Medical Device Link.

After many years of scientific and political struggles, the European Union now appears to be heading for success in the development of a new regulatory pathway for innovative therapeutic products, including those of tissue engineering. This article summarises the main issues of those developments and some essentials of the proposed new regulation.

The success of new product development (NPD) projects can be increased by employing a strategic and integrated approach to material selection and testing. The value of this approach is described and real life examples provide some useful practical recommendations for those embarking on a NPD project.

Many factors can affect the characterisation of biomaterials during testing. These include drugs administered prior to testing and shear stress on blood cells induced by different blood flows and specific blood donor conditions. Some of the misconceptions in testing are described here and serve to indicate that a systems approach, and not only individual test parameters, is best when testing for biocompatibility.

An integrative approach to building microprobe arrays with multiple functionalities is being developed for cerebral applications. This work aims to integrate electrical recording and stimulation, chemical sensing and drug delivery in the same device. It will allow the assembling of probes of different functionalities, configurations and sizes.

Healthy Aims is a large European Union Sixth Framework project. It has the overall goal to produce new intelligent medical implants, sensor systems and relevant technologies for clinical applications. Developments on some of the sensor systems are reported here.

This is the first in a series of articles that will address some of the major challenges facing the emerging area of medical nanotechnology. It explores what nanomedicine is and what it requires in terms of risk management. More risk research is advocated.

The research surrounding stent development has found surface analysis techniques to be invaluable tools. As this product sector works on its next-generation devices, combining the use of these techniques is providing critical qualitative and quantitative data. The value to other products that involve drugs is also highlighted.

The need to accelerate the identification and treatment of medical conditions presents new opportunities to demonstrate how sensors can improve practices in medical environments. The pitfalls and the support that is available for new product development in this area are examined with some examples of recent work.

Bioresorbable polymer implants are rapidly growing alternatives to traditional implants in many applications. Because of their resorption in the body, it is necessary to sterilise the complete product before application. The suitability of different sterilisation methods for bioresorbable polymers is discussed using polylactic acid implants as an example.

The changing health care landscape and a focus on innovation are leading to new initiatives in the Dutch industry, as reported here. The private sector and labour saving in care are two important development areas.

In this issue, Medical Device Technology (MDT) begins a new series of short interviews with some of the personalities that work in our diverse industry. Their different perspectives will provide personal insights into the ingenuity and industriousness that characterises the medical device manufacturing community. Our first interview is with Dr Leonard Fass.

A wide range of topics from national initiatives to European-level policies and actions were addressed at a conference hosted by the Italian Ministry of Health on 7–8 June 2007 in Rome, Italy. This article reviews the important issues that were discussed and the benefits of these types of conferences.