The use of modern software tools and processes can make a significant contribution to developing reliable software for medical devices. These techniques can help bring products to market more rapidly and cost-effectively because the production of compliance documentation is automated and ensures that quality control processes are strictly and demonstrably observed.
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.
Advances in microsensor technology have the potential to improve performance reliability in microfuidic applications. The technology and its capabilities are described.
Forty-four percent of hospital patients with indwelling catheters can develop significant bacteriuria within 72 hours of catheterisation. It is, therefore, critical that catheters are manufactured with perfectly smooth surfaces and apertures to reduce the potential for infection. An ultrasonic cutting technology is described here that produces smooth apertures and eliminates problems associated with debris.
The standardisation of analogue front end products is allowing the development of portable ultrasound devices that provide enhanced image quality while minimising power consumption. The design opportunities associated with the use of these products are described.
The simple canted-coil spring may be the answer to manufacturers' device fastening difficulties.
The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these documents.
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.
Products and packaging require leak detection for quality assurance. This article compares and contrasts the two commonly used methods of pressure decay and trace gas testing and provides examples of using these techniques on a catheter and a sealed, impermeable pack.
The latest materials testing and analysis techniques are examined. Examples of their use illustrate how they can help in the development of new products, solve product and process issues and ensure quality control.
As the applications for stents expand, contract manufacturers have responded with improvements in manufacturing operations.
New virtual test methods are being used to better understand the functional performance of implants within the musculoskeletal system. Developing validated virtual models and tests reduces prototyping costs and compresses product development cycles.
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.
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.
The latest machine vision technology is enabling manufacturers to increase production and offer complete quality control and traceability.
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.
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.
