Medical Device Link.

A confusing array of terms has arisen with the rapid emergence of the subject of nanotechnology. In this article a recently derived framework for definitions of these terms is discussed.

The number of applications and products utilising microfluidics technology has been growing rapidly. This article highlights the progress of this maturing technology and the significant factors that make it a valuable tool for new product development.

The technical challenges of developing combination products were addressed in Part I of this two part article.1 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.

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.

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.

Companies make the most of their environment to respond to market difficulties.

Many of the critical issues of 2007 are under review and legislative reforms can be expected.

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 Professor Dr Jörg Vienken.