RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
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Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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Welcome to The Sidley Podcast. Join us as we bring a unique perspective to complex issues at the intersection of law and business.
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A Ropes & Gray (RopesTalk) podcast series focused on the world of unfair import investigations at the U.S. International Trade Commission (ITC).
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Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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The American Health Law Association (AHLA) is the largest nonprofit, nonpartisan educational organization devoted to legal issues in the health care field. AHLA's Speaking of Health Law podcasts offer thoughtful analysis and insightful commentary on the legal and policy issues affecting the American health care system.
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FDA Imports
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Welcome to The Quality Grind Podcast, presented by Medvacon! Join hosts Joe Toscano, President of Medvacon, and Mike Kent, Director of Learning Platforms, as they (we) have some fun while tackling topics related to the “everyday grind” within Life Science industries. Featuring conversations with key industry players, they’ll dive into their unique problem-solving strategies, career paths and personal interests. Most importantly, their (our) goal is to cultivate a community where information ...
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Co -hosted by Glenn Hunzinger, US Health Industries leader, and Jennifer Colapietro, Consulting Commercial Leader, the Next in Health podcast series offers insights on the most important issues facing pharma, medtech and healthcare. PwC business leaders discuss the latest trends and their impact on health industries, whether it’s policy, AI, innovation, care delivery, business model reinvention or bold moves for the future. If it’s happening in health industries, we’re talking about it.
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Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other ...
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Dietitian Melinda Hemmelgarn helps listeners “think beyond their plates,” connect the dots between food, health and agriculture, and find food truth.
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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Anesthesiology News will be publishing a new season of our popular podcast series, “On the Case” and “Ask the Experts.” “On the Case” is a review series that features the authors of our popular case report series. We hear the behind-the-scenes story on the most unique clinical case studies published in the magazine directly from the professionals who managed them. The first episode of this new season features an interview with L. Jane Stewart, MD, JD, MPH, who co-wrote a case report about a ...
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16 Minutes on the News is a short news podcast where we cover the top headlines of the week, the a16z podcast way -- why are these topics in the news; what's real, what's hype from our vantage point; and what are our experts' quick takes on these trends? About the a16z Podcast: Discusses tech and culture trends, news, and the future -- especially as ‘software eats the world’. It features industry experts, business leaders, and other interesting thinkers and voices from around the world. This ...
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On the "Making it to Market" podcast, we discuss everything about brand inception and product/service creation through to commercialization. Industry experts and business owners are invited to share their insights and best practices related to business planning, legal and regulatory considerations, manufacturing, supply chain, marketing, merchandising, B2B buyer methodology and B2C consumer psychology.
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Eli Lilly’s GLP-1 Litigation: Issues Related to Corporate Practice of Medicine and FDA Regulations
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27:53In a groundbreaking development for the digital health world, Eli Lilly, one of the world’s largest pharmaceutical companies, has filed lawsuits against a growing number of telehealth companies over the sale of compounded drugs Mounjaro and Zepbound, two popular GLP-1 medications. Nawa Lodin, Associate, Wilson Sonsini Goodrich & Rosati, and Lauren …
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Workforce Issues in Health Care Transactions
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35:52
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35:52Tom Donohoe, Shareholder, Hall Render Killian Heath & Lyman PC, Kelly Adams, Region General Counsel, Intermountain Health, and Barb Grandjean, Partner, Husch Blackwell LLP, discuss the various labor and employment considerations that are present in health care transactions, with a focus on the current M&A environment. They cover issues related to p…
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Sandra Brooke, Ph.D., Florida State University’s Coastal and Marine Laboratory discusses oysters.
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28:09Did you know that oysters are not only popular items at seafood festivals, but vital to the health of our estuaries? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Sandra Brooke, Ph.D., research faculty at Florida State University’s Coastal and Marine Laboratory and scientific director and lead in…
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EU Market Entry: Mastering CE Marking for Medical Devices
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5:03This episode provides a comprehensive guide to CE Marking for medical devices, a mandatory certification for accessing the European Economic Area. We cover the essential requirements, including device classification, Quality Management Systems, technical documentation, conformity assessments by Notified Bodies, clinical evaluations, the role of the…
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Understanding FDA Expectations for Combination Products
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12:38
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12:38In this episode of RCA Radio, host Brandon Miller sits down with Jessica Schafersman, a design and development expert at RCA®, to break down the increasingly complex world of combination products—those that blend drugs, devices, or biologics. Jessica shares insights on why these products are uniquely challenging, the regulatory expectations compani…
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$14M Fine Says This “Free” Offer Wasn’t Legal
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3:40In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid. This wasn’t just bad billing—it was a ma…
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Lean Principles and Regulated Life Sciences - Part 2
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41:40Send us a text Join host Mike Kent and special guest Jose Mora as they continue to explore the application of Lean principles within regulated life science environments. In this episode, they explore seven key benefits of Lean: quality and compliance, throughput and operating expense reduction, speed to market, flexibility and adaptability, continu…
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This episode provides a comprehensive overview of the U.S. FDA's medical device approval process. We break down the three device risk classifications, detail the primary regulatory pathways including Premarket Notification (510(k)), Premarket Approval (PMA), De Novo, and Humanitarian Device Exemption (HDE). Listeners will also learn about the gener…
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Decoding MedTech Regulations: QMSR, ISO 13485 & Global Strategy
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3:32This episode unpacks the evolving world of medical device regulatory compliance. We explore crucial updates, including the FDA's QMSR Final Rule effective February 2026 and its alignment with ISO 13485:2016. We also cover diverse global frameworks, core compliance components like QMS and risk management, common challenges, and strategic approaches …
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Health Care Corporate Governance: DOJ’s Criminal Enforcement Plan and Board Oversight Responsibility
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21:26
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21:26Rob Gerberry, Senior Vice President and Chief Legal Officer, Summa Health, speaks with Michael Peregrine, Partner, McDermott Will & Emery, about the Department of Justice Criminal Division’s recent release of its new white collar criminal enforcement plan and the board’s oversight responsibility for corporate compliance with the law. They discuss h…
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Nonprofit Pharma Exists. Here is how it works
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11:50In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multip…
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Wearable Health: Revolutionizing Patient Care and Monitoring
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4:26This episode explores the dynamic field of wearable medical devices. The host discusses the various types, from smartwatches to specialized sensors, their key functions in monitoring, screening, detection, and prediction, and the significant benefits they offer for patient empowerment, remote care, and chronic disease management. The discussion als…
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Justin Swanson and Federal Efforts to Ban Hemp
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15:52Jonathan Miller interviews Justin Swanson, President of the Midwest Hemp Council, about legislation being considered by the House Appropriations Committee that could ban most consumable hemp products. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered…
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2024-2025 MedTech Frontier: Devices Changing Patient Care
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4:41This episode explores the cutting-edge medical device technologies set to revolutionize healthcare in 2024 and 2025. We delve into advancements in noninvasive wearables, home care systems, surgical tools, AI-driven diagnostics, and specialized treatments for cardiovascular, orthopedic, and neurological conditions, highlighting how these innovations…
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In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particula…
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Protect & Prosper: Insurance Essentials for US MedTech
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3:05This episode delves into the critical role of insurance for medical device companies in the USA. We explore the two main facets: securing product liability insurance to mitigate operational and legal risks, and navigating the health insurance reimbursement landscape to ensure patient access and commercial viability. We cover key steps like FDA appr…
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Navigating US Health Data Privacy: Is Your Device HIPAA-Ready?
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3:28This episode demystifies "HIPAA compliance" for medical devices. The host explores when manufacturers become subject to HIPAA, the essential administrative, physical, and technical safeguards for protecting patient health information (PHI), patient rights regarding their data, requirements for data sharing and Business Associate Agreements, and the…
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Operation Brace Yourself, Part Two: Defending DME Clients
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51:37
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51:37Operation Brace Yourself, a massive 2019 Department of Justice operation involving the durable medical equipment (DME) industry, was one of the largest health fraud enforcement actions in history and had major legal and compliance repercussions for DME companies. In this two-part series, Stephen Lee, Solo Practitioner, Law Office of Stephen Chahn L…
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Basel Musharbash, antitrust and trade regulation lawyer discusses fertilizer and consolidation in the agricultural sector. (Part 2 of 2)
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28:09Did you know that consolidation in the fertilizer industry results in environmental harm and less choice for farmers? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Basel Musharbash, antitrust and trade regulation lawyer, and author of Kings Over the Necessaries of Life: Monopolization and the Eli…
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Whistleblowing in Clinical Trials: Is It Worth the Risk?
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9:28In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors. They discuss examples…
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ISO 13485 Explained: Your Key to MedTech Compliance and Trust
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4:25
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4:25This episode demystifies ISO 13485 certification, explaining how it signifies a robust Quality Management System for medical device organizations. We explore the certification process, its broad applicability across the device lifecycle, the stringent requirements for risk management and regulatory compliance, and its crucial role in ensuring produ…
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Culture & Compliance Chronicles: Humanizing Compliance—Creative Approaches with Nicole Rose
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31:37On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, are joined by Nicole Rose, a compliance specialist and creative artist based in Australia who shares her unique insights on how creativity helps solve compliance challenges. Nicole d…
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Unlock Global MedTech Markets: Finding Your Ideal Distributors
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5:08
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5:08This episode delves into proven strategies for medical device companies to identify, vet, and secure local importers and distributors worldwide. We explore a multifaceted approach, combining digital tools, key industry events, professional networks, and crucial due diligence steps to help you effectively expand your product's global reach and navig…
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Navigating Cell & Gene Therapy: Accelerating Development and Innovation
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40:07Send us a text Welcome back to the Grind, where Joe and Mike continue their exploration of Cell & Gene Therapy with expert Ray Kaczmarek. In this episode, part 2 of our 4-part series, Ray provides perspective on navigating the development process, highlighting some key factors for success – robust science, integrous data and stage-appropriate syste…
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The Multi-Billion Dollar Diagnosis: Unpacking MedTech's Top Revenue Generator
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4:00
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4:00This episode delves into the dominant force in medical device revenue: In Vitro Diagnostics (IVDs). We uncover why IVDs consistently lead the global market, highlighting key drivers like early disease detection and the rise of chronic illnesses. We also explore the geographical strongholds, with a focus on the U.S. market's supremacy, and identify …
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The 5-Step Food Safety Framework That's Transforming State Garden with Dinesh Babu
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33:02Building a strong food safety culture requires deep organizational commitment and the systematic implementation of best practices across every level of operations. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams is joined by Dinesh Babu, Vice President of Quality and Food Safety at State Garden, for an i…
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Operation Brace Yourself, Part One: Advising DME Clients
43:37
43:37
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43:37Operation Brace Yourself, a massive 2019 Department of Justice operation involving the durable medical equipment (DME) industry, was one of the largest health fraud enforcement actions in history and had major legal and compliance repercussions for DME companies. In this two-part series, Stephen Lee, Solo Practitioner, Law Office of Stephen Chahn L…
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Fully Invested: Exchange Act Registered Private Funds (’34 Act)
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14:10On this episode of Fully Invested, Ropes & Gray asset management partner Jessica Marlin and capital markets counsel Marc Rotter discuss ’34 Act Registered Private Funds. These funds register under the Securities Exchange Act of 1934 and disclose information publicly, while remaining exempt from the Investment Company Act of 1940. Jessica and Marc e…
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The Right Way to Do Medical Affairs on LinkedIn
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14:58
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14:58In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn handles. Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receivi…
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Beyond EU Bottlenecks: MedTech's New Global Market Hotspots
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4:18
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4:18This episode explores the evolving global market entry strategies for medical devices. We discuss the significant regulatory hurdles in the EU due to MDR/IVDR, leading manufacturers to increasingly prioritize the U.S. market. We also delve into the burgeoning opportunities in high-growth emerging markets across Asia-Pacific and Latin America, offer…
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MedTech Goes Global: Top 3 Expansion Strategies
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2:37This episode delves into the three essential pillars for medical device companies aiming to expand their reach from local to international markets. We discuss the critical nature of understanding diverse international regulatory landscapes and the role of harmonization efforts. We also explore the importance of in-depth market research, effective p…
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Are We Paying Clinical Trial Patients Enough?
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14:56
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14:56In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more? Key Takeaways: The Coercion Concern Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. H…
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CE Marking: The Golden Key for Global MedTech Entry
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4:40CE marking is a crucial certification for medical devices, acting as a legal key to the European market and a global benchmark for safety and quality. It signifies compliance with strict EU regulations (MDR/IVDR), offers competitive advantages, and provides a solid foundation for other international regulatory approvals, making it essential for man…
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Decoding High-Risk Medical Device Classifications Worldwide
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3:29This episode unpacks the significant variations in "Class III" and "Class IV" medical device classifications across key global markets like the US, EU, Canada, China, and Saudi Arabia. We explore why a device's risk class in one country doesn't automatically apply elsewhere and what this means for manufacturers seeking international market access.K…
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Basel Musharbash, antitrust and trade regulation lawyer, discusses the high price of eggs. (Part 1 of 2)
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28:09Did you know that consolidation in our food and agriculture systems has more to do with the price of eggs than bird flu? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Basel Musharbash, antitrust and trade regulation lawyer, and author of Kings Over the Necessaries of Life: Monopolization and the …
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2025 MedTech Fast Track: FDA Breakthroughs & CMS Coverage Acceleration
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5:41This episode unpacks the 2025 landscape for the FDA's Breakthrough Devices Program and the transformative new CMS Transitional Coverage for Emerging Technologies (TCET) pathway. We explore how these initiatives are accelerating device clearance and Medicare coverage, including the impact of over 1,000 Breakthrough designations granted by September …
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Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying…
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Navigating Cell & Gene Therapy: Setting the Stage for Success
23:49
23:49
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23:49Send us a text Welcome to The Grind! Hosts Joe Toscano and Mike Kent caught up with special guest Ray Kaczmarek in San Diego for an insightful discussion highlighting the complexities and dynamic nature of Cell and Gene Therapy. In this episode, the first in a 4-part series, Ray shares his experiences from military service to multiple C-suite roles…
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Unlocking Global Markets: SaMD, AI, and Regulatory Fast-Tracks
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4:34
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4:34This episode provides a comprehensive guide to navigating the complex global regulatory landscape for Software as a Medical Device (SaMD), with a special focus on AI-enabled technologies. We explore SaMD risk classifications in key markets like the US, EU, and Canada, discuss recent AI-specific guidance from bodies like the FDA (including the Decem…
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Taking a closer look at the Most Favored Nation Pricing Executive Order
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16:47
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16:47Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, and Phil Scalfani, PwC’s Pharmaceutical and Life Sciences Consulting Leader, discuss the Trump administration’s executive order on Most Favored Nation (MFN) drug pricing and its far-reaching implications across the healthcare ecosystem. They break down what MFN pricing could mean for pharm…
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China's 2025 MedTech Surge: NMPA's New Fast-Track for Innovative Devices
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5:07
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5:07This episode delves into China's transformative 2025 NMPA Roadmap, detailing how the "NMPA regulation 2025" aims to accelerate approvals for innovative medical devices. We explore the new Special Review Pathway, shortened clinical trial timelines, priority review categories, and expanded domestic production opportunities, offering insights for manu…
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Putting Price Transparency into Perspective
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40:05Jackie Selby, Partner, Epstein Becker & Green PC, Maria Nikol, CEO, Revelar Analytics LLC, and Karen Mandelbaum, Senior Counsel, Epstein Becker & Green PC, discuss current trends and developments related to price transparency. They cover why price transparency is important; provide an overview of the hospital transparency rule and the transparency …
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Saudi MedTech Breakthrough: Understanding the SFDA's MDS-G002 Pathway
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3:55This episode delves into the Saudi Food and Drug Authority’s (SFDA) Innovative Medical Devices Pathway (MDS-G002), a strategic initiative designed to significantly accelerate market entry for novel medical technologies in Saudi Arabia. We explore the key features, eligibility criteria, and the profound impact this pathway has on reducing time-to-ma…
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Frank Santos and What's Next for Hemp in Texas
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16:56Jonathan Miller interviews Austin, Texas lobbyist Frank Santos, about the ever-changing state of play for hemp policy in Texas. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: What is Senate Bill 3 and how did it pass the legislatur…
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Brazil's RDC 751/2022: Your 2025 MedTech Compliance Guide
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3:21This episode unpacks Brazil's transformative RDC 751/2022 medical device regulation, effective since March 1, 2023. We cover the updated four-tier risk classification system, the 22 detailed classification rules (including those for SaMD and nanomaterials) aligning with EU MDR, and the distinct Notification (Class I/II) versus Registration (Class I…
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Unpacking Screen Fail Payments in Research
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11:42In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic. From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that pay…
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FDA's Landmark QMSR Rule: ISO 13485 Harmonization for 2026
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3:31This episode delves into the U.S. FDA's significant 2024 Quality Management System Regulation (QMSR) final rule. We explore how this rule, effective February 2, 2026, aligns 21 CFR Part 820 with the international standard ISO 13485:2016, discuss key changes, FDA-specific additions, and the crucial steps medical device manufacturers must take to pre…
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EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028?
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4:50This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. Th…
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Issues Related to Health Care Employment Arbitration
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44:32Linda A. Michler, Arbitrator and Mediator, speaks with Christopher C. Murray, Partner, Ogletree Deakins, about arbitration in the health care employment space. They discuss how arbitration works; the strengths and weaknesses of arbitration; and issues related to selecting an arbitrator, cost, mediation, class action waivers, and mass arbitration. T…
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Peter Lurie, MD, MPH Executive Director of the Center for Science in the Public Interest discusses food dyes, the FDA and RFK.
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28:09Did you know that some food dyes can have a negative influence children’s behavior? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Peter Lurie, MD, MPH, President and Executive Director of the Center for Science in the Public Interest (CSPI), a non-profit food and health watchdog organization base…
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