 November/December 2006
Medical Device Technology Selected Contents
Materials Late Thrombosis and Drug-Eluting Stents D.F. Williams
On 14 September 2006, the United States Food and Drug Administration indicated that it had some concern over “small but significant” increases in the rates of death in patients treated with drug-eluting stents. This article considers the background and consequences of this matter.
Benefit From the Properties of Copolyesters
Safety syringes as well as a range of other nonimplantable devices can benefit from the versatility of copolyesters.
BSE Regulatory Compliance For Plastic Components
Companies that use animal-derived materials in the manufacture of their products must follow strict documentation requirements. These are described here together with an alternative approach that eliminates this need.
Design D. Byrne
Advances in connector technology are supporting the requirements in medical electronics for greater speed, increased current handling and reduced size. A range of connector solutions are described. Technology Transfer: Seeking a More Efficient Way J.M. Wilkinson
The movement of knowledge and skills from academia to industry is paramount for continuing growth and innovation. A wide cultural gap persists between the two and an effective means of partnering is required. This review looks at current solutions and recent progress.
Ultra-Low Power Wireless Body Monitoring
A new mixed-signal paradigm combines nanopower analogue with digital elements to achieve ultra-low power.
Manufacturing S. Burnell
In the competitive market place, failure to keep up with market demands threatens revenues and even market share. Decisions and products need to be made quickly. High volume manufacture may be the next step. The issues involved in making this decision are identified here, together with a technique to employ, which uses lateral-flow strips as an example.
Quality Assurance For Antimicrobial Devices J. Bruenke, U. Aldinger, T. Bechert and P. Steinruecke
Quality assurance (QA) of products with antimicrobial claims is still a virgin field for medical devices. As the market pushes the development of new devices with antimicrobial properties there is rapidly growing interest in antimicrobial testing. QA systems for antimicrobial device testing are discussed here.
Using Ultrasonic Spray Nozzles To Coat Drug-Eluting Stents H.L. Berger
Polymer coatings containing drugs released over time are used to inhibit restenosis in bare-metal stents; however applying coatings to stents, which have intricate geometries, is challenging. Ultrasonic atomising spray nozzles can be effective in achieving continuous and uniform coatings. This article describes unique nozzle designs, the methodology and the results obtained.
Harnessing the Benefits of Modern Video Measuring Systems
Reproducibility, repeatability and simplicity give manufacturers the edge on quality.
Regulations & Standards The Review of the RoHS Directive K. Howes
The Directive on the Restriction of Hazardous Substances currently excludes in vitro diagnostic (IVD) medical devices from its scope. That exemption is being reviewed. This article examines the implications of this for the IVD industry.
New Efforts to Harmonise Clinical Evaluation M.E. Donawa
Manufacturers wishing to market globally face varying regulatory requirements for assessing and analysing clinical data in support of medical device safety and performance claims. This article discusses the need for harmonising these requirements and two proposed documents developed to address this need.
Guidance on the New Packaging Standard Flexible Packaging Association
Some of the important points of the revised ISO 11607, Packaging for Terminally Sterilised Medical Devices, are reviewed here. In addition, the contents of a Technical Information Report (TIR), which is scheduled to be approved and published in early 2007, are described. This TIR will provide in-depth guidance on how to comply with the requirements of the standard.
Markets The Irish Medical Device Industry in 2006 S. Higgins
Ireland has achieved exceptional growth and a variety of programmes are underway to ensure that this continues.
A hostile market that is discouraging investment in new products and in danger of driving companies abroad is how the medical technology market in the United Kingdom is being described. Yet one new procurement model offers companies some advantages, say its advocates.
This Month Developments Across the Industry • Point of care market analysis
• The industry can take heart • Genetic blood test • e-Health action required • EDMA restructure • Nanodirectory • Chinese RoHS • Research interest
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