What do you remember about 2004? That was the year that Stephen and Sarah founded Kymanox. In the upcoming episode of The Factor, we reflect on the past two decades
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This podcast explores how the medical device and pharmaceutical industries must consider sustainable design and manufacturing principles in keeping with improving health and quality of life. Our guest, Cormac O'Prey, covers the challenges, benefits, and potential solutions for reducing environmental impact, such as reusable medical devices and embracing circular product design. Additionally, Cormac provides insights into the global standards and practices, highlighting the collaborative efforts required for successful sustainability initiatives.
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Explore the transformative trends in AI from the 2023 AI Summit, where discussions shifted from continuous learning to large language models. Unveiling the power of SHAP values, addressing bias, and emphasizing stakeholder involvement, the summit highlights the evolving landscape and collaborative efforts shaping the future of AI in healthcare. Stay informed with our key takeaways.
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In the conclusion of our conversation with Stephen M. Perry we discuss the dynamic intersection of healthcare innovation and patient-centered solutions. Exploring the evolution from traditional clinic-based treatments to innovative home-based therapies. Join the conversation as they share powerful stories, discuss industry challenges, and illuminate the path toward a patient-centric future in healthcare.
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Stephen Perry provides a comprehensive overview of the historical evolution of combination products, emphasizing the pivotal role of insulin and diabetes in driving innovation. The discussion extends to Stephen's insights on the global regulatory landscape, he explores the promising potential of digital health and artificial intelligence, offering thoughts on their impact on drug delivery systems.
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Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combination product industry.
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In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into healthcare, describing how she ventured into remote areas to provide support with donated medical devices. This eye-opening experience underscored the critical importance of considering usability and human factors in product design.
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As we discussed in part 1 with Dr. Stefanie Johns, the problem of determining when your medical device or combination product is clinically ready can be a daunting puzzle. Today, Stefanie and Shannon Hoste dissect the nuances, discussing the importance of understanding the therapeutic index, managing risk, and incorporating the right data safety monitoring.
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How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of harmonizing drug and device elements, managing risks, and understanding variability can be overwhelming. Join the discussion on The Factor, with Dr. Stefanie Johns, Director of Regulatory Affairs at Kymanox.
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In this podcast episode, Dr. Bonnie Clipper, the founder of Innovation Advantage, a consultancy specializing in helping healthcare organizations embrace innovation, discusses various aspects of healthcare models, technology impact and the evolving role of nurses.
Check out the latest episode of The Factor, we speak with industry leader, Dr. Bonnie Clipper, to discuss innovations in technologies to empower nurses and improve patient care.
In this episode of The Factor Podcast, industry experts Dr. Christiana Hofmann and Richard Houlihan discuss the complexities of Unique Device Identification (UDI) compliance in the evolving European regulatory landscape.
In this informative episode of The Factor, we sit down with industry experts Dr. Christiana Hofmann and Richard Houlihan to discuss EU MDR's implementation journey and critical aspects of the EUDAMED requirements, the European Union's Medical Device Database.
Susan Neadle and Stephanie Canfield are back for part two. If you haven't listened to part one, do that first and then come back to this episode. Today, they continue the conversation, diving into risk management plans, control safety in the United States, and the polarizing viewpoints of ICH Q9 vs. ISO 14971.
Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that collects 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.
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We continue the conversation in Part 2, highlighting the importance of traceability, proper terminology, and the early integration of risk analysis as a design tool. How can we effectively implement risk management practices in medical device development and achieve improved product safety? Let's find out.
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Risk Management is becoming a growing theme within the medical device community. Listen to industry experts, Edwin Bills and Shannon Hoste with host Denise Wagner, as they discuss the history of the risk analysis landscape and the recent news that FDA is going to incorporate ISO 14971 into it's Quality Management System Regulation (QMSR).
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We are excited to launch our first podcast series featuring Pat Patterson, Founder and CEO of Agilis and Shannon Hoste, President of Agilis. We invite you to subscribe to our podcast, The Factor, anywhere you listen.
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