A Materials Database for Medical Devices

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2 OBSERVATIONS The crucial role of nanomaterials innovation Arecent study by the 3i Group suggests that nanostructured personal health diagnostics, artificial bones, artificial tissues, and artificial organs will be the most promising developments for improved medical devices over the coming decade. Currently more than 150 small, medium, and large companies are pursuing nanomaterial-based medical devices for treatment of orthopedic, ophthalmic, cardiology, urology, obesity, diabetes, and cosmetic conditions. These companies are seeking to develop or maintain high rates of profitability through development of revolutionary products (new devices) and evolutionary products (improved device functionality provided by nanomaterials). Several factors will influence nanomaterial-based medical device development over the coming years: • Appropriate nanotechnology-based medical devices. Laser-based procedures were developed in the 1970s and 1980s for treatment of nearly every human tissue; however, only laser-based dermatology and ophthalmology procedures remain in common practice today. • Pricing of nanomaterial-based medical devices. For example, a conventional uncoated metal stent is sold for $1000 and a drug-eluting stent is sold for $3200, although the manufacturing costs for these devices differ by only $225. As in the case of drug-eluting stents, the oper- Materials for Medical Devices and Processes 2008: Opportunities for Next-Generation Implants. August 5 – 7, 2008 Intercontinental Hotel Cleveland, Ohio For details of upcoming ASM seminars contact John Cerne. john.cerne@asminternational.org or call 800/336-5152 For a preview, more information or to arrange a site trial of The Materials for Medical Devices Database cosupported by ASM and Granta contact Raymond Sirochman. raymond.sirochman@ asminternational.org or 800/336-5152, ext. 5576 ating margins and stock values for medical device companies will rise and fall based on the progress of their nanomaterial-based medical devices. • Food and Drug Administration regulation of nanomaterials. Recent safety problems in Germany with Magic Nano household cleaner have resulted in increased scrutiny of all consumer nanomaterials. • Allocation of funding needed to take a nanomaterial innovation from concept to market. It is estimated that a new Class III medical device requires a minimum of ten years and twenty million dollars to gain approval. • Interaction among regulatory consultants, physicians, engineers, and biologists. Large companies often rely on broad technical expertise across the materials science, engineering, biological, and medical disciplines to internally develop novel devices. • Competition from Japan and Europe in the development of nanomaterial-based medical devices. Private companies in these regions bear lower operating costs and receive significant government incentives for applied research. • Consumer awareness. Advertising campaigns for medications are now common, and those for medical devices may become more prevalent in the future. • Complex reimbursement and payment issues. Health insurers, employers, and public health programs are placing stringent protocols on the adoption of medical devices in an effort to control costs. In spite of all of these challenges, there is no doubt that recent developments in nanomaterials research will have a profound influence on material suppliers, medical device producers, and health care providers over the coming years. Roger Narayan, M.D., Ph.D. Joint Department of Biomedical Engineering, University of North Carolina and North Carolina State University Department of Materials Science and Engineering, North Carolina State University 64 ADVANCED MATERIALS & PROCESSES/JANUARY 2008
An Image Is Worth A Thousand Words Just imagine what a photomicrograph in the world class ASM Materials for Medical Devices database will have to say. As a partner in developing this database, Buehler provided high quality cross section images of materials in various stages of processing including final products. After a recent demonstration, members of the National Academies' Roundtable on Biomedical Engineering Materials and Applications showed strong interest and enthusiasm for the database. "The BEMA Board was very impressed, " said Michael N. Helmus, Ph.D., chairman of the ASM Medical Devices Database Committee. Materials for Medical Devices Database - Cardiovascular Devices Module: • First comprehensive online database to support implantable medical device design • Screen, analyze and select candidate materials and coatings • Features authoritative biological response data • Information is peer reviewed, verified by specialists, and includes thousands of reference citations • "Powered by Granta MI" software, which enables powerful search, selection, graphing, and reporting of materials data Join the Buehler e-club at www.buehler.com for access to Buehler’s database of technical publications and material preparation solutions. Find technical support, and detailed equipment information at www.buehler.com/biomedical. Buehler - Your Partner in the Medical Community Screenshot from the Materials for Medical Devices database showing the easy-touse web user interface. Visit ASM International for additional information. CoCrMo beads on CoCrMo cast substrate. Etchant 5:1 HCl to H 2O 2 (3% conc.), Scale bar: 50�m. PROVIDING SOLUTIONS FOR OVER 70 YEARS CoCrMo structure at the joint between cast portion and wire. Etchant Lucas’ Reagent. 316SS Etched with 10% Sodium Metabisulfite viewed in brightfield. Worldwide Headquarters 41 Waukegan Road Lake Bluff, Illinois 60044 • USA Tel: (847) 295-6500 • Fax: (847) 295-7979 Email: info@buehler.com Web Site: http://www.buehler.com/biomedical.htm
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