Medical Device Link.

Injuries are often seen as unfortunate, inconvenient events, the recovery from which, for economic and social reasons, should be accelerated. However, nature is adept at repairing many injured tissues and we should refrain from unnecessary and illogical attempts to interfere with natural processes.

In the European Union, the use of Di(2-ethylhexyl)phthalate (DEHP) in medical devices has been under serious pressure. A proposed ban on its use was avoided and changed into a labelling requirement. This article reports the dramatic political developments that resulted in this requirement and highlights some new alternative plasticisers that can be used if poly(vinyl chloride) devices without DEHP are required in the future.

Polymers can be tailored for specific biomedical applications by synthesis, processing or surface modification. Knowledge-based choice of comonomers for acrylonitrile based copolymers influences the interaction profile with specific cell lines and blood. Processing or surface modification of poly(ether imides) results in materials having complex three-dimensional structures and/or specific adsorption profiles. Potential applications are dialysis, gas separation, cell/tissue systems, apheresis, and bioreactors.

Recent work on modifying silicone rubber to improve water permeability and biocompatibility is described. In addition, modifications to the interface between an active implanted device and the body are reported, which have led to reduced power consumption and improved device performance.

The properties of precious metals and their alloys make them suitable for an expanding number of applications. Their great capacity to be cold worked and other valuable characteristics for medical device applications are outlined.

Blindness is often the result of degeneration of the light sensitive rods and cones of the retina in conditions such as retinitis pigmentosa and macula degeneration. An implantable vision prosthesis has been developed that electrically stimulates the retinal ganglion cells in such a way that action potentials in retinal ganglion cells are evoked, causing a visual sensation in the visual cortex. Clinical trials are about to be conducted.

The first article in this new series on nanomedicine, advocated the need for more risk research in the field of medical nanotechnology.1 Here, some further aspects of risk at the nanoscale are considered and suggestions are made on where this risk effort should be focused.

The latest generation of inspection systems give operators the capability to reliably measure complexity.

Thin film metrology is suitable for characterising and performing quality control of a variety of coatings and films used in medical applications. The capabilities of today’s systems are described.

The Irish medical device industry employs, per capita, the highest number of people of all the medical technology sectors in the European Union. The industry is buoyant with many new initiatives underway to ensure its future growth.

The future prosperity of the United Kingdom medical technology industry depends on better access to its domestic market. Yet the persisting slowness of the National Health Service to adopt new products is driving investment abroad.

Medical Device Technology’s (MDT) new series of short interviews offers a range of personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Professor
Dr-Ing. Thomas Stieglitz.

Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability.