September 2008
Medical Device Technology
Selected Contents
MATERIALS
Material Matters Column: Caution and Causation: Lessons From the Delicate Story of Dental Amalgam
David Williams
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.
New Horizons For Biomedical Polymers
R.S. Ward
Surface chemistry determines biological interactions at the interface of a medical device. Novel technology is described here that allows engineers to build into the polymer the type of surface that is required for a particular device application. How the technology operates and its possibilities for use in disposables, implantables and prostheses are examined.
DESIGN
New Diagnostics With Wireless Pressure Monitoring
T. Goettsche, M.Graefe and P. Osypka
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.
R. Moore
This is the first article in a series on the impact nanotechnology is having on different types of devices. It considers how lab-on-a-chip approaches in diagnostics are evolving and discusses some areas of future development.
The Importance of Measuring Human Gait
D. Hodgins
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.
MANUFACTURING
Advances in Precision Machining and Moulding Technology Bring Design Opportunities
P. Glendenning
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.
Ten Considerations When Leak Testing Medical Devices
Maximising production without sacrificing quality when leak testing medical devices is a major objective for manufacturers. Here is some advice on how to achieve this.
Today’s moulding machines are built to provide efficiency and precision in the production of small and often intricate components.
Keeping Products in Close Focus
Today’s stereo inspection systems are increasing manufacturing efficiency.
REGULATION & STANDARDS
Addressing US and European Device Testing Requirements
Maria Donawa
Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.
Clinical Evaluations and Clinical Investigations Under the Amended Medical Device Directive
D.R. Dannhorn and H. Schwabedissen
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.
MARKETS
The Netherlands: Utilising Innovation
The publication of numerous reports is prompting significant changes for the Dutch health care system and its industry in 2009.
THE INTERVIEW
Medical Device Technology’s (MDT) series of interviews offers a range of personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Patrick Sabaria.
THIS ISSUE
Developments Across the Industry
- Orthopaedic implants increase momentum
- Manufacturers to check connector safety
- Alsace’s building project
- Refurbished MRI systems in demand
