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Project Medtech

Project Medtech

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The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.
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What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.
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Welcome to MENA MedTech Insights, the definitive podcast for professionals in the Middle East and North Africa's rapidly growing medical technology sector. Each episode, we explore the latest innovations, market trends, and regulatory landscapes, featuring exclusive interviews with the founders, investors, and leaders who are shaping the future of healthcare in the region.
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MedTech 101

Rodney Moses

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Discussions about Medical Technology, Pharmaceuticals and popular trends; covering from basic to complex topics in a simplified way to make you understand. Rodney is a Biomedical Engineer and co-inventor working in R&D, ex Johnson & Johnson.
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Welcome to LATAM MedTech Insights, your essential guide to the booming medical technology and digital health sector across Latin America. Each episode, we dissect the key trends, investment opportunities, and regulatory news shaping the industry. Join us for in-depth interviews with the innovators, investors, and policymakers driving the future of healthcare from Mexico to Brazil.
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Welcome to ASEAN MedTech Insights, the premier podcast dedicated to the thriving medical technology landscape of Southeast Asia. Each episode, we explore the cutting-edge innovations, investment trends, and regulatory developments in one of the world's fastest-growing markets. Join us for exclusive interviews with the founders, executives, and visionaries shaping the future of healthcare in the ASEAN region.
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Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
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Come hang with MedTech journalist Kayleen Brown. Every three weeks, she welcomes leaders from across medical devices—engineers, presidents, C-suite executives, investors, and clinical minds—to hear firsthand the stories, choices, and patterns that have shaped some of the most influential careers, teams, and technologies in the industry. The aim is simple: reverse-engineer the making of a MedTech leader and widen the path for who gets to lead.
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Medtech Matters

Medical Product Outsourcing

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A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
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Medtech Innovation Podcast: Spencer Jones dives deep into winning medtech startup strategies. Each episode unpacks hot takes and insider tactics from the trenches of medtech innovation. Join physician inventors, founders, engineers, and healthcare market makers as they share actionable insights to navigate the FDA, secure medtech funding, and drive medtech breakthroughs. No-nonsense advice to be a change maker in medtech.
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RQM+ is The MedTech CRO – a full-service partner supporting everything from groundbreaking innovation to well-established technologies. Our coordinated and comprehensive solutions are customized to each client’s product and life cycle stage. By aligning strategy and execution in one partner, we help reduce cost, accelerate timelines, and drive more successful outcomes. Visit RQMplus.com to see how we help MedTech companies of all sizes, spanning all device types and therapeutic areas. This p ...
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MedTech Trailblazers

Fogarty Innovation

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Welcome to MedTech Trailblazers where Andrew Cleeland, CEO of Fogarty Innovation, hosts in-depth conversations with the disruptors and innovators in the field of medical technology. Join him as he shares their insightful stories, effective leadership styles and what they're doing to transform patient outcomes and shape the future of human health.
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Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
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Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up to date on the latest breakthroughs in medical technology with the top five news stories to get your day started. Subscribe and join us every weekday for your daily medtech news roundup.
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Have you ever wondered how the machines in the hospital work? The doctors don't have time to explain them to you? Then you've come to the right place! The MedTech Hub is a podcast that explains medical technologies and new innovations in healthcare. I am a medical physicist and your host - Daniela Prinz. (Disclaimer: This podcast does not give medical advice, I am not a doctor, please always consult with your physician!) Uploads every Monday!
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Dive deep into the dynamic world of MedTech and pharmaceuticals with MedTech Talent Talks. This podcast explores cutting-edge industry insights, career opportunities, and the evolving landscape of healthcare technology. Whether you’re a healthcare practitioner seeking to transition into the pharmaceutical industry or a MedTech professional curious about advancements, this podcast is your go-to guide for understanding how to thrive in this growing field. Tune in to hear from industry experts, ...
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The many stages of market entry into the health and care industry can feel like a never-ending process. Join Kate Pym, healthcare consultant veteran with decades of experience, as she interviews some of the industry’s key players from product developers to startup managers. Unlock the key to transforming your ideas into impactful realities within the health and care industry with MedTech for Beginners. Kate Pym runs Pym's Consultancy, a multi-award-winning consultancy offering support and tr ...
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According to the CDC: Every three minutes and 11 seconds, someone dies of stroke. The medical device industry is answering the call in this country, developing new devices to help clear clots and speed patient recovery. Together with John Murray, Head of Global Strategic Marketing and Strategic Relationships at Johnson & Johnson MedTech Neurovascular, we'll talk with those pioneering neurosurgeons who are developing new procedures and setting higher expectations for new devices. We'll unders ...
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Welcome to Beyond the Lens: MedTech Insights with KARL STORZ, the podcast that delves into the rapidly evolving world of advanced surgical technology. For nearly eight decades, KARL STORZ has developed innovative imaging solutions and opened new possibilities in minimally invasive care. With a dedicated focus on improving patient outcomes, KARL STORZ collaborates with medical professionals world-wide to drive advancements in medical technology. This provides KARL STORZ with an insider view o ...
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In this episode of Medsider Radio, we sat down Dr. Adam Kadlec, practicing urologist and co-founder of Rivermark Medical. Rivermark is a clinical-stage company developing FloStent, a first-line, reversible device therapy for benign prostatic hyperplasia (BPH). Before launching Rivermark, Adam built a thriving urological practice in Milwaukee and co…
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This week, we dissect the groundbreaking joint "AI-Enabled Device Fast-Track Program" launched by Singapore and Malaysia. This new regulatory pathway promises to slash market approval times for AI medical software but introduces complex and continuous post-market compliance obligations that could catch many companies off guard.We explore the strate…
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This week, we dissect the immediate fallout from ANVISA's surprise regulatory shift in Brazil. While the move towards EU MDR alignment was expected, a hidden clause mandating local usability studies for high-risk devices has caught many international MedTech firms by surprise, threatening to delay launches and inflate budgets.We explore the specifi…
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This week on MENA MedTech Insights, we dissect the groundbreaking news from Saudi Arabia. The SFDA has just launched a new accelerated approval pathway for AI-driven medical devices, promising to slash market entry timelines. But is this new "golden ticket" too good to be true?We explore the fine print behind this opportunity, revealing the stringe…
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The US FDA is making its biggest change to quality system regulations in a generation, harmonizing with the global ISO 13485 standard. This shift, mandated by the new Quality Management System Regulation (QMSR), presents both opportunities for streamlined global compliance and significant hidden risks for unprepared manufacturers.Many global compan…
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Earned trust becomes leadership capital — and in MedTech, it compounds faster than most leaders realize. In this episode of the Women in MedTech podcast, host Kayleen Brown talks with Edwards Lifesciences’ Sarah Huoh, Corporate Vice President of Public Affairs, about why trust has to be built and demonstrated long before it can be communicated — an…
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Duane Mancini welcomes Ben Fogarty, a design generalist and strategist and founder partner at Council. Ben shares his journey from an art student to leading an independent design practice working with startups and Fortune 500 companies. The conversation delves into the vital role of design thinking in problem-solving, the importance of internal and…
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HSBC Innovations is the global bank’s financing arm for American and European startups, especially in the healthcare and life sciences industries. The bank’s semi-annual Venture Healthcare Reports document trends in the investment market. Key Tech’s Andy Rogers welcomes the report’s author, HSBC Innovation Managing Director Jon Norris in Episode 43…
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Surgical robotics is changing the landscape in healthcare. Stereotaxis is hoping to carve out its niche in the massive space, which is home to Intuitive Surgical, Johnson & Johnson, and Medtronic. David Fischel, the St. Louis, MO-based company’s chairman and CEO, is featured in this episode of Let’s Talk Medtech to discuss Stereotaxis’ journey from…
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Send us a Message In this compelling episode of MedTech 101, host Rodney Moses sits down with RenovoRx CEO Shaun Bagai to explore the latest breakthroughs in cancer treatment. The conversation opens with a clear-eyed look at the challenges pancreatic cancer patients face, before diving into Shaun’s remarkable journey—from aspiring pre-med student t…
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Meeting the right people can completely change the trajectory of one’s career. In this episode of Medtech Talk, host Geoff Pardo speaks with Stacy Enxing Seng, independent director and venture partner, about her journey from Harvard Business School to SciMed to ev3 and beyond. She delves into the lessons learned, the challenges, and—most importantl…
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This week, we go beyond the conference brochures and flashy booths of the International Medical Device Exhibition & Conference (IMDEC) in Kuala Lumpur. We dissect the real conversations and policy shifts that are redefining MedTech market access in Malaysia and setting the tone for the entire ASEAN region. We uncover how AI is moving from a buzzwor…
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Last week, Brazil's regulatory agency, ANVISA, unveiled a groundbreaking 2025 plan to tackle its notorious medical device approval backlogs. The initiative, named "AnvisAI," leverages artificial intelligence to create an automated fast-track system for lower-risk devices, aiming to cut review times by more than half and reshape the market access la…
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This week, MENA MedTech Insights dives into the seismic regulatory shifts in Saudi Arabia. The SFDA's new product safety framework is reshaping the market access landscape for medical device manufacturers, demanding a higher standard of clinical evidence and post-market surveillance that catches many international companies off guard.We break down …
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The promise of AI in MedTech is undeniable, but a major regulatory storm is brewing in the European Union. A new, complex dual-compliance framework now requires AI-driven medical devices to satisfy both the rigorous Medical Device Regulation (MDR) and the brand-new EU AI Act. This episode of MedTech Global Insights dives deep into what this means f…
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This week on ASEAN MedTech Insights, we delve into a groundbreaking development from Malaysia. The Medical Device Authority has just launched a new fast-track approval pathway for AI-driven diagnostic software, promising to slash review times and position the nation as a top destination for digital health innovation.But this speed comes with a sign…
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This week, we dissect a major regulatory shake-up in Latin America's largest MedTech market: Brazil. ANVISA, the national health surveillance agency, has just initiated a pivotal shift from paper to digital, while simultaneously revoking its traceability regulations. This move promises to cut costs and streamline logistics for manufacturers but int…
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Saudi Arabia is rewriting its MedTech rulebook. Driven by Vision 2030, the Saudi Food and Drug Authority (SFDA) is rolling out new regulations and incentives designed to shift the country from a top medical device importer to a powerful local manufacturing hub. This move creates immense opportunities for innovators but presents complex strategic ch…
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The explosion of AI in MedTech is met with a tangled web of new global regulations. This week, we dissect the latest guidance from the IMDRF and explore the growing divide between regulatory bodies in the US, Europe, and beyond. For AI device makers, the path to market is now filled with more hidden risks than ever.We explore the critical case of "…
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Malaysia's Medical Device Authority (MDA) has just unveiled a simplified regulatory framework for Software as a Medical Device (SaMD). This strategic shift is poised to slash market-entry timelines and costs, turning Malaysia into a magnet for digital health innovation across the ASEAN region.In this episode, we dissect the MDA's announcement from …
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Brazil's MedTech landscape is buzzing as its regulatory agency, ANVISA, puts Software as a Medical Device (SaMD) back under the microscope. In its newly released 2024-2025 agenda, ANVISA has signaled major revisions to the existing framework, a move that comes sooner than many in the industry expected. This suggests that the initial guidelines are …
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The MENA MedTech market is booming, but a new wave of complex regulations is creating significant challenges for market entry and growth. This episode of MENA MedTech Insights dives deep into the upcoming 2025 MEA MedTech Regulatory Summit, a pivotal event that signals a major shift in the region's approach to medical device and digital health over…
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In this episode of MedTech Global Insights, we dissect the FDA's newly finalized guidance on using Digital Health Technologies (DHTs) for remote data collection in clinical trials. This pivotal update opens the door for more decentralized and patient-centric studies but introduces stringent new requirements for verification, validation, and data in…
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In this episode, we unpack an urgent regulatory update from Indonesia. The Ministry of Health has announced a temporary but total shutdown of its medical device online registration systems scheduled for mid-December 2025 to early January 2026. This freeze will halt all new applications, renewals, and payment processing, creating a significant chall…
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Brazil's regulatory agency, ANVISA, is updating its rules for Software as a Medical Device (SaMD) as a key priority for 2025. This major overhaul will align Brazil’s digital health landscape with global standards like the EU MDR, introducing stricter requirements for cybersecurity, interoperability, and technical documentation.This change presents …
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This week on MENA MedTech Insights, we dissect the latest regulatory earthquake from the Saudi Food & Drug Authority (SFDA). As part of its Vision 2030, Saudi Arabia has issued new mandates that effectively require foreign medical device manufacturers to establish local production partnerships. This is a game-changer for anyone operating in or cons…
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The European Union has rolled out tough new cybersecurity regulations for medical devices, forcing manufacturers to rethink their entire approach to product security. This episode dives into the practical challenges companies are facing, from securing legacy products to meeting intensive new documentation and surveillance demands.We explore the cas…
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Malaysia's Medical Device Authority (MDA) has launched its first regulatory sandbox, a pivotal move for AI-driven medical devices in the ASEAN region. This controlled environment allows innovators to test and validate "Software as a Medical Device" (SaMD) in collaboration with regulators, balancing accelerated innovation with stringent patient safe…
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Last week, Brazil's ANVISA implemented a sudden and strict new regulation for cybersecurity in connected medical devices. This unexpected move introduces mandatory data localization, forcing companies to store Brazilian patient data on servers within the country, creating significant technical and financial hurdles for global manufacturers.This epi…
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In this episode of MENA MedTech Insights, we dissect Saudi Arabia's groundbreaking new regulatory framework for AI-powered medical devices and Software as a Medical Device (SaMD). The Saudi Food and Drug Authority (SFDA) is raising the bar, introducing complex requirements for cybersecurity, data management, and local clinical validation that will …
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This week, we dive into a major regulatory challenge brewing in the European Union. MedTech Europe has officially called on the European Commission to resolve the long-standing conflict between the Medical Device Regulation (MDR) and the WEEE directive on electronic waste. This move could reshape compliance for any company selling electronic medica…
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The ASEAN MedTech landscape is in constant motion. This week, we dissect two major regulatory shifts that could make or break your market access strategy. Malaysia's Medical Device Authority has unexpectedly extended the deadline for its mandatory import licenses, offering a lifeline to hundreds of companies. What does this "grace period" truly mea…
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Brazil's regulatory agency, ANVISA, has just redefined the future of digital health in Latin America with its new, comprehensive framework for AI-powered Software as a Medical Device (SaMD). This landmark regulation introduces a stricter risk classification system and new requirements for algorithm validation and cybersecurity, directly impacting a…
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This week on MENA MedTech Insights, we're diving into the United Arab Emirates' groundbreaking new regulatory sandbox for AI-powered medical devices. This initiative, launched just last week, is set to revolutionize how innovative MedTech gets to market, creating a fast-track for startups and challenging the traditional, slower approval processes.W…
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The first week of December saw Artificial Intelligence take center stage in MedTech, but not always for the right reasons. While new systems promise to revolutionize patient triage in Greece and reduce physician burnout in the US, a more alarming trend has emerged. Major health insurers are now using AI to automatically deny patient claims, raising…
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In this episode of Medsider Radio, we sat down with Andrew Holman, MD, CEO of Inmedix. Inmedix is commercializing CloudHRV, an FDA-cleared diagnostic that quantifies biological stress with clinical precision to guide treatment decisions in autoimmune disease and beyond. Andrew is a practicing rheumatologist in Seattle with 25 years of clinical and …
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As 2025 wraps up, MedTech companies face a critical wave of last-minute regulatory shifts in Southeast Asia. This episode of ASEAN MedTech Insights dives into urgent updates from Malaysia and Indonesia that could make or break your market access strategy for the new year.We uncover Malaysia's double-edged sword: a welcome extension on import permit…
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This week on LATAM MedTech Insights, we're diving into a groundbreaking regulatory shift in Brazil. For years, launching a clinical trial in Latin America's largest market was a high-risk gamble due to unpredictable and lengthy approval processes. Now, everything has changed.A new Clinical Research Statute is dismantling these old barriers, aiming …
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The MedTech sector in the Gulf is experiencing a transformative phase, with new reports forecasting a significant wave of mergers and acquisitions. This episode of MENA MedTech Insights delves into the driving forces behind this investment boom, exploring how government diversification strategies and a strong push towards digital transformation are…
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Last week, the US FDA's new digital health pilot program sent ripples through the MedTech industry. This is more than a simple regulatory update; it's a pivotal shift that moves cybersecurity from a compliance task to a major commercial and contractual battleground, fundamentally changing the rules for market access.This episode breaks down how the…
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Traditional MedTech global expansion is broken, defined by premium consulting fees, opaque processes, and frustrating delays. This episode of MedTech Global Insights unpacks the new playbook for international market access, revealing how companies are finally breaking free from the old model.We explore how the strategic fusion of advanced AI and on…
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This special episode of the podcast is a recording of a panel discussion that took place at the 2025 Ohio VC Fest powered by @JumpStart Inc. entitled "AI-Driven Healthcare: The Heartland Advantage." Panelists include Michael Dalton (CEO & Founder at @Ovatient), Kaleigh Gallagher (VP of Tech Services & Network Management at @JumpStart), Matthew Zenk…
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In this episode of MedTech Global Insights, we tackle the silent killer of speed-to-market: regulatory documentation bottlenecks. As companies expand globally, the sheer volume and complexity of preparing submissions for different health authorities can lead to costly delays and divert expert teams to low-value administrative work.We explore how cu…
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In the fast-paced world of MedTech, falling behind on regulatory changes isn't just a risk; it's a guarantee of costly delays and missed opportunities. The sheer volume of updates from global health authorities has made manual tracking an impossible task, leaving even the most diligent teams vulnerable to compliance gaps.This episode of MedTech Glo…
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Are you ready to accelerate your MedTech or IVD product's global launch by 75%? In this episode of MedTech Global Insights, we explore how Pure Global's advanced AI platform is dismantling the traditional barriers to international market access, transforming a multi-year ordeal into a matter of months.We dive into how this technology provides real-…
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In an industry where regulatory costs and complexities can stifle innovation, Pure Global's AI platform emerges as a game-changer. This episode of MedTech Global Insights delves into the five strategic advantages of leveraging their free, powerful AI agents to navigate the intricate world of global medical device registration. We explore how this t…
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In this episode of MedTech Global Insights, we explore the number one hurdle for ambitious medical device and IVD companies: navigating the fragmented and complex world of international regulations. We unpack why the traditional, country-by-country approach to market entry is inefficient and costly in today's fast-paced environment.We then break do…
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In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health. May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility. Before May Health, Colby served as Global Medtech Commercial Lead at …
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In this episode of MedTech Global Insights, we explore the paradigm shift in global market access strategy. We move beyond the traditional, fragmented approach of managing regulatory hurdles country by country and dive into the rise of integrated, technology-driven consulting firms. These firms are not just advisors; they are end-to-end partners wi…
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Navigating the complex, ever-changing web of global MedTech regulations is a primary barrier to market entry. The traditional, manual approach is notoriously slow, costly, and fraught with risks of rejection, delaying access to critical innovations for patients worldwide.This episode of MedTech Global Insights explores a new, technology-driven para…
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