European Medical Device Technology, March/April 2012, Volume 3, No. 2

Recently published guidance and, in particular, the decision trees it contains, can help manufacturers determine if their software should be regulated as a medical device. But the forthcoming recast of the medical device directives may add a few new twists and turns.

US FDA is increasing quality system inspections of foreign medical device manufacturers. Part 1 of this article discusses why this is occurring, situations that European manufacturers should avoid, the importance of US FDA inspection preparation and two topics that should be covered in inspection preparation. Part 2, published in the May/June issue, will discuss additional preparatory measures to take in anticipation of an inspection.

A biocompatible polymer from Invibio is utilised as a bearing material for the axle bearings in a rotational knee system from Aesculap. The material is used to provide wear and cold flow resistance and dimensional stability.

MEMS sensors combined with the use of biosignals are enabling the development of more innovative and smarter ambulatory medical devices.

EMDT’s series of interviews offers personal perspectives on the diverse and dynamic medical device technology sector. Here, we talk to Dr. Liu Daozhi, Senior Vice President for Business Development at MicroPort Medical in Shanghai.

Size, weight and volume matter when developing and manufacturing an electronic implantable device, but power supply issues are paramount. A look at current and emerging technologies.

Presenting the finalists of the 2012 MEDTEC EMDT Innovation Awards.

A cost-efficient, compact tool for two-photon cross-linking advances research into the generation of biomimetic scaffolds and artificial organs.

The mobile health market is surging, and competition will be intense in the coming years. Companies that embrace interoperability, generate actionable intelligence and design devices that delight users are the most likely to succeed.

Forecast to generate US$23 billion in global revenue by 2017, mobile health will be a key enabler of healthcare delivery, reaching every corner of the globe, says GSMA’s Jeanine Vos.

Polymer-based bioabsorbable stents are expected to grab significant market share from bare-metal and drug-eluting stents, reaching a value of more than US$1.7 billion by 2017, according to a recent report published by Global Data. Companies such as Abbott Vascular, Boston Scientific, Elixir Medical, ICON Interventional, Medtronic and REVA Medical are currently conducting research and clinical trials with the aim of commercialising their bioabsorbable stents. One of the pioneers of this technology, Kyoto Medical Planning Co. (Kyoto, Japan) successfully obtained the CE mark in 2007 for its bioabsorbable peripheral stents, which are sold in 11 European countries and Turkey. Keiji Igaki, co-developer of the innovative stents and President of Kyoto Medical Planning, told Japan Medical Design & Manufacturing Technology how he and the late Hideo Tamai, a cardiologist, developed this breakthrough device.

Replacing solid, fibre-reinforced plastics with twin-sheet thermoforming dramatically reduced the cost of the side doors of Immulite, a medical diagnostic testing instrument from Siemens.