Machining of materials for medical applications has moved to a new level of precision. In parallel with this, moulding technology has improved through the increased use of sensors in moulds, enhanced design simulation and processes such as micromoulding. This article examines the opportunities offered by these developments and includes examples of mass produced parts that demonstrate the new capabilities useful to product designers.
Finite element analysis can be a useful tool for assessing the clinical performance of a new product in addition to developing and evaluating its design. The benefits and limitations of using this technique for orthopaedic products are examined here.
Directive 2007/47/EC1 amends the earlier Medical Device and Active Implantable Medical Device Directives. Amongst its new requirements is the need for more clinical data and more frequent clinical investigations in the conformity assessment of innnovative medical devices. Details of the changes and the implications for manufacturers are outlined.
There is a long running debate about whether or not dental amalgams represent a serious health hazard because of the mercury they contain. A scientific opinion produced for the European Commission has recommended a solution to the conundrum and provides some lessons for other medical device related causation issues.
Clinical research has identified clear links between human gait characteristics and different medical conditions. However, there have been no sensor systems available to provide a reliable and quantifiable method of monitoring these parameters in a normal environment. The different technologies that can now be applied to a variety of medical applications are discussed.
Hypertonia and heart failures have become two of the main diseases affecting today's human population. A telemetric controlled sensor implant without a battery is being developed and evaluated with in vivo experiments for use as a powerful tool in long-term post surgical evaluation of heart pressure, body temperature and pulse rate. Its capabilities are reported here.
The number of applications and products utilising microfluidics technology has been growing rapidly. This article highlights the progress of this maturing technology and the significant factors that make it a valuable tool for new product development.
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