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.

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.

A microfluidics system, together with a novel biosensor based on magnetic actuation of colloidal particles, enables the production of handheld diagnostic testing devices. Using this technology, a disposable diagnostic tester with short bioassay times for drugs of abuse has been developed as well as a platform to produce disposable devices for several other applications.

A dedicated system-on-chip (SoC) integrates as much functionality as possible in a single chip and thereby allows miniaturisation of portable medical systems, while optimising performance and power consumption. Today's feature-rich semiconductor process technology platforms mean that SoC based solutions also optimise the cost and reliability of the overall system by reducing the number of components that are employed.

This two-part article considers the complexities of developing and commercialising combination products using examples from experience with drug-eluting stents and drug-eluting beads. Part I discusses the technical challenges of developing these products.

Some suggest that there is no such thing as nanotechnology and that it is only what scientists have been doing for a long time. This argument and some of the fact and fiction surrounding nanotechnology are assessed.

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.

Common medical device packaging problems are identified here together with their cause and the remedy. The discussion examines the causes of poor heat seal, misleading results from the measurement of seal strength, blister flange curl, damage to sterile barrier system and failure of the ethylene oxide sterilisation process.

This article outlines significant recent developments in radiation sterilisation and some of the initiatives currently underway. These include work on a method for sterilising combination products and revisions to several sterilisation guidelines, including those for selecting appropriate sterility assurance levels.

Advances in design-to-manufacture technology have led to shorter product development cycles and more online manufacturability analysis is on the way to further reduce the number of design iterations.

Today's packaging machines are built to help their operators achieve process reliability and qualification packages simplify the procedures for demonstrating it.

Unfortunately, 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).

Joint ventures with Chinese companies provide one of the most effective ways for international companies to establish a foothold in the booming Chinese economy. The benefits, opportunities and challenges of establishing a joint venture are explored here. Current partnering trends and successful Sino-foreign joint ventures in the fast-growing medical device industry in China are also highlighted.

Medical Device Technology’s (MDT) series of short interviews offers a variety of personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Markus Weder.