 March/April 2007
Medical Device Technology Selected Contents
MATERIALS Material Matters Column: Carbon Nanotubes in Medical Technology David Williams
One of the more important classes of material to emerge from the recent developments in nanotechnology has been the carbon nanotube. A variety of nanoscale carbon tube structures have been prepared and this article discusses their structure, properties and potential medical applications.
Regenerative Medicine The Industry Comes of Age
C. Mason
The regenerative medicine industry has moved into a new era in which commercialisation and not research is the number one priority. To achieve its new goal, much has had to change, including the introduction of expert business management, simpler but superior products and scalability of manufacture. Mass public and political support is supplying both long-term resources and the market demand to finally create a sustainable new health-care sector.
DESIGN Intelligent Drug Delivery From the Oral Cavity J. Kohnle and A. Wolff
A novel drug delivery device that is inserted into the oral cavity is being developed to treat chronic diseases and drug addiction.
Packaging Design: Basic Principles D. Slattery
This overview of the critical steps of the packaging design process highlights the effectiveness of design change and how it must be accommodated.
MANUFACTURING J. Masefield and R. Brinston
Sterilisation of drug-device combination products presents unique challenges and demands some new thinking. Issues such as dose setting and controlling free radicals for these ultraclean, high-cost products are discussed together with the future advancements required for their efficient terminal sterilisation.
Sidebar: Meeting
Reinventing Micro- and Nanomoulding
B. Whiteside and P. Manser
Recent advances in micro- and nanomoulding techniques are expanding the possibilities in polymer processing. New materials and ever more demanding end uses have prompted a structured rethink of many of the traditional “rules” and led to novel processing and measurement developments that are crucial for successful industrial exploitation of micromoulding.
MARKET PLACE Getting Medical Devices Faster to Market 50 Hz Fatigue Testing of Large Diameter Stent Grafts REGULATION & STANDARDS Revised Standards for Sterilisation: The Changes E. Hoxey, P. Strain, J. Harries and B. Kirk
The standards for the three main methods of sterilising medical devices, ethylene oxide, radiation and moist heat, have been revised. This article discusses the major changes in the requirements, which will need to be addressed to demonstrate compliance with the revised standards.
Sidebar: Ensure you read the right standard!
Risk Management of European Device Clinical Studies Maria Donawa
There is an increasing need to perform clinical studies to support device safety and performance claims. This article discusses risks associated with conducting European clinical studies of medical devices that are unrelated to risks concerning the use of the device. These can jeopardise the success of a clinical study regardless of the safety and performance aspects of the device.
THIS MONTH Developments Across the Industry • A wireless future
• Blood pressure monitors on the rise • Germans top the doc list • Why the radiation standards were changed
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