#AI-based medical devices and IVDs offer new opportunities, but they also pose new challenges – for entrepreneurs who want to bring such products to market, as well as for regulators who want to ensure their safety for patients. In our latest #4CCloseUp webinar, Dr. Vera Roedel and Michael Rammensee introduced us to Prof. Valmed®, a tool that uses innovative AI technology to provide healthcare professionals with validated medical information as a medical co-pilot. Together with MII expert Dr. Henrike Stutzki, they discussed the topics of validation, clinical evaluation and certification process in the context of such a Large Language Model. You missed the webinar? Here are our key learnings: ✅ The data sets used to train and test the AI/algorithm are crucial because they affect the safety and performance of your SaMD. Make sure they are comprehensively described and documented. ✅ Make sure you define the Intended Use generic enough so that planned future versions of the software will still be within the existing Intended Use. This gives you more flexibility. ✅ Start an early exchange with the Notified Bodies (NB) about your planned validation strategy. Also for NBs, AI-based medical devices are new and the existing regulations and guidelines need to be interpreted for such innovative software products. What are your experiences when it comes to AI in #healthcare? -- Your startup needs help with setting up a regulatory roadmap and implementing its milestones? We support you with individual #4CServices, just let us know your needs 📧 [email protected]
Medical Innovations Incubator GmbH
Unternehmensberatung
Tübingen, Baden-Württemberg 4.211 Follower:innen
Home of 4C - Enabling Life Science Innovations
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Medical Innovations Incubator GmbH (MII) from Tübingen is a wholly owned subsidiary of the non-profit Stiftung für Medizininnovationen. Thanks to our high degree of specialization and in-house developed concepts and methods, "4C" and "Regulatory Thinking®", we have become a central institution for the promotion of MedTech startups in Germany. Every year, over 120 international startups apply at the MII for support and training in order to work together with our experts to develop a promising and regulatory plausible business model. Our formats and services save startups valuable time and resources and reduce the risk of failure. This allows innovative products to reach patients faster! If this is of interest to you, just contact us via LinkedIn or our website. Best regards Ingo Hämmerle (CEO) -- Die Medical Innovations Incubator GmbH (MII) aus Tübingen ist eine 100%-ige Tochter der gemeinnützigen Stiftung für Medizininnovationen. Durch unseren hohen Spezialisierungsgrad sowie der eigens entwickelten Konzepte und Methoden, „4C“ und „Regulatory Thinking®“, haben wir uns zu einer zentralen Institution zur Förderung von MedTech-Startups in Deutschland entwickelt. Jährlich bewerben sich über 120 internationale Startups um Unterstützung und Ausbildung beim MII, um gemeinsam mit unseren Expert:innen ein erfolgsversprechendes und regulatorisch plausibles Geschäftsmodell zu entwickeln. Durch unsere Formate und Dienstleistungen sparen Startups wertvolle Zeit, Ressourcen und reduzieren das Risiko des Scheiterns. So gelangen innovative Produkte schneller in die Anwendung an den Patient:innen! Wenn das für dich interessant ist, dann kontaktiere uns einfach über LinkedIn oder unsere Website. Herzliche Grüße Ingo Hämmerle (CEO)
- Website
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http://www.mi-incubator.com/
Externer Link zu Medical Innovations Incubator GmbH
- Branche
- Unternehmensberatung
- Größe
- 2–10 Beschäftigte
- Hauptsitz
- Tübingen, Baden-Württemberg
- Art
- Privatunternehmen
- Gegründet
- 2014
- Spezialgebiete
- Entrepreneurship, Unternehmensgründung, Startups, Company Building, Medizin, MedTech, Funding, Life Science, MDR, ISO 13485, Pre-Seed, Finanzierung, Plattform, Chancen, Zertifizierung, CE-Kennzeichnung, De-Risking, Pitch-Training, Business Model und Netzwerk
Orte
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Primär
Eisenbahnstraße 63
Tübingen, Baden-Württemberg 72072, DE
Beschäftigte von Medical Innovations Incubator GmbH
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Sudheesh Kanichattumadathil Sudhan
Quality Manager, ET Elastomer Technik GmbH, Hammelburg, Germany
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Katarzyna Koba
AIXR Analyst and Strategist · CEO at RoboKoba · Digital Artist · Author · 5.0 Leadership · New Tech Popularize · Founder at SensiVR Health ·…
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Philipp Krais
Managing Partner | Audit & Advisory | WirtschaftsTreuhand
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Ingo Hämmerle
Coaching 4C-Connected and Building my Own Startup
Updates
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Application window closed – now it's back to our Idea Evaluation Board! For round no. 8 of the #4CAccelerator we received more than 40 applications from innovative #MedTech startups from all over Germany and beyond. But how to select the most promising product ideas? We are grateful that we can entrust this task to our Idea Evaluation Board. Its 13 members combine #industry experience, competencies in life science #research and experience from medical practice at #clinics – the necessary basis to ensure a qualitative evaluation. Many thanks to the entire board for its extraordinary commitment: ⭐ Prof. Dr. Hugo Haemmerle, chairman of the board & former director of NMI Naturwissenschaftliches und Medizinisches Institut ⭐ Prof. Dr. Michael Auer, chairman of Steinbeis Foundation - StW & managing director at Steinbeis Hochschule ⭐ Thomas Bogenschütz, CEO at MEDIRA ⭐ Dr. Thilo Brinkmann, managing director at B. Braun Stiftung - der Gesundheit neue Wege bereiten ⭐ Prof. Dr. Ulrike Ernemann, medical director of the Department of Diagnostic and Interventional Neuroradiology at Eberhard Karls Universität Tübingen ⭐ Prof. Dr. Bernhard Hirt, director of the Institute for Clinical Anatomy and Cell Analysis at Eberhard Karls Universität Tübingen ⭐ Dr. Klaus-Martin Irion, member of the board of administration of KARL STORZ ⭐ Dr. Ute Fink, project manager at Forschungszentrum Jülich. ⭐ Prof. Dr. Oliver G. Opitz, head of the Koordinierungsstelle Telemedizin Baden-Württemberg (KTBW) ⭐ Dr. Barbara Jonischkeit, division manager at BIOPRO Baden-Württemberg GmbH ⭐ Dr. Klaus Maleck, CFO at ITM Isotope Technologies Munich SE ⭐ Dr. Alfred Stett, CEO at Okuvision GmbH. ⭐ Prof. Eberhart Zrenner is Senior Professor at Eberhard Karls Universität Tübingen & founder of the Stiftung für Medizininnovationen.
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Have you already signed up for next week's #4CCloseUp webinar? On Tuesday, July 30, we'll tackle the question of how to certify an #AI-based product as a medical device. We have invited Dr. Vera Roedel, who will share practical insights from her startup Prof. Valmed® - validated medical information GmbH. Together with Michael Rammensee she will talk about validation, clinical evaluation and the certification process in the context of a #LargeLanguageModel. In the following Q&A you will have the opportunity to ask them and Dr. Henrike Stutzki, MII Consultant & Expert for C3-Clinical Studies, all your questions! Sound like a great opportunity? Then sign up here for #free 👉 https://lnkd.in/ekSF9sbX
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It's a wrap! Last week, batch no.7 of the #4CAccelerator successfully completed the #4CWorkshops 💪 In a total of 15 workshops, hosted by the Stiftung für Medizininnovationen, the startups gained a lot of new knowledge and transferred it directly into their businesses with hands-on exercises. To sum up this time and to quote one of the participants: "We had a mutually joyful and painful time." 😉 A special thank you to the teams for your commitment, your ambition and your passion to bring your innovations into the #healthcare system: Aicendence, EndoSurge, #LiSa, Powered Orthotics, Proskope, QuantiLight, relios.vision and SmartAIs! It was a pleasure to accompany you through the workshops and our 4C Experts Ingo, Christian, Ramona and Henrike are now looking forward to supporting your journey in 1-on-1 coaching for another year. Also, many thanks to Tilmann Petersen from HTGF | High-Tech Gründerfonds and Annika Russo from MBG Baden-Württemberg GmbH for being sparring partners in our final session. -- The program is funded by Start-up BW of the Ministerium für Wirtschaft, Arbeit und Tourismus Baden-Württemberg, the B. Braun Stiftung - der Gesundheit neue Wege bereiten, and the Hector-stiftung. #startupbw #startupbwaccelerator
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#NetworkNews – As part of the Tech & Trends Discovery Days on July 24, founders can get a free consultation with the experts from elbe electronic GmbH, Stefan Jacob and Dr. Volker Gengenbach! 👉 Secure your slot by sending an email to [email protected] For more information and to register for the event visit https://lnkd.in/e4YNk-WF
🚀 An alle Gründer:innen und Tüftler:innen: Am 24.07.24 bekommt Ihr Jahrzehnte an Elektronik Know-How for free! ✨ Unser TECH CONSULTING ist ein Format im Rahmen unseres TECH & TRENDS DISCOVERY DAY, bei dem wir Gründer:innen und sonstige Tech-Enthusiasten mit unseren erfahrenen C-Level Techies (Elektronikentwicklung Hardware/Firmware, PCB Design) zusammenbringen, um gemeinsam in die konkreten Projekte der Gründer:innen einzutauchen. In einem Beratungs-Slot von 20-30 min. könnt Ihr Fragen zu Eurem Projekt stellen und wertvolle Tipps erhalten, die Euch direkt voranbringen. Ob genereller Überblick über Euer Design oder sehr konkrete Fragestellungen im tiefsten Detail -- unsere Experten machen ihr geballtes Wissen aus mehreren Jahrzehnten Erfahrung und vielen hundert Projekten für Eure konkreten Themen verfügbar! Unser Angebot ist: ✅ live vor Ort ✅ auf Augenhöhe ✅ kostenfrei ✅ für alle interessierten Startups (oder sonstige Entwickler:innen) ✅ absolut vertraulich (gerne schriftlich untermauert durch ein NDA) Wenn das für euer Startup spannend klingt und Ihr einen der limitierten Slots ergattern wollt, dann meldet Euch am besten heute noch für das TECH CONSULTING an 📝 Außerdem habt Ihr an dem Nachmittag die Gelegenheit die sonstigen Angebote des TECH & TRENDS DISCOVERY DAY wie Werksführungen, Vorträge usw. kostenfrei zu nutzen. Den Link zur Anmeldung findet Ihr in den Kommentaren 👇 #techtrends2024 #electronics #engineering #startups #networking
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The countdown is on! ⏰ Only until this Friday, July 19, can founders with innovative products that will improve tomorrow's patient care apply for the sought-after #4CAccelerator. Your benefit of participating? ✅ Learn how to overcome the regulatory hurdles of the healthcare industry ✅ Build a proper market access strategy and learn how to implement it ✅ Become investor ready, because as Katharina Severin from HTGF | High-Tech Gründerfonds stated: "Without a clear understanding of the 4Cs, a MedTch startup will most likely not be able to raise venture capital." Find all information and the application here 👉 https://lnkd.in/gvby99JB The program is funded by Start-up BW, the B. Braun Stiftung - der Gesundheit neue Wege bereiten, and the Hector-stiftung. #startupbwaccelerator
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What an EVÄNT! This year's Start-up BW Summit took place in Stuttgart, the heart of THE LÄND 💛 And what can we say? It was a blast! 🎤 First: An engaging opening by Baden-Württemberg's Minister President Winfried Kretschmann and Minister of Economic Affairs Dr. Nicole Hoffmeister-Kraut. Both emphasized the value of founders and the startup ecosystem for our economy: Baden-Württemberg is a hotspot for innovation, a place where ambitious people dare to go the extra mile! 🚀 Then: More inspiring panel discussions and keynotes, where entrepreneurs and experts shared their experiences and discussed current topics. However, our highlight was the huge exhibition with more than 100 startups presenting their innovations. We are especially proud, that one could find so many startups of the #4CCommunity: Treyetech, EndoSurge, Powered Orthotics, EVERSION Technologies, Fysor GmbH, sync2brain GmbH, ACTIMI, eatappie, and coreway. Also showcasing, the ecosystem with all its various startup supporters – including us. Thanks to everyone who passed by our booth. Henrike and Lea enjoyed meeting you! 🍻 And finally: Grateful for this vibrant community, we raised our glasses and ended the day with sunshine and good company! Many thanks to the entire Start-up BW team for organizing and hosting the summit!
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#FemaleCommunity – How could #DigitalDetix help me become a better leader? At our last #FemaleFounders meeting with Miriam Moser, expert on digital transformation, we discussed the topic of #DigitalStress and how to avoid it. In her impulse talk, Miriam highlighted how taking a break from digital devices can enhance ... 💙... our health, especially in the long term, by reducing stress. 💡 ... our creativity and productivity by giving us a break. 🚀 ... our ability to lead, as stress is transferred to the team. Together we discussed strategies that are easy to implement in our daily lives: ✅ Having two phones or numbers to distinguish between business and personal communication. ✅ Turn off push notifications, such as your email inbox, on your phone. ✅ Use handwritten notes and excludes laptops and phones from meetings when possible. ✅ Plan your vacations well or – if there’s no way around – consciously schedule times to answer urgent emails. What are your strategies for avoiding digital stress?
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How to certify an #AI-based product as a medical device? Sign up for our next #4CCloseUp webinar on July 30, 2024, where we will discuss the topics of validation, clinical evaluation, and certification process in the context of a #LargeLanguageModel. 🗨 Meet our speakers! Dr. Vera Roedel is Co-Founder and CEO of Prof. Valmed® - validated medical information GmbH. As a lawyer holding a Master in Health and Medical Management she is active in the pharmaceutical industry and the healthcare sector for several years. This wealth of experience allows her, along with her Co-Founder Heinz Wiendl, to pinpoint the needs of healthcare professionals endorsing Prof. Valmed‘s® vision. Dr. Henrike Stutzki is Consultant & Expert for C3-Clinical Studies at our team. She has many years of experience in coordinating clinical trials for medical devices but also brings a scientific background in biology and neuroscience. In addition to MII, she works as Head of Clinical Affairs at the MedTech startup sync2brain GmbH. Her practical experience from previous positions as well as from her current role in a startup add great value to her coaching and consulting of our clients. Sign up here for #free 👉 https://lnkd.in/ekSF9sbX
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We already had a home game yesterday! ⚽ This year's #Sommerempfang of the BioRegio STERN Management GmbH took place in our hometown of #Tübingen. As always, it was a great opportunity for all stakeholders from the #MedTech and #BioTech sectors in the region to come together and discuss the latest developments. Also, the winners of the #Science2Start competition were award. Congratulations to all the winners! 👏 Ingo Hämmerle, Dr. Ramona Samba and Christian Dorn from the MII team enjoyed a great evening with lots of insightful conversations. Thanks to the BioRegio STERN team for hosting this valuable event: Klaus Eichenberg, Margot Jehle, Klara Altintoprak, Anja Reutter, & Lara Tank, just to name a few!
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