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.
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1
Balancing Claims and Compliance in Healthcare Marketing, with Group 31 CEO Crystal Weber
29:20
29:20
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29:20
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…
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1
Invisible Users: Applying Human Factors to Medical Device Servicing and Maintenance
33:43
33:43
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33:43
Medical device design often focuses solely on clinical users, overlooking a crucial group: maintenance personnel. This oversight can lead to inefficient servicing, increased downtime, and potential safety risks. In this episode, we explore the importance of applying human factors principles to medical device maintenance and servicing. Our expert gu…
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1
Secrets of Biopharma Tech Transfers: Lessons Learned and Best Practices
24:34
24:34
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24:34
Biologic drug developers face a persistent challenge - executing successful tech transfers of their processes between sites and scales. These transfers are pivotal but extremely complex, prone to issues from changes in facilities, equipment, materials, and process nuances. Failed or delayed tech transfers can derail entire programs, costing compani…
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1
Aligning with the Right CMO
33:06
33:06
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33:06
Today's episode is all about Contract Manufacturing Organization (CMO) selection. When organizations are considering a CMO, how do they find the right one for them? We're joined by two Kymanox executives, Ryan Doxey, Senior Director of Technical Services, and Jason Martin, Senior Director of CGXP Technical Services. They highlight the importance of…
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1
Mastering the Product Development Lifecycle for Commercial Readiness
25:36
25:36
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25:36
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 …
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1
QMSR, ISO 13485:2016, and What It All Means for Medical Device Risk Management
50:21
50:21
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50:21
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 c…
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1
Kymanox: Two Decades of Excellence
58:54
58:54
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58:54
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 t…
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1
The Path to Sustainable Practices in Medical Device Design and Combination Product Manufacturing
55:32
55:32
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55:32
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 Dire…
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AI Summit Highlights: Transparency, Bias in AI, and Exciting Advances
19:06
19:06
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19:06
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 t…
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1
Innovating Patient-Centric Healthcare: A Conversation with Stephen M. Perry
19:54
19:54
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19:54
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,…
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1
Combination Product Universe: PDA Conference Recap with Keynote Speaker Stephen Perry
24:30
24:30
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24:30
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 compre…
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Unpacking the Role of Human Factors in Medical Device Development
29:13
29:13
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29:13
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 …
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1
Navigating the Real-World Environment of Medical Products
21:38
21:38
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21:38
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 …
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1
Creating a Successful Roadmap: Lab, Clinic, Market
16:55
16:55
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16:55
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 us…
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1
Factors to Consider in Clinical Readiness for Medical Device and Combination Product
21:20
21:20
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21:20
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 D…
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1
Future Healthcare Models: The Evolving Role of Nurses in Advancing Patient-Centered Care
26:00
26:00
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26:00
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 healt…
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1
Transforming Nursing through AI and Innovation, with Dr. Bonnie Clipper
16:00
16:00
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16:00
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 d…
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1
Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape (Part 2 with Dr. Christiana Hofmann and Richard Houlihan)
30:32
30:32
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30:32
In this episode of The Factor Podcast, industry experts Dr. Christiana Hofmann and Richard Houlihan discuss the complexities of Unique Device Identification (UDI) compliance in the evolving European regulatory landscape. From the daunting task of collating data to the importance of strategic planning, they reveal the critical factors that can make …
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1
Exploring EUDAMED Requirements for EU MDR, with Richard Houlihan and Christiana Hofmann
26:59
26:59
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26:59
In this informative episode of The Factor, we sit down with industry experts Dr. Christiana Hofmann and Richard Houlihan to discuss critical aspects of EUDAMED, the European Union's Medical Device Database, and the EU MDR's implementation journey. The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new …
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(Part 2) Winning Formula: Combination Products Unveiled, with Susan Neadle
33:11
33:11
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33:11
Today, Susan Neadle and Stephanie Canfield are back for part two. If you haven't listened to part one, do that first and then come back to this episode. Susan and Stephanie chatted about Susan's new book, The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems. And how it brings clarity of unders…
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1
Winning Formula: Combination Products Unveiled, with Susan Neadle
24:41
24:41
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24:41
Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that distills her years of industry experience into a comprehensive resource. She shares the backstory behind the book and its journey to becoming a peer-reviewed publication by the FDA. With Stephanie Canfield and Shannon Hoste, they discuss the …
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1
(Part 2) ISO 14971 and Risks in Medical Devices: What You Need to Know
28:37
28:37
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28:37
In part one, we chatted about the overarching risk management process for medical device development. Today we continue the conversation, digging into the complexities of medical devices, including AI and other MedTech. Can risk management keep up with the evolving medical tech landscape? What about complex systems? Let's find out. Today's episode …
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1
Risk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to Excellence
18:46
18:46
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18:46
Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin Bills and Shannon Hoste, and they touch upon the challenge of consolidating numerous standards and documents while ensuring the consideration of overall residual risk, encompassing aspects like AI, cybersecurity, and…
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1
Secret to Succes: Human Factors for Medical Product Development
29:08
29:08
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29:08
EP1: Human Factors Secrets to Success. In this episode the host, Sophia Kalita, interviews Pat Patterson and Shannon Hoste with Agilis Consulting Group on how they found themselves drawn to MedTech and what they hope to continue to accomplish. Memorable Quotes: If you understand the importance of being able to describe human performance and are, ar…
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