The requirement for greater performance in smaller spaces has increased demands for product and process innovation in tubing and other medical products. In turn, these developments have placed greater demands on the producers of the advanced tooling for these products. Tooling manufacturers must now continuously design equipment with much tighter tolerances for more sophisticated coextrusions and for newer generations of multilumen and multilayer tubing.
The 33 winners of the 2008 Medical Design Excellence Awards have been announced. Their innovative products display outstanding design and engineering achievements. A selection of them is described here. For details of all the winners go to www.mdeawards.com.
A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer's devices in Italy in a new online data bank. This is incorrect. This article discusses the new requirements for registering medical devices in Italy, together with the steps in the registration process and common problems encountered.
The technical challenges of developing combination products were addressed in Part I of this two part article. Part II reviews the preclinical tests and shelf-life testing that are required using drug eluting stents and drug eluting beads as examples. Regulatory considerations and ways to simplify development are also examined.
Efficient treatment of diseases is expected when the timing of drug delivery is taken into account and adjusted in a proper way. This implies an easy to use, noninteractive and user independent drug delivery system that allows delivery at anytime. This article discusses developments in chronotherapeutic delivery devices that offer a form of drug administration that maximises drug effectiveness.
The capabilities and potential of polyimide and polyimide tubing are gaining popularity in the medical design market place as a result of the increasing need for minimally invasive surgical devices. This article looks at the myths surrounding the tubing to better understand its advantages for medical applications.
The need for micro joining metallic alloys for surgical instruments, implants and advanced medical devices is driving a rapid increase in the implementation of laser welding technology in research, development and volume production. This article discusses the advantages of this welding method and the types of lasers used in the process.
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