Medical Device Link.

 

March 2006
Medical Device Technology
Selected Contents

Materials

A Novel Polymeric Coating for Enhanced Ultrasound Visibility of Medical Devices
M. Tavakoli, E.J.C. Kellar, D. Nassiri, and A.E. Joseph

A dynamic novel coating, consisting of a hydrophilic polymeric matrix and a bubbling agent, has been developed for precise entry and positioning of needles, and accurate collection of biopsy samples. These coated biopsy needles have been successfully used in in vitro trials. The results are discussed here. Potential application areas include vascular, cardiovascular and orthopaedics.

The Korean Stem Cell Fiasco: Shifting the Focus
C. Mason

No one could have failed to have seen the dramatic headlines surrounding Professor Woo Suk Hwang of the Seoul National University. Hwang claimed first place in the race to create patient-specific stem cells from cloned human embryos, only to be discredited shortly afterwards. This article discusses whether such high-profile negative publicity has damaged the regenerative medicine industry in general or whether it has merely shifted the stem cell focus away from South Korea.

Design

Pills and Potions: Will Transdermal Patches or Needle-Free Injection Ever Replace Them?
J.M. Wilkinson

Just over two years ago, it was forecast that transdermal patches would be one of the fastest growing sectors of the drug delivery market. Has the promise of new technology been fulfilled or do pills and potions taken orally still dominate the market? This review will look at the most recent developments and update the technology roadmaps in this US$40-billion market.

Evaluating New Hypodermic and Intradermal Injection Devices
P.E. Laurent, R. Pettis, W. Easterbrook and J. Berube

Measuring the completeness and accuracy of dosage delivered by parenteral injection is crucial to evaluating new injection devices. This study compares a capillary tube method used in routine blood sampling with a wicking spear gravimetric method, which are used to collect and measure fluid leakage at the site of drug delivery. Validation of these methods is also reported.

Drive Systems for Miniature Pumps
D. Borstell

The huge variety of medical applications demands a similar number of pumps customised for optimum performance in each application. One important element that has a significant influence on the overall performance of a pump is its drive system. This article describes the typical drive systems employed in miniature pumps and highlights the consequences of selecting one type over another.

Designing Screened Enclosures: Part II
J. Bearpark

Techniques to achieve cost-effective emissions and immunity screening solutions that meet electromagnetic compatibility requirements were provided in Part I of this article, which covered design options for seams and gaskets. Part II continues with a discussion of materials compatibility, corrosion and apertures.

Manufacturing

Implementing Continuous Improvement

Companies should employ Six Sigma to improve their decision-making, gain better control and improve business efficiency, says one advocate.

Regulations & Standards

US Guidance on Formatting 510(k)s
M.E. Donawa

There is no official form for submitting a United States premarket notification or 510(k) submission. A recent Food and Drug Administration guidance document describes the manner in which this type of premarket submission should be formatted. This article discusses this document and some important aspects of the 510(k) process.

MDT 06 Event

Meeting the need

Medical Device Technology's annual UK exhibition can only be described as a great success. Read on for industry comments and highlights of the event, held on 15-16 February 2006 at the NEC, Birmingham, UK.

MDT Regulatory Update Conference

Packed audiences for Show-floor talks

Developments in micro- and nanotechnology

Some of the product innovations launched/new to see at MDT06

Even bigger and better next year

Market Place

Sterilisable Packaging To Reduce Cost

A sterilisable packaging system has been developed that utilises a different combination of materials to reduce the overall cost of the pack.