Medtech Manufacturing

Worried AI will make your medical device obsolete? Discover why traditional devices remain viable and how to incorporate AI in your development process. AI is transforming healthcare, but it’s not replacing traditional devices. The FDA has approved over 1,000 AI-enabled devices, mainly in radiology and cardiology, where AI excels in image and pattern recognition. Outside these areas, AI integration is limited. Devices like insulin pumps and surgical instruments rely on mechanical or biological mechanisms, not AI. The regulatory landscape ensures a stable environment for current device development. AI can support your process without complicating your product. Use AI strategically to enhance development, not as a core feature. Focus on solving real medical problems and stay updated with emerging technologies. At Concise Engineering, we help you navigate these challenges. Contact us to explore how AI can fit into your strategy. 👓 Read the blog now: https://lnkd.in/ek_eBZp3 🖊️Subscribe to our newsletter: https://lnkd.in/ekJUfpnb #medtechman #medtech #innovation #AI #healthcare

Following the record-breaking success of The MedTech Forum 2024 in Vienna, comes the The MedTech Forum 2025 in Lisbon from May 13-15. This event will bring together leading voices in medical technology to explore innovation, digital transformation, regulatory developments, and sustainability. https://lnkd.in/dvQZcfg Get in on the chance to network, share ideas, and forge new partnerships. Key sessions will address the EU-UK market access reset and the transformative potential of digital solutions in the IVD sector. Show up to shape the future of #medtech! #MedTechForum2025 #Lisbon #MedicalTechnology #Innovation #Networking #MedtechMan

Hey Amazon, I hear a gauntlet has been thrown! The debut of drone delivery for urgent blood samples is set to revolutionize patient care in London. https://lnkd.in/ewifj64D Electric drones will transport samples between Guy’s Hospital and St Thomas’ Hospital in under two minutes, significantly faster than traditional road transport. This innovation not only speeds up analysis, crucial for patients at high risk of complications, but also offers environmental benefits by reducing carbon emissions. The six-month trial, a collaboration between Guy’s and St Thomas’, Apian, and Wing, marks a first for the NHS in London. This initiative highlights the potential of drones to enhance healthcare logistics, making them more responsive and sustainable. #medtechman #medtech #innovation #dronetechnology #healthcareinnovation #sustainability #NHS #London #amazon

Unlocking market gaps in the medical device industry is crucial for innovation. As the landscape shifts from traditional ORs to ASCs, opportunities arise for compact, portable devices. Identify market gaps by: Observing clinical settings Talking to clinicians Examining underserved areas. Then validate your idea through market research, patent searches, and competitor analysis. By addressing real market needs, your innovation can thrive. 👓 Read the blog now: https://lnkd.in/e82nWZtD 🖊️Subscribe to our newsletter: https://lnkd.in/ekJUfpnb #medtechman #medtech #innovation #healthcare #medicaldevices

Join us for an insightful episode of the Community Industry Podcast featuring Axel Strombergsson, VP at QuickVault, Veeva Systems. LISTEN: https://lnkd.in/euzwJxvJ With 18+ years in #medtech, Axel shares his journey from mechanical engineering to a leader in medical device innovation. Discover AI breakthroughs, startup growth, and investor insights. Axel discusses AI-powered diagnostic tools, proactive healthcare models, and the evolving role of startups in advancing medical technologies. Gain valuable advice on preparing for funding rounds, building impactful pitch decks, and addressing key investor concerns. Don't miss this opportunity to learn from a fellow seasoned expert in #medtech innovation. #AI #startups #healthcare #entrepreneurship #investorinsights #medtechman #medtech #innovation

In NPD, you never know what to expect! Unpredictability is the only constant. Embracing the unexpected, knowing that innovation often emerges from the most surprising places..... "Polar bears on average succeed only once in 20 hunts!" The Polar bear despite its struggle continues to try. Each failed hunt is a moment that tests the bear's determination and reliance. True character emerges when things don't go your way. Who are you when it goes South? When you really pay attention, everything around you is your teacher. #nature #perseverance #resilience #medtechman

Navigating the complexities of risk management is crucial for successful project execution. We proudly bring over two decades of expertise in crafting risk management SOPs and managing essential documentation across diverse projects. Our deep understanding of the DFMEA process allows us to minimize late-stage design changes, ensuring smoother project flows. https://lnkd.in/ef-MPx43 We handle every analysis and compliance document with precision, including 510(k), PMA, Electrical Product Safety, and more. Whether working within your existing processes or providing comprehensive documentation, we ensure all requirements are met. Trust us to guide you through ISO 14971:2007 / EN ISO 14971:2012 standards, Risk Management Plans, and Risk Analyses like PHA, DFMEA, PFMEA, and FTA. Let's turn today's vision into tomorrow's innovation. #RiskManagement #MedTech #Innovation #EngineeringExcellence #ProjectSuccess #medtechman

NEWS: Movano Health has received FDA 510(k) clearance for the pulse oximeter feature in its Eviemed smart ring. Interestingly, this development comes amid industry focus on addressing racial bias in pulse oximeters, with Movano's device showing accurate readings across diverse skin tones. https://lnkd.in/gmwBRdxR This milestone allows Movano to market the device to clinical trial organizations and healthcare companies managing chronic diseases. The clearance was achieved through trials comparing its accuracy to traditional pulse oximeters. Movano's focus on FDA-grade accuracy and a comfortable wearable design sets it apart in the market. With active discussions with major partners, including a global pharmaceutical company and a clinical research organization, Movano is poised to make significant strides in both clinical and consumer applications. The company is also in the agreement phase for a pilot study with a large payor, aiming to use the ring as part of a metabolic solution for chronic disease management. #medtechman #medtech #innovation #biomedicalengineering #healthcaretechnology #fda

Let's get to the "heart" of the matter with AI. A Primary Care physician, a 58-year-old advocate for healthy living, discovered the life-saving power of technology. Despite an active lifestyle and no family history of heart disease, a CCTA with AI scan revealed a blocked coronary artery. https://lnkd.in/ectNXhyK This non-invasive test uses AI to produce 3D images of the heart's arteries, identifying plaque buildup that could lead to heart attacks. Early detection through AI-driven CCTA can save lives by allowing timely intervention. Heart disease remains the leading cause of death in the U.S., often striking without warning. This physician's experience underscores the importance of regular check-ups and advanced diagnostics. Take charge of your heart health today. #HeartHealth #AIinMedicine #PreventiveCare #LeeHealth #ValentinesDay #medtechman #medtech #innovation (Image courtesy of: https://lnkd.in/ejzTMUeu)

Ever wondered when to add data collection and cybersecurity to your device? Timing is everything! In the world of medtech, integrating data collection and cybersecurity at the right moment is crucial. #medtechman #medtech #innovation #cybersecurity #datacollection #biomedicalengineering #funny