The standard tests for the biological evaluation of biomaterials, as promoted by the International Organisation for Standardisation, have evolved over the years to become an important part of the process for ensuring, as far as is possible, the biological safety of medical devices. There is, however, some scope for improvement, especially when we consider the extremely different requirements for new medical technology products.
A magnetic-based sensing platform with increased sensitivity has been developed for integration into lab-on-a-chip systems. The methodology consists of moving the magnetic particles to the most sensitive spot of the sensor. To demonstrate its effectiveness, the protein S100betabeta, a diagnostic marker for stroke, was used as target protein.
Breakthroughs in technology are progressing at a phenomenal pace, but bringing them to the patient in the form of a device remains a challenge.The technical issues involved in designing an implantable device are outlined together with some potential solutions.
The latest machine vision technology is enabling manufacturers to increase production and offer complete quality control and traceability.
The use of gas atomised alloy powders for the fabrication of medical devices offers a number of cost saving benefits and is therefore gaining in popularity. Their use in established and emerging manufacturing processes for products including hip and knee implants is described.
Engineers developing medical electrical equipment in accordance with IEC 60601-1 3rd edition are in immediate need of short- and long-term solutions to avoid potentially hazardous designs as a result of misinterpretation of the requirements. Several options are described to ensure consistency and safety of devices.
A recently developed laser fusion technique allows polymers to be attached to metals and ceramics in short cycle times. The process and its capabilities are reviewed together with its growing range of applications.
Excimer and increasingly ultra-short-pulsed lasers are important tools in the creation of microstructures and nanostructures. Capabilities of the latest systems are described, which include drilling 30-microm diameter holes in 50 to 100 microm thick metal foils and subsurface engraving of transparent materials.
The lifecycles of many medical devices are extremely complex, as is their design process, which requires a great investment in time and expert procedures at all stages. This article highlights the critical issues to consider when embarking on a design project and how to reduce the risks involved in long life cycles.
As health care expenditure rises in the United States, experts are calling for comparative effectiveness research to help decision makers determine whether therapies and tests are reasonable or necessary.
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