Essenvia’s Post

Don't get trapped in the Regulatory Room. Locked door, no windows.. Happens all the time in early-stage MedTech. Regulatory is treated as the be-all, end-all. Teams take regulatory guidance as gospel. And ignore the most important factors -- around marketability. Don't get me wrong -- Regulatory Strategy is crucial. But, it needs to FOLLOW the right Market Strategy. ✅ Do the indications serve your target market? ✅ Do your medical claims provide differentiation? ✅ Does the intended use support the value prop? ✅ Will copycats easily follow the path you pave? These types of questions relate to the marketability of your medical device. And that's what you should care about. Your ultimate destination in MedTech is Market Adoption. Regulatory clearance is one of the hills to climb along the route. == Want to avoid the Regulatory Room? Join 1,500+ MedTech professionals for tips, tools, and insights at buff.ly/3xkxrXM #medtech #medicaldevices #regulatory #marketfirstmedtech

As you may have seen over the last few weeks, MedTech Impact Partners collaborated with our friends at Essenvia on a report designed to help medical device manufacturers gain insights on the best regulatory strategies to consider when it comes to getting their products through the FDA and to market. The key question is "Does the Breakthrough Device Designation make a difference with a product's time to market?" We have the answer in this video and data to support it in the "2024 State of U.S. MedTech Regulation" full report: https://lnkd.in/gcCBKh2s Christian Johnson Soumya Mahapatra #industryinsights #data #medtech #fdaapproval #healthcare #breakthroughdevicedesignation

The right strategy to enter and scale in the MedTech market 👇 Launching a technology is both exciting and challenging. To achieve success, you must understand the market, manage costs, and navigate strict standards: every detail matters. Here are 5 key activities for a successful entry: 📈 In-depth market research ⏳ Cost and timeframe management ⚙️ Accurate FDA medical device classification ✅ Final validation 📣 Strategic launch preparation Eager for more insights? Don't miss out on expert winning strategies on our blog 👉 https://lnkd.in/ea9yuG4T #MedicalDeviceDevelopment #MedTech #Healthcare #MedicalDevice #Innovation #ProductDevelopment

Are you a medical device manufacturer? What are some of the biggest challenges you've faced? I'd bet they have a lot to do with regulatory changes and new technology advancements; just to name a few. With its brand-new “2024 State of US MedTech Regulation” report, Essenvia has pinpointed eight specific hurdles that many medical device manufacturers will have to jump over in the coming years. Learn what they are and how you can position your product to have a successful path to market. Access the report: https://hubs.ly/Q02tkv5k0 Soumya Mahapatra Dhriti Roy, Ph.D., MBA, RAC Christian Johnson MedTech Impact Partners #medtechregulation #medtechmanufacturing #regulatory #regulatorystrategy #industryinsights #lookahead #innovation

With its brand-new “2024 State of US MedTech Regulation” report, Essenvia has pinpointed eight specific hurdles that many medical device manufacturers will have to jump over in the coming years. Learn what they are and how you can position your product to have a successful path to market. Access the report: https://hubs.ly/Q02tkv5k0

Dr. Bassil Akra from AKRA TEAM GmbH explores the intricate EU medical device approval process. Uncover the hurdles and innovative strategies that medtech companies use to navigate regulatory compliance. https://hubs.la/Q02QzwN00 #Medicaldevice #healthtech #medtech

Innovation in medical technology is crucial for advancing healthcare and improving patient outcomes. However, the journey from development to market can be lengthy due to regulatory requirements. The FDA introduced the Breakthrough Device Designation (BDD) program to streamline this process for devices that offer significant advantages over existing alternatives. This blog explores what the Breakthrough Device Designation is, its benefits, the criteria for qualification, and the application process. Read More Here: https://lnkd.in/dgSU-5b9

Delighted to have my article, "A Year of Progress-Reflecting on MedTech and IVD in 2024" published in Medical Buyer. It highlights key achievements and ongoing challenges in MedTech, along with what we can expect in 2025. Looking forward to what the future holds for healthcare innovation. Read more about the milestones, insights, and projections that are shaping our industry's path forward! #MedTech #IVD #HealthcareInnovation #MedicalBuyer

Sharing some of the latest investment, innovation and industry insights within the MedTech sector. Starting with our fantastic Lift Up teams live event, diving into some exciting funding announcements, at both ends of the scale and more life-changing innovation getting CE Marking and FDA approval. Links to all articles in the comments. Keep on making a difference MedTech! #medtech #insidemedtech #medicaldevices #medtechnews

Breaking Through the Regulatory Maze: Elos Medtech are here to help. In the fast-evolving world of medical devices, innovation isn't just about developing ground breaking technologies—it’s also about ensuring they meet stringent regulatory standards across global markets. Today, manufacturers face a host of challenges: 🔹 Ever-changing regulations: From MDR in Europe to FDA updates in the U.S., staying ahead of the curve is essential but demanding. 🔹 Extended approval timelines: New compliance requirements often mean longer pathways to market, impacting time-to-market strategies. 🔹 Increased scrutiny: Authorities now require more robust data on safety, efficacy, and post-market surveillance than ever before. 🔹 Global inconsistencies: Navigating the unique regulatory frameworks of different countries can be overwhelming, especially for companies operating on a global scale. At Elos Medtech, we recognize these challenges and partner with our customers to tackle them head-on. By integrating regulatory expertise into every step of the product lifecycle, we help ensure that devices not only meet the highest standards of quality and compliance but also reach the market as efficiently as possible. Our team stays up to date with the latest regulatory developments, enabling us to support our customers in making informed decisions and reducing the risk of costly delays. From design controls to documentation, we’re here to help turn challenges into opportunities. What are the biggest hurdles you see in navigating regulatory approval for medical devices? Let’s discuss how we can solve them together! Get in touch or check out our offering on our website. https://lnkd.in/dg99VEZB #MedicalDevices #MedTech #Innovation #Quality #ElosMedtech