Archetype MedTech’s Post

🚀 9 Essential Resources Every MedTech Professional Should Bookmark! 🩺 In the fast-paced world of medical technology, staying informed and ahead of the curve is crucial. Whether you're in research, product development, or regulatory affairs, having the right resources at your disposal can make all the difference. Here are 9 must-have sources that every MedTech professional should consider: 1. PubMed Comprehensive biomedical literature, clinical trials, scientific advancements. 🔗 Visit PubMed https://lnkd.in/e963Ktnd 2. Nature Biomedical Engineering Cutting-edge research and reviews in biomedical engineering. 🔗 Visit Nature Biomedical Engineering https://lnkd.in/e-qMSFxs 3. FDA Medical Devices Regulations, approvals, and guidance for medical devices. 🔗 Visit FDA Medical Devices https://www.fda.gov/ 4. MedTech Europe News, regulatory changes, market trends, industry innovation. 🔗 Visit MedTech Europe https://lnkd.in/ehdmcH3S 5. Journal of Medical Devices (ASME) Peer-reviewed research on medical device design and application. 🔗 Visit Journal of Medical Devices (ASME) https://lnkd.in/e2h9NYzu 6. IEEE Transactions on Medical Imaging Research articles on medical imaging technology and applications. 🔗 Visit IEEE Transactions on Medical Imaging https://lnkd.in/eJcdS2us 7. Medical Design & Outsourcing News, trends, and analysis on medical device design. 🔗 Visit Medical Design & Outsourcing https://lnkd.in/enwdrZZx 8. MIT Technology Review - Biomedicine Trends and breakthroughs in biomedicine, diagnostics, and treatments. 🔗 Visit MIT Technology Review - Biotechnology and health https://lnkd.in/e9jk43n2 9. HealthTech Magazine Insights on technology transforming healthcare and patient care. 🔗 Visit HealthTech Magazine https://lnkd.in/ewPjDnJK   These resources offer a comprehensive view of the MedTech landscape, helping professionals stay informed about the latest developments, regulatory updates, and technological innovations. Make sure to keep these sources handy to stay ahead in this dynamic field! 👉 Follow me for more insights and updates, and don't forget to repost to share this valuable list with your network! 👥

Pushing the boundaries of medical innovation: In-house ex-vivo testing at Sinai Medical 🫀 At Sinai Medical, we're passionate about developing life-changing medical devices. But before they reach patients, our talented engineering team puts them through rigorous testing using a unique in-house ex-vivo approach. What is ex-vivo testing? Ex-vivo means "outside the living body." In our case, we create a realistic environment that mimics the human body using tissue samples or organ models. This allows us to: Simulate real-world conditions: We can test device performance under various physiological conditions, mimicking the body's response. Gather valuable data: Ex-vivo studies provide crucial insights into device efficacy, safety, and durability before moving to clinical trials. Refine and improve: The data guides our engineers in iterating and optimizing the device design for optimal patient outcomes. Why is this important? In-house ex-vivo testing offers several advantages: Faster development cycles: By testing early and often, we can identify potential issues and refine designs quickly, accelerating the path to market. Reduced animal testing: Whenever possible, we prioritize ex-vivo testing over animal models, aligning with ethical research practices. Increased confidence: Having robust ex-vivo data strengthens our clinical trial applications and provides greater confidence in device safety and effectiveness. Sinai Medical's engineers are at the forefront of medical device innovation. Their dedication to in-house ex-vivo testing ensures our devices are rigorously evaluated before ever reaching a patient. #medicaldevices #engineering #exvivo

The Challenges of Developing a New Medical Device. Webinar: 12 December 2024 @ 7pm Developing new products is always a challenge and this is particularly so for new medical devices which are subject to tight regulatory control. The talk will cover the intricate journey to develop a new medical device. It will provide an insight into the key phases of the development lifecycle, including formulating the product idea, design and prototyping, regulatory pathways, verification and validation and post market surveillance. For more information and booking: https://lnkd.in/e6MGxAp4

DESIGNED TO FAIL In the competitive world of medical device innovation, it’s tempting to rush into prototyping with a ground breaking idea. However, jumping to design and development without a deep understanding of the clinical needs and market dynamics can lead to costly failures and its VERY common. Understanding the Clinical and Market Fit First: 1) Misaligned Solutions: Prototyping a medical device without thoroughly understanding the healthcare provider’s and patient’s needs can result in a product that doesn’t address the real clinical problem. The healthcare ecosystem is complex, and if your device doesn’t solve a critical issue, it risks being dismissed, no matter how advanced the technology. Worse still, you might hurt someone! 2) Wasted Resources: Developing a medical device is a capital-intensive process. Regulatory hurdles, clinical trials, and manufacturing costs make it vital to avoid missteps early on. If resources are poured into the wrong product concept, it can delay timelines, burn through funding, and severely limit your chance of success. 3) False Validation: Building a prototype too soon may create a false sense of progress. Even a functional medical device doesn’t guarantee success if it’s not addressing the most pressing clinical needs or fitting into existing healthcare workflows. Premature development can also overlook critical regulatory and reimbursement pathways that should influence design. Our Key Takeaway: Before jumping to prototyping, focus on comprehensive clinical research, engage with key stakeholders (doctors, patients, regulators), and ensure the problem-solution / market-product fit is clear. Identify your evangelists and your blockers ... ignore them at your peril. In the medical device world, it’s not just about innovation, it’s about solving real problems in a complex, regulated environment. Avoid the trap of developing the wrong device at the wrong time. #medtech #medicaldevices #productdevelopment #innovation #healthcare #medicalresearch Interested in learning more about medical research translation and commercialisation? Reach out to Mimetic - MedTech Foundry and lets have a chat. Edwina Lim, NSW Medical Research, NSW Health, UNSW, University of Newcastle, Western Sydney University, University of Sydney, University of Technology Sydney, University of Wollongong, Monash University, University of Melbourne, RMIT University, The University of Queensland, Australian Clinical Entrepreneur Program, The Australian National University, MTPConnect, Medical Technology Association of Australia (MTAA), Duncan Macinnis, Lance Chia GAICD, Rahul Shaw, Arthur Brandwood, Luther Poier

" 💥 Recommended Prompt " Advancements and Innovations in Medical Engineering - 4IRGPT.com is an AI Knowledge Trading & Prompt Media Platform for everyone and experts like you. Signup free! Use it to Monetize followers and build subscribers who follow your insider knowledge about anything. Set your own Subscriber fees with 4IR Credits. Make $$$ Prompt Synopsis Medical engineering is at the forefront of transforming healthcare through cutting-edge technologies and groundbreaking research. This field encompasses the development and application of engineering principles to improve medical practices, devices, diagnostics, and treatment methods. This exploration delves into recent advancements and innovations in medical engineering, including the latest in biomedical devices, diagnostic tools, therapeutic technologies, and healthcare systems. By examining these innovations, we uncover how medical engineering is enhancing patient care, improving outcomes, and addressing some of the most pressing challenges in modern medicine.

Start with the problem not the solution. A very informative post by Ben Wright GAICD. Very common is the culprit. If it’s a common pitfall, then it desserves you to take a pause and ask yourself if you have “a deep understanding of the clinical needs and market dynamics” Accelerators and incubators can be the difference between success and failure because they provide crucial advice at every turn. You dont have to it alone. Find the right support network from day 1.

Why Are Medical Device Development Costs So High? Developing medical devices is a complex, expensive, and time-consuming process. Our blog post below dives deep into the various factors contributing to these challenges and explores why innovation in this field comes at a premium. From regulatory hurdles to rigorous testing and compliance, we cover it all to help you understand the intricacies involved in bringing a medical device to market. Whether you're an industry professional or simply curious about the behind-the-scenes of medical technology, this post is for you! To Read More: https://lnkd.in/ge548F2W

Great insights from Galen Data about the cost drivers for medical devices. For startups and innovators embarking on the development of a new device, the key is managing complexity throughout the product lifecycle. Keeping things simple at the early stages of product design and development will go a long way to ensure faster time to commercialization, streamlined regulatory approvals, and lower risk for innovators and investors. Easier said than done, right? Check out these tips for keeping things simple in a complex medical device - https://lnkd.in/eXkZtuur

Medical device innovation isn't always about fancy tech or earth-shattering science. The most impactful innovations come from small changes. Small changes that make a big difference in patient care or clinical efficiency. For entrepreneurs in the medical device industry, determining if your idea is truly innovative can be a tough question. Creating a truly innovative medical device is a long process, but it's possible with the right approach and guidance. At Concise Engineering, we help entrepreneurs tackle those tough questions. Read the blog now: https://lnkd.in/efzDqc88 🖊️Subscribe to our newsletter here https://lnkd.in/eNUXv6bB #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog #MedTechman

Easy13485 again plays a leading Role in the Lesson of Volker Klügl at the FAU MT Medical Device Regulation Workshop. 𝙎𝙮𝙨𝙩𝙚𝙢𝙖𝙩𝙞𝙘 𝙈𝘿𝙍-𝘾𝙤𝙢𝙥𝙡𝙞𝙖𝙣𝙩 𝙈𝙚𝙙𝙞𝙘𝙖𝙡 𝙋𝙧𝙤𝙙𝙪𝙘𝙩 𝘿𝙚𝙫𝙚𝙡𝙤𝙥𝙢𝙚𝙣𝙩 can only be done with a SYSTEM. What a surpise 😆! The SYSTEM is: Avoid all the pitfalls we have made in managing hundreds of MD Development Projects for the last 20 Years. These Products now earn millions in profits for our Customers. We know it all: Idea to Product. Engineering to Regulatory. Requirement to Validation. And did you know? Easy13485 QM Service is not just Quality it exactly includes this step by step LIFE HACK to your MDR-Compliant Medical Product. Learn from the Best! 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙝𝙤𝙬 𝙬𝙚 𝙨𝙚𝙚 𝙞𝙩: 𝙜𝙚𝙩 𝙩𝙤 𝙮𝙤𝙪𝙧 𝙂𝙤𝙖𝙡 𝙛𝙖𝙨𝙩, 𝙬𝙞𝙩𝙝𝙤𝙪𝙩 𝙝𝙖𝙨𝙨𝙡𝙚! #MedicalDevices #MDRCompliance #QualityManagement #ProductDevelopment #HealthcareInnovation #Startup