September 2009
Medical Device Technology
Selected Contents
MATERIALS
Material Matters Column: Different Directions for the Biological Evaluation of Biomaterials
David Williams
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.
DESIGN
Stroke Diagnosis with Lab-on-a-Chip
E. Parton, L. Lagae and G. Borghs
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 S100ββ, a diagnostic marker for stroke, was used as target protein.
Patient Protection at Risk in IEC 60601-1 3rd Edition
K. Dybdahl
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.
Implantable Devices: Challenges and Opportunities
R. Srinivasan
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.
MANUFACTURING
M. Turner
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.
Micro Abrasive Blasting Delivers 21st Century Stents
T. Whelan and S. Parmelee
As the applications for stents expand, contract manufacturers have responded with improvements in manufacturing operations.
Advanced Materials: Testing, QC and Inspection
R. White
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.
REGULATION & STANDARDS
New European Guidance on Borderline Products
Maria Donawa
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.
MARKET PLACE
Today’s Machine Vision Systems
The latest machine vision technology is enabling manufacturers to increase production and offer complete quality control and traceability.
THE INTERVIEW
Medical Device Technology’s (MDT) series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Alain Anfosso.
