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.
