Medical Device Link.

 

April 2006
Medical Device Technology
Selected Contents

Materials

New Interests in Magnesium
D.F. Williams

After decades of developing strategies to minimise the corrosion of metallic biomaterials, there is now increasing interest in using an intentionally corrodible alloy in a number of critical medical device applications. This article examines the rationale for using magnesium alloys in cardiovascular and orthopaedic devices.

PVC and Phthalates in Medical Devices: A Never Ending Story
O. Grøndahl Hansen

Phthalate-plasticised poly(vinyl chloride) (PVC) medical devices have been subject to critical attention for 15 years. This article reviews latest developments. It addresses whether hospitals have achieved their goal of phasing out PVC and phthalates and if it is a certainty that a medical device is better with regard to health and the environment just because it does not contain PVC and phthalates. European risk assessments are also reported.

Stem Cells: The Blue Print for the Future
C. Mason

The investment going into stem-cell therapies and technologies is impressive. The objectives are great, including the aim of tissues on demand within 20 years, and the rewards potentially huge with a suggested annual market of US$500 billion. This article outlines current activities on both sides of the Atlantic.

Design

Experiences of New Product Development in the Medical Device Industry
D. Dixon, A. Brown, B.J. Meenan, and J. Eatock

A survey of medical device professionals has revealed the factors that influence the development time and market success of new products. The vital elements that deliver commercial success are reported here.

Cultivate Technology Convergence for Product Innovation
J.M. Wilkinson

Technologies from diverse scientific disciplines are being combined to drive innovation in medical devices. How technology convergence and innovation could be further stimulated is explored here using developments in imaging and point-of-care devices as examples.

What a Difference Good Design Makes
J. Hogan

Ways to build product differentiation into the development process are outlined here in one company's case study.

Designing Screened Enclosures: Part III
J. Bearpark

Parts I and II of this article looked at the numerous considerations that must be addressed during the design stage of screened enclosures. This final part of the article focusses on optical windows, plastic enclosures and cables to ensure the electromagnetic compatibility requirements are met in the most cost-effective way.

Manufacturing

How To Respond To Changes in the Regulation of the Ethylene-Oxide Sterilisation Process
W.T. Young

The standards relating to ethylene-oxide sterilisation of medical devices are being revised. This article examines the implications of the changes for medical device manufacturers and advises what process innovations and other actions can be taken to ensure compliance.

A New Method for Controlling Radiation Sterilisation

A new statistical process control method for gamma and electron-beam sterilisation processes has been established to meet new requirements to take measurement uncertainty into account when product is released. The method, outlined here, uses probability-based data to determine the appropriate target dose for each type of product and thereby avoid unnecessary product rejections.

A Complementary Sterilisation Strategy Using Cold Atmospheric Plasmas
M.G. Kong

Drug-resistant bacteria and pathogenic proteins in hospitals are causing major problems for sterilisation services and require new and novel strategies to ensure clinical areas are infection free. This article reports on the capabilities and opportunities offered by cold atmospheric plasmas in the sterilisation of medical devices during their manufacture as well as health care.

Line 3D X-Ray Inspection

Three-dimensional X-ray imaging on the production line offers manufacturers quality control assurance.

Supplying the Power for Medicine

The specification of power supplies for medical applications needs to be approached with care. The check list here, which is designed to help the selection process, includes a look at the performance benefits of switch-mode circuitry.

Regulations & Standards

Organising European Technical Documentation to Avoid Duplication
M.E. Donawa

The development of comprehensive, accurate and well-organised technical documentation that demonstrates compliance with regulatory requirements is a resource-intensive, but critically important activity for medical device manufacturers. This article discusses guidance documents and methods of organising technical documentation that may help avoid costly and time-consuming duplication.

Markets

The Medical Technology Industry: A Competence Centre for Health
J.M. Schmitt and M. Beeres

This report on the current status of the German market finds the huge potential of the German medical technology industry stifled by the country's reimbursement system.

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