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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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ماهیانه+
 
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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Poetic Devices: (Type) Writing Life

Kro, The Traveling Typist

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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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ماهیانه
 
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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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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We sat down with the Product Security Officer - Healthcare at Barco to discuss the intersection of QA and Product Security, the Secure Software Development Life Cycle, and cybersecurity standards from NIST and IEC.توسط 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 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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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 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.توسط 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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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.توسط 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.توسط 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 Dr Abhinanda Sarkar faculty director of Great Learning. AI has been a central theme to this podcast this season, and to contribute further to it, today we talk about GenAI and how it is manifesting itself in educa…
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On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…
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In this special bonus episode, we welcome back Tom Alrich, an expert in supply chain cybersecurity to discuss one of the most pressing issues in cybersecurity right now. Tom discusses the current issues with the National Vulnerability Database (NVD) and the challenges it presents for effective vulnerability management. We explore his proposed solut…
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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. Rohini Srivathsa, Chief Technology Officer, Microsoft India and South Asia. AI has been a central theme to this podcast this season, and to contribute further to it, today we talk about Microsoft Copilot and h…
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On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reaut…
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Join us as we dive into the journey of Ashwini Siddhi, Director of Product Security Engineering at GoDaddy. Ashwini shares her experiences from Dell to GoDaddy, her expertise in threat modeling, and the pivotal role of Bengaluru in her career. We also explore her advocacy for diversity and inclusion in cybersecurity and her influential mentorship w…
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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 Akis Evangelidis, Co-founder, Nothing. Smartphones have become a very common gadget these days, and all sorts of innovations have already been tried and tested on them. But, Nothing comes like a breath of fresh ai…
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On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview00:04 David DeSalvo's Career Journey02:13 Understanding Injection Systems04:22 Early Career at BD10:51 Transition to SHL17:50 Starting a New Venture24:54 Experience at …
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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 Josh Foulger, President, Consumer Electronics, Zetwerk. Josh shares his experience in manufacturing and what makes India a perfect destination for the same. He talks about the challenges that were faced by the sup…
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On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024.Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie wit…
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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 Sivakumar Selva Ganapathy, Vice President of OpenBlue India Software Engineering & APAC at Johnson Controls. We are living in the age of artificial intelligence, and we cannot even imagine the ways in which it can…
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On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Mana…
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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 Sandip Patel, Managing Director, IBM India & South Asia. IBM is one of those organizations that has been at the forefront of AI development. In fact, they brought out their own AI platform - Watsonx. Sandip Patel …
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On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and…
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