Life Science Solutions – Details, episodes & analysis

In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO of Project MedTech, to discuss the importance of agility, strategic planning, and value creation for life science startups. Duane shares his insights on effective fundraising, the vital role of treating consultants as team members, and the need for startups to optimize marketing and value proposition in the healthcare ecosystem. 

He also delves into the significance of building a unique company culture and the phased approach to implementing quality management systems. This conversation is essential for MedTech professionals ready to take their idea from concept to commercialization, offering practical advice and real-world examples to navigate the complex landscape of medical technology innovation.

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.

Creating labeling claims that support business goals without getting into compliance issues can be a tough sea to navigate.

Today, join Kymanox Director of Regulatory Affairs Stefanie Johns as she sits down with Crystal Weber, CEO of Group 31, in this episode on The Factor, to discuss the complexities of marketing in the highly regulated healthcare industry. From navigating FDA regulations to ensuring ADA compliance, Crystal shares invaluable insights on how biotech and pharma companies can effectively communicate their message while staying within legal boundaries. 

Discover why early-stage planning, strategic partnerships, and a deep understanding of regulatory nuances are crucial for success in healthcare marketing.

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.

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.

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.

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.

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.

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.

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.

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.

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.