European Medical Device Technology, February 2010, Volume 1, No. 2

Nanocomposites are undoubtedly making an impact in many fields of technology, where profound advantages over conventional composites can be readily identified. Whether they have a role in medical technology is yet to be determined. The answer may lie in the degree of subtly that is brought to the underlying scientific issues.

Part 11 of this two-part article discussed the requirements on clinical data and evaluation that will come into effect on 21 March 2010. Part 2 covers the revisions of requirements on clinical investigations, the European database, postmarket clinical follow up and conformity assessment of clinical data. It also discusses the revised standard on device clinical investigations and useful global harmonisation guidance documents and suggests how to avoid problems in complying with the new or clarified requirements.

Some of the important issues facing the sterilisation of medical devices include the sterilisation of combination products, and improvements in the processes being employed. This article outlines recent developments in X-ray sterilisation and low- and medium-energy electron beam capabilities, and reports industry association news.

High volume processing of medical devices sterilised with X-rays is expected to take off in 2010. The properties, processing characteristics, dose uniformity and cost of X-ray versus gamma sterilisation are reviewed.

Affinity membranes can selectively remove bacteria, endotoxins and viruses from biologically active liquids and water. Their use is set to rise. The mechanism and capabilities of the technology are described.

The technologies, equipment and skills required to manufacture micro-components or for micro or nano-structuring of devices are reviewed here. Application examples illustrate the latest possibilities when working at these dimensions.

Parylenes N and C have been employed for coating a range of ever smaller implantable and external devices. The recent availability of Parylene HT now offers additional advantages for medical device applications. The properties of these materials are reviewed.

The results of clinical trials of a gait measuring system are reported here that is designed for use in the outpatient clinic or the home. Its capabilities and range of potential applications are described.

A customised welding programme fast tracks the production of a left ventricular assist system.

This article describes the tests used to assess the integrity of insulation in electrical appliances. Each test method has its relative merits and place in periodic testing, providing the different limitations of each are understood.

The surface finish and precise tolerances of the device chamber and ram make it possible for the mechanism to successfully fire drugs into the body

Today’s porous adhesives can add functional capabilities beyond bonding to diagnostic and wound-care devices. Their properties and potential applications are described.

Partnering with a knowledgeable cleanroom assembly provider can help medical device OEMs improve efficiency and simplify compliance with regulatory requirements.

A series of interviews from EMDT that offers personal perspectives on the diverse and dymanic medical device industry. Here we talk to Arindam Mukherjee.