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DTX Unplugged

Digital Transformation EXPO (DTX)

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DTX Unplugged delves into the major challenges and innovations shaping business transformation, embodying our event's focus on the critical intersection of people, process, and technology. While rooted in the DTX ethos, this will be an industry-focused platform, tackling key issues, spotlighting groundbreaking innovations, and raising awareness for important topics across the sector.
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The Race DTx

Malcolm Little

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A platform for my friends to express their brands and initiatives.. as well as a lifestyle fusion encompassing all of TwoKool_NUPE(s) exploits more specifically travel, sports, music, and current - indefinite events. Follow theRace_DTx
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DTx Equals

Slice of Healthcare LLC

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The podcast where thought leaders in digital therapeutics put a stake in the ground about what makes DTX DTX. Hosted by Acacia Parks, PhD. Produced by Slice of Healthcare LLC.
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DTx Podcast with Eugene Borukhovich

Digital Health Today with Eugene Borukhovich

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Host Eugene Borukhovich explores how non-molecular therapies and interventions can prevent, manage or even cure diseases. Learn about the rapidly evolving field of Digital Therapeutics, its history, the evolving regulatory and reimbursement frameworks, and the trailblazers creating and advancing this industry.
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Micro Learning Podcast on Data Convergence (DISE)- Digital Business Transformation, Industry 4.0 and 5.0 , Sustainability and Emerging Technologies by solving the Industrial Pain areas for SMB, MSME and Enterprises- A Data Convergence Foundation initiative. A Peer2Peer Global Data Convergence Thought Leaders, Experts , Entrepreneurs, Academicians sharing their experiences and knowledge in the areas of Digital Transformation, Industry 4.0 and 5.0 and Emerging Technologies Subscribe to Micro P ...
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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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Innovation by design is a pilot project of members of DTX and the Design@Business Community in collaboration with the Center for Business Innovation at Chalmers University of Technology to explore podcasts as a way to share community knowledge and gain research insights.
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A series of interviews with some of the industry's top professionals, discussing the latest topics circulating the world of science; brought to you by SciPro, Life Science Recruitment Specialists, and hosted by our very own expert consultant, Nick Mahoney.
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This week on MENA MedTech Insights, we dissect the groundbreaking new regulatory framework for Digital Therapeutics (DTx) just launched by the UAE's Ministry of Health and Prevention (MOHAP). This policy creates a dedicated, clear approval pathway for software-based treatments, ending the uncertainty that previously stalled market access for this i…
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In this episode of DTX Unplugged, Sarah Leteney, Group CIO at Urenco, discusses the challenges and strategies of digital transformation in the highly regulated nuclear sector. She emphasizes the importance of cultural considerations, the impact of AI, and the need for diversity and inclusion in the workplace. Sarah shares insights on attracting tal…
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This week on MENA MedTech Insights, we dissect the big news from Saudi Arabia. The SFDA has just launched an exciting fast-track approval process for AI-powered medical software, promising to open the market to global innovators faster than ever before. This move signals the Kingdom's strong commitment to becoming a hub for digital health technolog…
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This episode unpacks a critical update from the Saudi Food and Drug Authority (SFDA) that is reshaping the landscape for digital health and Software as a Medical Device (SaMD) in the Kingdom. As Saudi Arabia tightens its requirements, we explore the new, unwritten rules around cybersecurity and data integrity that are becoming a major hurdle for ma…
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In this episode, we dissect a pivotal, late-2025 development from the United Arab Emirates that is set to redefine the MedTech landscape in 2026. As the holiday season concluded, the UAE's health authorities released a new draft guidance targeting digital health, AI, and software as a medical device (SaMD), signaling a major regulatory shift.We exp…
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This week on MENA MedTech Insights, we dissect the major regulatory shift from the Saudi Food and Drug Authority (SFDA). The release of new guidance for AI and Machine Learning-based medical devices has created new, complex challenges for manufacturers aiming to enter the Saudi market. We provide an insider's look at what these changes mean for you…
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The Saudi Food and Drug Authority (SFDA) just opened a new fast-track for EU MDR-approved medical devices. This move is set to reshape market entry strategy for Saudi Arabia, creating a massive opportunity for global manufacturers with a CE Mark. But this "bridge" to market access is not as simple as it seems and is filled with local requirements t…
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Last week, Saudi Arabia's SFDA implemented a pivotal update to its safety framework, introducing stringent new cybersecurity regulations for connected medical devices. This move, while aimed at enhancing patient safety, creates a complex new layer of compliance for manufacturers, potentially stalling market entry for those unprepared for the specif…
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This week on MENA MedTech Insights, we dissect the groundbreaking new fast-track approval pathway for AI-based medical devices announced by the Saudi Food and Drug Authority (SFDA). This move catapults Saudi Arabia to the forefront of digital health adoption, presenting a massive opportunity for global innovators.However, behind the promise of rapi…
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Saudi Arabia is opening its doors to AI-powered medical devices with a new "fast-track" approval process. But behind the promise of speed lies a maze of complex new requirements that could trap unprepared companies. This episode of MENA MedTech Insights unpacks the SFDA's latest guidance, revealing the hidden challenges in algorithm validation and …
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This week on MENA MedTech Insights, we dissect the groundbreaking new policy from the Saudi Food and Drug Authority (SFDA). In a move set to redefine market access, the SFDA has announced a major harmonization with the European Union's Medical Device Regulation (MDR) for Class IIa and IIb devices.This policy creates a powerful new "regulatory bridg…
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This week, we dive deep into a seismic shift in Saudi Arabia's MedTech market. Recent regulatory updates are aggressively prioritizing local manufacturing, creating new, complex challenges for international medical device companies wanting to enter or stay in the Kingdom. We explore what these changes mean on the ground and how firms can turn this …
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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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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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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 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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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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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 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 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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In this episode, Fergus Hay, CEO & Co-Founder of The Hacking Games explores the fascinating overlap between gaming, cybersecurity, and the power of neurodivergent minds. Recorded live at DTX London 2025, join Fergus and DTX Unplugged hosts Ollie Pickup and Sabrina Berko in solving one of today’s biggest challenges - the cyber talent gap. From shock…
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The MENA region is a goldmine for MedTech innovation, but its complex and fragmented regulatory landscape can be a major barrier to entry. This episode of MENA MedTech Insights dives deep into the two largest markets: Saudi Arabia and the United Arab Emirates.We uncover the most common pitfalls companies face, from underestimating the SFDA's unique…
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This episode of MENA MedTech Insights dives into the critical regulatory nuances for medical device companies expanding into the MENA region, particularly those with existing EU supply chains and approvals. We uncover why a CE mark is only the beginning of the journey and explore the growing divergence between EU standards, like EUDAMED, and the sp…
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In this episode of MENA MedTech Insights, we explore the number one reason why medical device companies fail when entering markets like Saudi Arabia and the UAE: a lack of upfront regulatory clarity. We break down why a detailed understanding of the authorities, device classifications, and submission mechanics is non-negotiable *before* a single do…
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Expanding your MedTech footprint in the MENA region is far more complex than a single market entry. Each country, from Saudi Arabia to the UAE, presents unique regulatory and commercial hurdles. This episode of MENA MedTech Insights dives into a powerful strategy: using your initial regulatory submission as the blueprint for rapid, compliant, and s…
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This episode of MENA MedTech Insights dives into the complexities of entering the region's top markets: Saudi Arabia, the UAE, Egypt, and Israel. We explore the common pitfalls of using separate vendors for each country's unique regulatory hurdles and reveal how a unified market-access strategy can dramatically accelerate growth and reduce costs.We…
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The MENA MedTech market is booming, but its regulatory landscape is a minefield of constant updates. Authorities like the Saudi FDA are frequently amending rules, and a single missed update can derail your entire market access strategy, costing you time and money. This episode dives into the critical importance of continuous regulatory monitoring.W…
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In this episode of MENA MedTech Insights, we delve into the lucrative yet complex Israeli medical device market. We uncover the critical regulatory hurdles and requirements set by AMAR, the medical device division of Israel's Ministry of Health, and explain why securing a knowledgeable local partner is paramount for international companies.We explo…
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Egypt is a top-tier market for MedTech expansion in the MENA region, but gaining access requires navigating the complex regulations of the Egyptian Drug Authority (EDA). For foreign manufacturers, the process is filled with unique challenges, from dossier submissions to the critical appointment of a local legal representative. A single misstep can …
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The UAE's MedTech market is booming, but a key MOHAP regulation can stop foreign companies in their tracks: the requirement of a local Authorized Representative. Many manufacturers default to appointing their distributor, a decision that can lead to significant business risks and loss of market control.This episode explores the strategic importance…
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Saudi Arabia's rapidly expanding MedTech market presents a golden opportunity, but navigating the stringent Saudi Food and Drug Authority (SFDA) regulations is a critical challenge. A successful market entry hinges on one key requirement: appointing a local in-country representative. This episode of MENA MedTech Insights breaks down why this choice…
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In this episode of DTX Unplugged, hosts Ollie Pickup and Sabrina Berko sat down with Gina Gill, Chief Information Officer at Apollo, live at DTX London 2025 to unpack the realities of digital transformation across both public and private sectors. Together, they explore what it really means to transform while keeping the business running, why curios…
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In this episode of MENA MedTech Insights, we delve into the booming market for electrophysiology (EP) mapping and ablation systems across the Middle East and North Africa. As nations like Saudi Arabia and the UAE heavily invest in advanced cardiac centers, the demand for cutting-edge MedTech solutions to treat arrhythmias is at an all-time high.We …
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In this episode of MENA MedTech Insights, we delve into the high-stakes world of cardiac rhythm management devices in the Middle East and North Africa. As cardiovascular disease rates climb, we explore the immense opportunities and the daunting regulatory hurdles manufacturers face when trying to enter lucrative markets like Saudi Arabia, the UAE, …
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In this episode of MENA MedTech Insights, we explore the billion-dollar market for hemodialysis and peritoneal dialysis equipment in the Middle East and North Africa. As rates of chronic kidney disease climb, we uncover the immense opportunities for MedTech manufacturers in key markets like Saudi Arabia and the UAE.We break down the complex and fra…
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The market for CT imaging systems in the MENA region is booming, fueled by ambitious healthcare projects and substantial government investment. For global MedTech manufacturers, this translates into a massive opportunity. However, the path to market is paved with complex and varied regulatory requirements that can easily derail even the most prepar…
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In this episode of MENA MedTech Insights, we explore the rapidly growing market for MRI scanners across the Middle East and North Africa. As governments in Saudi Arabia, the UAE, and Egypt heavily invest in healthcare infrastructure, the demand for advanced medical imaging technology is soaring. However, tapping into this lucrative market requires …
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In this episode of MENA MedTech Insights, we explore the booming market for Continuous Glucose Monitoring (CGM) devices across the Middle East and North Africa. Driven by some of the world's highest diabetes rates, countries like Saudi Arabia and the UAE represent a massive opportunity for MedTech manufacturers, but also a significant regulatory ch…
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This episode of MENA MedTech Insights dives into the booming market for robotic surgical assistance systems in the Middle East and North Africa. We explore the key drivers behind the rapid adoption in countries like the UAE and Saudi Arabia, from government initiatives like Saudi Vision 2030 to the clinical demand for minimally invasive procedures …
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The market for Transcatheter Heart Valve (TAVR) systems in the MENA region is experiencing unprecedented growth, fueled by healthcare modernization in countries like Saudi Arabia and the UAE. For global MedTech companies, this represents a golden opportunity. However, the path to market access is paved with complex and fragmented regulatory hurdles…
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The United Arab Emirates is a cornerstone of the MENA MedTech market, but gaining access requires mastering its specific clinical trial regulations. As the UAE's Ministry of Health and Prevention (MOHAP) enhances its regulatory framework, understanding the precise requirements for medical device investigations is more critical than ever for interna…
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Maintaining market access in Saudi Arabia is even more challenging than gaining initial approval. The SFDA's post-market surveillance (PMS) requirements are rigorous and demand a proactive, systemic approach. Many international manufacturers are caught off guard by the depth of these expectations, risking compliance actions that could jeopardize th…
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This episode of MENA MedTech Insights tackles one of the most significant hurdles for device manufacturers entering Jordan: the Legalized Free Sale Certificate (FSC). We demystify the stringent requirements set by Jordan's JFDA under Law 21 of 2014, moving beyond the basics to uncover the specific, multi-step legalization process that trips up even…
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In this episode of MENA MedTech Insights, we demystify the process of registering medical devices in Israel. We explore the strategic advantages of the AMAR Medical Device Law of 2012, which leverages prior approvals from recognized countries like the U.S. and the E.U. to create a streamlined market-entry pathway.This episode breaks down the essent…
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This episode of MENA MedTech Insights unpacks the transformative impact of the Egyptian Drug Authority's (EDA) Decree 892/2022 on medical device registration. We explore the critical changes manufacturers must understand to successfully navigate one of the region's most important healthcare markets.From the alignment of risk classifications with gl…
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In this episode of MENA MedTech Insights, we take a deep dive into the United Arab Emirates' stringent regulations for medical device advertising. We unpack the essential framework established by the Ministry of Health and Prevention's (MoHAP) Circular No. 23 of 2020, a critical piece of legislation for any MedTech company operating in or entering …
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In this episode of MENA MedTech Insights, we dissect the UAE's transformative Cabinet Decision No. 58 of 2022. This new regulation is a critical hurdle for any MedTech or IVD company looking to enter or remain in this key Middle Eastern market. We provide a clear, actionable breakdown of the most significant changes you need to be aware of.We explo…
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In this episode of MENA MedTech Insights, we provide a deep dive into the Saudi Food and Drug Authority's (SFDA) Unique Device Identification (UDI) system. We explore the critical requirements of guidance MDS-G34, a non-negotiable for medical technology companies operating in Saudi Arabia, a key market in the Middle East. Understanding this framewo…
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