c-arm «cyberbloc fp» brand new flat panel generation ultralight and compact full touch smart user interface welcome to our booth hall 10 f 74 contact us by email: sales@primaxint.com d d monday @ medica 2 eh @ medica no 1 2016 the melody system is the world’s first remote ultrasound imaging system. produced by french com- pany adechotech, and developed by radiologists for radiologists, the system has evolved to meet the real needs of an ultrasound examina- tion. recognising that the necessary precision would be impossible using only a voice-controlled robot, the system incorporates the most recent audio-visual teleconference technol- ogy with advanced remote robotics similar to those used in space explo- ration. the lead radiologist controls the entire examination from a central workstation, where the video link enables the patient, operator and ultrasound images to be seen on high-resolution computer screens throughout the examination. the highly sensitive audio-link also ena- bles the expert radiologist to instruct the operator and discuss with the patient throughout the procedure. however, most importantly, it is the use of a ‘dummy’ probe by the expert that drives the robot and therefore, ensures exam qual- ity. while watching the images, the expert moves the dummy probe as they would if physically at the patient’s side. currently used primarily for abdominal ultrasound examinations, the lead radiologist has complete control over the set-up parameters of the images, such as gain con- trol, depth control, frequency change body and applied gel. the probe on the robot, inclined at 45° then fol- lowed the movements of the expert’s dummy probe to perform the exami- nation. the team were quite surprised at how quickly they adapted to using the system, within two-three exami- nations ‘to use a dummy probe hon- estly became completely natural’. and activation of various ultrasound modes, such as colour doppler and pulse wave doppler. is the system as good as it seems? claudon’s team organised a test to find out. the melody system was set- up in the lunéville hospital centre, over 30 km away from the specialist centre in nancy. the equipment was very easy to set-up – within a day it was com- pletely operational in the lunéville ultrasound room with the secure audio-video link picking-up the images in nancy. over the next three days approxi- mately 30 different abdominal ultra- sound examinations were performed with the system. following instruc- tions from nancy, the patients placed themselves on the couch and opera- tor positioned the robot over their also the images provided are com- pletely compatible with the hospital’s pacs, so they could be automatically archived for future reference. what about the patient? in this series of tests, patients were com- pletely relaxed and compliant and had absolutely no difficulty with the concept of having the specialist at a distance. for them the end result of the examination is the same but without the loss of time and other potential difficulties of having to travel to the specialist centre. are there limitations? the system is as good as the internet connec- tion for the specialist to feel that they are present at the examination. it has to be performed in real time, with no pauses and screen break-up. while fibre-optic cable will produce the best results, for longer distances satellite connections may add up to a millisecond of difference, which nevertheless should be imperceptible to the radiologists concerned. there is also the ergonomic ques- tion of probe depth because the pressure exerted by the robotically controlled probe is not the exact equivalent of the radiologist’s hand but, as with robotic surgery, future developments and greater use of such systems will overcome. the team in nancy are unanimous in praising the system and can see advantages far outweigh the minor disadvantages. they consider it could enable specialist radiologists to inter- vene earlier in diagnoses, reduce travel for frail patients, training of junior radiologists and a host of other applications. * european hospital would like to acknowledge the help of dr alix martin- betaux, dr frédéric lefevre (chru nancy) and dr eric lefebvre (adechotec) in producing this article. audio-visual teleconferencing with advanced remote robotics long distance ultrasound is not so distant the future of medicine lies at a distance, underlined in our eh interview with professor michel claudon, head of radiology at the regional university hospital, nancy, france, whose particular interest is ultrasound. advances in it and telecommunications have driven expert healthcare provision even into the most remote rural areas – underlined by this notable test in ultrasound michel claudon, professor of radiology, head of the radiology department at the brabois adult hospital, and a past president of wfumb – the world federation of ultrasound in medicine and biology, carries out an examination remotely, using a ‘dummy’ probe that drives the robot. the operators, like the one here, said they quickly adapted to using the melody system representatives from various german authorities and institutions of are at medica to explain and dis- cuss the country’s government sup- port measures aimed specifically at small and medium- size enterprises (sme). the government’s aim is to sup- port smes through the risks involved in research and development to the transfer of scientific research find- ings into the industry through its various initiatives, for example kmu- innovativ: medizintechnik, or the central innovation programme for the mid-size sector (zim). the government, represented by the federal ministry of education and government sup technology innov eh @ medica no 12016

monday @ medica 4 eh @ medica no 1 2016 medica a very bes medica 2016 has attracted a high level of british healthcare companies keen to develop and nurture world- wide trade links post brexit. the organiser, the association of british healthcare industries (abhi) reports that the uk pavilion is demonstrat- ing cutting edge technologies and world-class uk innovations. it is also visit the uk pavil at medica hall 16 ultrasound examinations are con- sidered cost-efficient, fast and effec- tive. the e-fast (extended-focused assessment with sonography for trauma) is a standardised examina- tion used in accident & emergency medicine worldwide. the procedure helps to diagnose internal bleeding and organ damage in severely injured patients in the resuscitation room and, in some regions, even during emergency transport to the hospital, gaining valuable time for the pri- mary care of these patients. [awmf register no. 012/019]. ‘apart from haemorrhagic shock there are other forms of traumatic shock which are just as life-threat- ening,’ explains dr dieter von ow, assistant director of the central accident & emergency department at the cantonal hospital st. gallen. although haemorrhagic shock is common, there are also non-haemor- rhagic types of shock, such as tension pneumothorax, cardiac tamponade or severe paraplegia with neurogenic shock. with tension pneumothorax, a valve mechanism, particularly during artificial ventilation, increases pressure in the pleural cavity so much that the venous return to the heart is impaired, resulting in circulatory shock. a cardiac tamponade leads to direct compression of the cardiac chamber and thus a reduction of the stroke volume. cardiac tamponade is relatively rare, but fatal if not diag- nosed. these two types of shock are not caused by blood loss,’ von ow explains, ‘but by the aforementioned, direct increases in pressure in the mediastinum or the pericardium. not rarely do the latter two types of shock also occur combined with blood loss, which leads to severe impairment of the patient’s circulation and requires fast treatment.’ each patient with potential mul- tiple injuries or uncertain injuries diately given a polytrauma ct scan and, depending on the results of this scan, the further (surgical) strategy is then determined,’ von owe explains. [klinikarzt 2012; 41 (1): 26-30] this point-of-care ultrasound is handled in a very similar way in many trauma centres and is always carried out at the beginning of treatment. it is conducted by specialists in emergency medicine, traumatologists, anaesthe- tists or radiologists in the resuscitation room, requires six sectional planes to ensure a safe diagnosis and takes only a few minutes. it answers a small number of spe- cific questions: is it a tension pneu- mothorax? a cardiac tamponade? is there fluid – i.e. blood – in one of the three large cavities, i.e. the tho- admitted to the central accident and emergency department at the cantonal hospital st. gallen is exam- ined with the e-fast procedure. ‘this involves assessing the thoracic cavity, or the pleural cavity respectively, in so- called sectional planes, ventrally and from the side towards the armpits. this provides clues as to the potential presence of tension pneumothorax or haemothorax. the subcostal plane makes it possi- ble to diagnose a cardiac tamponade. a tension pneumothorax, a massive haemothorax or a cardiac tamponade require immediate release of air, or blood respectively, by the insertion of the appropriate drainage in the resus- citation room.’ the peritoneal cavity is also exam- ined for the presence of free fluid via sectional planes from the sides, toward the abdomen and in planes directed towards the lesser pelvis. finding shocking and potentially fatal bleeding in the lesser pelvis is not always easy because rupturing aneu- rysms are not always easy to detect retroperitoneally. severely injured patients in persistent shock, i.e. so- called ‘non-responders’ defined by unchanged blood pressure readings below 80mmhg, despite the adminis- tration of fluid, who have large blood loss in the thorax, abdomen or pelvis diagnosed via the e-fast procedure must undergo emergency surgery without delay. multiple trauma patients who need to be stabilised in the resuscitation room – the so-called ‘responders’ or ‘transient responders’ – are imme- internal medicine and intensive care specialist dieter von ow is also qualified in clinical emergency medicine at sgnor (swiss society for accident and emergency medicine). he is a course instructor and tutor for abdominal ultrasound and point- of-care ultrasound (basic emergency ultrasound, echocardiography, thoracic and musculoskeletal ultrasound), as well as course director/instructor for advanced trauma life support (atls) american college of surgeons and advanced cardiovascular life support (acls), american heart association. he has worked in the central accident and emergency department at the cantonal hospital st. gallen for 15 years, where he is currently assistant director. this is eastern switzerland’s main hospital providing maximum care for around 40,000 patients annually. as one of the swiss trauma centres it is included in the national trauma register. ultrasound can reveal different types of shock in trauma resuscitation: e-fast or ct? tension-/pneumothorax: (lack of lung sliding in the moving image), lack of comet tail artefacts and distinct reverberations (‘lines’) pericardial effusion: fluid (blood, hypoechoic) between the pericardial sac and the heart suggested compression of the right ventricle (tamponade) normal findings: (lung sliding, moving image), comet tail artefacts (on the left in the image) haematoperitoneum: fluid (blood, hypoechoic) between kidney and liver, i.e. in the morison’s pouch (massive) haemothorax: fluid (blood, hypo­ echoic) between diaphragm and thoracic wall, with an atelectatic lung section (half moon) ‘swimming’ inside haematoperitoneum: fluid (blood, hypo­ echoic) in the lesser pelvis, with the uterus and full bladder, separated by the bladder wall (on the right in image) ‘swimming’ inside rax, abdomen or pelvis? (the ability to differentiate between these types of shock requires conducting 50-100 such bedside examinations under supervision). the results of the examination either lead to life-saving intervention in the resuscitation room, or they support the life-saving triage decision ‘emergency surgery or poly-trauma ct’. in other words, ‘e-fast can save lives,’ von ow is convinced. current data from large trauma registers con- firm this statement. when multiple trauma patients are given a ct scan without being assessed via this system beforehand, this does not improve their chances of survival [the lancet 2016; 388: 673-83] the parenchymal organs, the liver, spleen and kidneys can also be assessed via contrast medium ultra- sound instead of ct, he explains. however, there are only few radiog- raphers experienced enough to carry out the procedure on trauma patients. nevertheless, it does significantly reduce the potentially carcinogenic radiation exposure from ct scans and other radiological examinations, par- ticularly for children and adolescents, given that the radiation exposure fol- lowing relevant trauma exceeds the average annual terrestrial exposure per patient 15-30 times. eh @ medica no 12016

professional cleaning and disinfection technology in good hands topline – reliable hygiene management for dirty utility rooms www.meiko.info looking for hygiene standards you can trust in the nursing or care sector? meiko topline washer-disinfectors offer a reliable way of preventing infections and protecting patients and care staff. topline technology has earned our customers’ trust and loyalty all over the world thanks to its outstanding ability to clean and disinfect care utensils such as bedpans, urine bottles, and commode buckets. from stand-alone appliances and combined care units to fully-fitted utility rooms, meiko topline offers top-quality clean solutions custom-made to your specifications. consistently hygienic, economical and user-friendly, topline is the clean solution from meiko. meiko at medica, düsseldorf 14.–17.11. 2016 hall 12, booth d50 m_topline_210x148_mst_medica_gb.indd 1 06.09.16 10:50 internet touch control proxy server encode video signal to vy-net decode vy-net to video signal ethernet infrastructure dtr is at medica hall 16 / stand f42 monday @ medica 6 eh @ medica no 1 2016 now available with full hd camera optional a highly versatile surgical led lamp textile and flexible a refined the single-use cervical rotating bio easing medical video networking starled3 nx, a lamp pro- duced by acem medical company, is based on the next generation led technology ‘… assuring cold light, long life and low energy consump- tion,’ the manufacturer reports. ‘it’s suitable for countless applications both for surgery and the operating theatre – it is ideal for d i a g n o s i s , gynaecology, dermatol- ogy, general medicine and surgery. ‘starled3 nx grants a homoge- neous and shadow-less light thanks to its special led optics created by award-winning united kingdom manufacturer dtr medical produces inno- vative, high quality single- use instruments. at medica this year the firm is showing a new cervical rotating biopsy punch featuring a low profile jaw. in busy clinics, the single-use punch is valuable because the metal jaw ensures a sharp, clean, 3.0 x 7.5 mm cut that delivers consist- ent results. hilda dunsmore, gynae- cologist & colposcopist at the uk’s victoria infirmary, echoes the ben- efits of this product saying ‘…it gives me an accurate biopsy as it has sharp edges so i know i will get a good sample.’ the cervical rotating biopsy punch has been designed with a low profile jaw to ensure better access to the transformation zone. with a rotating head, the tool facilitates positioning and enables increased visibility, making it an instrument of choice. with a straightforward design, vy-net, a video over ip network solution for surgical and other departments, ‘deploys quickly, inte- grates smoothly, and can be updat- ed remotely,’ the supplier reports. ‘the vy-net system utilises existing ethernet infrastructure, and keeps new hardware requirements to a minimum.’ within its straightfor- ward design, video source signals from medical imaging equipment are received into small vy-net converter boxes, set up as encoders. these transform video into an ethernet/network-compatible sig- nal, and supply a format compatible with display monitors or other medi- cal visualisation com- ponents. on the touch- screen interface, video sources and end- point destinations are clearly shown. ‘simply select a source, and then select a destina- tion to automatically route the video signal,’ the firm explains. additionally, a live pre- view can be displayed on the touchscreen. the interface also has options for naming equipment, reor- ganising the touchscreen dashboard, and saving personal preferences for later use. benefits of vy-net include very low latency (under 200ms glass to glass). www.foreseeson.com acem that directs light beams at best according to the needs,’ the firm continues. ‘the visual area is perfectly illuminated assuring both excellent visual comfort and working conditions. its next generation leds produce an unparalleled quality of light with a colour temperature (cct) of 4.500 k and a colour rendering index (cri) of 95.’ with light intensity of 130.000 lux the lamp also has a low ener- gy consumption of 69w. ‘the life cycle of its leds is about 50,000 hours.’ acem points out. composed of three reflectors, these produce a well-blended and intense cone of light focusable through the auto- matic adjustment of the light spot diameter. the firm also points to assets in the lamp’s slim, practical and compact and ergonomic design and suitability for the laminar flows of the operating theatre. now avail- able with full hd camera optional the endo function (light for endoscopy) also adds the value of using this lamp for minimally invasive surgery. ‘functions are adjusted by its innovative easy-to-read, ergonomic and easy-to-clean i-sense control panel,’ the manufacturer confirms, and lists attributes that include light intensity adjustment; dof – depth of field – for a deep light; endo – for endoscopy; size – light spot diameter adjustment to focus the operating area; sync – an optional function to synchronise controls of the combined lamps: starled3 nx double (twin dome configuration) and starled3 nx with starled5 nx or starled7 nx. the lamp also can be ceiling, wall or trolley mounted (abps battery on demand). www.acem.it acem is at medica hall 10 / stand e31 techtera is an innovation cluster dedicated to textiles and flexible materials in the auvergne-rhône- alpes region, the french leader in the textiles and composites fields. this sector offers many medical appli- cations (implants, bandages, ppe), which represent a growing market for the french textile companies (+1,9%, 2014). ‘we support our 120 members in the emergence, structuring and implementation of their collaborative r&d projects. ‘since 2005, we have approved and supported 182 r&d projects. among them, the global r&d budget for medical projects only represents more than €120 million. ‘these projects are under devel- opment or finalised, with innova- tions already available on the medical market. ‘our members offer textile and flexible medical materials, three of which we are presenting at this year’s medica trade fair. the bilicocoon pad from neomedlight treats neo- natal jaundice; the silicone yarns and dyed covered yarns for medical use, from massebeuf and, from bertheas, for orthopaedics etc. the 3-d elastic grip belt, plain elastic fabric or open ribbed fabric with airtex microfibre.´ www.techtera.org techtera is at medica hall 17 / stand a24 fsn is at medica hall 10 / stand g39 m_topline_210x148_mst_medica_gb.indd 106.09.1610:50 eh @ medica no 12016

monday @ medica 8 eh @ medica no 1 2016 european regulators have turned the world of in vitro diagnostics (ivds) upside down with new legisla- tion that will come into effect at the end of this year. the stricter rules are especially tougher for advanced molecular diagnostics and lab-on-chip assays used in the clinic to help identify a patient’s pathology. but also coming under scrutiny for the first time will be diy pregnancy kits or at-home nutrigenetic tests that have not been covered by the current regulations. outraged by the scandal over breast implants that fraudulently used industrial-grade silicon and with on-going concerns for metal- on-metal hip implants, the european parliament launched a total overhaul of the directives for awarding the ce mark for medical devices and in vitro diagnostics (ivds) devices. the reform movement in brussels has resulted in nothing less than an upheaval of the landscape for manu- facturers. for example, all ivds will need to be recertified, including products already on the market. and where the current eu directives allowed a self-certification of the vast majority of tests, the new ivdr now requires 80 percent of all assays and reagents to undergo a strict level of inde- pendent scrutiny that runs up the supply chain to include subcontrac- tors and software associated with the product. while there is a five-year transi- tion period provided in the new laws, that may not be enough for many manufacturers, according to gert bos, the executive director at qserve group, a medical device consulting firm based in amsterdam. he also is the past-president of the european association of notified bodies for medical devices. the notified bodies are the gate- keepers for access to the eu market, independent companies accredited by a member state to assess whether a product to be placed on the market meets the preordained standards. ‘most manufacturers will have to revisit all technical files and the qual- ity systems for all their devices, they will need to generate additional clini- cal and performance evidence,’ bos wrote in a detailed guide entitled, dos and don’ts: how to prepare for and implement the upcoming in vitro diagnostic regulations (ivdr). the white paper was co-authored by erik vollebregt, a partner at axon lawyers in amsterdam, an expert on eu regulation and the author of the widely followed blog, medical device legal. with permission of the authors, this article extracts highlights from the white paper. ‘the ivdr will bring about extremely significant changes. most critical is the full revision of the classi- fication system into a rule- based risk classification matrix. in contrast to the current situation, this means the vast majority of products will need to be evaluated by the notified bodies.’ as the result of greater scrutiny since 2013, the number of noti- fied bodies has been dramatically reduced, a critical issue for manufac- turers. bos estimates that, by the end of 2016, there will be from 40 to 45 certified notified bodies remaining from approximately 80 before the 2011 breast implant scandals that provoked the reform movement for eu regulations. ‘manufacturers must be aware that they may need to change a noti- fied body as a result of this develop- ment, and act accordingly if their current notified body is not able to support the manufacturer anymore,’ he cautions. in addition, he said that the administrative burden will increase substantially for manufacturers as a result of registration require- ments and the implementation of a unique device identification (udi) system. ‘consequently,’ he wrote, ‘manufacturers must take a proactive approach to the new regulation, plan and budget for the transition of exist- ing devices in a timely and detailed way, and allocate resources for this effort.’ ivdr shares many new fea- tures with the upcoming eu medical devices regulation (mdr) proposal, such as new supply chain require- ments and the implementation of a central database (eudamed) here are the four major develop- ments specific to the ivdr field high- lighted by bos and vollebregt. 1. extension of the concept of in vitro diagnostic devices to include tests of ‘indirect medical purpose’ and ‘prediction’ to include nutrige- netic tests and lifestyle tests, which are not covered by the current ivd directive. 2. ivds will no longer be sub- ject to the list-based system cur- rently in the ivd directive, but to the risk classes developed by the global harmonisation task force (ghtf), dividing the landscape of ivds into risk classes from a (low- risk) to d (high public and high patient risk) with seven classification rules. with notified bodies having to perform conformity assessment on all but class a devices, the landscape is dramatically changing in terms of files to be reviewed and audits to be performed pre- and post-market. 3. the conformity assessment routes for ivds are amended to fit the new classification logic. ivds that do not fit any of the other classifica- tion rules fall into class b and have to be certified by a notified body. this is a major change compared to the ivd directive, which allows such ivds to be self- certified. as a consequence 80 percent of all ivds will need to be certified by a notified body under the ivdr, as compared to 20 percent cur- rently under the ivd directive. 4. clinical performance studies will be required to support the ce mark under the ivdr. as a conse- quence ivd manufacturers will need to produce significantly more clini- cal evidence. the ivdr will contain rules for interventional clinical perfor- mance studies and other clinical per- formance studies that largely overlap with the clinical studies regime in the mdr proposal. it is crucial for manufacturers of ivds currently on the market to plan the generation of additional clini- cal evidence well, and timely assess what clinical evidence will likely be required, how long it will take to generate this and plan ahead for notified body slots for conformity assessment. in short, the clinical performance evaluation will include not only the classic clinical performance and analytical performance, but also sci- entific validity. with this change, the first steps towards manufactur- ers becoming fully responsible for the clinical utility of their devices are initiated. the ivdr will bring about extremely significant changes ivds under the microscope new eu legislation gives manufacturers five years to meet strict standards. that may not be enough time, john brosky reports gert bos phd is an influential voice for european regulatory issues. for many years he served as the president of the notified body association team- nb, and asvice chair of the medical notified body forum. until 2016 he was the head of regulatory and clinical affairs of british standards institute for medtech. currently he is the executive director and partner at qserve consultancy. eh @ medica no 12016

microcirculation assessment non-invasive diagnosis lea medizintechnik gmbh, germany www.lea.de • sales@lea.de • • • • • • vascular surgery wound healing flap monitoring plastic surgery venous insufficiency diabetic foot syndrome we are looking for distributors who can provide a detailed application information in the market to offer our customers the best option. visit us at medica: hall 9 booth d42 critical limb ischemia flap training monday @ medica 10 eh @ medica no 1 2016 whilst objects such as beds, medical devices or other materials may be easy to acquire, lease or hire, the situation is different when it comes to human resources. there is a lack of nurses, doctors, medical engineers and it specialists, across the entire european employment market. nothing dam- ages a hospital’s reputation more than a rating that states it does not provide adequate patient care. there has been no getting away from it: long waiting times and deteriorating care caused by a lack of staff on the wards are standard in many hospitals. this is particularly frustrating for all con- cerned when the respective budget is actually in place but suitable staff cannot be found. there are obviously various ways to solve these problems. the easiest, but not necessarily most effective solution is to put the blame and responsibility on the ‘system’ and to wait until the system solves the problem. actually, this tends to be the most common approach! a much more successful line is to utilise improve productivity in existing resources more efficiently. a closer look at workflows repeatedly reveals a multitude of activities that originated in the past, but the necessity of which has never since been questioned. one of the factors that could lead to a significant improvement in the situation is the handling of laboratory tests beyond the laboratory. a look at the entire process for some essen- tial laboratory tests shows, without a doubt, that some tests could benefit from substantial improvements if the analysis was carried out on site, i.e. via a point-of-care test (poct), rather than by a centralised service provider – the laboratory. some excellent examples of poct can be found in the a&e department. nowadays, to determine a troponin level via a poct, within 15 minutes, is no longer a problem. however, the majority of a&e departments still send samples to the central laboratory. this results in long waiting times, unneces- sary additional work for nurses and doctors and in patients spending far too much time in treatment rooms. what applied in the past is still rel- evant today: time is money. a solid analysis of the current situation and the willingness of all those involved to allow changes can lead to consider- able increases in efficiency. naturally, it would be wrong to say that poc does not exist in european hospitals at all; it is already in practice in many places. the most important examples are blood glucose measur- ing systems and blood gas analysis. the question is, whether the right systems are being used. finding sys- tems that actually worsen a situa- tion, instead of improving it, is not uncommon. systems must fit into the workflow. in other words: when the decision is taken to establish poc, the optimum work process must be defined before the required systems are chosen. whether or not a poc concept supports workflows in a meaningful way depends to a large part on the performance of the it sys- tems used. modern systems specifi- cally developed for poc offer the user many opportunities to make working with the systems as easy and safe as possible. however, for this, an it sys- tem that supports the different oppor- tunities offered by poct systems is a prerequisite. the latest systems make the use of pen and paper completely redundant. it makes no sense to make laboratory test results available more quickly if old, standard forms are then used to document patients’ results, or for the obligatory quality control documentation still required in some countries. a combination of ‘modern’ with ‘stone age’ would be coun- terproductive in this case. what we would like to tell the observant reader with this contribution is that the inte- gration of poc can only be successful if thorough preparation takes place beforehand. the change to poc is more than a discussion as to whether a system is technologically suitable to carry out certain types of analyses or not. as the resulting profitability of a poc project directly depends on the increase in efficiency expected, all those involved should take enough time for a detailed analysis of the current situation and the results to be expected. if everything has been done properly poc will be the quiet force that helps to utilise the existing resources in the best possible way for a long time to come. the quiet force to optimise existing resources the value of point-of-care some significant changes in the european hospital sector have occurred over the last 20 years. ‘the necessity to contain the exploding costs in particular has led to a reduction in the number of hospitals and hospital beds, and staffing levels have also been affected by the many cost cutting measures. this has not been without its consequences, as we now know,’ writes ludwig f rutten. currently co-owner of poct medconsult gmbh, in germany, ludwig rutten has more than 10 years’ experience in marketing point of care (poc) products. in a previous role, for example, he initiated several studies and workshops on process optimisation and poc. equipment advances according to needs. pocts can increasingly be carried out beyond a centralised service provider, easing pressures on hospital or external laboratories our knowledge of causes and mechanisms of current and future diseases is on ice – not the perpetual ice of the polar caps but artificial ice. it is stored in biobanks at -80 to -160 °c. one of europe’s leading biobanks is the interdisciplinary bank of biomaterials and data würzburg (ibdw), germany. since 2013, bioma- terials culled at würzburg university hospital are stored centrally for research purposes in a state-of-the- art facility. any discipline can make use of the quality-assured bank con- tent. ibdw is one of the first biobanks to implement the concept of ‘broad consent’ and to almost fully auto- mate its processes. availability of biomaterials will allow research on issues and diseases that are not even known today. broad consent since 2010, the german federal ministry of education and research (bmbf) has supported the estab- lishment of centralised structures at five selected german locations to systematically collect liquid and solid human biomaterials. the university hospitals in aachen, kiel, heidelberg, berlin und würzburg were the first to implement centralised biobanks and the umbrella organisation ‘german biobank nodes’, founded in late 2013, will continue to develop the concept. the purpose of a biobank is stor- age of patient tissue, blood and dna samples donated for research. prior to participating in a study, a patient signs a detailed consent form describing the research and the future use of the donated samples. ‘this broad consent is unique,’ says professor r jahns md, cardiologist and director of the interdisciplinary bank of biomaterials. ‘drawing on our experience, a working group of the german ethics commission drafted a text template for non- specified storage and use of donor material for medical research purpos- es, since we don’t know today what research might be necessary 20 years down the road. the consent survives the death of the donor.’ ethically and legally this is a bal- ancing act that requires numerous accompanying measures. for exam- ple, the donor can withdraw consent at any time, research results must be presented to the donor and the public in a transparent and compre- hensible way and, prior to the release of material that is not tied to a spe- cific purpose, an ethics committee must approve the research project for which the material was requested. automation makes reproducibility a further unique feature of the würzburg biobank is the high degree of automation. it facilitates qual- ity assurance and makes processes and results reproducible and com- parable across locations. the oecd standard that defines handling of human biomaterials requires end-to- end documentation of the sample path, from sample taking to storage. ‘we document each and every step with a timestamp,’ jahns explains. ‘on average we have ten to twelve timestamps per sample – completely automated. we are pioneering this process in germany.’ the lack of reproducibility of research results prompted the federal ministry to intensify funding of cen- tralised biobanks. healthcare facilities have long been collecting blood and tissue samples in refrigerators. any graduate student can take a frozen sample, thaw it, remove whatever he or she needs and refreeze it. in a modern biobank, a blood sample is separated into smaller 300 ml units prior to storage. these subsamples german biobank develops standards for european research association frozen samples are scientists with a medical degree from the university of würzburg, professor roland jahns became a cea fellow in sophiaantipolis (france) and dfg fellow at the institute of pharmacology and toxicology in würzburg. he specialised in cardiology in 2002 and received the gobio award of the german federal ministry of education and research (bmbf) in 2006. in that year he also became chair of the working group at rudolf virchow centre for experimental biomedicine. he became a professor in 2008 and, since 2011, has been in charge of implementing the university hospital würzburg central biobank, becoming its director in 2013. eh @ medica no 12016

hall 3 booth no. e92 www.kugel-medical.de we create solutions for histo-pathology labs all around the globe azg_km_european-hospital_210x148.indd 1 27.10.16 15:17 monday @ medica 12 eh @ medica no 1 2016 a northwestern university research team has developed 3-d printable ink that produces a synthetic bone implant that rapidly induces bone regeneration and growth. this hyper- elastic ‘bone’ material, whose shape can be easily customised, one day could be especially useful to treat bone defects in children. bone implantation surgery is never an easy process, but is par- ticularly painful and complicated for children. with both adults and children, often times bone is har- vested from elsewhere in the body to replace the missing bone, which can lead to other complications and pain. metallic implants are some- times used, but this is not a per- manent fix for growing children. ‘adults have more options when it comes to implants,’ said ramille n shah, an assistant professor of materials science and engineering in northwestern’s mccormick school of engineering and of surgery in the northwestern university feinberg school of medicine, who led the research. ‘paediatric patients do not. if you give them a permanent implant, you have to do more surger- ies in the future as they grow. they might face years of difficulty.’ shah and her team aim to change the nature of bone implants, and they particularly want to help pae- diatric patients. their 3-d printed biomaterial is a mix of hydroxyapatite (a calcium mineral found naturally in human bone) and a biocompat- ible, biodegradable polymer used in many medical applications, including sutures. shah’s hyper-elastic ‘bone’ material shows great promise in in vivo animal models; this success lies in the printed structure’s unique properties. the material is majority hydroxyapatite, yet it is hyper-elastic, robust and porous at the nano, micro and macro levels. ‘porosity is huge when it comes to tissue regeneration, because you want cells and blood vessels to infil- trate the scaffold,’ shah pointed out. ‘our 3-d structure has different levels of porosity that is advantageous for its physical and biological properties.’ while hydroxyapatite has been proven to induce bone regenera- tion, working with it is also notori- ously tricky. clinical products that use hydroxyapatite, or other calcium phosphate ceramics, are hard and brittle. to compensate for that, pre- vious researchers created structures composed mostly of polymers, but this shields the activity of the bio ceramic. shah’s bone biomaterial, however, is 90 percent by weight hydroxyapatite and just 10 percent by weight polymer, and it still main- tains elasticity because of the way its structure is designed and printed. the high concentration of hydroxyapatite creates an environment that induces rapid bone regeneration. ‘cells can sense the hydroxyapa- tite and respond to its bioactivity,’ shah said. ‘when you put stem cells on our scaffolds, they turn into bone cells and start to up-regulate their expression of bone-specific genes. this is in the absence of any other osteo-inducing substances. it’s just the interaction between the cells and the material itself.’ this is not to say that other sub- stances couldn’t be combined into the ink. because the 3-d printing process is performed at room tem- perature, shah’s team could incorpo- rate other elements, such as antibiot- ics, into the ink. ‘we can incorporate antibiotics to reduce the possibil- ity of infection after surgery,’ shah explained. ‘we also can combine the ink with different types of growth factors, if needed, to further enhance regeneration. it’s really a multi-func- tional material.’ one of the biggest advantages, however, is that the end product can be customised to the patient. in traditional bone transplant surger- ies, the bone -- after it is taken from another part of the body -- has to be shaped and molded to exactly fit the area where it is needed. using shah’s synthetic material, physicians would be able to scan the patient’s body and 3-d print a personalised product. alternatively, due to its mechani- cal properties, the biomaterial also can be easily trimmed and cut to size and shape during a procedure. not only is this faster, but also less painful compared to using autograft material. shah imagines that hospitals may one day have 3-d printers, where customised implants can be printed while the patient waits. ‘the turna- round time for an implant that’s specialised for a customer could be within 24 hours,’ shah pointed out. ‘that could change the world of craniofacial and orthopaedic surgery, and, i hope, will improve patient outcomes.’ source: northwestern university a promising biomaterial to build better bones cross-section of an adult human femur, 3-d printed using ink developed at northwestern university (c) adam e jakus, northwestern university malta takes a closer look at 3-d prin implants printed while you wait a radical one of the biggest challenges of our existence is the possibility of our technological dreams actually becoming a reality. for surgeons, one such dilemma is the introduction of 3-d printing. 21st century technology has outpaced our expectations. one such example is the invention of advanced digital manufacturing techniques, better known as 3-d printing. patients and the medical community are yet to see the full implementation of this technology within healthcare, moira mizzi reports the possibility of manufacturing tissues and organs is especially exciting due to the lack of transplant organs editor-in-chief: brenda marsh art director: olaf skrober managing editor: sylvia schulz editorial team: sascha keutel, marcel rasch senior writer: john brosky executive director: daniela zimmermann founded by heinz-jürgen witzke correspondents austria: walter depner, michael kraßnitzer, christian pruszinsky. china: nat whitney france: annick chapoy, jane macdougall. germany: anja behringer, annette bus, cornelia wels-maug, holger zorn. great britain: brenda marsh, mark nicholls. malta: moira mizzi. poland: pjotr szoblik. russia: olga ostrovskaya, alla astachova. spain: mélisande rouger, eduardo de la sota. the netherlands: madeleine van de wouw. usa: cynthia e. keen, i.t. communications, lisa chamoff. subscriptions liane kaiser, european hospital, theodor-althoff-str. 45, 45133 essen, germany subscription rate 6 issues: 42 euro, single copy: 7 euro. send order and cheque to: european hospital subscription dept azg_km_european-hospital_210x148.indd 127.10.1615:17 eh @ medica no 12016

complete 2d/3d spine analysis in weight-bearing position seamlessly integrates into any existing x-ray suite no additional irradiation p r e s e n t s medica’2016: booth 10d78 monday @ medica 14 eh @ medica no 1 2016 report: marcel rasch cognition-guided surgery aims to enable surgeons to make knowl- edge-based computer-aided deci- sions during surgery – with the help of computers. this requires the crea- tion of a database that is filled with factual and practical knowledge that a machine can process and use. the underlying idea is for a sur- geon to be able to call up suitable actions when planning or performing an intervention. ‘you can compare it to a cognitive vehicle. while we are in the car driving along the road we often don’t notice that there are technologies in the background that control traction or chassis or whatever. ‘when problems occur, a warning is displayed. as an advanced devel- opment, the cognitive car is auton- omous, entirely disconnected from the human driver,’ mis and bariatric surgery expert professor beat müller explains. the human brain can process or access a maximum of about seven pieces of information at a time. however, large amounts of data are not a problem for a computer. the challenge for the machine is not data volume but data interpretation. ‘in surgery we are dealing with mas- sive data volumes. every day, new knowledge is published in thousands of books and articles, new insights are culled from diagnostics, which is an increasingly complex discipline. a few decades ago x-ray images were all we had; today we are looking at ct and endoscopy images, at lab and histology parameters previously unknown. ‘to collect these data and chan- nel them into a sound decision – that’s the complex art of medicine. unfortunately humans do make poor decisions every once in a while. thus cognition-guided surgery wants to create a system that helps to make good decisions.’ initial results that’s a long way to go. it won’t suf- fice for scientists to access big data and to design analytical tools; they must consider a very special factor, as müller points out: ‘the ability to learn is a crucial feature of the machine. the computer must be able to process not only factual knowl- edge, or book knowledge, but also practical knowledge gathered over time in the course of our everyday work. all these types of knowledge are input for the knowledge base. what we are aiming at is a system that does not suggest certain proce- dures anymore, because of the nega- tive outcomes this procedure yielded in the past. instead the system sug- gests only procedures with a higher probability of success.’ such a system might indeed work, as was demonstrated by an initiative funded by the german research fund (dfg) between 2012 and 2016. ‘in the special research area cognition- guided surgery, teams from a con- sortium of researchers, including the german cancer research centre and the karlsruhe institute of technology, looked at several key aspects of this idea,’ müller reports. in the course of the project an adaptive autonomous camera-guidance robot was devel- oped. ‘when the computer correctly guided the camera during an inter- vention, this experience was stored as “positive”. ‘but when the camera-guidance robot was corrected, it stored the correction,’ he explains. thus the system learns the correct camera positions step by step. the road ahead however, many challenges lie ahead. ‘don’t forget – we are at the very beginning of our research,’ says müller, dampening unrealistic expec- tations. ‘on the one hand we have to make the required data available in a machine-compatible way. when, as trained physicians, we look at an x-ray image and can read it – we understand what we are seeing. the more x-ray images we read, the more we learn. ‘the computer must also go through this phase of gathering experience and knowledge.’ on the other hand, müller explains, ‘a computer can eas- ily do statistical analyses, but seman- tic assessments are a major obstacle. we are talking about model-based or pattern-based action. it’s not only about gathering data but about the way these data are perceived and evaluated.’ a third difficulty is system valida- tion. ‘the computer has to show that its suggestions, which are based on the learning process, are indeed bet- ter. human beings learn from success and failure. ‘machine learning happens in smaller increments. if an error made by the system is not corrected, the system will store it as “positive”, no matter whether there might have been specific reasons for not correct- ing the error in this particular case. in short: we must ensure the system not only gathers knowledge but that it indeed improves. ‘poor approaches to learning might very well lead to poor therapy suggestions. and the worst-case sce- nario is that we don’t even realise that the surgeon performs worse with computer aid than without it,’ müller warns. despite these caveats, the vision is alive. ‘there is enormous potential to make surgery safer and more efficient,’ müller believes. however, today there are only a few isolated solutions and there are not enough research partners for large interdisci- plinary research projects. ‘however, if we look at cognitive vehicles again, there are market-ready solutions claimed to be safer than human driv- ers. this is what i’d like to achieve for surgery.’ details: www.cognitionguidedsurgery.de http://rob.ipr.kit.edu/837_1586.php seeking the gateway towards deeper computer intelligence cognition-guided surgery medical technology: a b in transition surgery will change – with all the challenges that developments such as big data create there are no two ways about it. however, how deep those changes run remains to be seen. in a rather young field of research, scientists look at the ways all components used during surgery can be interlinked. professor beat müller, co-initiator of the project ‘cognition- guided surgery’, explains results achieved so far and coming challenges examining the business performance of the medical technology sector, consultancy firm ernst & young forecasts changes in this industry, as reported by medizintechnologie.de, the national information platform for medical technology. leading senior physician professor beat müller md, head of section for minimally invasive and bariatric surgery at the department for general, visceral and transplantation surgery at heidelberg university hospital, also researches computer-based surgery. he has been lead investigator in several interdisciplinary and multi-partner research projects such as ‘intelligent surgery’ and ‘cognition-guided surgery’ (both underpinned by the german research fund (dfg) until 2014 and 2016 respectively. beat müller is also a key participant in innoplan (innovative, data-driven efficiency of surgery-related process landscapes), a project funded in the framework of the technology programme ‘smart data – innovations from data’ by the german federal ministry for economic affairs and energy, and the eu-funded project combioscopy (computational biophotonics in endoscopic cancer diagnosis and therapy). last year, the global turnover in medical technology sales shrank for the first time, although the mar- ket value increased. digitisation, cost pressures and increasing demand for patient oriented, complete solutions led to drastic changes, a transforma- tion highlighted by ernst & young in ‘pulse of the industry’, the firm’s current global medical technology report. after years of low growth, the medical technology turnover in 12 months from june 2015 shrank by 1.2% to us$ 337 billion. whilst the turnover in the usa decreased by 11%, sales in the european medical technology sector increased by 21% and, despite worldwide revenue loss- es, the market value of the industry increased by 13%. the current key performance indi- cators paint a mixed picture of the med-tech performance and show that the sector is in a transitional phase to a previously unseen extent. ‘the tradition of step-by-step innova- tions is no longer effective today,” says dr siegfried bialojan, head of life sciences at ernst & young (ey). ‘big data, enlightened patients and cost pressures call for fast, real inno- vations which offer breakthroughs and convince customers of the added value of development. therefore, the industry is undergoing a transforma- tion: whilst some companies’ strat- egy in this competitive sector is to focus on the size and depth of their portfolio, others try to meet custom- ers and their requirements in a more wide-ranging manner.’ springboard type innovations are urgently needed to make the medi- cal technology sector grow again, the consultancy suggests. new busi- ness models are also required for the transformation to ‘medicine 4.0’. digitisation has created a need for additional services going ‘beyond the product’ and for patient orientated, complete solutions that link various competencies. ‘cross-sectional coop- eration could be a drive for innova- tion,’ says bialojan. an example of this is the joint venture between johnson & johnson and the google parent company alphabet inc, which aims to try to revolutionise surgery with big data and intelligent robots. a partner- ship between boehringer ingelheim and qualcomm aims to develop an eh @ medica no 12016