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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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Left to Our Own Devices

Cybellum Technologies LTD

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Introducing Left to Our Own Devices - the podcast dedicated to everything product security. Every other week, we will be talking with a different cybersecurity policymaker, engineer, or industry leader to hear their war stories and get their insider tips for surviving the product security jungle. From Medical SBOMs, to WP. 29 and the latest industrial security threats, this is your place to catch up and learn from the pros. Left to Our Own Devices is brought to you by Cybellum. To learn more ...
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I make my living as an on-demand typewriter poet. I peddle surprise and delight. These are my stories, methods, and philosophies. My mission is to bring poetry to the people. Tune in for tales of typewriter theater, my stance on creative bravery, and to hear poetry from the streets.
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Beyond Devices Podcast

Jan Dawson and Aaron Miller

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The Beyond Devices podcast is brought to you by Jan Dawson and Aaron Miller. Jan is the author of the Beyond Devices blog, as well as the owner and Chief Analyst at Jackdaw Research, a research and advisory firm focused on the consumer electronics market. Aaron is a business school professor, but in a past life ran one of the most popular iMovie blogs and co-authored several books in the iMovie: the Missing Manual series with David Pogue, and remains an avid follower of all things Apple. Jan ...
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The Medical Devices Group is the medical device industry hub that connects you with experts cherry-picked among our 350,000 members. • MedicalDevicesGroup.net – 1,000+ archived discussions + resources • medgroup.biz/premium – direct access to medical device experts • medgroup.biz/10x – in-person events • medgroup.biz/linkedin – legacy group • medgroup.biz/podcast – this podcast • medgroup.biz/eavesdrop – sister podcast Medical device work saves and transform lives, so we make our recordings, ...
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Their Own Devices

Marc Groman and David Reitman

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No matter how tech savvy you are, your kids likely have you beat. Digital natives see the world in a fundamentally different way than all previous generations. This makes 21st century parenting an unprecedented challenge. Join Marc Groman, an Obama White House tech and privacy adviser, and David Reitman, an adolescent medical doctor, for candid discussions and helpful tips about screen time, social media, sexting, privacy, online gaming, and other challenges facing parents today. Marc and Da ...
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Devices and Desires

Fr. Bryan Wandel, Fr. Andrew Thebeau, James Kibby

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We're taking a deeper dive into the culture we live in. We'll need three things: (1) An understanding of the culture we find ourselves in. (2) A sharp analysis of the cracks in the smooth, seemingly solid narrative that our culture tells us about what it means to live a good life. (3) A new imagination of what it looks like for the gospel of Christ to open up and thrive from within the cracks of our culture. This podcast comes from clergy and laypeople at Church of the Atonement in Buffalo, ...
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In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins, key elements, similarities, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combina…
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We sat with the Senior Industry Analyst at Frost & Sullivan to learn from her cross-industry experience in automotive, mobility, technology, oil & gas, and manufacturing. We talked about innovation, market strategy, cybersecurity, and consulting for multiple industries, and gathered tips & insights for cybersecurity professionals from her experienc…
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What makes a tabletop RPG truly come alive: a tightly woven plot that pulls players down a thrilling path, or an open world where their every choice shapes the unfolding story? In this episode, we dive deep into the age-old debate between railroad and sandbox adventures, exploring the benefits and challenges of each style. We’ll discuss how player …
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Dr. Manish Gupta, Director, Google DeepMind. In this conversation, Dr. Gupta talks about the vision that Google holds as far as AI is concerned. He shares how their team is extensively working on capturing the nua…
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In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses…
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In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. The…
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In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution.00:00 Welcome and Podcast Jo…
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In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spendin…
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In this special episode, David and Shlomi, hosts of the Left to Our Own Devices podcast, sit down with Aaron C. Crow, a seasoned Cyber and Strategic Risk leader with 25 years of experience. Together, they share valuable insights on OT and product security, while also exploring the future direction of the industry. This episode is a republish from A…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Devita Saraf, Founder, Chairperson and CEO of the Vu Group. In this very interesting episode, she shares with us the innovations that have made Vu TVs stand out ever since their inception. Devita talks about the g…
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On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the chall…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by two guests - Ashim Mathur, Vice President- Marketing, Asia Pacific, Dolby Laboratories and Aamir Hasan, Head Marketing, Home Entertainment Division, LG Electronics. In this very interesting episode, our guests tal…
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Constructing and running role playing game sessions which involve mysteries and investigation can be a challenge sometimes. How to make sure the players find all the clues? What if they miss something? How to adapt your gaming style not to run into bottlenecks and dead ends in this style of adventure. These are the questions we seek an answer to in…
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On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…
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We sat down with the Cybersecurity & Functional Safety Senior Engineering Specialist at Eaton to discuss the intersection of safety and security in the automotive world, upcoming updates to ISO/SAE 21434, and learn from his vast experience in the automotive and medical device industries.על ידי Cybellum Technologies LTD
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by AMD's Sanjay Churiwala. Today, we talk about Field Programmable Gate Array or FPGAs. Sanjay breaks down the whole concept for us in simple words, he shares details about FPGAs, their applications in daily products…
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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Idit Yaniv, Head of Design at WhatsApp. We are all familiar with WhatsApp. We all use it on a daily basis. But what goes into designing an app that caters to billions of users daily? Idit Yaniv unpacks that. From …
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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We sat down with Melissa Rhodes, the Product Security Program Manager at Medtronic and an MDM security thought leader for a fun and insightful conversation about SBOMs and her journey from firmware engineering to leading product security.על ידי Cybellum Technologies LTD
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Ramaprakash Ramamoorthy, Director of AI Research at Zoho Corp. A common theme in this season of Our Own Devices has been Artificial Intelligence. And today we talk about Zoho's contribution in the field. Our guest…
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Jasmeet Sethi, Head of ConsumerLab at Ericsson. Today's discussion will revolve around 5G. 5G will soon be completing two years in India, and Jasmeet helps us understand where it stands vis-a-vis the Indian market…
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…
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In this episode of "Left to Our Own Devices," we dive into the world of automotive cybersecurity with Heather Vermillion, a security engineer at PACCAR, who shares her journey from the Department of Defense to safeguarding advanced automotive technologies, while also championing the next generation of cybersecurity professionals.…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Shyam Motwani, Business Head of Locks & Architectural Fittings and Systems business of Godrej & Boyce, part of Godrej Enterprises Group. Godrej locks are a constant in every household and have been so since decade…
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Astraterra is a Finnish roleplaying game from author Miska Fredman. Astraterra is a steam fantasy role-playing game for all ages and it mixes elements from fantasy, steampunk, and science-fiction genres. In this episode I talk with Miska about how the game was born and about RPG authoring. We also go through various elements of the game itself. Mis…
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On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Rahul Mahajan, CTO, Nagarro. Our guest today talks about how different companies can optimise artificial intelligence according to their needs and requirements. He shares how cost impacts the choice for the kind a…
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On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading an…
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In this episode of Left to Our Own Devices, Rob Putman, Global Manager of Cybersecurity Services at ABB, shares his journey from Sony PlayStation to leading cybersecurity in industrial automation. Tune in for insights on product security and industrial control challenges.על ידי Cybellum Technologies LTD
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Durga Raghunath, Head, News Partnerships, India and South East Asia at Google and Chitra Srivastava, Account Manager, Insights Division, Kantar South Asia. Our guests today share their insights on the new trends i…
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On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. …
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In this episode, Dr. Allan Friedman from CISA returns to discuss the upcoming SBOM-a-Rama, a pivotal event in supply chain cybersecurity. He shares insights on the evolution of SBOMs, the significance of community collaboration, and what to expect from this year's hybrid event, including a showcase of innovative SBOM solutions.…
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In this episode of The Indian Express tech podcast – Our Own Devices, host Nandagopal Rajan, COO, The Indian Express Online is joined by Abe Thomas, CEO, Reliance Broadcast Network. AI has been a central theme to this podcast this season, and to contribute further to it, today we talk about its impact on the radio and audio industry. Our guest talk…
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On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in bi…
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In this episode, we welcome the Director of Product Security at Edwards Life Sciences. Samuel shares his journey from IT roles in a Zimbabwe safari to leading product security in the medical device industry, discussing challenges, solutions, and the impact of FDA regulations on their processes.על ידי Cybellum Technologies LTD
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