European Medical Device Technology, April 2010, Volume 1, No. 4


April 1st, 2010


This Issue's Articles

As medical technologies evolve and the performance of biomaterials within the human body becomes better understood, there appears to be an increasing demand for degradable and resorbable polymers. New strategies are being developed to meet this demand.

Part 1 of this two-part article discussed important principles underlying the approach taken in the new European guidance on clinical evaluation.1 Part 2 covers advice provided in the guidance on how to perform a clinical evaluation, guidance appendices, the role of the Notified Body in assessing clinical evaluation, a clinical evaluation assessment checklist and the need for written procedures.

There are four clear strategies to adopt to minimise a cleanroom’s carbon footprint without compromising its cleanliness. The savings defined here in ecological and cost terms suggest that a move to a more sophisticated cleanroom control system has distinct advantages.

Polyether block amide (PEBA) is used successfully in a range of catheter designs. This article describes how PEBA’s compatiblity with laser machining can simplify catheter manufacturing, for example, transforming single durometer extrusions into multi-durometer shafts more easily than with other fabrication methods.

The ability of ultrasonic welding to meet difficult bonding challenges is described. The use of specialised joint geometry in the case of dialysis components shows the quality, reliability and output that are possible for a range of plastic applications. 

The ideal for intravenous drug delivery in the home is a small portable device that can be hidden discretely on the patient. The development and manufacture of a micro drug pump of this type are described.

This article charts the important design steps involved in creating a single device on which are integrated all the analytical process steps necessary for diagnosis. Two examples of innovative devices of this type are given, which are taking the microfluidics sector closer to commercialisation of this long-held goal.

This review of surface solutions describes some of the latest technologies available to improve device performance. These include a non-biofouling technology that offers mechanical durability and the inhibition of microbial adhesion, as well as technology that modifies rather than coats the polymer from which a device is fabricated.

Much can be done to reduce costs, improve throughput and increase productivity in the manufacture of orthopaedic products. The hip- and knee-implant markets are set to rise by 20% by 2012.1 A range of options are described here that will allow manufacturers to continue to effectively service these increasing demands.

The healthcare industry is on the cusp of significant change. The value-for-money evaluation of a product/treatment on a patient-by-patient basis, the increasing integration of electronics and communication and the move towards diagnostic test kits and medical devices directly linked to individual health portals are driving this change and creating demands for new systems and devices.

A gundrilling system for creating deep holes in trauma nails and similar products can help manufacturers overcome the challenges of machining titanium orthopaedic components

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