EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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emdt.co.uk European Medical Device Technology Spring 2014 | 3 contents Spring 2014 Volume 5 Number 1 28 32 42 Features InnovatIon 28 Bioprinted organs: Disruptive or Elusive? While the concept of printing organs engi- neered from human tissue holds unfathom- able potential for health- care, there are still many obstacles to overcome. Thomas Klein 46 Breakthroughs in Molecular Diagnostics Numerous technological advancements in molecu- lar diagnostics may help to fuel growth in this innovative sector. Thomas Klein MaRKEtS 32 opportunities abound in Brazil's Medical Device Market—But Expect Delays Demand for improved healthcare and changing demographics make Brazil's medtech market ripe for targeting. Stephanie v. Meien MatERIaLS 50 the Risky Role of Extract- ables and Leachables in Dialysis treatment Medical device engineers must understand possible polymer degradation products that may be released into body tissue. Jörg Vienken SPEcIaL REPoRtS 36 owning the Disease: How Medtech companies are adapting to Survive Traditional medtech com- panies are increasingly turning to more inte- grated business models. Thomas Klein 42 How to Survive an Unannounced audit In the wake of the PIP debacle, Notified Bodies will be cracking down on day-to-day compliance by way of unannounced audits. Shana Leonard REgIonaL FocUS 40 tübingen: Where tradition Meets High tech In the region surrounding the old university town of Tübingen, high-tech start-ups benefit from proximity to universities, clinics and established medtech companies. Thomas Klein COLuMNs REgULatIonS anD StanDaRDS 24 How Will changes to European Medical Device Regulation affect clinical Data Requirements? Uncertainty looms as a plethora of proposals and amendments threaten to alter the European medical device regulatory landscape. Maria E. Donawa reGuLars 4 a note from the Editor 8 news trends analysis 16 Breakthroughs 68 advertiser Index SPEcIaL SEctIon MEDtEc EURoPE 53 Introduction 54 Exhibition Highlights 65 In Focus: optical technologies 62 Spotlight: Packaging 66 In Focus: testing MarketpLaCe Cover photography courtesy of Fraunhofer IGB ES430968_EMDT1405_003.pgs 04.29.2014 03:40 UBM black yellow magenta cyan

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