Betthera

💡 Navigating Medical Device Development: KEY LESSONS FOR INNOVATORS AND INVESTORS 🧠 The path from idea to market in the medical device sector is full of complexity — from risk assessment and clinical validation to navigating shifting regulatory landscapes. 📈 ‼️ There are five crucial stages to consider: 1. Opportunity and Risk Analysis 2. Concept and Feasibility 3. Verification and Validation 4. Market Readiness 5. Market Launch & Post-market Surveillance 🗝️ Key takeaways: • Early engagement with end-users is essential to avoid costly redesigns later. • Regulatory hurdles vary significantly between regions, but harmonization remains a challenge. • Risk management must be iterative and span the entire product lifecycle. • Sustainable design and manufacturing strategies are critical for long-term safety and success. 🚀 For biotech leaders, entrepreneurs, and fund managers, this highlights the strategic value of integrating user-driven design and regulatory foresight from day one. 🔗 Source: Betthera 🖱️ #MedicalDevices #HealthInnovation #RegulatoryAffairs

❕ Introducing our services ❕ 7. REGULATORY STRATEGY AND CE MARK 🌍 Ready to take your medical device to new markets? With our Regulatory Strategy & CE Mark of Conformity service, you're never alone on the compliance journey! ✅🧭 📋 From EU MDR to FDA, we’ve got your back across borders — with smart strategies, smooth assessments, and strong partnerships with notified bodies 🤝💡 🚀 Let’s unlock your path to market success — with confidence and clarity. 😎📈 Are you interested in this option? 🚀 Get in touch with us. 📧 #BettheraServices #HealthEconomics #RegulatoryAffairs

💬 Curious about pain biomarkers? 🧠 Check out this bite-sized explainer from our colleagues at the PAINLESS project! 👇 Our colleagues from the Painless project have put together a clear and concise post explaining what biomarkers are and how they help us better understand cancer-related pain. 🔬🦷 Did you find this educational post interesting? Follow PAINLESS Horizon Europe Project for more insights from the world of pain research! ✨ #Betthera #PainlessProject #Biomarker

❕ Introducing our services ❕ 6. QUALITY MANAGEMENT SYSTEM 🚀 We deliver end-to-end QMS implementation fully aligned with ISO 13485. We start with personalized interviews to tailor the system to your needs. 💬 📈 Our focus is not just compliance, but smart, efficient processes. ⚙️ With ISO 13485 alignment, you gain quality and a competitive edge. 🏅🌍 Let’s build a QMS that works for you! 💡 Interested in this opportunity? 🚀 Get in touch with us today! 📩 #BettheraServices #QualityManagement #MedicalDevices

3D PRINTING IN HEALTHCARE: A REVOLUTION IN PATIENT CARE 🖨️ 3D Printing in Healthcare: A New Era of Personalized Care 🏥 3D printing is revolutionizing healthcare by enabling personalized treatments and improving patient outcomes. From custom implants and prosthetics to detailed anatomical models for surgical planning, this technology is making care more precise and efficient. It also speeds up the production of medical devices while potentially reducing costs. ⚙️💡 🚀 Opportunities and Challenges Ahead 🔬 Despite its promise, 3D printing in healthcare faces challenges such as regulatory hurdles, limited materials, and economic feasibility. However, ongoing innovations — like bioprinting tissues and organs or creating personalized medications — are bringing us closer to a future where medical care is even more tailored, effective, and accessible. 🧬🧠 #Betthera #3DPrinting #HealthcareInnovation

❕ Introducing our services ❕ 6. REGULATORY AFFAIRS FOR MEDICAL DEVICES 🔬 In the fast-moving world of medical technology, innovation must be backed by careful planning and smart decision-making. From R&D to collaboration with patients and providers, success depends on thorough assessments and clear evidence. 📊 💡Whether you're aiming for internal buy-in, investments, or public funding, our expert evaluation of economic, social, and regulatory aspects helps bring your medical device to market with confidence. 🚀 Excited to learn more? 🚀 Reach out to us — we’d love to connect! 📩 #BettheraServices #RegulatoryAffairs #HealthEconomics

Betthera is in Ostrava for the AdvanceMed CZ conference! 🤩 😱 We’re excited to be part of this event and will be presenting on Friday. 📆 Looking forward to insightful discussions and connecting with fellow experts! 🤝 Stay tuned and come say hello! 👋 🔗 https://lnkd.in/d7-9y69F #Betthera #AdvanceMed #HTA #MedicalDevices

❕ Introducing our services ❕ 5. BUDGET IMPACT ANALYSIS 🧠 We evaluate how new health technologies affect resource use and budgets. 💰 💡By analyzing treatment effects, target population size, disease prevalence, and healthcare needs, we estimate their financial impact on public and insurance systems 📊 Interested in this opportunity? 🚀 Get in touch with us today! 📩 #BettheraServices #HealthEconomics #RegulatoryAffairs 

🚀 Our project FORCE REPAIR Wounds is in Barcelona right now for EWMA • European Wound Management Association 🤩 😱 🚶♀️ Come visit them at their booth #112. 👋 #ForceRepair #EWMA #Betthera