Is Europe Still More Attractive Than the US, China, India or MENA for Medtech Investment, Bernard Bichsel?

In the latest Market Access Podcast episode, host Stefan Walzer sits down with Bernard “Bernie” Bichsel – one of Europe’s most experienced voices in medtech regulation and former Head of the Medical Devices Division at Swissmedic – to unpack how regulation and market access truly fit together. They discuss why medical device regulation in Europe is still young compared to pharma, why the MDR/IVDR “notified body bottleneck” is largely yesterday’s problem, and how smart startups build regulatory timelines, costs, and clinical evidence into their plans from day one.They then zoom out to Omnibus, the AI Act, and geopolitics, and what all of this means for the attractiveness of Europe vs. the US, China, India, and the rapidly growing Arabic region as medtech markets. Despite the challenges, Europe still offers world‑class innovation, strong universities, and a powerful SME ecosystem – and remains a key region for medtech investment. If you’re a medtech founder, regulatory lead, or market access professional, this episode will help you rethink when and how you integrate regulation and reimbursement into your strategy.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #MedTech #MDR #IVDR #RegulatoryAffairs #HealthEconomics #medtech #medtechregulation #Reimbursement #Startups #EUHealthcare #marketaccess #marketaccesspodcast

In this episode, Stefan Walzer talks with experienced Market Access manager Helmut Butscher about concrete AI applications across the full Market Access value chain. They explore how AI accelerates systematic literature reviews, unlocks real‑world evidence from complex data sources, supports HTA dossier preparation, and enables smarter decisions on pricing, reimbursement and global launch sequencing. They also address the limits and risks of AI in a highly regulated setting – from opaque HTA and payer decisions to regulatory uncertainty around AI‑generated evidence and the ethical tension between efficiency and fairness in health technology assessment.Stefan and Helmut then look ahead to the evolving role of the Market Access manager – not as someone replaced by algorithms, but as a central orchestrator who uses AI as a powerful sparring partner to make better, faster and more transparent decisions. Whether you work in Market Access, HEOR, pricing, strategy or related fields, this episode offers a clear, practice‑oriented view on how to start using AI meaningfully in your daily work – and where it pays to remain cautious.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #OrphanDrugs #RareDisease #DrugPricing #HealthEconomics #CostEffectiveness #BudgetImpact #RealWorldEvidence #InnovativeContracting #GeneTherapy #HealthcarePolicy #Payers #MAPPodcast #marketaccess #marketaccesspodcast

In this thought‑provoking Market Access Podcast episode, host Stefan Walzer sits down with Omar Ali – Head of Payers at Vipora, former NICE advisor, and one of the sharpest minds in drug pricing and innovative contracting to unpack where drug pricing and reimbursement are really heading.They explore why cost‑effectiveness thresholds are making market access tougher than ever, how uncertainty around CAR‑T, gene therapies and orphan drugs fuels the “orphan bubble”, how innovative contracting and pay‑for‑performance can (sometimes) rescue multi‑million‑euro therapies and why the US is doing HTA at the end, not the beginning – with CMS negotiations, MFN and tariffs reshaping global pricing strategies.If you work in Market Access, pricing, Health Economics and Outcomes Research (HEOR) or policy, this conversation will resonate with the pressures you feel every day.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #OrphanDrugs #RareDisease #DrugPricing #HealthEconomics #CostEffectiveness #BudgetImpact #RealWorldEvidence #InnovativeContracting #GeneTherapy #HealthcarePolicy #Payers #MAPPodcast #marketaccess #marketaccesspodcast

In this Market Access Podcast episode, Dr. Stefan Walzer sits down with Prof. Zanfania Ademi, a health economist at Monash University, to explore how Australia’s healthcare system is tackling key issues in market access and health technology assessment. Discover how Australia blends international approaches and new methods being developed by Zanfina and her team like distributional cost-effectiveness and productivity-adjusted life years to advance equity and value in healthcare. Tune in for fresh insights on health as an investment, not just a cost, and what’s next for decision-makers.Key takeaways from the episode include the shift from qualitative to quantitative measures of equity in HTA, and the use of complex disease models and real-world evidence to drive smarter prevention strategies. The discussion also covers the growing recognition of both paid and unpaid work in productivity metrics, along with lessons from Switzerland on disinvestment, transparency, and the challenges of implementing new value measures in healthcare. Perfect for professionals in market access, health economics, and policy.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #HTA #Reimbursement #HealthEquity #Productivity #HealthcareInnovation #Australia #HealthEconomics #Prevention #MAPPodcast #marketaccess #marketaccesspodcast

In this episode of the Market Access Podcast, Erica Bersin—founder of ERO Health Communications—joins Dr. Stefan Walzer to discuss the changing role of patient involvement in healthcare. Drawing on her experience in both Europe and the U.S., Erica explains how single-payer systems make patient engagement easier, while the U.S. faces more challenges but also unique advocacy opportunities. She highlights the work of organizations like PCORI and the need for better data transparency.The episode features real-world examples from HIV/AIDS and breast cancer advocacy, as well as pharma’s efforts to involve patients in clinical trials. Erica’s personal story with multiple sclerosis underscores why every patient’s voice matters. Tune in for a hopeful look at how patients can help shape future healthcare decisions. Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts. If you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #PatientEngagement #PatientAdvocacy #MedicalAdvocacy #HealthEconomics #Pharma #HealthcareInnovation #HealthcareDecisions #MAPPodcast #marketaccess #marketaccesspodcast

In this episode of the Market Access Podcast, Dr. Stefan Walzer sits down with strategy consultant and XR advocate Günther Illert to explore how virtual, augmented, and extended reality are reshaping healthcare—from patient training and pain therapy to surgical planning and medtech education.Learn how cross-sector collaboration and early adoption—especially outside traditional reimbursement systems—can unlock the full potential of immersive technology in medicine. A must-listen for innovators, health tech professionals, and digital health strategists.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS — and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #DigitalHealth #HealthcareInnovation #MedTech #VirtualReality #TrainingInHealthcare #HealthTech #XR #AugmentedReality #MAPPodcast #marketaccess #marketaccesspodcast

Tune in to this new episode of MAP to explore New Zealand’s unique healthcare and reimbursement landscape with Dr. Stefan Walzer and health economist Dr. Julius Ohnberger. Learn how PHARMAC combines HTA and payer roles, why equity and Māori health outcomes are central to market access and what global pharma can gain from launching in Aotearoa. Key insights include why New Zealand’s HTA model stands out as a global unicorn, how to navigate cultural and equity requirements in submissions, the importance of local evidence and stakeholder engagement, the impact of budget constraints and the shift toward real‑world data and outcome‑based reimbursement, and why the country may be the ideal testbed for innovations in AI, screening, and chronic care. Essential for professionals in pricing, market access, and global health policy.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!"MAP is the first and only bi-weekly market access podcast provided by MArS — and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #HealthEconomics #Pharma #Reimbursement #NewZealand #DigitalHealth #HTA #Pharmac #HealthcareInnovation #EquityInHealthcare #MAPPodcast #marketaccess #marketaccesspodcast

In this brand new episode of MAP - the Market Access Podcast, Dr. Stefan Walzer sits down with Elizabeth Shanahan, AI Strategy Lead at Sanofi, for a refreshingly honest conversation on the real-world implementation of artificial intelligence in pricing, evidence generation, and HTA processes.From streamlining evidence generation to enhancing pricing strategies and dossier creation, they explore how AI tools are driving efficiency and strategic thinking. Learn how cultural change, human-in-the-loop systems, and transparency with payers are key to success in the digital health era. Whether you're exploring AI for the first time or scaling adoption across teams, this episode offers strategic insight, hard-won lessons, and a clear-eyed look at the future of pharma.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts — and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS — and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #HealthEconomics #ArtificialIntelligence #PharmaInnovation #HTA #DigitalHealth #AIinPharma #MAPPodcast  #marketaccess #marketaccesspodcast

Tune in to this new episode of MAP, the Market Access Podcast, where Dr. Stefan Walzer is joined by Anne Loos from Wickenstones, to explore the evolving landscape of U.S. market access and reimbursement. The U.S. reimbursement landscape is changing — driven by AI, global influences with the European JCA and political programs such as the Inflation Reduction Act. As fragmentation and rising complexity are pushing pharma to rethink strategy and timelines - this is a must-listen for professionals in pricing, HEOR, and market access.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS — and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #ArtificialIntelligence #Reimbursement #PharmaAI #HealthcareStrategy #HTA #USHealthcare #MAPPodcast #marketaccess #marketaccesspodcast

Join this episode of MAP – The Market Access Podcast as Dr. Stefan Walzer sits down with Anna Forsythe, founder of OncoScope-AI, to explore how Living Systematic Literature Reviews (Living SLRs) are redefining evidence generation in oncology and beyond - highlighting the power of real-time updates, advanced automation, and the essential role of human insight.Traditional SLRs are static snapshots, while Living SLRs are real-time, dynamic, and AI-powered—delivering continuously updated insights crucial for life-or-death decisions and payer evaluations. Join this discussion as they explore the myth of AI chatbots as true decision support tools, the need for actionable data over summaries, and the future of evidence synthesis, clinical decision-making, and smarter market access.Stay updated for upcoming webinars through LinkedIn, and take the chance to stay connected through subscribing with your favorite podcasting platform or directly listen on our website: MAP Podcasts MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy visit: https://marketaccess4-0.com/#MarketAccess #HealthEconomics #AIinHealthcare #SLR #Oncology #HTA #MAPPodcast #marketaccess #marketaccesspodcast