Winning Formula: Combination Products Unveiled, with Susan Neadle

Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that distills her years of industry experience into a comprehensive resource. She shares the backstory behind the book and its journey to becoming a peer-reviewed publication by the FDA. With Stephanie Canfield and Shannon Hoste, they discuss the top considerations in Combination Products, covering topics such as regulatory strategies, human factors engineering, risk management, and more.With insights from experts around the world, the book offers valuable recommendations, case examples, and even real-life warning letters to guide those venturing into the realm of Combination Products. Tune in as Shannon, Susan, and Stephanie unpack the complexities and global perspectives surrounding this innovative field. Whether you're a seasoned professional or just curious about the industry, this podcast episode promises to captivate and educate, shedding light on the ever-evolving landscape of Combination Products.Today's episode is hosted by Shannon Hoste, President of Agilis by Kymanox, and Assistant Professor in the Quality Education Program at Pathway for Patient Health. She's joined by Susan Neadle, an internationally recognized Combination Products expert, and Stephanie Canfield, a Senior Consultant in human factors engineering.About the Factor:The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry. About Kymanox:Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.The Factor is edited and produced by Earfluence.