Shows
Life Science SolutionsNavigating a CDMO-Based CRL: From Crisis to ComplianceDealing with an FDA Complete Response Letter (CRL) is one of the most stressful challenges in drug development, but managing one that stems from a failed inspection at your Contract Development and Manufacturing Organization (CDMO) adds a unique layer of business and operational complexity.In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo (Senior Director of Quality at Kymanox) and Anthony Stewart (Senior Process Engineer at Kymanox) to dissect a real-world case study of remediation and return to GMP manufacturing following a failed Pre-Approval Inspection (PAI).The team explores...
2026-02-1731 minLife Science Solutions5 Steps to Operationalizing FDA’s QMSThe FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David expl...
2026-01-1622 minLife Science SolutionsIn Silico Modeling: A Drug Developer's SuperpowerDeveloping complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the formulation landscape.In this episode of Life Science Solutions, host Chris Adkins is joined by Andrea Arsiccio, PhD, Senior Scientist and Team Lead In Silico at Coriolis Pharma, to discuss how in silico modeling is revolutionizing the assessment of developability and formulation strategies for new drug products.Andrea breaks down how Coriolis Pharma combines physics-based models and Artificial Intelligence with traditional wet lab experimentation to predict molecule behavior, identify liabilities early, and solve complex problems like aggregation and vi...
2025-12-1530 minLife Science SolutionsSmarter Design Controls with AI - Is It Possible?Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards. Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.Topics Include:What design controls are and...
2025-11-1835 minLife Science SolutionsBeyond 200 mg/mL: The Science and Scaling of High-Dose BiologicsPushing biologics beyond 200 mg/mL isn’t just a formulation challenge - it’s a delivery, manufacturing, and regulatory challenge too. Aggregation, precipitation, and sky-high viscosity make scaling these therapies a gauntlet for drug developers.In this episode of Life Science Solutions, host Chris Adkins continues the conversation on hyper-concentrated biologics with Ryan Doxey, VP of Tech Ops & CMC at Kymanox, and Nick Letourneau, PhD, Associate Director of Product Development & Commercialization. Together, they unpack how dehydrated protein microparticles suspended in hydrophobic carriers (like MCT oils or ethyl oleate) can dissolve instantly upon injection, and why this breakthrough coul...
2025-10-2030 minLife Science SolutionsHigh Stakes, High Concentrations: Inside Biologics Innovation (Part 1)In today’s pharma landscape, patient convenience and drug delivery innovation go hand in hand. But how do you deliver life-saving biologics at higher concentrations without sacrificing safety, stability, or patient comfort?In this live-recorded episode of Life Science Solutions, host Chris Adkins sits down with Ryan Doxey, Vice President of Technical Services at Kymanox, for part one of their conversation together. Ryan unpacks the opportunities and challenges of hyper-concentrated formulations, from why patients stand to benefit to how technical hurdles like viscosity, stability, and scale-up shape the path forward.Chris and Ryan dig into wh...
2025-10-1330 minLife Science SolutionsTraining Tomorrow’s Biopharma WorkforceAs the biopharmaceutical industry expands, companies face a constant challenge: How do you find and train the talent needed to sustain growth? And how is technology reshaping the way we prepare the workforce?In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Gary Gilleskie, Executive Director of the Biomanufacturing Training and Education Center (BTEC) at NC State University. Together, they explore the evolution of biologics manufacturing in NC, BTEC’s hybrid industry-academia training model, and the center’s unique impact on workforce development in biopharma and beyondGary shares insights from...
2025-09-2234 minLife Science SolutionsIs Onshoring Biomanufacturing Really Happening?As pharmaceutical companies grow, they face critical choices: Where should you manufacture your product? How do you choose the right CDMO? What risks come with global supply chains?In this episode of Life Science Solutions, host Chris Adkins sits down with Roger Lias, PhD a 35-year veteran of the biologics manufacturing industry, to dig into the realities of onshoring in pharma and the evolving CDMO landscape.Roger walks through geopolitics and the BIOSECURE Act to the practical hurdles of talent shortages and infrastructure buildouts. Roger outlines what sponsor companies need to consider when choosing a...
2025-08-1831 min
PharmaTalkRadioBalancing Between Concentration and Volume when Developing Patient-Centric BiologicsSummary:When developing patient-centric products for biologics, different doses, expressed by different combinations of volume/concentration may require different delivery devices. As a result, it takes a great deal of time and effort in planning and coordinating the formulation and device activities. In this podcast, Pharma and Drug Delivery executives from Nanoform, Pfizer, GSK, Takeda and Kymanox discuss how they facilitate partnerships between drug product development, device engineering and clinical study teams to determine how to balance concentration and volume and develop optimal devices for delivery and commercialization. Specifically:Impact on increasing concentration of drugs on...
2025-08-1228 minLife Science SolutionsAI and the Future of Cancer ResearchIn this eye-opening episode of Life Science Solutions, Chris Adkins sits down with Marcel Frenkel, PhD, CEO and Co-Founder of Ten63 Therapeutics—a biotech startup using AI and quantum physics to design drugs for the most elusive and "undruggable" cancer targets.Marcel shares the groundbreaking science behind Ten63’s BEYOND platform, which navigates a chemical space of 10⁶³ possible molecules to find solutions the pharmaceutical industry previously considered impossible. With personal insight from his mother’s cancer journey, Frenkel explains how traditional drug discovery fails patients—and how Ten63 is flipping the script.Whether you're in biotech, ph...
2025-07-2232 min
Let's Combinate - Drugs + Devices194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike DenzerIn this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a foundation for building a meaningful and resilient career in pharma and medtech.Mike shares what it’s like to develop life-changing devices like Amgen’s Auto Click autoinjector, how he built credibility across R&D and regulatory teams, and why asking good questions and being generous with your time pays off more than any formal title. If you’ve eve...
2025-06-2519 minLife Science SolutionsThe Blueprint for Science Marketing Success with Elizabeth ChabeIn this episode of Life Science Solutions, we’re joined by Elizabeth Chabe — author of The Giant’s Ladder and CEO of High Touch Group — to unpack one of the most underestimated challenges in life sciences: how to market innovation without losing trust, clarity, or credibility.From childhood ventures to advising billion-dollar diagnostics companies, Elizabeth’s journey is a masterclass in what it really takes to move science from the lab to the world stage. She shares why so many scientists struggle to communicate their value, how to align messaging with your stage of growth, and why strategic...
2025-06-1633 min
Life Science SolutionsHow Startups and Industry Support Each OtherIn our latest Life Science Solutions podcast, we sit down with Lydia Thomas from UNCW’s Center for Innovation and Entrepreneurship to talk about the real-world gaps academic startups face—and how her team is helping solve them.From lacking investor networks to navigating IP challenges, Lydia shares how CIE supports faculty and students developing high-potential innovations. We also dive into the Blue Economy Index, plastic waste reduction in drug delivery, and how startups can partner with established life science companies to scale breakthrough technologies.Whether you’re in pharma, biotech, or innovation strategy, this episod...
2025-05-1918 minLife Science SolutionsCapturing Venture Capital: What Makes Life Science Startups Stand Out to InvestorsIn this special episode recorded live at CED Venture Connect, host Chris Adkins sits down with Dave Ousterout, Co-Founder and General Partner at CapeFear Biocapital. Drawing from his unique journey as both a biotech entrepreneur and now a venture capital investor, Dave shares what it really takes to stand out in the early-stage life sciences space.Listeners get a behind-the-scenes look at how CapeFear Biocapital is fueling North Carolina’s innovation ecosystem with pre-seed investments tailored for biotech startups. Dave unpacks the key attributes his team looks for in founding teams, the value of thoughtful op...
2025-04-2327 minLife Science SolutionsManufacturing Intelligence for BioprocessingOn this episode, host Chris Adkins speaks with Gerry Farrell, a seasoned expert with over two decades of experience in the CDMO space and current executive advisor at Kymanox. Their discussion explores three key areas of the evolving bioprocessing landscape: 1. The Evolution from Antibodies to Gene Therapy. How bioprocessing has grown increasingly complex from the relatively straightforward days of monoclonal antibody manufacturing to today's gene therapy challenges. Gerry highlights the critical importance of analytical development for early-stage companies and why having the right methods—not necessarily more methods—is crucial for success. 2. Economic Realities and CDMO D...
2025-03-2529 minLife Science SolutionsThe ten23 health Approach to Biologics DevelopmentHow is ten23 health revolutionizing biologics drug delivery and CDMO services?In this episode, we sit down with Hans-Christian Mahler, Founder and CEO of ten23 health, to break down the latest advancements in sterile fill-finish capabilities and combination product development. From prefilled syringes to large-volume subcutaneous administration, we’ll look at how ten23 health is tackling the challenges of high-concentration, high-viscosity formulations. Plus, we’ll dig into their unique approach to integrating formulation development, manufacturing, and testing services to support complex biologics.Key Takeaways:Industry Evolution: While advancements in drug delivery and patient convenience have...
2025-02-1932 minLife Science SolutionsDisruptive Trends in Drug and Device Development, with Kymanox President Evan EdwardsIn this episode of Life Science Solutions, Evan Edwards, President of Kymanox, explores the key trends shaping the life sciences industry in 2025. From groundbreaking advancements in cell and gene therapies to the rise of GLP-1 drugs and the essential scaling of CDMO operations, Evan highlights the innovations driving product development and commercialization. Key Takeaways:Kymanox Growth: The company is expanding its capabilities, workforce, and global footprint, now employing nearly 300 people across the U.S. and Europe.Industry Trends:Cell and Gene Therapy: Emerging targeted treatments are transforming patient outcomes and delivery methods, including potential home-based solutions.G...
2025-01-2122 min
Let's Talk Risk! with Dr. Naveen AgarwalLTR 84: Think of human factors for AI as levels of automation“Many of the AI/ML devices are going through De Novo and (in these) human factors considerations are specifically being called out as special controls.”In this Let’s Talk Risk! conversation, Shannon Hoste highlights some of the new concerns emerging for human factor considerations for AI/ML devices in MedTech. She explains how we could consider the level of automation as we think about new hazards related to the user interface. For example, in a clinical decision support system, having appropriate levels of trust with the physician is important. Shannon emphasizes the need for transp...
2025-01-1734 minLife Science SolutionsProject Management Strategies for Effective CommunicationIn this episode, we discuss the cornerstone of successful project management: COMMUNICATION. Join Shivali Patel as she sits down with project management experts Max Tenebaum and Natalie Hrabrick to discuss overcoming communication challenges, aligning stakeholders, and keeping teams on track. From navigating written misunderstandings to crafting effective communication workflows, this conversation is packed with actionable insights and relatable experiences. Discover: The critical role of communication in team alignment and project success Strategies for handling common breakdowns in project teams Tools and techniques to streamline collaboration and manage expectations Plus, enjoy a fun ra...
2024-12-0933 min
Project MedtechEpisode 202 | Staci Miller, Founder at Gen UX Consulting | Fashion Designer to Human Factors Consulting in MedtechIn this episode, Staci Miller at Gen UX Consulting and Duane Mancini discusses her background as a fashion designer, cognitive psychology, how she got into human factors testing, what she learned from her time with Medtronic and Abbott, and so much more.
Staci Miller LinkedIn
Gen UX Consulting LinkedIn
Gen UX Consulting Website
Duane Mancini LinkedIn
Project Medtech LinkedIn
Project Medtech Website
Beginski Wegner & CO
Rook Quality Systems
Kymanox
2024-12-0247 minLife Science SolutionsMaking BioPharma Partnerships WorkIn this episode of The Factor, host, Chris Adkins interviews Bill Monteith, Kymanox Executive Advisor, to discuss the art of building successful partnerships in biopharma manufacturing. With over 40 years of experience, Bill shares how aligning operations, quality, and patient focus is essential for success.From preparing CDMOs for FDA scrutiny to designing flexible Quality Management Systems (QMS) and fostering patient-first cultures, this episode provides actionable insights for navigating the complexities of biologics and advanced therapies. If you're scaling operations or managing critical partnerships, this conversation is a must-listen.About the Factor:The Factor...
2024-11-1844 minProject MedtechEpisode 200 | Aaron TenHuisen, Rich Mazzola, and Jamie Easterling | Celebrating Project Medtech's Growth and Future VisionIn this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much
Duane Mancini LinkedIn
Aaron TenHuisen LinkedIn
Rich Mazzola LinkedIn
Jamie Easterling LinkedIn
Project Medtech LinkedIn
Project Medtech Website
Rook Quality Systems
Beginski Wegner & CO
Kymanox LinkedIn
2024-11-0455 minProject MedtechEpisode 200 | Aaron TenHuisen, Rich Mazzola, and Jamie Easterling | Celebrating Project Medtech's Growth and Future VisionIn this episode, Aaron TenHuisen, Jamie Easterling, and Rich Mazzola at Project Medtech and Duane Mancini discuss the growth at Project Medtech, the growth of the commercial consulting group, our expansion into talent and quality support, and so much
Duane Mancini LinkedIn
Aaron TenHuisen LinkedIn
Rich Mazzola LinkedIn
Jamie Easterling LinkedIn
Project Medtech LinkedIn
Project Medtech Website
Mittal Consulting
Rook Quality Systems
Beginski Wegner & CO
Kymanox LinkedIn
2024-11-0455 minLife Science SolutionsHow RNA Origami is Revolutionizing Drug DevelopmentIn this episode of The Factor, Ryan Doxey (Senior Director of Technical Services at Kymanox) and David Harrell (CEO of Helixomer) discuss the innovative potential of RNA Origami in transforming drug development and precision medicine, and the challenges faced by startups in this complex landscape.So what exactly is RNA Origami?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...
2024-10-1425 minProject MedtechEpisode 195 | Don Pohl and Sheri Krajewski at NAMSA | Tips to Successfully Navigate Biocompatibility Testing of Medical DevicesIn this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more.
Don Pohl LinkedIn
Sheri Krajewski LinkedIn
NAMSA LinkedIn
NAMSA Website
Duane Mancini LinkedIn
Project Medtech LinkedIn
Project Medtech Website
Mittal Consulting
Rook...
2024-10-0148 minLife Science SolutionsAdopting Agile Strategies in Emerging MedTechIn this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO of Project MedTech, to discuss the importance of agility, strategic planning, and value creation for life science startups. Duane shares his insights on effective fundraising, the vital role of treating consultants as team members, and the need for startups to optimize marketing and value proposition in the healthcare ecosystem. He also delves into the significance of building a unique company culture and the phased approach to implementing quality management systems. This conversation is essential for MedTech professionals r...
2024-09-1638 minLife Science SolutionsBalancing Claims and Compliance in Healthcare Marketing, with Group 31 CEO Crystal WeberCreating 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 industry. From navigating FDA regulations to ensuring ADA compliance, Crystal shares invaluable insights on how biotech and pharma companies can effectively communicate their message while staying within legal boundaries. Discover why early-stage planning, strategic partnerships, and a deep understanding of r...
2024-08-1229 minLife Science SolutionsInvisible Users: Applying Human Factors to Medical Device Servicing and MaintenanceMedical 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 humanfactors principles to medical device maintenance and servicing. Our expert guest, Avital Zik from Medtronic, discusses strategies for incorporating service personnel needs into device design, creating more user-friendly maintenance processes, and improving overall devicereliability. Rita Lin, Director of HFE at Kymanox, also offers her insight from past experiences working at the FDA and in industry.Learn...
2024-07-1533 minLife Science SolutionsSecrets of Biopharma Tech Transfers: Lessons Learned and Best PracticesBiologic 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 companies millions. So what's the solution? In this episode, biomanufacturing veteran Marcelo Anderson provides a masterclass on mastering tech transfers through fostering cross-functional collaboration and open communication. With 27 years of experience, Marcelo emphasizes the critical "human element" often underestimated. Whether preparing for an upcoming biologics tech t...
2024-06-1724 minLife Science SolutionsAligning with the Right CMOToday'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 finding a CMO with the right capabilities and expertise, as well as the significance of project managers in successful collaborations. Trust, cultural fit, and regulatory compliance are crucial factors when selecting a CMO - and there are complexities of CMO selection and strategic planning in...
2024-05-1333 minLife Science SolutionsMastering the Product Development Lifecycle for Commercial ReadinessHow 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 t...
2024-04-1525 minLife Science SolutionsQMSR, ISO 13485:2016, and What It All Means for Medical Device Risk ManagementNaveen 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, Sen...
2024-03-1850 minLife Science SolutionsKymanox: Two Decades of ExcellenceTake 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 Tr...
2024-02-1558 minLife Science SolutionsThe Path to Sustainable Practices in Medical Device Design and Combination Product ManufacturingSustainability 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...
2024-01-0955 minLife Science SolutionsAI Summit Highlights: Transparency, Bias in AI, and Exciting AdvancesThe 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 e...
2023-12-1819 minLife Science SolutionsInnovating Patient-Centric Healthcare: A Conversation with Stephen M. PerryIn 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...
2023-12-0619 minLife Science SolutionsCombination Product Universe: PDA Conference Recap with Keynote Speaker Stephen PerryAt 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 comprehensive overview of the historical evolution of combination products, emphasizing the pivotal role of insulin and diabetes in driving innovation. Technologies like insulin pumps and reusable pen injectors have played a crucial role in advancing injection systems. The discussion extends to Step...
2023-11-2024 minLife Science SolutionsUnpacking the Role of Human Factors in Medical Device DevelopmentShannon 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 importance of risk management, regulatory considerations, and the impact of AI and machine learning in healthcare. The conversation also delves into the importance of real-world evidence, collaboration, and education within the industry.About the Factor:The Factor, your trusted podcast for the life...
2023-11-0829 minLife Science SolutionsNavigating the Real-World Environment of Medical ProductsIn 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 usability and human factors in product design.Shannon Hoste shares a similar background, transitioning from a more conventional engineering role to human factors engineering after encountering issues related to device usability in post-market settings. Their experiences highlight the vital role of understanding user...
2023-10-2521 minLife Science SolutionsCreating a Successful Roadmap: Lab, Clinic, MarketIn 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 users, how best to manage risk, and incorporating the right data safety monitoring. Additionally, Stefanie and Shannon emphasize the importance of collaboration with regulatory authorities and leveraging risk management plans throughout the product development process. They stress that there is no one-size-fits-all approach to being c...
2023-10-1116 minLife Science SolutionsFactors to Consider in Clinical Readiness for Medical Device and Combination ProductHow 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 Dr. Stefanie Johns, Director of Regulatory Affairs at Kymanox, as she shares her strategies to solve the clinical readiness puzzle. Shannon Hoste, Vice President of Agilis by Kymanox and Stefanie delve into factors like patient safety, human factors engineering, and the challenges faced b...
2023-09-2521 minLife Science SolutionsFuture Healthcare Models: The Evolving Role of Nurses in Advancing Patient-Centered CareDr. 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 healthcare professionals and utilizing assistive technologies in supporting distributed care models. Dr. Clipper encourages staying informed about emerging technologies and identifying opportunities to address healthcare challenges. The conversation underscores the ongoing transformation of healthcare through technology and the need for a holistic approach to healthcare delivery and education. Dr. Clipper's r...
2023-09-1325 minLife Science SolutionsTransforming Nursing through AI and Innovation, with Dr. Bonnie ClipperToday 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 device manufacturers, health care institutions, and health care professionals to ensure the successful integration of innovative technologies and practices that empower nurses and improve patient care. Dr. Clipper is the founder of Innovation Advantage, a consultancy that focuses on helping health care organizations adopt innovative approaches. She is a...
2023-08-2915 minLife Science SolutionsNavigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape (Part 2 with Dr. Christiana Hofmann and Richard Houlihan)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 or break a successful UDI implementation. Join the conversation as they shed light on the need for collaboration, the impact of AI on data reporting, and advice for manufacturers to scale the mountain of UDI compliance. Richard Houlihan is the former IT consultant for t...
2023-08-1630 minLife Science SolutionsExploring EUDAMED Requirements for EU MDR, with Richard Houlihan and Christiana HofmannIn 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 rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU).Our experts discuss the challenges and o...
2023-08-0226 minLife Science Solutions(Part 2) Winning Formula: Combination Products Unveiled, with Susan NeadleToday, 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 understanding for global Combination Products guidance and regulations. Today, they continue the conversation, diving into risk management plans, control safety in the United States, and the polarizing viewpoints of ICH Q9 vs. ISO 14971.Today's episode is hosted by Shannon Hoste...
2023-07-1933 minLife Science SolutionsWinning Formula: Combination Products Unveiled, with Susan NeadleSusan 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 top considerations in Combination Products, covering topics such as regulatory strategies, human factors engineering, risk management, and more.With insights from experts around the world, the book offers valuable recommendations, case examples, and even real-life warning letters to guide those venturing into the realm of...
2023-07-0524 minLife Science Solutions(Part 2) ISO 14971 and Risks in Medical Devices: What You Need to KnowIn 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 is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group. Today's guests are Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development f...
2023-06-2128 minLife Science SolutionsRisk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to ExcellenceToday 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 biocompatibility. The conversation explores the need for manufacturers to embrace comprehensive risk management, focusing not only on individual risk analysis but also on evaluating the overall risk of complex systems. We also review ISO 14971, the expansion of guidance documents, and the importance of putting patient safety at t...
2023-06-0818 min
Let's Combinate - Drugs + Devices070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul JansenOn this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses:
- His experience leading combination product focused organizations at Eli Lilly & Sanofi
- The first autoinjectors and the history surrounding ISO 11608
- Managing a product line, owning P&L and the product development mindset shift that came with that
Paul Jansen is currently working as a Drug Device Development Consultant. He is also on the Board of Directors at Subcuject and sits on the Advisory Boards of E...
2023-02-0150 min
Life Science SolutionsSecret to Succes: Human Factors for Medical Product DevelopmentEP1: 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, are able to do that to me that's the secret sauce. All things are possible after that. Human factors is about the users, ensuring that they can safely and effectively use the medical device or combination product they are given. About th...
2022-12-0529 min
Chaos CorralCreating High Performance Teams w/Stephen PerryStephen Perry, CEO of Kyamanox, talks with Jerel Bonner, your host of Chaos Corral, and discusses authentic leadership behaviors that create high-performance teams. Stephen will shine his expertise on: How do Kymanox leaders make employees feel special?
Psychologically
Measurable
And one very special CAVEAT
Listen for his gems of insights.
2021-02-2318 min
The Life Sciences Careers PodcastCOVID Hiring What Are Companies Doing Differently?For Triangle Biotech Tuesday, Don Alexander of Genecoda hosted a panel discussion on the topic of "COVID hiring: What are companies doing differently?", featuring Andrea Johnson – Senior HR Manager - Kymanox and Aaron Turner – Talent Acquisition Manager at RTI International.
2020-09-0845 min