Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory... more
In this episode of The Factor, host, Chris Adkins interviews Bill Monteith, Kymanox Executive Advisor, to discuss the art of... more
In this episode of The Factor, Ryan Doxey (Senior Director of Technical Services at Kymanox) and David Harrell (CEO of... more
In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO... more
Creating labeling claims that support business goals without getting into compliance issues can be a tough sea to navigate.Today, join... more
Medical device design often focuses solely on clinical users, overlooking a crucial group: maintenance personnel. This oversight can lead to... more
Biologic drug developers face a persistent challenge - executing successful tech transfers of their processes between sites and scales. These... more
Today's episode is all about Contract Manufacturing Organization (CMO) selection. When organizations are considering a CMO, how do they find... more
How can medical device and combination product companies bridge the difficult "valley of death" between early product design and commercial... more
Naveen Agarwal, PhD and Nate Blazei discuss the QMSR and the relationship to ISO 13485:2016 and how Risk Management is... more
Take a trip to 2004 for a moment. Yahoo was the #1 website on the planet. Mark Zuckerberg came up... more
Sustainability isn’t a buzzword - it’s a crucial aspect of the mission within medical device and combination product design and... more
The Agilis by Kymanox experts in digital health, Lauren Horn, PhD and Alexandria Kruzer, attended the 2023 AI Summit and... more
In the conclusion of our conversation with Stephen M. Perry (part 1) we explore the dynamic intersection of healthcare innovation... more
At the PDA Universe of Pre-filled Syringes and Injection Device Conference in Gothenburg, Sweden, Kymanox Founder and CEO Stephen Perry... more
Shannon Hoste and Rita Lin discuss Rita's recent presentation at the RAPS Convergence conference in Montreal and share insights about... more
In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering.... more
In this episode of The Factor, Shannon continues her conversation with Stefanie Johns, PhD, Director of Regulatory Affairs at Kymanox... more
How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical... more
Dr. Bonnie Clipper, the founder of Innovation Advantage, a consultancy specializing in helping healthcare organizations embrace innovation, discusses various aspects... more
Today we explore the dynamic synergy between healthcare innovation and human factors engineering in nursing, with Dr. Bonnie Clipper. We... more
How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to... more