European Medical Device Technology, June 2010, Volume 1, No. 6


June 1st, 2010


This Issue's Articles

Manufacturers entering the European medical device market in recent years may not be aware of the complexities of trying to achieve this objective 20 years ago. Significant progress has been made, although much remains to be done. This article provides a personal view of the innovative approach to medical device regulation introduced in Europe in the early 1990s.

Building on advances in brain-computer interface technology and computational biology, the ReNaChip project lays the groundwork for the use of a prosthetic chip to recover function to nervous system deficiencies.

Employing factorial experimental design modelling during product development can bring a number of benefits. These include consistency and improved quality of granulate coatings for metal implants as well as the ability to predict possible osteoblast–osteoclast behaviour following implantation.

Medical software design standard IEC 62304 has just come into force. This article describes how it will impact the software development process for medical device manufacturers.
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Regulators and end users alike demand product traceability. The right combination of marking techniques and machine vision systems can help to achieve that.

High-voltage, optical, position and current sensor assemblies support the precision, stability and reliability requirements of medical equipment.

As EMDT marks 20 years of publishing for the medtech industry, David Hill, Design Manager at Rocket Medical and longstanding editorial advisory board member, comments on the evolution of the publication and the industry it serves.

Significant changes in materials usage, the rise of electron beam sterilisation and a reminder of some unrecognised heroes are featured in this 20-year perspective on industry developments.

From a greater understanding of how biomaterials and living tissue interact to the advent of individualised therapies, here are some reflections on medical technology’s permanent revolution

The changing practices in medical device manufacturing are illustrated in the development of a new piece of dispensing equipment. Initially, it met with resistance, but over time it has been adopted by the majority of the companies involved in the manual assembly of disposable plastic circuits. Most recently, of course, high-volume production that requires a high level of labour has moved to areas of the world where labour costs are lower.

Exciting developments over the past 20 years include stem cell biology, advances in bioreactor systems for engineering cell assays, injectable interactive materials, nanostructuring of biomaterials and progress in directing biodegradability. This commentary, provided by a life scientist, also highlights some of the goals yet to be achieved.

From robust validation protocols designed into packaging equipment to pristine orthopaedic implants that go directly from a sterile barrier pack to the surgeons’ hands, progress has been constant.

What is the need? What will add maximum value for the end user? It is in this area that the design industry has developed significantly over the past 20 years.

Experience in the medical market and knowledge of current manufacturing trends and regulatory issues are among the most important criteria to look for in a contract extruder.

A spinal implant manufacturer relies on high-tech multi-axis machining systems to develop its products


EMDT’s series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Tim Mead.