reliable materials and clean room manufacturing processes are critical for safety in medical production. Hence a wide range of test protocols are specified by the regulatory and standards authorities, primarily the FDA and ISO, to maximise the safety of healthcare technology at source. This includes chemical tests on the materials and devices for extractables and leachables, which could migrate out in use: Aspen Research has reviewed how to set up and conduct one of these studies. Fresenius Kabi has recently tested an acrylate–based device, while Toxicon examines issues such as the safety and efficacy considerations of device/drug/biologic interactions. Plasticisers leaching from vinyl materials have caused concern in the past: BASF will review the selection of these additives. Sterilization protocols and packaging can affect devices and must be carefully specified.
Device failures do occur and statutory reporting ensures that lessons are learned. Battelle has looked at some of the issues and is shedding light on some of the factors that affect material stability. Companies like Exponent undertake a range of testing and at Medical Grade Polymers 2015 they will speak on structure-property relationships in material selection.
Infection prevention is a big issue for healthcare providers who aim to eliminate the pain and costs of hospital-acquired infection; there are options in device development to incorporate antimicrobials in coatings and device surfaces. Sciessent is developing some of these antimicrobial materials.
AMI’s Medical Grade Polymers 2015 hosts the next networking debate on successful medical device engineering with polymer materials on September 15-16, 2015 in beautiful Boston.