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Life Science SolutionsPresented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Author: Kymanox
Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join us as we explore the journey of modern medicines, ensuring every product reaches its full potential in safety, quality, and accessibility. Language: en-us Genres: Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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Smarter Design Controls with AI - Is It Possible?
Episode 40
Tuesday, 18 November, 2025
Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards. Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.Topics Include:What design controls are and why they matter for medical devices and combination products.How AI is evolving from a personal tool to a professional asset in regulated environments.Practical applications: analyzing FDA trends, summarizing post-market data, and streamlining documentation.Specific uses within Design Verification, including sample size determination and data analysis.Managing AI risks: why "hallucinations" happen and the need for expert human oversight.Sustainability considerations: could AI use impact environmental goals in MedTech?Whether you’re a MedTech engineer, quality professional, or regulatory strategist, this conversation offers a roadmap for integrating AI safely and effectively into your design control process.📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.#MedTech #AI #DesignControls #MedicalDevices #RegulatoryScience #LifeSciences
