We are excited to host a guest speaker, an expert in medical device process development, whose extensive experience spans across industry and research. This podcast offers a deep dive into the journey of taking a medical device from concept to manufacturing, the challenges of regulatory compliance, the impact of automation, and insights into working in this dynamic field. Whether you're a seasoned professional or new to the medical device industry, this discussion promises to provide valuable perspectives and practical advice.正在研发：VITA系列新型长生不老药目前在售：VITA1001小药丸在售平台：Apple Podcasts/Spotify/YouTube Music/小宇宙/喜马拉雅/网易云音乐🔍搜索：VITA1001 Modern Pharma/ VITA1001大药厂欢迎一起来玩：小红薯：VITA1001 Modern Pharma微信号：VITA1001 Modern Pharma📮邮箱：[email protected]:01:50 Guest self-introduction02:55 The experience that shaped their experimental skill sets05:10 First industry experience07:00 Maintaining a positive attitude during massive layoffs08:00 Passion for diagnostic tools11:30 Day-to-day work life, from concept to product manufacturing● Discussion of the development pipeline:concept -- prototype -- process (scale up)● Importance of finalizing processes during development, since changes are restricted post-manufacturing due to regulatory requirements.16:35 Biosensor technologies and current research status20:20 Medical device classification and regulatory overview● Classification based on device risk levelsClass II Medical Device Regulation:ISO 10993: Framework for biocompatibility evaluation.ISO 14971: Risk management for medical devices.ISO 13485: Quality management system for manufacturing.24:00 Premarket Approval (PMA) submission24:40 Premarket Notification (510(k)) process27:15 Clinical trial requirement for medical device (feasibility study/ pivotal trial)29:00 Detailed explanation of ISO 1099331:40 Clean room costs34:35 Importance of clean room and sterilization process38:25 Handling contamination from machines40:15 Impact of automation in the medical device industry42:20 Process that can not be automated45:00 Challenges in implementing automation47:38 The future of automation48:20 Challenges in Medical Device Process Development50:50 Industry vs. research52:52 Large company vs. start-ups56:45 Advice for aspiring medical device professionals59:15 Case studyGlossary:Feasibility Study: An early-stage clinical trial designed to evaluate the safety and preliminary efficacy of a medical device.ISO 10993: An international standard for assessing the biocompatibility of medical devices.ISO 13485: An internationally recognized standard for a quality management system (QMS) for medical device manufacturing.ISO 14971: A standard outlining risk management processes for medical devices.Premarket Approval (PMA): The FDA’s regulatory pathway for Class III devices, requires robust evidence of safety and effectiveness.Premarket Notification (510(k)): A less stringent FDA pathway for demonstrating that a new device is substantially equivalent to a legally marketed device (predicate).Prototype: An early working version of a medical device used for testing and refinement during development.Quality Management System (QMS): A structured system of procedures and processes ensuring that medical devices meet regulatory and quality standards.Risk Management (ISO 14971): The systematic application of policies, procedures, and practices for identifying, evaluating, and controlling risks associated with medical devices.

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