Hardian Health’s Post

Thought-provoking panel session on Day 3 of the #medtechcon focusing on regulatory strategies. Some great pick-ups from the speakers: - Engage early and often with the FDA, explore non-binding pre sub meetings to gain validation on your proposed pathway. - Understand that evidence development is a continuum, need to continue building evidence to strengthen your reimbursement case. - Never too early to build a regulatory strategy when you are seeking funding. Surprising data - PMA approval rates are about 85%, 510(k) approval rates are about 80%, but the De Novo pathway is only 48% approval, although 75% of De Novo pathways which get approved have an IDE. #startups #medtech #medtechinnovation

Check out this valuable resource from Mittal Consulting and Center For Entrepreneurial Innovation (CEI) in Arizona! They've crafted a playbook to guide founders entering the world of medical device development. Learn about the FDA regulatory pathway, associated costs, and the importance of robust quality system documentation—essential elements often overlooked by startups. #MedicalDevice #FDA #OBI4You

Big thanks to Mittal Consulting for sharing their expertise for the Founders Playbook! Many founders struggle with understanding the FDA pathway and associated costs. This playbook, developed from questions the Center For Entrepreneurial Innovation (CEI) receives from medtech startups, is a FREE resource. Don't miss out – grab it now! #medtechstartups #FDA

Mittal Consulting and Center For Entrepreneurial Innovation (CEI) (Arizona) put together this playbook for founders venturing into the realm of medical device development, understanding the FDA regulatory pathway, associated costs, and the importance of robust quality system documentation that are critical elements often overlooked by startups. Thanks Patti DuBois for the initiative and collaboration on this! #regulatoryaffairs #medicaldevices #startups #cei #fda

One of the major challenges for medical startups is the #Regulation issue. Navigating the #regulatory landscape is where many #startups get stuck. It’s not just about #innovation; it’s about meeting strict standards to ensure safety and compliance. Here’s what I’ve learned from my experience: Start early: Begin thinking about #regulatory requirements from day one. Understand the rules: Whether you’re dealing with the #FDA, #CE marking, or other bodies, each has its own rules. Knowing them upfront can save you headaches later. Seek help: #Regulations can feel like a maze. Having experts on board who understand the landscape can make all the difference. #Regulatory approval is a long road, but it’s essential if you want your product to reach the market. #MedTech #Regulation #Startups #Healthcare #Innovation

Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed

Supporting Med-tech Start-ups Start-ups face unique challenges in the medical device industry. Discover how TS Quality & Engineering helps new ventures ensure safety, efficacy, and regulatory compliance from the outset. #Startups #MedTech #RegulatoryCompliance #Innovation Read more: TS Q&E Helping Med-tech Start-ups from the Ground to Succeed

📊 𝗗𝗶𝗱 𝗬𝗼𝘂 𝗞𝗻𝗼𝘄? 𝗜𝘁’𝘀 𝗲𝘀𝘁𝗶𝗺𝗮𝘁𝗲𝗱 𝘁𝗵𝗮𝘁 𝗱𝗲𝗹𝗮𝘆𝘀 𝗶𝗻 #regulatory 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗰𝗼𝘀𝘁 #startups 𝗻𝗲𝗮𝗿𝗹𝘆 𝟱𝟬% 𝗼𝗳 𝘁𝗵𝗲𝗶𝗿 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗿𝗲𝘃𝗲𝗻𝘂𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝘆𝗲𝗮𝗿 𝗼𝗳 𝗺𝗮𝗿𝗸𝗲𝘁 𝗹𝗮𝘂𝗻𝗰𝗵 In the #MedTech industry, regulatory hurdles are often cited as one of the top challenges for startups. The cost and complexity of navigating frameworks like the EU Medical Device Regulation (#MDR) or the FDA’s regulatory pathway can significantly delay a product’s market entry. to share the full recording of the panel discussion I participated in at MedTech World Malta 2024 titled "Navigating the Regulatory Maze for Startup Success" Including myself as host Karandeep Singh Badwal (QRA Medical) and speakers Kenneth Shaw ( Specculo), James Romeo🧬 (Romeo Life Sciences Consulting ), Marco Gullà (HTH ), Frank Enright ( CompanionQMS) We delved into topics like: - Key regulatory pathways for medical devices. - Strategic approaches for compliance in the EU and beyond. - The role of innovation in overcoming regulatory hurdles. 🎥 𝗪𝗮𝘁𝗰𝗵 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗱𝗶𝘀𝗰𝘂𝘀𝘀𝗶𝗼𝗻 𝗵𝗲𝗿𝗲: https://lnkd.in/d7GWNFG2 #MedTechWorld #Startups #RegulatoryPathways #MedicalDevices #medtechmalta24

👉 WEBINAR! “All you need is approval” #SAVETHEDATE 31, Oct 2024 – with Custom Medical and seleon GmbH. We will help start-ups to meet all MDR-requirements! This event is specially crafted for medical device start-ups who are navigating the complexities of introducing new devices in the European Union (EU) market under the new Medical Devices Regulation (MDR). 🔍 Webinar Focus: Breaking into the EU market is a significant challenge, particularly for startups and small companies with limited resources. Our webinar will address these challenges, providing essential insights and strategies to streamline your journey. 🔍 Webinar Highlights: ·      Early International Approval Strategies ·      Streamlining Regulatory and Usability Processes ·      Learning from Industry Challenges ·      Gain insights to accelerate market entry and save resources.  Special focus on startup needs! 🗓️ Save the Date: ·      Date: October, 31 2024 ·      Time: 16:30 P.M. CET ·      Hosts: Dr. Michaela Kauer-Franz from Custom Medical & Peter Hartung from seleon GmbH Don’t miss out on invaluable tips to streamline your product development. 🔗 Register now! https://lnkd.in/eFBzuzNr #MedicalDevices #regulatoryaffairs #Webinar #MDR #Startups #Startup #ProductDevelopment #IVDR #FDA #requirements #market #entry #accelerate #EU #Europe #legalmanufacturer #CDMO

Launching a new medical device or acquiring a company in the MedTech industry is exciting. However, neglecting regulatory requirements can result in fines, delays, and reputational damage, potentially derailing the deal. Regulatory due diligence is key to avoiding fines, delays, and reputational damage. In our latest blog, Stefan Menzl dives into why regulatory due diligence is critical for ensuring compliance, mitigating risks, and smooth transactions. Don't miss these valuable insights for navigating the complex world of MedTech regulations. Read the full blog here: https://lnkd.in/eS6HApxU. #MedTech #RegulatoryCompliance #DueDiligence #MedicalDevices #Startups