Medical Device Link.

As many sectors of medical technology move away from traditional metals and plastics towards more sophisticated materials derived from supramolecular chemistry, some of the principles developed by nature’s best engineering materials are being borrowed. Discussed here are the structural characteristics of fibrous proteins.

Some hospitals in Europe still recommend medical devices that are not made from poly(vinyl chloride) (PVC) mainly because of environmental concerns. Yet, a brand new life cycle analysis that compares a medical device made from PVC with two devices made from alternative plastic materials shows that deselection of PVC is not advisable. This article reports on the latest scientific opinion on the possible risks related to the use of di(2-ethylhexyl) phthalate in medical devices and addresses some of the conclusions of the life cycle analysis

Implantable grade polyetheretherketone is increasingly viewed as a contender to replace metal and ceramics in a variety of applications. The properties of the material and some of its new application options are reviewed.

It is asserted that by understanding the science behind the coating, developers will be able to produce formulations and robust manufacturing processes that deliver a medical device/combination product that consistently meets requirements. To meet this objective, Part 1 of this article focuses on the coating formulation and early development of the coating. Part II will address the testing challenges and verification of the finished coating on the device.

When starting to design a medical product, designers will often need more information than merely the material properties shown on a data sheet. This article looks at the pitfalls of relying too heavily on what is effectively a summary generated from perfectly moulded test bars.

This, the second in the series on the impact of nanotechnology on different types of medical devices, looks again at the field of medical and biological diagnosis and detection. It examines how knowledge at the nanoscale is also helping to develop new generations of miniature devices that are capable of detecting, in vivo, minute levels of analytes or even individual pathogens.

Micro blasting is used in a range of applications including catheter, stent and pacemaker manufacturing. The correct media to use for the required surface is defined here together with some of the finer points of the process to ensure successful results.

A new European guideline on drug-eluting stents (DES)¹ introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discusses European requirements that apply to DES. Part II will discuss the new guideline, other stent guidelines and evolving process of drug–device regulatory review in Europe.

Five important areas of change are being advocated to improve the health care market.

Medical Device Technology’s (MDT) series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Professor Chris Toumazou.