Physicians forecast benefits for healthcare providers and patients The impact of technology in 2030 How will digital technology impact on healthcare in 2030? If challenges to acceptance and utilisation can be overcome, healthcare providers and patients will benefit significantly, according to physicians participating in a recent online seminar on this topic. 15-18 November 2021 m e t s y S h t l a e H c i n i l C d n a l e v e l C © Amy Merlino MD is Enterprise Chief Medical Information Officer and a staff physician in obstetrics and gynaecology for the Cleveland Clinic Health System. She directs a team of physicians who have dual appointments in clinical practice and technology, working to optimise electronic records data and to promote evidence-based best practices. Report: Cynthia E. Keen ‘Smart’ technology is already utilised today to personalise interactions with a person by an entity in the consumer and financial industries. One example: online clothes shop- ping services, which assess physi- cal size, body characteristics, age, budget, and wardrobe preferences by a professional stylist, and then use algorithms to subsequently select and sell clothing for subscribers. The healthcare industry was a laggard in converting from analogue to digital technology and, for many reasons, this still continues today. Digital technology can make health- care better for patients, can enable physicians and healthcare providers to do a better job, increase efficiency, and lower costs. ‘But what do we specifically want it to do, and how are we going to pay for it?’ asked Bob Kocher MD, Senior Fellow at the University of Southern California’s Schaeffer Center for Healthcare Policy and Economics and Adjunct Professor at Stanford Medicine. Fee-for-service healthcare model Kocher said the healthcare technol- ogy IT software that exists in the United States is designed to make the fee-for-service healthcare model work better and to optimise the net revenue for individuals/ organisa- tions that deliver healthcare services. ‘We need to change how health- care is delivered. How do we get technol- ogy to do this? If we change the business model of healthcare, tech- nology will rap- idly adapt.’ Eyal Zimlichman MD is an internal medicine physician, healthcare executive, and researcher focused on assessing and improving healthcare quality and value, patient engagement and patient safety. He is currently Deputy Director General, Chief Medical Officer and Chief Innovation Officer at Sheba Medical Centre, Israel’s largest hospital. o r u o L s i u L / k c o t s r e t t u h S © Visit us at Hall 9, Stand D41 When Sterility is Indicated... There’s Only One Choice: Sterile Aquasonic® 100 Ultrasound Transmission Gel. 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The current healthcare model is based on intermittent care, usually initiated by a patient with a healthcare crisis.’ Future healthcare will be ever-present in life She predicts that the future of healthcare will be one in which healthcare will be an ever-present part of a person’s life, unobtrusive- ly and securely collecting data that can be AI-analysed to keep a per- son healthy, as well as proactively predict and respond to a person’s healthcare needs throughout their lifespan. Wearable devices providing data to artificial intelligence tools will alert specific caregivers to intervene appropriately if medical attention is needed and to provide proactive assistance to support best-practice outcomes. More patient centricity Eyal Zimlichman MD, Deputy Director General, Chief Medical Officer, and Chief Innovation Officer of Sheba Medical Center in Tel Hasomer, Israel, believes that healthcare is on the brink of major transformation. Redesigned hospitals will need to be much more patient-centred, providing better personalised care at lower cost using best-practice- based AI decision support tools and Continued on page 3 © 2019 Parker Laboratories, Inc. The sound choice in patient care is a trademark of Parker Laboratories, Inc. MKT-0101-2 REV 3 WWW. H E A LT H C A R E - I N - E U R O P E . C O M To achieve this, it will be neces- sary to change the business model of healthcare. ‘Payment models are most important. Healthcare is driven by the power of local hospitals and regional health systems throughout the U.S. because insurance compa- nies need these organisations to be able to sell health insurance policies.’ Kocher noted that major problems include lack of standardised software that can be universally used, lack of invulnerable secure software, and the expense of getting patients and healthcare providers to purchase the technology. Amy Merlino MD agrees. ‘We are using technology to mimic old processes. We need to rethink how digital technology can be utilised, keeping in mind that Internal medicine physician Bob Kocher MD is a partner at Venrock where he focuses on healthcare IT and services investments. An Adjunct Professor at Stanford University School of Medicine and a non-resident Senior Fellow and advisory board member at the Leonard D Schaeffer Center for Health Policy & Economics at USC, he also serves advisory of the National Institute of Healthcare Management. board on the

E H @ M E D I C A 3 The ‘bio space race’. Who will win the day? Cybersecurity professionals are scarce invited interested parties to their Cybersecurity in Healthcare briefing. cybercrime does not stop at national borders. With this in mind, the United The Covid pandemic swung a spotlight onto the increasing role of cyber- attacks and weaknesses in healthcare. In healthcare as in other industries, States consulate general in Düsseldorf and the US embassy in Vienna recently Report: Dr Christina Czeschik The meeting kicked off with a keynote talk by Supervisory Special Agent Edward You (FBI), who pre- sented the US perspective on current cybersecurity threats and counter- measures in healthcare and the wider bio-economy. Perhaps not surprisingly, Special Agent You saw the most significant threat to information security and patient safety of US patients in the activities of Chinese companies. He even made the Cold War analogy explicit by calling the competitive race between Chinese and US com- panies the ,bio space race’, with data as its fuel. In You’s words regarding genom- ics and other big data-powered bio sciences: ‘Whoever generates the largest, most diverse dataset is really gonna own the day’. As early as 2015, 30% of the world’s genetic sequencing machines were located in China; the proportion is increas- ing. Many healthcare providers in the US and internationally contrib- ute to China’s dominant position on the market by sending samples to the BGI Group (formerly Beijing Genomics Institute), the incumbent on the genome sequencing market and provider of the popular NIFTY prenatal test. invested Another important Chinese play- er is the WuXi conglomerate: one subsidiary in 23andMe, the personal genomic sequencing company, and another, the WuXi NextCode Sequencing Facility, was accredited by the American College of Pathologists, now accepting sam- ples directly from US patients. However, the generation and analysis of genomic data seems to be a one-way street to Chinese cor- porations and governments, You reported. China’s state council order demands that foreign entities analys- ing the material of Chinese citizens must cooperate with a Chinese com- pany and must share all data and patents with their Chinese partners. US institutions managing the risks and threats associated with the Chinese predominance in the bio-economy include the FBI and the National Academies of Sciences, Engineering and Medicine. While the former is concerned with cyberse- curity and protection against eco- nomic espionage, the latter pub- lished a report titled ‘Safeguarding the Bioeconomy’ in 2020, focusing less on cybersecurity issues than on issues of the competitive fitness of the US economy and the contribu- tions of the sciences. EU: Directives and regulations In the second keynote, Maria Papaphilippou, Cybersecurity Officer of ENISA, reported on the policy and regulatory frameworks of cyber- security in healthcare in the EU. The European Union Agency for Cybersecurity (ENISA) counts the increasing frequency and differen- tiation of ransomware attacks, the increase in teleworking due to the pandemic and last but not least the enduring lack in skilled cybersecurity professionals among the most impor- tant threats to healthcare cyberse- curity. In incident reporting and analysis, ENISA has identified systems fail- ure as cause for 59% of incidents, human error and malicious intent for 19% each and natural phenomena as cause for only 2% of incidents. Data breaches and leaks, with 49%, are the most frequent type of inci- dent in healthcare, followed by ran- somware attacks with 26%, other malware with 7%, threats targeting e-mail with 4% and fraud with 2%. As two of the most important reg- ulations safeguarding cybersecurity in EU healthcare Papaphilippou cited the NIS directive (in full: Directive […] concerning measures for a high common level of security of network and information systems across the Union) and the EU MDR (Medical Devices Regulation). NIS implementa- tion is guided by the NIS Cooperation Group and its various working groups, one of which is dedicated exclusively to cybersecurity in health- care (WS12). However, while these regulations may serve as a good start and foun- dation of healthcare cybersecurity, Papaphilippou had to admit, upon questions from the audience, that ENISA does not currently pursue any collaboration with institutions out- side of the EU, and that it does not concern itself with genomics and the associated threats to personal data at the moment. Hospitals are ‘target rich and cyber poor’ After several of commercial entities had the chance to present their prod- Continued from page 1 ucts and services during the event, the Cybersecurity in Healthcare Briefing concluded with a panel discussion of government officials from Germany (Jeffrey Fleischle, German Federal Ministry of Health), Austria (Robert Scharinger, Austrian Federal Ministry of Health) and Switzerland (Marc Henauer, National Cybersecurity Centre Switzerland), as well as Josh Corman of the US Cybersecurity and Infrastructure Security Agency (CISA). Participants in general agreed that international collaboration is key to fighting cybercrime in healthcare. However, regulatory measures seem to be on the forefront of thinking for many EU member institutions. Jeffrey Fleischle set out by explain- ing how regulatory holes were closed by including smaller hospitals in criti- cal infrastructure regulations. Corman suggested that maybe the patient safety aspect of cyber- security was neglected in the past, concentrating on personal data secu- rity instead. Time and again, the discussion circled back to the lack of patient-specific precision medicine treatments. ‘AI developments today, such as automated interpretation of screen- ing mammograms to aid radiologists, show its potential. Radiology has always been an early adopter of new technology, and digital pathology is close behind. Like mammography, artificial intelligence deployed in pathology can analyse digital slides to acceler- ate rapid decision-making but, in five years,’ he added, ‘may independently make new discoveries to revolution- ise diagnoses.’ Zimlichman believes that AI will transform early detection of disease. Much like at airports, he predicts that AI-driven ‘control tow- ers’ will manage hospital operations, directing patient flow for diagnoses and treatment, and monitoring/alert- ing when change is needed, such as transferring an inpatient to an ICU. ‘Today nurses capture vital data in hospitals. What is going to happen when we have ambulatory patients with patches on their chest that generate hundreds of parameters of data? Who is going to analyse and make sense of this? We need to develop detailed processes to deter- mine what is vital and what is noise,’ Zimlichman pointed out. He believes that patients who require chronic disease management or have chronic pain will be the initial beneficiaries of new AI tools. With respect to artificial intel- ligence healthcare-related apps that exist today, he recommends regulato- ry assessments to verify their quality, and which are most appropriate for specific medical conditions. ‘These need to be used better. I predict these may even be prescribed like drugs in the not-too-distant future.’ EH @ MEDICA 2021 n g i s e d o t o h p - b k / k c o t s r e t t u h S © trained professionals in cybersecurity. Corman described many hospitals in the US and abroad as ‘target rich and cyber poor’ or even living below the ‘infrastructure poverty line’. Even if sufficient funds were available, Scharinger added, the cybersecurity professionals who could be paid with those funds are presently extremely scarce. Visit us at Hall 9 Stand D41 ASAP-approved for facilitating Standard-ANTT® DRESS FOR SUCCESS Introducing the World’s First Barrier and Securement Dressing Minimize cost and eliminate secondary cleaning procedures with UltraDrape® from Parker Laboratories. UltraDrape is cost-efficient compared to the alternative use of sterile gels and covers, while its inventive design allows an aseptic, no touch procedure. 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Interview with Professor Maciej Pech, Director of the Department of Radiology and Nuclear Medicine at University Hospital Magdeburg Histotripsy: Microbubbles oy tumours Professor Pech performing histotripsy. Image: (c) Christian Morawe. Universitätsmedizin Magdeburg E H @ M E D I C A 5 monitor wounds. That is why this is a conceivable outpatient treatment that does not require an overnight stay at the hospital. The patient could simply return to the hospital the next day for a checkup if he lives near the facility. Are there any known risks? So far, we are not aware of any. In theory, there is always the risk of poor planning, or that the energy is applied at the wrong spot. This is why visual tracking during the pro- cedure is key. The robotic arm is far more accurate in applying the energy than humans. Another risk is that the patient could make involuntary movements by breathing or coughing, for example. You would have to stop and resched- ule the intervention immediately, which is why anesthesia is used for the purpose of this study. However, one might also consider simple seda- tion in the future. What follows next? It is currently a classic phase I clinical trial that seeks to evaluate the safety and efficacy of the process. In the next phase, the mechanism of his- totripsy would be tested in a rando- med setting against an established method. This could be thermal ablation, radiofrequency ablation, or stereotactic radiation therapy. This interview was conducted by Timo Roth and translated from German by Elena O’Meara. MEDICA-tradefair.com Monitor CL-S600 Six megapixels for diagnostic radiology Everything but mammography, that‘s what JVCKENWOOD‘s new CL-S600 6-megapixel monitor can do. olled high With its 30-inch display, it can show medical images of different modali- ties such as CT, CR/DR, MR, ultra- sound and pathology side by side. The arrangement of the win- New: the six megapixel monitor CL-S600 (c) JVCKenwood Fully synchronised group measuring Bittium NeuroOne ‘Bittium NeurOne is one of the quickest and most accurate EEG measuring devices in the world designed for clinical and research use,’ the manufac- turer reports. ‘Bittium NeurOne system enables fully synchronised group measuring of up to 30 people simultaneously, for example in different types of psychological studies. ‘The solution is optimised for use with transcranial magnetic stimulators (TMS-EEG), with optional possibility to use it during magnetic resonance imaging procedures (fMRI-EEG).’ Bittium Biosignals Oy is at Medica Hall 9 / C15 EH @ MEDICA 2021 color temperature are automatically adjusted in real time on the CL-S600. ‘The built-in color front sensor on the screen constantly measures the color temperature and adjusts changes over a long period of time,’ says Herrmann. This is easy on the eyes of the person reading the images – as is the built-in lighting on the back of the monitor and the indirect lighting of the keyboard and mouse. JVCKenwood is at Medica Hall 14 / A17 Visit us at Hall 9, Stand D41 dows can be freely selected. The large screen without a center bar creates a comfortable environment for radiological diagnostics. The monitor is equipped with the latest technology. The patented Dynamic Gamma function, for exam- ple, analyses the entire screen content and selects the correct gamma curve for each individual pixel in real time. This applies to all images – whether ultrasound, endoscope, pathology or nuclear medicine – and always results in an optimum representa- tion. ‘This works without problems even with moving images, although millions of operations per second are necessary here,’ explains Marcel Herrmann, Marketing Manager for Medical Imaging at JVCKenwood. The novel turbo luminance func- tion can increase the brightness and contrast of the screen for a maximum of 30 seconds to magnify recognis- able gray scales. This allows the radiologist to reliably assess even the finest calcifications. The effect is further enhanced by the Visual Point mode. This increases the con- trast in certain areas controlled by the mouse pointer. Luminance and ©2019 Parker Laboratories, Inc. The sound choice in patient care is a trademark of Parker Laboratories, Inc. AD 38-1 REV 3

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E H @ M E D I C A 9 Lessons learned in hospitals Covid-19 accelerated digital transformation Digital transformation has been a significant factor in the way hospitals have responded to the challenges posed by the Covid-19 pandemic. the importance of ensuring person- nel are included in discussions and decision-making and offered relevant training. Good preparation Vasco Antunes Pereira said that tech- nology as a promoter of excellence in healthcare has been proven during the pandemic within his hospital in Portugal. adapt fast, with technology as an enabling tool to deliver better health- But he underlined the importance of good preparation in the ability to Continued on page 10 Report: Mark Nicholls Professional cleaning and disinfection technology The ability to rapidly share data, monitor patients, and forecast future patterns has helped tackle the cor- onavirus crisis. However, during a presentation on the subject of Digital Transformation for Hospitals at the online HIMSS21 European Health Conference, a panel of experts were also quick to point out that the approach of the ‘human resource’ to the challenges and changes was a key factor. The session shared best practic- es from hospitals in the UK, the Netherlands and Portugal, highlight- ing lessons learned from the pan- demic, and how HIMSS (Healthcare Information and Management Systems) models have supported digital transformation. Digital maturity Covid-19 highlighted the need to accelerate the digital maturity of health systems to improve patient health but also to be better prepared to respond to future public health crises. The session, chaired by HIMSS Analytics regional director (Europe and Latin America) John Rayner, examined how to overcome major challenges through information and technology. Katie Trott, Chief Nursing Information Officer at the Royal Free London NHS Foundation Trust, detailed the pandemic experience in London, particularly surrounding the creation of the 4,000-bed temporary Nightingale hospital in a large exhibi- tion hall. ‘One thing we learned from that was the ability to be able to share our information on patients that were transferred there,’ she said. ‘Staff at the Nightingale hospital were able to see everything about patients because of the electronic health records and the health information exchange we set up at the start of the pandemic.’ Rapid transformation That demonstrated how quickly transformation could happen, and the appetite for doing this at speed and scale, not only from staff but patients too, she said, alongside a greater willingness to share informa- tion from organisations that were previously more cautious about doing so. However, she stressed the impor- tance of keeping the end users’ preferences in view when switching to new technologies, and also of undertaking the right evaluation pro- cesses while trying to respond swiftly. Going forward, Trott noted a renewed enthusiasm among staff at the Chase Farm Hospital – which is part of the Royal Free London NHS Foundation Trust group – and other medical units, in wanting to adopt new ways of working, and for quicker data sharing, but stressed EH @ MEDICA 2021 Discover the new pearl in our care collection *Full range of advantages only available when all options are selected Experience MEIKO technology first hand at our stand 10E69 in hall 10No need to select, confirm and start the right programme – the MEIKO TopLine can do that. Hands full when you want to open the machine door? No problem – it‘s all contact-free.* Short on time between patients? The MEIKO TopLine shows you from a distance whether the care utensils are ready to be unloaded. Allow us to introduce you to the new generation of MEIKO washer- disinfectors. This machine boasts user convenience, intelligent functionality and future-proof hygiene settings.Find out more on www.meiko.info/pearl

E H @ M E D I C A 1 1 ‘XR is fusing surgical reality with medical images’ Extended realities in the operating room Leading medical extended reality (XR) experts gathered at Shift Medical to discuss developments on the use of immersive technologies in medicine. For European Hospital, Sascha Keutel interviewed Doctor Egidijus Pelanis of Oslo University Hospital about applying extended realities in the operating room. they still use for the traditional way of examining. ‘I believe that doctors, surgeons, and even patients should start ask- ing for 3D representations of their anatomy and pathology. ‘Virtual reality (VR) is often used for education and training, for example in anatomy teaching, where the stu- dents can examine the virtual mod- els,’ Egidijus Pelanis explained. ‘In medical school, the students train on artificially created anatomical mod- els. If it is not a cadaver, or comes from patients’ images, the models are standardised. But that’s not how it is in reality because patients have anatomical variations. In VR, you can create highly detailed and realistic patient-specific 3D models. The users can also be placed in life-like environ- ments, simulations, and use control- lers to get haptic feedback during interactions to train before the actual procedure.’ Augmented reality (AR) ‘AR comes closer to the actual surgery because virtual images can be over- laid on top of the real-world object. In the Intervention Centre at Oslo University Hospital, we have tested AR for laparoscopic liver surgery. Here, the user can place 3D models and see these virtual elements in the 3D camera view. However, there are still some limitations related to the complex workflow, visualisation and how these virtual elements should be presented on the laparoscopic cam- era view.’ ‘In MR, the user views the digital images in the physical world and interacts with them. At our hos- pital, we’re working with Microsoft’s HoloLens 2, which allows us to put virtual objects into our environment. We create holograms of patients to walk around and to look at their anatomy and pathology individually, or in groups of clinicians. ‘One of the advantages of using MR is that the clinicians are more acces- sible and not bound by the physical location of the hardware. With a head-mounted mixed reality device, one can see a model with depth as if it were in real life and can point and interact using one’s hands. You can toggle the visibility of the vir- tual elements or peek inside to better understand the spatial distribution of the anatomy and pathology.’ Challenges to XR imple- mentation in surgery ‘It’s crucial to remember that patients are in three dimensions, but medi- EH @ MEDICA 2021 Egidijus Pelanis a PhD candidate working at The Intervention Centre, Oslo University Hospital in Norway. He works with technologies in healthcare and is part of both the Section of Clinical Research, led by Professor Bjørn Edwin, and the Section of Medical Cybernetics and Image Processing, led by Professor Ole Jakob Elle. Then treatment is performed by a robot-assisted surgical system with current and accurate visual controls that support surgeons in their intra- operative decision-making and sur- gery. ‘Whatever new gadgets or tech- nologies are brought into the OR, I hope these will seamlessly integrate into the whole imaging, diagnostic and treatment workflow.’ Could XR become the new standard for sur- gery? ‘First, we should remain focused on the patient by improving patient care from a value-based healthcare per- spective and not get distracted by all futuristic emerging technologies – which resonate with our Sci-Fi fan- tasies from childhood. ‘Secondly, various modalities will find their place in healthcare systems. ‘Surgeons, and clinicians in general, will use what they have available and what works best. We are always looking for solutions to solve prob- lems, to treat the patient. XR is one potential candidate for solving par- ticular communication, visualisation and navigation challenges.’ to lay over the patient during sur- gery. Once patient-specific 3D mod- els are created, physical and virtual spaces can be combined with track- ing technology. You can, for exam- ple, have an optical tracking system with cameras in the OR that detect spheres placed on various objects to be tracked. This enables real-time tracking of objects and the ability to place virtual elements in the OR. These fused scenes and images can be presented either on screens, in augmented reality, or in mixed reality. ‘This process can need some navi- gation system set-up and a certain amount of input from the users. HoloLens offers eye-gaze control so that some functions can be con- trolled by looking at them. For exam- ple, when the surgeon’s hands are occupied during surgery, he can look at and activate certain buttons for interaction to reduce the physical clicking of buttons.’ Pelanis: A ‘perfect’ future OR ‘Today, we miss a complete solution for integration. Existing and new technologies in the OR are mostly independent; they have different sys- tems and standards. ‘I see a bright future where all systems talk to each other, where images and information are synergis- tically flowing between devices; I see decision-support mechanisms using AI that provide automatic patient- and user-specific workflow in which next steps are predicted and shown. ‘Maybe the patient lies on a table and complete patient data is shown holographically in the surroundings. s i n a l e P s u j i i d g E © Augmented reality laparoscopic image cal professionals still focus on flat images for decision-making. For edu- cation and case reporting, documen- tation is commonly limited to text or annotations on medical images. It is constrained and needs a lot of imagination to understand where all these locations are inside the patient. By creating 3D volume renderings and holograms, you can point and show virtual models and combine all these mediums and information for more detailed documentation. ‘However, one major challenge is the preparation of XR, the data that needs to be processed into 3D models and holograms. Hospitals are sitting on a lot of unprocessed data ‘Then again, to create 3D mod- els of every patient, you need to have sufficient evidence that it will help, that you cannot make the best decision for the patient without it. Hospitals are sitting on this resource, but too few are processing it; too few are bold enough to invest with- out solid evidence that having that data processed will be important in the future. But the proof can only be established if someone spends enough time on this and publishes the research results.’ Different navigation and visualisation methods in XR ‘Medical images can be used, for example, to create virtual 3D models Booth Hall 15 - G10 Technical & innovative textiles for health The French innovation cluster for the textile industry Tech to protect you Vertically integrated elastic bands producer Compresion and self-supporting stockings N TIO A V O N IN R&D PROJECTS network EUROPE ratio textiles n e p o o c The technology platform dedicated to textile innovation

E H @ M E D I C A 1 3 Neuro and spine surgery in a networked OR A robot, neuro-navigation and VR headsets Neurosurgeons must often make compromises because most ORs were not designed for the specific needs of their discipline. Addressing this issue, the University Hospital in Essen, Germany, equipped an OR specially for neuro and spine surgery. The aim is nothing less than revolutionising the field with the help of digitisation and cutting-edge technology. Report: Sonja Buske integrate ‘For some time, we had been plan- ning to intraoperative imaging in the OR but there was no device on the market that met our requirements,’ says Professor Karsten Wrede MD, Deputy Director of the Department of Neurosurgery and Spine Surgery at the University Hospital Essen. While previously, as Professor Wrede explains, the sur- geons had to make a choice for their intraoperative imaging modality – either MRI or CT – now ‘The robot- guided angio system Artis pheno by Siemens Healthineers provides CT images thanks to 3-D acquisition The new operating room is only used exclusively by the Department of Neurosurgery and Spine Surgery. To accommodate all the technology, a wall had to be moved and significant safety precautions undertaken. technology in top quality and which allows us to perform angio at the same time. Thus we have a single system with which we can perform almost all interventions and which makes the choice between CT and MRI obsolete.’ Installation with no shut-down To be able to install this innova- tive technology in the OR the space had to be expanded. ‘Not a trivial task without a shut-down,’ Wrede remembers. Moreover, Siemens requirements, such as lead-enforced walls and adequate safety distances, had to be met. ‘In this particular case the Corona pandemic turned out to be an advantage. Since we had to reduce the number of surgeries we could entirely close one OR for five months,’ Wrede explained. In addition to the x-ray robot a complex neuro-navigation system and a robotic arm by Brainlab were installed. After almost three years of prep work, the big day came: right after Easter 2021 the new operating room was opened. The systems combination is unique ‘The systems by themselves are noth- ing spectacular – they are used in many hospitals. What’s unique in Germany is the combination and the networking as well as the fact that this OR is specifically set up for neuro and spine surgery,’ Professor Wrede proudly reports. At the same time he concedes that not all technology is fully used in each intervention: ‘When we are dealing with an aneu- rysm, we do use the entire set-up but when we fixate screws in the spine, that’s not necessary.’ The surgeon is particularly impressed by the many advantages of the networked robotic unit: ‘Before, we made X-rays while fixating the screws in order to check their position. This means high radia- tion exposure for the patient and the team. Later, we used a 3-D X-ray sys- tem, which was rather cumbersome. Now we can take a 3-D image in the OR within 10 seconds without the staff having to leave the room. The image is sent right to the navigation software and we can then guide the robot to the sites in question.’ Before the patient leaves the OR a final image is acquired, to check the screws. With this technology, Wrede explains, ‘Screw positions that need to be corrected are a thing of the past.’ In brain surgery the combina- tion of neuro-navigation and ultra- sound is crucial. When for example a tumour has been partially removed a 3-D ultrasound image can be acquired intraoperatively that shows the remaining tumour tissue live. ‘That’s much faster than a time-con- suming intra-operative MRI,’ Wrede points out. Moreover, the ultrasound data can be transmitted to the micro- scope. Thus the surgeon does not have to interrupt the workflow to review the images on-screen. Virtual anatomy becomes reality Aneurysm patients also benefit from the checks in the OR. Whilst before, an angio had to be performed three to four days after the surgery without anaesthesia, it can now be done on the open skull. Thus remaining dam- aged vessels are instantly detected and treated. With aneurysms another new technology is used: VR headsets. Although not yet approved for intraoperative use, they are a help- ful tool for preoperative planning: ‘Particularly for junior physicians it is quite a challenge to fully understand the complex anatomy of the brain © UK Essen (2) VR headsets are used in preoperative planning at the Essen hospital and the spinal cord. Thus our young physicians and students love this technology because the VR head- set shows them the patient’s vessel structures on-site. They don’t have to imagine where exactly the aneurysm is located in the head. They see it right in front of them.’ Professor Wrede can well imagine that, in the future, stand-alone navi- gation systems will be replaced by VR headsets with integrated navigation. With all these benefits, we must not forget that the complex tech- nology requires a longer learning curve and a well-attuned team. ‘We had one week of training, but still only scratched the surface,’ Wrede admits. ‘No manual tells you how to position a patient for a certain inter- vention. That’s something we learn with practice. ‘Additionally, it’s not sufficient for a few physicians to master the technology; the entire team must be familiarised with their tasks and that takes time,’ Wrede emphasises. Nevertheless, Wrede is convinced that the approach of the University Hospital Essen is the future. ‘The technology – particularly VR and AR – will revolutionise healthcare.’ Robot-supported technology simplifies everyday medical life with the appropriate adjustment. The spinal application is used to assist with operations. Here, the robot is either guided by hand to the location on the spine to be operated on or – with appropriate imaging or connection of an external camera – can automatical- ly move to the desired position. At the site to be treated, the ‘LBR Med’ holds its defined position and supports the doctor during the procedure. Hall 10 / A44 EH @ MEDICA 2021

E H @ M E D I C A 1 5 Body-on-a-chip technology Michael Shuler is Professor Emeritus of Engineering at Cornell University in New York and former Samuel B. Eckert Professor of Chemical Engineering at the Meinig School of Biomedical Engineering. He maintains a funded research program at Cornell, which focuses on applying chemical reaction engineering principles to biological systems. be affected by other medications patients are taking, before they are advanced to the clinical trial stage. ‘It may be helpful for some chronic diseases where it could take the cells from a body and expand or use them directly to test multiple potential treatments and see which of those treatments work best,’ he continued. While a drug may work well in the majority of the population, there may be a proportion of the popula- tion in which they do not, so a clini- cal trial can be designed to select a subpopulation in which the drug should be tested. ‘You can also build a system where you have represen- tation of different types of pheno- types, people from different back- grounds and groups and see how the treatments will work,’ he added. Future applications Professor Shuler suggests an addi- tional area where the technology may be applied is the support of regulatory approval. In the future, he believes a strong application for the technology will be in personalised medicine, rare diseases, and immu- nological disorders where there are no robust animal models at present. ‘Having a human-based model is better for predictions than animal models. In some cases, for example for rare disease where there are no animal models, it becomes essential,’ said Professor Shuler. ‘This kind of technology will have a major, or more immediate, impact because there is not a good alternative.’ A boost for drug development of drug development. Integrating laboratory functions on a microchip circuit is helping to improve the cost-effectiveness Report: Mark Nicholls So-called ‘lab-on-a-chip’ or ‘human- on-a-chip’ technology can highlight which treatments may, or may not, work before advancing along the clinical trial process. It can also have benefits for chronic and rare diseases, as well as helping shape personalised medicine. Professor Michael Shuler, who is one of the pioneers of this technol- ogy, outlined how it has evolved. Over the past two decades his group at Cornell University in New York has applied chemical reaction engineer- ing principles to biological systems to develop conceptual tools to test hypotheses about cellular mecha- nisms. This work combines math- ematical models of subcellular and cellular mechanisms with models of the whole body as a means to relate the rapidly increasing insight from molecular toxicology and pharmacol- ogy with human and animal physi- ology via body-on-a-chip devices constructed on a microscale using the techniques of nanotechnology. ‘My work has focused primarily on micro-physiological systems, or body- on-a-chip, where we try to emulate what happens in the body and use it in terms of drug development to determine which drugs may most likely be successful in clinical tri- als,’ said Professor Shuler, who is Professor Emeritus of Engineering at Cornell and CEO & president of Hesperos, Inc. in Orlando, Florida. The technology integrates multiple analytic steps (such as measuring the time-dependent concentrations of drug and metabolites as well as cellular activities) on a single chip with the physiological-based phar- macokinetic models mimicking the integrated responses of organs such as the liver, colon, heart or lung to predict outcomes and reactions of proposed new therapeuti- cal approaches. Weeding out the drug candidates The body-on-a-chip technology can also be used for rapid analysis or screening, and while Professor Shuler believes the main application is with- in pharmacology, the technology can be applied to toxicology and even to determine the safety of cosmetics. Professor Shuler said: ‘At present, it is generally associated with pharma- ceuticals and developing new drugs in clinical trials. A key question is how to decide which drug is best to take into clinical trials. About 10% of drugs in clinical trials are approved as useful. The rest are not, but it still costs a lot of money to go into clini- cal trials, particularly with those can- didates that get to Phase III trials. So, if you could have a device which tells you which drugs in the human body are likely to fail and which are likely to succeed, there could be savings of hundreds of millions of dollars. ‘The idea is to divide the body into different organ compartments and use the physiologically based pharmacokinetic model, in conjunc- tion with a physical microscale model with organs represented by living cell constructs, to predict the efficacy of a drug (i.e.: ‘does it work on a critical organ?’) and determine the potential side effects. A whole-body model is needed because many drugs fail due to side effects even if they work on the primary target. The ulti- mate idea would be to have a system to improve the success rate of drugs in clinical trials.’ He said it is a fast- evolving field with major opportunities to improve the suc- cess rate for phar- maceutical com- panies in clinical ) 3 ( . c n I , s o r e p s e H © trials. Professor Shuler, who was the first to demonstrate the feasibil- ity of such body-on-a-chip systems, explained that while he focussed on the whole body on a chip looking at multiple organ systems and their behaviour, others have developed more specific systems for a single organ-on-a-chip, such as a detailed liver model for liver response, for example. ‘Our model is a physiological model which predicts what will happen in the human, and is being applied to dif- ferent diseases – some chronic and rare diseases, although cancer is a big area of application,’ he added. Finding the right diseases and target groups With drug development, the technology can exam- complications from drugs and how they may ine EH @ MEDICA 2021

E H @ M E D I C A 1 7 Labmed Forum D O N ’ T M I S S ! The Labmed Forum presents short talks and panel discussions on microbiology & Covid-19 diagnostics, cardiological & oncological diagnostics, diversity and AI-driven diagnostics and innovations in the pandemic. Wednesday, 11:00: Prof. Dr. Billy Sperlich Training and fitness testing in long Covid patients. This session will detail the benefits of physical exercise in patient recovering from Covid-19. Monday, 10:45: Prof. Dr. Dr. André Gessner Metagenomics in Covid-19 and its co-infections. The session will showcase systematic studies using next generation sequencing (NGS) and reveal why clinicians should pay special attention for fungal infections in critical ill Covid-19 patients. Tuesday, 10:45: Prof. Dr. Dr. Perikles Simon Potential of free circulating DNA (cfDNA) to predict hard endpoints of intensive care patients. This touches the realm of sports medicine, as cfDNA serves as a stress marker in both marathon runners and Covid-19 patients. Thursday, 14:45: Tara Moghiseh, ‘Jugend forscht‘-Winner AI-supported automated white blood cell differential counting. Insights will be given into the development and functionality of CELLnet, a deep convolutional neural network, that overcomes the classification problem of leukocytes in a desirable accuracy and speed. Hall 1 / G37 Conformity declaration accessible) nificantly cheaper for labs. However, the comments on IVDR point out that economic considerations must not be the reason for the use of LDTs. Thus, the hospitals have no incen- tive any more to develop their own tests. In the long run this will impair the ability of hospitals and labs to react in acute situations. During the pandemic, imagine if we would have had to wait for commercial manufac- turers to offer Covid-19 tests.’ What other difficulties will labs and hospitals have to face in the wake of IVDR? ‘The term in vitro diagnostic device was expanded to include software. While this is only one line in the regu- lation, it has immense consequences: software developers have to meet the same requirements as the manu- facturers of lab products. ‘In Next Generation Sequencing, human genetics or molecular tumour diagnostics labs use complex soft- ware solutions that integrate several test results. All these software solu- tions must be reviewed to make sure they are not lab-developed items Product monitoring / vigilance under IVDR. Hardly anybody has ever validated software – much less vali- dated for IVDR conformity.’ How can this issue be navigated? ‘I am chair of a sub-group in the Working Group of Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften – AWMF), which deals exclusively with software issues in the context of IVDR. ‘We compiled a guidance docu- ment for all those who develop such software solutions. After all, IVDR is not overly specific with regard to software, which gives us some room to manoeuver. But the requirements exist and must be complied with. At the end of the day we will have to jump through that hoop.’ EH @ MEDICA 2021

E H @ M E D I C A 1 9 An overview COMPAMED 2021 the CompaMed High-Tech Forum, Dr Martin Schädel, Head of the MOEMS Division at the CiS Forschungsinstitut für Mikrosensorik, gives a lecture on this development High-tech communication between the body and modern IT With its next-generation electrode design, CorTec creates new path- ways for communication between the body’s own electric signals and modern information technology. This young medical technology company specialises in developing efficient technology for active implants for recording over long periods of time and stimulation of neuronal activity. The technology comprises custom- ised components such as electrodes for derivation and stimulation within the central and peripheral nervous systems. Its patented AirRay elec- trode technology has enabled CorTec to overcome the current limitations when working with electrodes with mechanical properties that can be adapted flexibly and highly precise manufacturing conditions. The man- ufacturing process, using ultrashort pulse lasers, makes the technology highly reproducible even at very small dimensions as little as 25 µm, and with a high density of electrical con- tacts. The flexibility of the technology enables a wide variety of product properties, such as thickness, the number of contacts, contact spacing and contact shape, and the total size of the electrode, to be modified. The components can, for exam- ple, help localise the epileptogenic focus that needs to be removed using surgery in patients with certain types of epilepsy . CorTec’s aim is to be a leading partner in developing innovative therapies. In particular, the design flexibility of the AirRay elec- trode technology makes it an impor- tant building block for the approach of communicating with the human nervous system and connecting it with AI. This special electrode technology is, like the ceramics-based hermet- ic encapsulated casing, part of the CorTec Brain Interchange, a technol- ogy platform for innovative neuro- therapy in a variety of fields of appli- cation, such as epilepsy, Parkinson’s disease, or bioelectronic medicine. * More information from COMPAMED 2021: https://www.compamed-tradefair. com. munication are either integrated into one system or into separate units. An important factor for all versions is the question of which radiocom- munication standard they need to be certified with. These vary throughout Europe and the USA and also differ based on the country in which one is based. Large countries such as China, Russia and Canada also have their own standards. Mechatronic emphatically pleads the case for AEDs that execute an automatic test every day and has developed the relevant hardware to enable the test state to be monitored via a cloud solution. Background: 30% of the devices that are available in public space do not work because the main- tenance and servicing have not been performed correctly. the Measuring blood pres- sure via an optical sensor Highlights on IVAM stand include new sensory developments. Conditions involving the cardiovas- cular system are among those which are most frequently cited as a cause of death in the industrialised nations. An important indicator for this is high blood pressure, which is currently still diagnosed and monitored by regular- ly taking blood pressure mechanically using an upper arm cuff. This method is uncomfortable and limits the patient in their daily activi- ties, and, in comparison to other methods, only delivers a few selective measured values. An optical sensor can provide help here. This sensor, which works using the basic princi- ple of photoplethysmography (PPG), records the fill level of the blood ves- sels in the skin over time. Using the contour curve (pulse waves) recorded in this manner, a patented procedure is used to identify relevant points in time to determine the cycle of the pressure wave in the aorta, which enables conclusions to be drawn on changes in central blood pressure. In addition to offering an alterna- tive to classic cuff measurement, the process also gives a blood pres- sure result for each individual heart- beat. With this analysis of short-term and mid-term fluctuations, doctors expect to achieve a novel diagnos- tic approach for early detection of a variety of conditions in multiple different patient groups (e.g. pre- eclempsia). The sensor developed at the CiS Forschungsinstitut für Mikrosensorik (CiS Research Institute for Microsensors) can be worn in the ear, which, in addition to numerous physiological advantages for signal quality and signal stability, means that it is comfortable to wear through- out the day. In addition to blood pressure, it can record many other vital signs, such as heart rate, heart rate variability as well as the blood oxygen levels.Within the scope of Additive manufacturing for customised implants Additive manufacturing and robotics remain exciting themes in medical technology. Toolcraft AG sees itself as a pioneer of future-oriented technol- ogy such as additive manufacturing and in the construction of individual robot cells. As a partner for complete solutions, the company offers the entire process chain, from the con- cept to manufacturing to qualified precision components using additive manufacturing, machining and injec- tion moulding, electrical discharge machining and mould making. Within the scope of robotics, cus- tomised, fully programmed integrat- ed solutions are implemented. Daniel Distler and Patrick Meyer (Head of the Robotics Division and Head of Technical Sales and Distribution at Toolcraft) put their knowledge gained over 30 years of experience in the industry to good use in their talk at the CompaMed Suppliers’ Forum and detail the advantages of additive manufacturing using a wide variety of application cases for medi- cal technology. For example, Toolcraft AG uses additive manufacturing to make cus- tom implants for individual patients. Furthermore, this mid-sized com- pany has developed an automated complete solution for manufacturing and packaging a cerumen filter for hearing aids (which protects against contamination with ear wax and moisture). Holger Frank, CEO of Mechatronic, talks about ‘The potential of the IoT in medical technology – using the example of the AED. An AED is an automated external defibrillator, a portable medical device that can also be used by people without medi- cal training. ‘In terms of the future development of important IT tech- nology, 80% of all those surveyed assume that the Internet of Things will play an important role, according to a study by PwC’, Frank explains. Mechatronic delivers important devices for IoT developments in the medical field, which enable com- munication between the device and the cloud. In essence, two solutions are possible: the device and com- Consequences of the pandemic, supply bottlenecks, and a multitude of innovations all result in an agenda full of exciting topics customers in order to keep their own economies running. However, according to IVAM, there should still be local supply chains for critical components – particularly for sensi- tive products that are important for basic care of the entire population, for example in the healthcare sector. Current developments throughout the entire process chain The CompaMed Suppliers’ Forum has even more to offer in terms of content. Current developments throughout the entire process chain are presented in a hands-on way: mechanical and electronic compo- nents have their moment in the spot- light in the expert talks, along with innovative basic materials, manufac- turing processes, all types of con- tract manufacturing, design and use- ability aspects and quality assurance. Keynote speeches on new markets complete this diverse programme. Further focal themes include the added manufacturing, electronic and regulatory affairs sectors. Thus, Dr Benedikt Janny, who is the Managing Director of USE-Ing. and Head of the User Research and Usability Engineering Division there, reports on human-centred develop- ment of medical technology prod- ucts, better known as useability engi- neering: This is not only a regula- tory obligation for medical device approval, but also offers medical device manufacturers the opportu- nity to differentiate themselves in the market by taking relevant user wishes into account early on in the product development process and implementing them in innovations. The keynote speech (15 November) explores which regulatory require- ments are applicable for useability engineering and the opportunities that exist to establish human-centred development processes and to create actual added value for the product user by increasing useability within the scope of user-centred innova- tions. The useability engineering pro- cess is closely linked with quality management and the requirements of the engineering process. In addi- tion, Dr Janny, as an expert, will indicate which types of use-based risks exist and are to be analysed within the course of product devel- opment. Additionally, the question is also explored regarding which proto- types companies can generate with- out great cost and effort in order to validate their medical products early on with real users. Since COMPAMED could only be held digitally last year, due to the pandemic, the event now takes place publicly again. Almost 500 regis- trations from exhibitors prove that there is a high level of interest from medical technology suppliers – a huge step towards reaching normal- ity again. Both the omnipresent Covid-19 pandemic and its consequences pro- vide much food for thought: ‘Due to the impact of the corona crisis, supply bottlenecks have occurred: flight and seaborne transportation cancellations have led to huge sup- ply bottlenecks, particularly for elec- tronic products. During the crisis, this was exacerbated by unnecessary stockpiling. Companies bought and stored more components than they needed to ensure they were safe, because they were scared of experi- encing a shortfall in supply,’ explains Dr Thomas R Dietrich, CEO of the IVAM International Microtechnology Business Network. Raw materials and individual com- ponents were also scarce, because the industry recovered more quickly than many suppliers expected it to. However, this will return to normal within a short period of time. Computer chips also became in short supply during the crisis because medical technology suppliers in par- ticular suddenly needed far more of them. Dr Meinrad Lugan, CEO of BVMed, recently put the situation into perspective: In many sectors, the issue was not shortages in terms of quantity but, instead, distribution issues. Lugan notes that there was a ‘trend to make huge excess orders or multiple orders’. The resulting sup- ply bottlenecks should be combated using ‘smart digital solutions based on existing e-standards’. According to IVAM, internation- alisation of the economy would still be expedient, as the global sup- ply chains could not be maintained, which is the opposite of constructive. European manufacturers need the option to carry out production at a lower cost in other countries in order to remain competitive. These produc- ing countries, in turn, need European EH @ MEDICA 2021