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PODCAST

Life Science Solutions

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

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All Episodes

24:05

Secrets of Biopharma Tech Transfers: Lessons Learned...

Life Science Solutions ·

2024/06/17

Biologic drug developers face a persistent challenge - executing successful tech transfers of their processes between sites and scales. These transfers are pivotal but extremely complex, prone to issues from changes in facilities, equipment, materials, and process nuances. Failed or delayed tech transfers can derail entire programs, costing companies millions. So what's the solution? In this episode, biomanufacturing veteran Marcelo Anderson provides a masterclass on mastering tech

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32:38

Aligning with the Right CMO

Life Science Solutions ·

2024/05/13

Today's episode is all about Contract Manufacturing Organization (CMO) selection. When organizations are considering a CMO, how do they find the right one for them? We're joined by two Kymanox executives, Ryan Doxey, Senior Director of Technical Services, and Jason Martin, Senior Director of CGXP Technical Services.They highlight the importance of finding a CMO with the right capabilities and expertise, as well as the significance of project managers in successful collaborations. Trust,

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25:08

Mastering the Product Development Lifecycle for...

Life Science Solutions ·

2024/04/15

How can medical device and combination product companies bridge the difficult "valley of death" between early product design and commercial readiness? In this episode, Nick Ciccarelli, Chief Technology Officer at Kymanox, shares insights into their integrated product design, development, and commercialization approach with host Evan Edwards, Chief Innovation Officer. He explains how their cross-functional teams leverage diverse expertise to provide streamlined end-to-end services tailored

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49:52

QMSR, ISO 13485:2016, and What It All Means for...

Life Science Solutions ·

2024/03/18

Naveen Agarwal, PhD and Nate Blazei discuss the QMSR and the relationship to ISO 13485:2016 and how Risk Management is the cornerstone to success. The new Quality Management System Regulation (QMSR) from the FDA represents a significant shift in expectations for how medical device companies manage their quality systems. At its core, QMSR requires companies to take a more process-based and risk-based approach that fully integrates risk management activities throughout the entire product

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58:25

Kymanox: Two Decades of Excellence

Life Science Solutions ·

2024/02/15

Take a trip to 2004 for a moment. Yahoo was the #1 website on the planet. Mark Zuckerberg came up with Facebook. 14-year-old Taylor Swift signed on with Sony to pursue her career in country music. And from Stephen and Sarah Perry's perspectives, the Life Science industry was in desperate need of improvement. There was a lot of bureaucracy and red tape, and modern medicine that needed to be in patients' hands were slowed down by extra expense and scheduling delays. So, they did something

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55:03

The Path to Sustainable Practices in Medical Device...

Life Science Solutions ·

2024/01/09

Sustainability isn’t a buzzword - it’s a crucial aspect of the mission within medical device and combination product design and manufacturing. But it’s not always easy to figure out all the design considerations that make products cost efficient, sanitary, AND sustainable. So how can we do it as an industry?Today, Cormac O’Prey, Principal and Director at the Kestrel Consultancy Group, and Agilis VP of Human Factors Engineering Shannon Hoste explore strategies for reducing waste, meeting NHS

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18:38

AI Summit Highlights: Transparency, Bias in AI, and...

Life Science Solutions ·

2023/12/18

The Agilis by Kymanox experts in digital health, Lauren Horn, PhD and Alexandria Kruzer, attended the 2023 AI Summit and share their key takeaways. They showcased a notable shift in AI discussions from continuous learning to the evaluation of large language learning models. Transparency in AI, particularly using SHAP values, emerged as a critical theme, contributing to the usability of algorithms. The summit delved into addressing bias in AI, emphasizing the importance of understanding how

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19:25

Innovating Patient-Centric Healthcare: A Conversation...

Life Science Solutions ·

2023/12/06

In the conclusion of our conversation with Stephen M. Perry (part 1) we explore the dynamic intersection of healthcare innovation and patient-centered solutions. Exploring the evolution from traditional clinic-based treatments to innovative home-based therapies, they highlight the impact on patient experiences, emphasizing dignity, reduced anxiety, and improved quality of life.Discover how Kymanox, a global life science solutions provider, is navigating challenges, fostering a culture of

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24:02

Combination Product Universe: PDA Conference Recap...

Life Science Solutions ·

2023/11/20

At the PDA Universe of Pre-filled Syringes and Injection Device Conference in Gothenburg, Sweden, Kymanox Founder and CEO Stephen Perry delivered a keynote address titled "The Inspiring Evolution of Parenteral Combination Products from 2004 to Today from an Entrepreneurial Perspective – And a Peek at What Is Coming." Stephen Perry provides a comprehensive overview of the historical evolution of combination products, emphasizing the pivotal role of insulin and diabetes in driving innovation

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28:43

Unpacking the Role of Human Factors in Medical Device...

Life Science Solutions ·

2023/11/08

Shannon Hoste and Rita Lin discuss Rita's recent presentation at the RAPS Convergence conference in Montreal and share insights about their experiences in the field of human factors and regulatory affairs in the medical device industry. They touch on various topics, including the challenges and opportunities in combination product development, the importance of risk management, regulatory considerations, and the impact of AI and machine learning in healthcare. The conversation also delves

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21:08

Navigating the Real-World Environment of Medical...

Life Science Solutions ·

2023/10/25

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.Shannon Hoste shares a similar background, transitioning from a more conventional engineering role

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16:25

Creating a Successful Roadmap: Lab, Clinic, Market

Life Science Solutions ·

2023/10/11

In this episode of The Factor, Shannon continues her conversation with Stefanie Johns, PhD, Director of Regulatory Affairs at Kymanox (part 1). They review how companies can a create a successful roadmap to bring their product from lab to clinic and commercialization. Reviewing the importance in understanding the therapeutic index, understanding users, how best to manage risk, and incorporating the right data safety monitoring. Additionally, Stefanie and Shannon emphasize the importance of

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20:50

Factors to Consider in Clinical Readiness for Medical...

Life Science Solutions ·

2023/09/25

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. If clinical readiness is on your product development plan, join our discussion with Dr. Stefanie Johns, Director of Regulatory Affairs at Kymanox, as she shares her strategies to solve the clinical readiness puzzle. Shannon Hoste,

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25:30

Future Healthcare Models: The Evolving Role of Nurses...

Life Science Solutions ·

2023/09/13

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. Dr. Clipper highlights the importance of incorporating technology, such as virtual reality, into training healthcare professionals and utilizing assistive technologies in supporting distributed care models. Dr. Clipper encourages staying informed about

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15:30

Transforming Nursing through AI and Innovation, with...

Life Science Solutions ·

2023/08/29

Today we explore the dynamic synergy between healthcare innovation and human factors engineering in nursing, with Dr. Bonnie Clipper. We focus on patient care transformation through bridging the technology gap, standardizing practices, and optimizing medical device integration. This episode will emphasis the need for collaboration between medical device manufacturers, health care institutions, and health care professionals to ensure the successful integration of innovative technologies and

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30:01

Navigating the Challenges of UDI Compliance in...

Life Science Solutions ·

2023/08/16

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. From the daunting task of collating data to the importance of strategic planning, they reveal the critical factors that can make or break a successful UDI implementation. Join the conversation as they shed light on the need for collaboration, the impact of AI on data

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26:29

Exploring EUDAMED Requirements for EU MDR, with...

Life Science Solutions ·

2023/08/02

In this informative episode of The Factor, we sit down with industry experts Dr. Christiana Hofmann and Richard Houlihan to discuss critical aspects of EUDAMED, the European Union's Medical Device Database, and the EU MDR's implementation journey. The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). EUDAMED will provide a

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32:41

(Part 2) Winning Formula: Combination Products...

Life Science Solutions ·

2023/07/19

Today, 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. Susan and Stephanie chatted about Susan's new book, The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems. And how it brings clarity of understanding for global Combination Products guidance and regulations. Today, they continue the conversation, diving into risk management plans,

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24:12

Winning Formula: Combination Products Unveiled, with...

Life Science Solutions ·

2023/07/05

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

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28:07

(Part 2) ISO 14971 and Risks in Medical Devices: What...

Life Science Solutions ·

2023/06/21

In part one, we chatted about the overarching risk management process for medical device development. Today we continue the conversation, digging into the complexities of medical devices, including AI and other MedTech. Can risk management keep up with the evolving medical tech landscape? What about complex systems? Let's find out.Today's episode is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group. Today's guests are

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42 results

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