Friday, May 9, 2008

> Medical Device Technology

Medical Device Technology (MDT) magazine is a comprehensive source of technical information on all aspects of the design, production and manufacture of finished medical devices and in vitro diagnostic (IVD) products. With in-depth applications-orientated articles and extensive product news, MDT magazine is a practical resource that helps European medical product designers, and manufacturing, regulatory and management staff do their jobs more effectively.

 

MATERIALS FEATURE

In Vitro Biocompat-
ibility Testing of Biomat-
erials and Medical Devices

Biomaterials used for medical devices must be thoroughly tested according to ISO 109931 before their introduction so that any negative effects on the body are known about and prevented. By using in vitro laboratory tests, dangers for patients and unnecessary animal experiments can be avoided. Here, in vitro tests for cell compatibility (cytotoxicity) and blood compatibility (haemocompatibility) are described.
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MANUFACTURING FEATURE

X-Ray Sterilisation

Radiation sterilisation of medical products has traditionally been done with gamma rays from radioactive sources or with electron beams produced by accelerators. Both methods sterilise by destroying microorganisms with ionising radiation. High energy X-rays sterilise in the same way. X-ray sterilisation is still a young process, however, considerable industrial experience has been gained through its post 9/11 use for sterilising large quantities of mail.
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REGULATION AND STANDARDS

Who Owns the 510(k)?

Unfortunate-
ly, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).
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MATERIAL MATTERS

Technolog-
ies of Heart Transplant-
ation

It is now 40 years since the world's first heart transplant was performed at the Groote Schuur Hospital in Cape Town, South Africa. It is interesting to assess just how far heart transplantation has come since then.
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This Month

Developments Across
the Industry

Drug-eluting stent guidance

The UK's National Institute for National Health and Clinical Excellence has published its final draft guidance on the use of drug-eluting stents (DESs) for the treatment of coronary artery disease. It recommends DESs for patients who would be at higher risk of needing further stents if a conventional bare-metal stent is used instead. In addition, it states that a DES should only be used if the price difference between it and a bare metal stent is no more than £300.


Increasing commercial opportunities

The demand for pain delivery products that allow patients to play an active role in the timing and dosing of their medication is growing. According to a report by Applied Data, current pain management philosophy is based on treating pain early and aggressively. It is now believed that chronic pain causes physiological release of enzymes that can damage healthy tissue. In addition, there is a growing market of mature and elderly people who need therapies to treat a range of conditions associated with the ageing process.

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