Archer Research’s Post

In today’s dynamic MedTech world, every step — from strategic planning to regulatory submissions — has an impact on the success and speed of bringing innovations to market. Our expert clinical operations services are designed to make your clinical studies efficient, cost-effective and compliant with regulatory standards. 👉 Check out our slideshow to learn more about how we can support your clinical study. #ClinicalOperations #MedicalDevices #IVD #ClinicalStudies #MedTech

A short and sweet Iain's Industry Insights this week before I travel to Ireland... We cover a substantial carve out, a large contract win in the U.S. and innovative FDA approval and some significant leadership hires. Not forgetting a quick plug for our upcoming Inside MedTech Event! Links to all articles in the comments. Keep on making a difference MedTech! #medtech #insidemedtech #medtechnews #medicaldevice

Launching a medical device in Europe can be challenging, especially when it comes to navigating the complex regulatory landscape. If this sounds familiar, you’re not alone! ▶️Check out the interview where I describe some regulatory hurdles medtech companies are expected to face in the upcoming months and we offer actionable strategies for overcoming them. Link: https://lnkd.in/eTGj-iYP We hope reading this interview helps you discover how to stay compliant with changing requirements and adopt a proactive and effective approach for success. #MedicalDevices #Medtech #RegulatoryAffairs #AliraHealth #MDR #IVDR

Iain's Industry Insights covering the latest Investments, Innovation and MedTech Insights. Some exciting investment stories that could unlock the potential of some fantastic innovation; a couple of FDA approvals for two MedTech goliaths and a couple of significant C-Suite changes. Links to all articles in the comments. Keep on making a difference! #medtech #insidemedtech #medicaltechnology #medicaldevices #industrynews

There are just over two months to go until the 11th annual American Medical Device Summit comes to Chicago! The Summit gathers 200+ industry leaders as a platform to explore where medical device meets opportunity. We are excited to share one of our esteemed emcee's: Juan Daccach MD, VP, Global Product Safety at Merz Aesthetics. Join Juan and explore strategies for product development and design, optimizing regulatory strategies, managing costs, and more! Discover more summit details here: https://hubs.ly/Q02HP3Xp0 -- #GenerisAMD #MedDeviceUS24 #MedicalDevice #MedDevice #QualityandRegulatory #Clinical #Quality #Regulatory

Most early-stage MedTech companies tend to follow the 510(k) pathway for market approval in the US. But what about market adoption? 🤔 Just because you don’t need a clinical trial to get your device to market, that doesn’t mean you’ll never need to carry one out. 👀 Then you have to get clinicians to actually use your device—and oftentimes that requires clinical evidence. 🏥 In this article, we're breaking down why your Class II device may need a clinical investigation and what endpoints you should be looking at as you build your study. https://hubs.ly/Q02Vsctv0 #classII #medicaldevices #medtech #greenlightguru #marketaccess #marketadoption #clinicalevidence #fda

Looking to hear from 40+ medical device executives, to learn current trends, strategic insights, and best practices in the #meddevice industry? Secure your spot to this years American Medical Device Summit, taking place from October 1-2 in Chicago! Engage with Quality & Regulatory expert Kamaal Anas from B. Braun Medical Inc. (US) for his session "Leveraging Data From Regulatory Bodies for Successful Future Submissions." Learn more about the Summit and how to expand your industry expertise here: https://hubs.ly/Q02GNs4F0 -- #GenerisAMD #MedDeviceUS24 #MedicalDevice #MedDevice #QualityandRegulatory #Clinical #Quality #Regulatory

FDA Approval Is Just the Beginning! In our latest blog, Meredith Estep Wilkerson, PhD, highlights key insight for medical device innovators: FDA approval alone won’t guarantee acquisition. To attract buyers, founders must also establish a strong reimbursement strategy for market adoption. Key Questions for Success: 1. Does your product target the right patient population for insurers? 2. Can existing codes cover your tech? 3. Will provider payments support adoption? With a focus on value-based care, aligning regulatory, clinical, and reimbursement plans can set startups up for long-term success. Read more: https://lnkd.in/gJQdn8sW #plainsventures #FDAApproval #HealthcareInnovation

There's still time to register for today's webinar “CE Certification vs. FDA Strategy” 🔗 Register: https://lnkd.in/eQxbBRJi 🚀 750+ registrants can't be wrong! Join MedTech Leading Voice today at (18:30 CET / 9:30 AM PST/ 12:30 EST) for an interactive presentation and panel discussion (bring your questions) featuring our expert speakers: • Ronald Boumans – Co-Founder of AR2-C2 GmbH, strategic regulatory consultant with extensive experience in R&D, market surveillance, and medical device policymaking. • Michelle Lott, RAC – Founder of LeanRAQA LLC, regulatory strategy expert with over 20 years in the healthcare industry. • Nika Mendelev – Co-Founder of AR2-C2 GmbH, specializing in regulatory market access, clinical data, and marketing strategy for medical devices. ✅ Key Topics: • Regulatory Quality and Complexity • Market Size and Value • Essential Elements for Market Entry • Key Differences between the EU and US Markets There’s still time to register! 📅 https://lnkd.in/eQxbBRJi Even if you can’t join live, please register to receive a copy of the recording and the slides. 📧 See you there! #MedTech #RegulatoryStrategy #CECertification #FDAStrategy #Webinar #MedicalDevices #HealthcareInnovation #MarketEntry

📍 MedTech Path to Market Virtual Summit, August 6-8th📍 You know you want to join. Here's why 🔥 What is it? Free virtual summit designed to support you in bringing a medical device to market all the way from product development to regulatory submissions. Any hot topics? Plenty. 🤩 🌠 Design Controls and QMSR 🌠 Intended Use, indications for use 🌠 PMA, 510(k) & De Novo 🌠 EU MDR technical documentation, clinical evaluation and audits and many more... Expert speakers? Absolutely! 💪 Kyle Rose, Peter Sebelius, Allison Komiyama, PhD, RAC, Ben E., Adnan Ashfaq, Helene Quie, Eric Henry, and so on. What's in it for me? 🤔 On top of free, expert insights and strategies, you get to participate in fun activities and engage with industry leaders and fellow professionals throughout the entire event. 🎲 🏆 Make a friend, win a prize (or 2, or 3) and help us foster a sense of belonging and community in MedTech. 👥 Who knows when there'll be a global glitch again 😳, so go register while you still can: https://lnkd.in/dz469csE #medtechpathtomarket #premarket #medicaldevices #medtech #virtualsummit #productdevelopment #quality #regulatory #greenlightguru