The Factor, a Trusted Podcast for the Life Sciences Industry Kymanox

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, andsuccessfully 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.

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 Kymanox 
Key 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.

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.

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.

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.

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.