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.
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Timeline:
01:50 Guest self-introduction
02:55 The experience that shaped their experiment skill sets
05:10 First industry experience
07:00 Maintaining a positive attitude during massive layoffs
08:00 Passion for diagnostic tools
11:30 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 status
20:20 Medical device classification and regulatory overview
● Classification based on device risk levels
Class 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) submission
24:40 Premarket Notification (510(k)) process
27:15 Clinical trial requirement for medical device (feasibility study/ pivotal trial)
29:00 Detailed explanation of ISO 10993
31:40 Clean room costs
34:35 Importance of clean room and sterilization process
38:25 Handling contamination from machines
40:15 Impact of automation in the medical device industry
42:20 Process that can not be automated
45:00 Challenges in implementing automation
47:38 The future of automation
48:20 Challenges in Medical Device Process Development
50:50 Industry vs. research
52:52 Large company vs. start-ups
56:45 Advice for aspiring medical device professionals
59:15 Case study
Glossary:
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.