Medical Device Link.

Techniques for spinal surgery are developing apace, and there are divergent views on the merits of facilitating spinal fusion or attempting to replace or regenerate the degenerative intervertebral disc. The different strategies and preferred materials are described.

A processing technology has been developed that can be applied to many different fine wire medical alloys to improve their fatigue properties. This technology has been used to process a low inclusion alloy, 35 cobalt-35 nitinol-20 chromium-10 Molybdenum (ASTM F562 chemistry), hereinafter referred to as System A. After processing, this ultra fine microstructure exhibited relatively high yield strength, good axial ductility and a fatigue limit of 1 GPa at a fatigue lifetime that exceeded 100 million cycles, as reported here.

A malfunctioning device causes problems, as does misuse by users. To reduce the risk of developing malfunctioning or misused products, companies are incorporating Human Factors Engineering (HFE) methods into the product design and development process. By integrating research, HFE and user interface design, companies can identify usage errors and differentiate their products from their competitors. This article describes several ways in which HFE can be used throughout the product development process, and provides some examples of products designed using HFE methods.

Force testing in the design and production of medical tubing is an essential ingredient in the delivery of functional and consistently high quality devices. This article describes a range of typical tests, how they are performed and the benefits they offer.

The decision to outsource the manufacture of an entire device can be difficult, yet the advantages of this business strategy are huge. The important elements of the process are examined here so that
companies can adopt this approach with confidence.

The science and technology of making good quality holes in tubing is an important issue for the success of the application. The process options and their benefits and limitations are examined.

Increasingly, contract manufacturers are offering design services to the industry. The advantages of this to medical device companies are outlined.

Manufacturing an array of complex products in relatively small quantities is challenging. Outsourcing can be the answer. Here are some important questions to ask when selecting an electronics manufacturing services partner.

The new IEC standard for the in-service and post repair testing of electromedical devices introduces new requirements. These and their implications are outlined.

Essential factors to identifying the right automation company and the benefits that can be gained from partnering in the product concept phase.

As innovation activity remains high on the industry’s agenda, it is calling for a renewed focus on the economics of health care.

The venue gets larger, and the focus gets smaller.

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 Dr. Ralf Heijkants.

The new European vigilance guidelines come into force on 1 January 2008. In addition, the Directive amending the medical devices Directives, which includes some aspects of the vigilance system, was recently published. This article discusses the amendments concerning vigilance requirements, the new European vigilance guidelines and steps that manufacturers should take now to prepare for these.