2011 Medical Devices
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Vol.Vol. 18, 20, No. No. 2, 2, 2009, 2011, ISSNISSN 1854-8466.1854-8466. Medical Devices Vol. 20, No. 2, 2011 The Write Stuff EMWA Executive Committee Journal insights The Write Stuff is the offi cial publication of the European Medical Writers Asso- ciation. It is issued 4 times a year and aims to provide EMWA members with relevant, President: informative and interesting articles and news addressing issues relating to the broad Rita Wellens arena of medical writing. We are open to contributions from anyone whose ideas can Wellens Clinical Research Consulting complement these aims, but opinions expressed in individual articles are those of the Rillaar, Belgium authors and are not necessarily those held by EMWA as an association. [email protected] Articles or ideas should be submitted to the Journal Editor (see below) or another member of the Editorial Board. Vice President: Susan Batti Subscriptions Subscriptions are included in EMWA membership fees. 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Salita [email protected] Columnists Alistair Reeves Wendy Kingdom Alison McIntosh Journal Editor Françoise Salager-Meyer Elise Langdon-Neuner Karin Eichele Baxter BioScience Dianthus team Vienna, Austria Gabi Berghammer [email protected] Greg Morley Freelance forum columnists Raquel Billiones Sam Hamilton EMWA Head Offi ce Durford Mill, Petersfi eld, GU31 5AZ, United Kingdom Disclaimer Tel: +44 (0)173 071 5216, Fax: (+44) 870 442 9940 The views and opinions expressed in The Write Stuff are those of the individual [email protected] authors and do not necessarily represent those of the European Medical Writers As- EMWA website: www.emwa.org sociation or its Executive Committee. The Write Stuff is printed on 100% recycled paper. 68 The Journal of the European Medical Writers Association The Write Stuff Vol. 20, No. 2, 2011 TOC Medical Devices Vol 20, No. 2, 2011 Claudia Frumento Adam Jacobs How do medical device Quis custodiet ipsos custodes? industry managers tick? 76 Getting away with publication misconduct: A ghostly tale 108 Diarmuid De Faoite and Melissa Wilhelmi Ethical and practical problems Chandrima Pal in clinical research with medical Going home 111 devices in traumatology 81 Freelance Section Claudia Frumento Diana Raffelsbauer Classifi cation of medical devices 84 Going freelance: The second of a series of interviews 120 Jane Opie Life as a medical writer Gregory Morley for a medical device company 88 Professional indemnity insurance: Should we bother? 123 Wendy Kingdom Take as directed: Has the recommended cautionary and advisory labelling for Kathryn White st dispensed medicines been improved? 90 My fi rst EMWA conference: 31 EMWA Conference, Nice, November 2010 128 Jack Aslanian Pondering the subtext: Q-tips and Translation Section toothpicks as putative measures Marion Alzer of public intelligence 92 Global Value Dossier translation—A team approach 135 Kathleen Lyle and Helen Stevens What price quality? A summary of the Society for Editors and Proofreaders’ report on the overseas outsourcing Cover photograph of editorial services 94 The front cover is a photograph of Thomas Geierspichler Andrea Rossi (http://www.geierspichler.com/) who has won various medals in the European and PubMed: Scientifi c literature panacea? 99 world championships as well as in the Paralympics. Daniel Heuman Photo by Nadja Meister Science writers and editors hijack ([email protected]) software designed for management Graphic design by Anders Holmqvist consultants 101 ([email protected]) Regular features Sanja Pavlica From the Guest Editor’s desk 70 The personalised medicine revolution: Erratum 71 New opportunities for medical writers 103 Message from the President 72 In the bookstores… 113 Webscout 115 Gina M Dungworth Vital signs 115 Medical writing for the veterinary Journal watch 116 Good writing practice 118 pharmaceutical industry, Words, Grammar & Co 130 take two: Pharmacovigilance 106 For the regulatory writers 132 The Journal of the European Medical Writers Association 69 Vol. 20, No. 2, 2011 The Write Stuff From the Guest Editor’s desk Medical devices by Claudia Frumento What do a wheelchair, a magnetic resonance tomograph, a the production batches? Why should medical device com- cochlear implant and an infusion pump have in common? panies have easier marketing release procedures for their new medical-device-based therapies than pharmaceuti- They are all medical devices! The world of medical devic- cals? A new therapy is a new therapy; whether it is based es is complicated and not getting easier. Microtechnology, on a medical device or a new drug does not really make a nanotechnology and bionics, among others, are making huge difference. such rapid progress that one could get dizzy in an attempt to follow all the new developments: new mechanical limbs But there are valid arguments for a faster market release that can be connected to the nerve endings at the stump of of some medical devices, particularly for those that are not an amputated arm or leg and can be steered just as a nor- used for new diagnostic or therapeutic procedures such as mal arm or leg without even thinking; implantable micro a syringe or a clamp and that are not based on new tech- cameras that permit the blind to recognise objects in their nologies. Nobody with a bit of common sense would ask a way; pills that can be swallowed and deliver exact pictures company that wants to market a ‘me too’ pacemaker with of their journey through the intestinal tract; CT scanners no new features or technological gadgets to run a double blind controlled clinical trial. We must also take into ac- that produce real-time 3-D images of the coronary arteries count that it is not so easy to run controlled clinical trials as the heart beats and make invasive coronary angiogra- with medical devices, as Diarmuid De Faoite and Melissa phy look like a primitive method. The oncologist’s dream Wilhelmi describe in their article “Ethical and practical of delivering chemotherapy only where it is needed and problems in clinical research with medical devices in trau- when it is needed is already under clinical testing—want matology” on page 81 of this issue and Geert Hertecant more? You name it and for sure somebody in some high mentions in the interview on page 78. tech company is already working on it! Moreover, the risk of a wide-spread and uncontrolled use But why have most of us—medical writers—had little or of medical devices that have been newly introduced to the no contact with this fascinating world? A simple answer European market is quite low, since the market release of could be: there was and still is less regulatory control of a new medical device does not automatically lead to its medical devices by independent authorities than of drugs, reimbursement. This is frequently the biggest obstacle not because control is not wanted but simply because of to an unlimited use for some devices. In the last decades the intrinsic explosive characteristic of new developments: the Health Technology Assessment (HTA) has developed the regulatory and legal authorities cannot respond at the into a multidisciplinary method to systematically examine pace dictated by the creative minds of engineers, entrepre- the safety, clinical effi cacy and effectiveness, cost, cost- neurs and investors. This is not specifi c to medical devices, effectiveness, organisational implications, social conse- we see it often when new technologies, developments, or quences, legal, and ethical considerations of the applica- even life-style fashions are introduced to the market: did tion of a health technology—usually a drug, a medical anybody think to seriously study the possible negative ef- device or a clinical/surgical procedure. “HTA acts as ‘a fects on the eyes (or brain) of sitting for hours in front of a bridge’ between evidence and policy-making. It seeks to PC screen? Was the use of nano structures ever tested for a provide health policy-makers with accessible, useable and negative impact on the environment? evidence-based information to guide their decisions about the appropriate use of technology and the effi cient alloca- Times are changing though, and demands for more and tion of resources” [2].