European Medical Device Technology, May 2010, Volume 1, No. 5

Gold, as with some other noble metals such as platinum and silver, has a fascinating, if checkered history in medicine, with some unexplained benefits and significant powers to do harm. Interest in this metal is now increasing thanks to a greater understanding of the mechanisms by which it interacts with the body and new means to exploit these.

For many medical devices, the submission of a United States premarket notification, a 510(k), is no longer a routine process with a relatively predictable outcome. It can often be difficult, time consuming and costly to achieve. This article discusses Food and Drug Administration’s initiatives for improving the 510(k) process and factors to consider when planning the submission of a 510(k).

Surface characteristics such as roughness, micro geometry or the thickness of a transparent coating can determine the therapeutic and economic success of a medical device. Optical three-dimensional measurement systems are gaining increasing significance in this area, because they can be flexibly applied to provide fast and meaningful high resolution measurement data. The application examples described here include implants, stents and micro fluidic components.

It is difficult to find a terminal sterilisation method that addresses all the material compatibility needs of combination medical devices. These products have at least two of the following components: medical devices, active agents (pharmaceutical or biologic), bioabsorbable polymers and active electronics. Novel sterilisation technologies and validation methodologies are being developed to minimise the stress on materials and to optimise the chance of finding solutions to these issues.

This article takes a broad overview of some of the ways nanotechnology is being applied to medical technologies and assesses the impact that this may have for industry.

Strategic long-term partnerships with suppliers can help medical device manufacturers increase innovation, improve instrument performance and leverage their own unique expertise.

A large range of medical devices access the vasculature in a minimally invasive manner, usually percutaneously. Rigorous testing is required for design verification, CE-marking and US FDA submissions of these products. As an example, an overview is provided of the requirements for design validation of an intravascular stent and its delivery system.

Flow-based micro-dispensing techniques apply patterns of functional materials to the outside or inside of medical devices. The factors to consider to benefit from using this technology are discussed together with application examples that illustrate its capabilities.

The benefits of track and trace holographic technology are described as the battle to thwart medical device counterfeiters steps up. Track and trace systems allow a medical device to be tracked through the many layers of the distribution chain and the data linked to an enterprise resource planning system.

Sustainability is a growing ambition in the medical device industry. The changes outlined here that can be made to pack design to meet this goal will also bring other beneficial efficiencies. Options exist to increase product protection, enhance end-user convenience and improve manufacturing.

When volume supports the investment and packaging design warrants it, significant cost savings can be gained by thermoforming, loading and sealing trays in-line rather than purchasing preformed trays, handling them individually and then sealing after loading on a tray sealer. The factors to consider when making the transition to in-line horizontal-form-fill-seal process are examined.

Inline labelling systems increase efficiency and safety

From enhancing wear resistance to improving biocompatibility, surface treatment can be used to achieve a variety of objectives in the medical device sector. Setting up an in-house surface treatment operation, however, can be a challenge.

 A series of interviews with EMDT that offers personal perspectives on the diverse and dynamic medical device industry. Here we talk to John Walters.

To remain competitive, medtech companies are seeking partners that offer a full range of outsourcing services including design, manufacturing and after-sales support