 May/June 2007
Medical Device Technology Selected Contents
MATERIALS Material Matters Column: Metastable Biocompatibility:
A New Approach David Williams
The performance of biomaterials may be better understood by viewing biocompatibility not as a stable state, but as a metastable state. This concept is explored in the context of long-term implantable medical devices and biocompatibility failures.
DESIGN Microfluidics in
Medical Applications U. Michelsen
The challenge of microfluidics is to control liquids or gases on the micro scale. The developing use of microfluidics in diagnostics, drug delivery and implants is discussed. These technology advances include electro-wetting and a piezo-driven membrane micropump.
The Search For Endothelium Friendly Stents C. McCormick
The concern regarding late-stent thrombosis with the use of drug-eluting stents provides the basis for an examination of alternative approaches to stent design. This article outlines the biological mechanisms behind the thrombosis and hence provides a framework for understanding the types of drug actions that will be required for the next generation of stents.
Enhancing Existing Products with
New Technologies M. Lloyd
In the rush to innovate companies often fail to notice the untapped
potential in existing products. This article explores how cost and time efficiency can be ensured by making the best of what is already available.
Preventing Iatrogenic
Air Embolism
In the Intensive Care Unit L.A. Evans and P.J. Young
Air embolism is a potentially fatal consequence of incorrect connection of endotracheal tube cuff inflator devices. Currently, air lines from these devices can be connected to indwelling cannulae without impediment. This possibility can be eliminated with a simple modification of the air line, as described here.
MANUFACTURING R. Hoyle
Laser machining technology can be used to create micro features and discrete parts of a few microns in size in any material.
The latest technology and its capabilities are described.
Choosing the Right Adhesive Processing Equipment
S. Ginger
Processing equipment is often the forgotten part of adhesives application. Yet the right equipment can improve efficiency and reduce costs for medical device manufacturers. The factors to consider are outlined.
Sterilisation of Bioresorbable Polymer Implants
M. Bernkopf
Bioresorbable polymer implants are rapidly growing alternatives to traditional implants in many applications. Because of their resorption in the body, it is necessary to sterilise the complete product before application. The suitability of different sterilisation methods for bioresorbable polymers is discussed using polylactic acid implants as an example.
Save Money by Understanding Variance and Tolerancing
S. Kay
Manufacturing processes are inherently variable, which results in component and assembly variance. Unless process capability, variance and tolerancing are fully understood, incorrect design tolerances may be applied, which will lead to more expensive tooling, inflated production costs, high reject rates, product recalls and excessive warranty costs. A methodology is described for correctly allocating tolerances and performing appropriate analyses.
MARKET PLACE The Italian Market: Procurement Update Cost Reduction Throughout the Lifecycle REGULATION & STANDARDS Complying With US
Nonconforming Product Requirements Maria Donawa
Medical device companies are often surprised to learn that their procedures for controlling nonconforming products meet European requirements, but do not meet United States requirements. This article discusses why this occurs and how to avoid this discrepancy.
MARKETS United States Laws
Under Review M. Leahey
As well as reauthorisation of the Medical Device User Fee and Modernization Act, other issues are under consideration by the
United States Congress. These include the introduction of incentives
for the development of medical devices for paediatric care.
MEDICAL DESIGN EXCELLENCE AWARDS Design and Engineering Winners THIS MONTH Developments Across the Industry• Device Directives approved • Biomaterials accolade • Nano advances in the US
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