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

In this episode of The Factor Podcast, industry experts Dr. Christiana Hofmann and Richard Houlihan discuss the complexities of Unique... more

In this informative episode of The Factor, we sit down with industry experts Dr. Christiana Hofmann and Richard Houlihan to... more

Today, Susan Neadle and Stephanie Canfield are back for part two. If you haven't listened to part one, do that... more

Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that distills her years of industry experience... more

In part one, we chatted about the overarching risk management process for medical device development. Today we continue the conversation,... more

Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin... more

EP1: Human Factors Secrets to Success.  In this episode the host, Sophia Kalita, interviews Pat Patterson and Shannon Hoste with... more