Episodit
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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, cultural fit, and regulatory compliance are crucial factors when selecting a CMO - and there are complexities of CMO selection and strategic planning in delivering better therapies to patients.
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.
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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 to each client's specific stage in the product lifecycle. The podcast covers understanding phase-appropriate activities, using the right tools like prototyping and human factors studies at the optimal times, and
successfully navigating that critical path to market viability.Other topics include industry trends like minimally invasive surgery, drug delivery innovation, sustainability balanced with usability, connectivity, and the role of AI.
Throughout, Nick emphasizes focusing on the core goal of safe and effective patient treatment.
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.
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Puuttuva jakso?
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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 lifecycle and organizational processes.
This episode features:
Naveen Agarwal, Ph.D. - Principal and Founder, Let’s Talk Risk!
Nathan Blazei, Senior Director, Regulatory Affairs, Kymanox
with your host Shannon Hoste, Vice President of Human Factors Engineering at KymanoxKey Points:
- Risk management can no longer be a separate activity but must be embedded into all quality processes under QMSR.
- Process mapping and understanding information/data flows is critical for building an integrated risk management system.
- A lifecycle approach to continually updating risk assessments based on real-world data is expected, not just a one-time activity.
- The two-year transition period allows companies to identify gaps, update processes, and make a plan to implement QMSR’s risk-based expectations.
- While not mandating ISO 14971 specifically, the FDA acknowledges it provides an excellent model for risk management that most companies should leverage.
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.
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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 about it, creating Kymanox, which means Ideal Knowledge Transfer.
Today, 20 years and 300+ employees later, Stephen and Sarah share their first memories of starting Kymanox, the challenges faced, and the pivotal moments that shaped its growth and success. We also hear from employees who have been involved in the company's growth and success. They reflect on their experiences, the culture, and the impact Kymanox has had on their professional development and personal growth.
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.
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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 sustainability goals, and the work being done on standards by the BSI and ASTM.
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.
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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 user interfaces can influence bias in datasets. Stakeholder involvement, especially healthcare providers, was highlighted as crucial in the development process to design for end-users. The summit also tackled the broader issues of medical errors as a system design problem, emphasizing the need for transparency in medical outcomes. Overall, the summit provided valuable insights into the evolving landscape of AI, its challenges, and the collaborative efforts needed to advance the field.
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.
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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 collaboration, and driving innovation to create a higher quality of life for patients.
Join the conversation as they share powerful stories, discuss industry challenges, and illuminate the path toward a patient-centric future in healthcare.
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.
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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. Technologies like insulin pumps and reusable pen injectors have played a crucial role in advancing injection systems.
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.
Stephen concludes by sharing his vision for data-driven approaches in shaping the future of drug delivery and personalized medicine.
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.
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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 into the importance of real-world evidence, collaboration, and education within the industry.
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.
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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.
Shannon Hoste shares a similar background, transitioning from a more conventional engineering role to human factors engineering after encountering issues related to device usability in post-market settings. Their experiences highlight the vital role of understanding user diversity, technological access, and cultural differences when designing products for a global audience.
The conversation also delves into the pressing need for greater diversity in clinical trials and research projects. Rita and Shannon emphasize the importance of including populations from US territories and underrepresented regions, aiming to create more inclusive and relevant healthcare technologies.
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.
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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 collaboration with regulatory authorities and leveraging risk management plans throughout the product development process. They stress that there is no one-size-fits-all approach to being clinically ready, and it depends on the specific stage of the clinical trial and the product's characteristics.
Dr. Stefanie Johns is the Director of Regulatory Affairs at Kymanox.
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.
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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. 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, Vice President of Agilis by Kymanox and Stefanie delve into factors like patient safety, human factors engineering, and the challenges faced by pharmaceutical companies entering the device realm. They emphasize the importance of understanding the interplay between the device and drug, highlighting that any source of variability can be amplified in clinical trials. Additionally, they discuss how best to utilize a risk based approach in determining strategy and to ensure product success and regulatory compliance. A must-listen for those in the medical device and pharmaceutical industries.
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.
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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 emerging technologies and identifying opportunities to address healthcare challenges. The conversation underscores the ongoing transformation of healthcare through technology and the need for a holistic approach to healthcare delivery and education.
Dr. Clipper's recent book, “The Innovation Handbook”, is a pragmatic guide and toolkit that seeks to enlighten nurse leaders as they evolve through the current healthcare crisis.
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.
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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 practices that empower nurses and improve patient care.
Dr. Clipper is the founder of Innovation Advantage, a consultancy that focuses on helping health care organizations adopt innovative approaches. She is a trailblazer in her industry and was the first Vice President of Innovation at the American Nurses Association. Dr. Clipper is the sole nurse member of the HIMSS Innovation Board of Advisors and is a start-up coach for MATTER international health tech accelerator.
Her recent book, “The Innovation Handbook”, is a pragmatic guide and toolkit that seeks to enlighten nurse leaders as they evolve through the current healthcare crisis.
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.
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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 reporting, and advice for manufacturers to scale the mountain of UDI compliance.
Richard Houlihan is the former IT consultant for the European Commission during the creation of EUDAMED, and today he supports medical device manufacturers with their submission through his company, Eirmed.
Dr. Christiana is an Executive Consultant and Business Development Manager at Anteris by Kymanox, and formerly Regional Manger at TUV SUD.
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.
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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 living picture of the lifecycle of medical devices that are made available in the European Union (EU).
Our experts discuss the challenges and opportunities brought about by the EUDAMED requirements, and explore how the delay in MDR implementation impacted the industry and why the EUDAMED platform holds promise for ensuring safe devices and empowering patients and healthcare professionals with critical information.
Richard Houlihan is the former IT consultant for the European Commission during the creation of EUDAMED, and today he supports medical device manufacturers with their submission through his company, Eirmed.
Dr. Christiana is an Executive Consultant and Business Development Manager at Anteris by Kymanox, and formerly Regional Manger at TUV SUD.
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.
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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, control safety in the United States, and the polarizing viewpoints of ICH Q9 vs. ISO 14971.
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.
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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.
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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 Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971.
Documenting medical device risk management through the risk traceability summaryImplementation of risk management principles and activities within a Quality Management SystemMedical devices — Guidance on the application of ISO 14971About 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.
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Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin Bills and Shannon Hoste, and they touch upon the challenge of consolidating numerous standards and documents while ensuring the consideration of overall residual risk, encompassing aspects like AI, cybersecurity, and biocompatibility.
The conversation explores the need for manufacturers to embrace comprehensive risk management, focusing not only on individual risk analysis but also on evaluating the overall risk of complex systems. We also review ISO 14971, the expansion of guidance documents, and the importance of putting patient safety at the forefront of the risk management process.
Join us as we uncover the intricacies and advancements in medical device risk management.
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 Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971.
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.
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