Nikos Galanis

A date for the diary ⬇️ Get more medical insights on diagnosis of Colorectal Lesions Using the #JNET Classification with Dr. Alanna Ebigbo (Germany), and level up your knowledge in Endoscopic Suturing (Experience, Tricks and Possibilities) with Dr. Enrique Rodriguez de Santiago (Spain).

2

🏥🇩🇪 𝙈𝙚𝙙𝙞𝙘𝙖𝙡 𝙩𝙚𝙘𝙝𝙣𝙤𝙡𝙤𝙜𝙮 𝙞𝙣 𝙂𝙚𝙧𝙢𝙖𝙣𝙮: 𝙀𝙭𝙘𝙚𝙡𝙡𝙚𝙣𝙩, 𝙗𝙪𝙩 𝙩𝙝𝙧𝙚𝙖𝙩𝙚𝙣𝙚𝙙! 🚀 The autumn survey of the German Medical Technology Association (BVMed) shows alarming results. Although Germany's medical technology sales has a 4.8 percent increase in turnover compared to 2022, the challenges are enormous. Here are the main reasons: 👇🏻 1. 𝘽𝙪𝙧𝙚𝙖𝙪𝙘𝙧𝙖𝙘𝙮 𝙖𝙣𝙙 𝙧𝙚𝙜𝙪𝙡𝙖𝙩𝙞𝙤𝙣: ⚙️ Excessive bureaucracy and regulation slow innovation and increase administrative burdens. 2. 𝘾𝙤𝙨𝙩 𝙞𝙣𝙘𝙧𝙚𝙖𝙨𝙚𝙨: 💰 Rising costs for labour, logistics, raw materials and energy put pressure on companies' profit margins. 3. 𝙈𝘿𝙍 𝙞𝙢𝙥𝙡𝙚𝙢𝙚𝙣𝙩𝙖𝙩𝙞𝙤𝙣: ⏳ The high cost and effort required to comply with the EU's Medical Device Regulation (MDR) is an additional burden on the industry. For marketers, three key factors are now important: 1. 𝙄𝙣𝙘𝙧𝙚𝙖𝙨𝙚 𝙫𝙞𝙨𝙞𝙗𝙞𝙡𝙞𝙩𝙮: 👁️ Use targeted marketing to increase the visibility of your brand and products. Digital channels offer great potential for spreading your message. 2. 𝙃𝙞𝙜𝙝𝙡𝙞𝙜𝙝𝙩 𝙮𝙤𝙪𝙧 𝙞𝙣𝙣𝙤𝙫𝙖𝙩𝙞𝙤𝙣: 🗣️ The medtech industry is in desperate need of innovative solutions and your products can make a difference. 3. 𝙎𝙩𝙧𝙚𝙣𝙜𝙩𝙝𝙚𝙣 𝙘𝙤𝙡𝙡𝙖𝙗𝙤𝙧𝙖𝙩𝙞𝙤𝙣: 💪🏻 Work closely with policymakers and industry to increase the resilience of the German healthcare system. A strong community is key to success. Germany can maintain its outstanding position in medical technology, but only if we face the current challenges with courage. Together, we can protect and strengthen this location. ❗️What threats do you see for Germany as a medical technology location? Are you willing to continue investing in Germany? 🤔 #Medtech #Germany #Innovation #Marketing #Sales #MDR #Medicaltechnology #Medicaldevices #Technology Thanks to BVMed - Bundesverband Medizintechnologie https://lnkd.in/enUbPzMn

1

I had the (unpleasant) opportunity to test the Austrian healthcare system from the patients side lately (don’t worry, nothing that serious). Here are some observations on the digitization of the Austrian healthcare system: in a nutshell it's none-existing… 🤷‍♂️ There is a total disconnect between office based primary care and hospital / secondary care. The patient has to hand carry handwritten, illegible notes between the institutions. All on paper. 📜 I received a paper binder in primary care full of forms to fill by hand and bring to my surgery (medical history, anesthesia questionnaire, informed consents, etc - all paper). Everyone relied on me as a patient to know prior procedures, underlying disease and medication. 🏥 Also all processes in the hospital were paper based (was a small private institution). My release note of course again printed on dead trees and had to be hand carried back to primary care to get medication prescription (at least the prescription was finally digital). I checked my electronic personal medical record (ELGA), which has been in place in Austria for many years, and - surprise, surprise, almost totally empty (just a lonely MRI report in there). Unbelievable waste of money. So in summary: the system totally relies on the patient and on paper - this is so bad from different angles - quality, efficiency, cost - prone to mistakes. Just thinking how this would ever work with patients that have dementia and no relatives that manage the process properly. The ELGA system (personal electronic medical record) is not used and thus just waste of money. Digitization in healthcare is a big opportunity, but we have a long way to go in Austria………. Johannes Rauch Andreas Huss Stefan Sabutsch #digitalhealth

81

26 Kommentare

Meet Prof. Dr Wieland Sommer, our next guest on Staying Zoned In, "Entering a New Era of Radiology Reporting", June 6. He brings a unique perspective to this episode, being a radiologist, Professor in oncologic imaging, and founder of two digital health companies. We’ll discuss topics such as large language models, generative AI, ambient reporting, and other new advances that are aligning to create a reporting renaissance!

1

Lung cancer screening and "body checkups" in China Recently, I visited China again and had the chance to interact with clinicians and visit a hospital. A very frequent phenomenon in China are so-called "body checkups", CT scans of the chest or other examinations that are either self-paid or employer-paid, as part of a salary package. These chest CTs are often carried out on people who have no specific risk of lung cancer: Young, often female, many non-smokers without family history. These scans are often actively marketed by commercial providers. This of course raises concerns with regards to overdiagnosis, and indeed this has been studied - see the attached graph from Wang et al (DOI: 10.1016/j.chest.2022.08.2207). We see a steep raise in diagnosed cases of lung cancer, especially among women, which is not accompanied by a decrease in late-stage diagnosis or mortality. This is a pathognomonic sign of overdiagnosis. Of course this needs longer follow-up and more data about the "natural" progression of slow-growing adenocarcinomas - the observation period may just be too short, given that the raise in diagnosis started just around 2012, so there is only 5 years of follow-up. We know from other studies that adenocarcinomas are often relatively stable for several years before they start growing. Still, these CT-scans in low-risk persons are clearly not what we would consider evidence-based. As there seems to be relevant demand, and this practice will likely continue, what can be done: - Most important: Longer follow-up before any invasive measures - we know from the results of the International Early Lung Cancer Action Program (I-ELCAP) team that gound-glass lesions can safely be followed up over longer time - Lower radiation doses: As the benefit of these scans is not clear, at least the radiation dose should be carefully monitored and reduced - Establish targeted lung screening programs for at-risk-populations as an alternative Also, more data is needed on the "natural" course of indolent adenocarcinomas - is there something like "spontaneous regression" or adenocarcinoms? Or just slow progression? P.S.: I forgot to add the price for these examinations: Payment is around 15-30 Euro. In the wealthy cities, this is very affordable.

46

14 Kommentare

One line of code = 4 years of validation. The essential risk score for stroke. Just one sum. Some notified bodies classify it as Class IIb. How can that be? Because a mistake could endanger millions of lives. Indeed, that one calculation took 4 years to validate. 100 000+ patients. The complexity of your product does not matter. It doesn’t matter whether it contains one line of code or millions. Nor if it incorporates AI, quantum computing, or teleportation. What matters to the patient is the medical impact. And that's also all that matters for notified bodies.

63

27 Kommentare

🚀 𝑩𝑰𝑶𝑻𝑹𝑶𝑵𝑰𝑲 𝑹𝒆𝒗𝒐𝒍𝒖𝒕𝒊𝒐𝒏𝒊𝒛𝒆𝒔 𝑪𝒂𝒓𝒅𝒊𝒂𝒄 𝑴𝒐𝒏𝒊𝒕𝒐𝒓𝒊𝒏𝒈 𝒘𝒊𝒕𝒉 𝑮𝒍𝒐𝒃𝒂𝒍 𝑳𝒂𝒖𝒏𝒄𝒉 𝒐𝒇 𝑩𝑰𝑶𝑴𝑶𝑵𝑰𝑻𝑶𝑹 𝑰𝑽 𝒘𝒊𝒕𝒉 𝑺𝒎𝒂𝒓𝒕𝑬𝑪𝑮 🚀 #Cardiovascular #MedicalTechnology #AI I'm so excited to announce the global market release of BIOTRONIK's 𝐁𝐈𝐎𝐌𝐎𝐍𝐈𝐓𝐎𝐑 𝐈𝐕 with SmartECG, the latest generation of implantable cardiac monitors (ICMs) powered by Artificial Intelligence (AI)! 𝗧𝗵𝗶𝘀 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗜𝗖𝗠 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝘀: 🏅 Increased Arrhythmia Detection Accuracy: New AI algorithms reduce false positives by 86% across major arrhythmias. 🏅 Enhanced Workflow for Clinicians: Clinical evidence shows SmartECG significantly reduces workload, freeing up valuable time for patient care. 🏅 Industry-First PVC/PAC Discrimination: BIOMONITOR IV clearly reports the burden of Premature Ventricular and Atrial Contractions, aiding personalized treatment decisions. 𝐁𝐈𝐎𝐌𝐎𝐍𝐈𝐓𝐎𝐑 𝐈𝐕 represents a leap forward in cardiac monitoring, empowering clinicians with actionable data and improved efficiencies. Key Takeaway: "Intelligence. Confidence. Clarity" - This tagline reflects the key benefits: reduced review burden, operational efficiency, and personalized treatment decisions. Call to Action: Are you interested in learning more about how BIOMONITOR IV with SmartECG can benefit your practice? Connect with me to discuss how this innovative technology can improve your patients' care! #BIOTRONIK #BIOMONITORIV #SmartECG #CardiacMonitoring #AI #CardiovascularTechnology

45

1 artificial night -  3'000 - 5'000 USD 100 objective nights - much much less    Yes, polysomnography is the most accurate way of monitoring sleep. I agree.  However, is it really worth 100x more than an objective sleep measurement at home?   Imagine you can choose between the two - How would you make your decision? #sleepmonitoring #realworlddata #digitalhealthtechnology #dht #dct #decenteralizedclinicaltrials

6

Good bye #Directives for Medical Devices in the #EU. Now, the real countdown is running and we should not lose any more time. #Authorities should stop overexpecting from notified bodies, #Notifiedbodies should act as professional and pragmatic experts, and #Manufacturers should deliver good documentation in line with current state of the art and standards. We need to work together towards ensuring continuity of an efficient healthcare system!!! Read the amendment 2023/607 to understand your deadline! Have your manufacturer declaration and its supportive evidence ready for any request by authorities or notified bodies. #MDD #AIMDD

376

13 Kommentare

#foodforthought 💡 After familiarizing myself with the technology AI / GenAI in my private and professional life, I created an overview including 4 pillars (for now) which I - personally consider as important when getting in touch with this topic. #GenAI

32

Our plea to the MDCG: keep it fair, keep it neutral. MEDDEV 2.7/1 revision 4 was remarkable in many good ways. Not least because it kick-started evidence-based medicine in medtech. Not just in Europe: in the world. However, it could also be remembered for one negative aspect. It was the first EU guidance to explicitly promote private services. Specifically, it promoted paywalled services for device name searches. We believe that this matters because: - Horrendous subscription costs can bankrupt startups and small companies; - Clinical research should champion open access; - The guidance overlooked more comprehensive, free alternatives; (list of links alternatives coming in the comments soon) The MDCG Update of the clinical evaluation guidance is on its way. Our plea to the expert group is simple. Please, keep it fair, keep it neutral.

102

20 Kommentare

Yes, it's real! The VivaScope 2500 (Ex Vivo) can scan the excised tissues during surgery so that the cut edge can be checked immediately and further surgery can be performed within minutes. VivaScope Confocal Microscopy Europe #VivaScope #Digitalization #Histopathology #Cancer

11

2 Kommentare

Martin Guttman explains beautifully in this TEDx Talk why our heroes tend to come from a lot of drama and action rather than detailed planning and seamless (i.e. no drama) implementation. After all, we all love a good Hollywood story more than a boring story where no heroic action is needed, mainly because all issues are carefully prevented from the beginning. Martin's talk is a good reminder that avoiding (preventing) problems from the beginning is much better than heroically struggling to find a way out of them. A good problem is the one that never happened. In my experience, the action bias -- the cognitive bias that nudges us towards celebrating action, any action, over inaction including thinking and planning -- is one of the most common causes of failures in the problem solving world too. I have seen many problem solving teams jumping hastily to their first actions before spending even half an hour on reflecting on the problem itself. Action bias creates an impatience that leads individuals to jump over critical steps to fact-check their problem knowledge, go and see the problem in reality and carefully consider various aspects of a problem. When there is an urgent problem, there is pressure on the team to "take action". This can lead to insufficient understanding of the problem and missing various risks in implementation. Furthermore, most of the problem solving teams struggle with making the fix permanent -- updating protocols, processes and checklists and making them stick. If you are in a #leadership position and want to enable your team to be real heroes, be sure to change your questions from "time focused" to "facts focused". Instead of asking "how fast can you solve this problem?", try asking "what plans do you have to solve this problem? What steps should we take?" and even "do we have facts to fully understand this problem?" The thing is that you will get "speed" automatically when you have good facts and plans and when you enable your team to see the problem clearly. The alternative is chaos -- even though it "feels" fast. People running around gives a false feeling of being fast but there is nothing substantial achieved. Actually, there is a big risk that people running around are just trying to put out small fires that they helped create!

5

Here is a good example of how a successful robotic program is delivered. #roboticsurgery #mdtemployee #medtech #medtechmarketing #urology

15

Together with the cluster organizations Standortagentur Tirol, LISAvienna, Human.technology Styria GmbH, Medizintechnik-Cluster and ecoplus. Niederösterreichs Wirtschaftsagentur GmbH, we are once again expanding the regional MDR regulars‘ tables into an Austria-wide online forum roundtable. ONLINE-ROUNDTABLE: Regulatory Update for Medical Software, Apps, Digital Health and AI (English) 📆 May 13, 2024 ⏲ 4:00-6:15 p.m. 👉 This will be our first one in English and will focus on what manufacturers need to know about Medical Device as Software under MDR with reflections on the impact of AI. PROGRAM: 👉 Update: Life Science Cluster Austria 👉 Regulatory Update: Medical Device Software & Apps, Digital Health and Art. Intelligence: Martin Schmid, en.co.tec - Medizinprodukte-Consulting & Akademie 👉 Challenges for Medical Device Software under MDR Sreenath S. – BSI AI Regulatory Services 👉 Best Practice: Medical Software, Apps, KI under MDR Health Pioneers 👉 Standards for artificial intelligence in medical devices: what we have – what we need – what we can expect! Volker Sudmann, mdc medical device certification GmbH Each presentation will be followed by an opportunity to ask the experts your specific questions! 🎫 Information & Registration (free of charge): https://lnkd.in/djttYUAq We would be delighted if you could be there!

6

Regulatory Thinking® means considering the (additional) regulations of the target markets, the strategy for clinical evaluation, the (subsequent) market position and classification from the outset. One example: Odilia has launched VISIOCOACH, a SaMD that is now listed in the GKV's list of medical aids (Hilfsmittelverzeichnis / HMV) based on the principles of regulatory thinking. A new subgroup was defined in 2024 in HMV specifically for VISIOCOACH: "Medical training software". This is a proof of „The Power of Regulatory Thinking“ #OdiliaVisionGmbH #RegulatoryThinking #dTIP #CASRegulatoryThinking #ETH #MII #4CAccelerator #SARMA

4

Wouldn't life be better if removing uncertainty were part of everyone's goal? With TÜV SÜD's Structured Dialogues we provide clarity prior to a formal MDR application for your orthopaedic medical devices. Structured Dialogues are independent of your MDR conformity assessment to ensure impartiality and objectivity in your framework. 💡The purpose of a structured dialogue prior to lodging a formal MDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents. Be one step ahead of every change in the next generation of safety and reliability! 👉 Do you have any questions? Reach out to us and apply today! https://lnkd.in/gUYVKTTD #TUVSUD #MDR #medicaldevices

24