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

Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory... more

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Episodes

Making BioPharma Partnerships Work

In this episode of The Factor, host, Chris Adkins interviews Bill Monteith, Kymanox Executive Advisor, to discuss the art of... more

18 Nov 2024 · 44 minutes
How RNA Origami is Revolutionizing Drug Development

In this episode of The Factor, Ryan Doxey (Senior Director of Technical Services at Kymanox) and David Harrell (CEO of... more

14 Oct 2024 · 25 minutes
Adopting Agile Strategies in Emerging MedTech

In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO... more

16 Sep 2024 · 38 minutes
Balancing Claims and Compliance in Healthcare Marketing, with Group 31 CEO Crystal Weber

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

12 Aug 2024 · 28 minutes
Invisible Users: Applying Human Factors to Medical Device Servicing and Maintenance

Medical device design often focuses solely on clinical users, overlooking a crucial group: maintenance personnel. This oversight can lead to... more

15 Jul 2024 · 33 minutes
Secrets of Biopharma Tech Transfers: Lessons Learned and Best Practices

Biologic drug developers face a persistent challenge - executing successful tech transfers of their processes between sites and scales. These... more

17 Jun 2024 · 24 minutes
Aligning with the Right CMO

Today's episode is all about Contract Manufacturing Organization (CMO) selection. When organizations are considering a CMO, how do they find... more

13 May 2024 · 32 minutes
Mastering the Product Development Lifecycle for Commercial Readiness

How can medical device and combination product companies bridge the difficult "valley of death" between early product design and commercial... more

15 Apr 2024 · 25 minutes
QMSR, ISO 13485:2016, and What It All Means for Medical Device Risk Management

Naveen Agarwal, PhD and Nate Blazei discuss the QMSR and the relationship to ISO 13485:2016 and how Risk Management is... more

18 Mar 2024 · 49 minutes
Kymanox: Two Decades of Excellence

Take a trip to 2004 for a moment. Yahoo was the #1 website on the planet. Mark Zuckerberg came up... more

15 Feb 2024 · 58 minutes
The Path to Sustainable Practices in Medical Device Design and Combination Product Manufacturing

Sustainability isn’t a buzzword - it’s a crucial aspect of the mission within medical device and combination product design and... more

09 Jan 2024 · 55 minutes
AI Summit Highlights: Transparency, Bias in AI, and Exciting Advances

The Agilis by Kymanox experts in digital health, Lauren Horn, PhD and Alexandria Kruzer, attended the 2023 AI Summit and... more

18 Dec 2023 · 18 minutes
Innovating Patient-Centric Healthcare: A Conversation with Stephen M. Perry

In the conclusion of our conversation with Stephen M. Perry (part 1) we explore the dynamic intersection of healthcare innovation... more

06 Dec 2023 · 19 minutes
Combination Product Universe: PDA Conference Recap with Keynote Speaker Stephen Perry

At the PDA Universe of Pre-filled Syringes and Injection Device Conference in Gothenburg, Sweden, Kymanox Founder and CEO Stephen Perry... more

20 Nov 2023 · 24 minutes
Unpacking the Role of Human Factors in Medical Device Development

Shannon Hoste and Rita Lin discuss Rita's recent presentation at the RAPS Convergence conference in Montreal and share insights about... more

08 Nov 2023 · 28 minutes
Navigating the Real-World Environment of Medical Products

In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering.... more

25 Oct 2023 · 21 minutes
Creating a Successful Roadmap: Lab, Clinic, Market

In this episode of The Factor, Shannon continues her conversation with Stefanie Johns, PhD, Director of Regulatory Affairs at Kymanox... more

11 Oct 2023 · 16 minutes
Factors to Consider in Clinical Readiness for Medical Device and Combination Product

How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical... more

25 Sep 2023 · 20 minutes
Future Healthcare Models: The Evolving Role of Nurses in Advancing Patient-Centered Care

Dr. Bonnie Clipper, the founder of Innovation Advantage, a consultancy specializing in helping healthcare organizations embrace innovation, discusses various aspects... more

13 Sep 2023 · 25 minutes
Transforming Nursing through AI and Innovation, with Dr. Bonnie Clipper

Today we explore the dynamic synergy between healthcare innovation and human factors engineering in nursing, with Dr. Bonnie Clipper. We... more

29 Aug 2023 · 15 minutes
The Factor, a Trusted Podcast for the Life Sciences Industry
Factors to Consider in Clinical Readiness for Medical Device and Combination Product
The Factor, a Trusted Podcast for the Life Sciences Industry
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Description

How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to... more