Regulation is not background noise. In European life sciences, it is part of the commercial model.
This section tracks the policy, access, compliance, and approval changes that shape adoption, timing, and strategic options.
Even with the right product, market, and team — many MedTech startups fail. And the reasons often come down to avoidable commercialization mistakes: misjudging the buyer, skipping regulatory nuance, or assuming your tech will sell itself. This final post in the Scaling MedTech: From Product to Market series lays out the most common missteps in…
Pricing in MedTech isn’t just a number — it’s your business model. In the EU, where public payers dominate and health systems are increasingly value-driven, getting paid requires clinical validation, health economic proof, and a clear story about long-term cost savings. This post breaks down how to approach reimbursement and pricing for MedTech startups, with…
Getting into the hospital is no longer the endgame. For MedTech startups in Europe, getting reimbursed — and doing so consistently across fragmented markets — is what separates hobby projects from scalable businesses. In this second post of our series, we dive into the European market access landscape for medical devices and digital health, with…
Breaking into healthcare is hard. Breaking into MedTech is harder — thanks to complex regulations, long sales cycles, and conservative procurement paths. For early-stage medtech startups, choosing the right go-to-market (GTM) strategy can be the difference between scaling and stalling. This guide breaks down the GTM playbook for MedTech in 2025, with a focus on…
With over €20 billion in public and private capital flowing into digital health ventures since 2020, the European Union has become a strategic launchpad for healthtech founders. But where exactly does this capital come from? And what’s the smartest path for early-stage startups looking to digital health funding? This in-depth guide breaks down the EU…
The intersection of medicine and technology is rapidly transforming healthcare worldwide. If you’ve ever wondered, what is MedTech?, you’re not alone. This beginner’s guide explores the definition, industry scope, and the latest trends shaping medical technology today. What Is MedTech? MedTech—short for medical technology—refers to the vast range of products, services, and solutions that leverage technology to…
Introduction: Medtech Unicorns on the Rise in Europe The medtech unicorn phenomenon is transforming healthcare in Europe. As one of the world’s largest industries—nearly 20% of U.S. GDP (about $5 trillion)—healthcare has long been ripe for disruption. Yet, medtech unicorns (startups valued at $1 billion or more) have historically represented only about 8% of all…
Understanding the 23andMe Journey 23andMe was founded in 2006 by Anne Wojcicki, Linda Avey, and Paul Cusenza with a bold vision: to put the power of genetics directly into the hands of consumers. The startup pioneered the direct-to-consumer (DTC) genetic testing market, offering affordable at-home DNA test kits that could reveal ancestry roots, inherited traits,…
23andMe, renowned for ancestry tracing, steps into healthcare with “Total Health”, a service set to decode your health secrets embedded in your genes for $1,188 a year. This leap from mere curiosity to actionable health insights exemplifies 23andMe’s ethos of evolving with scientific advancements. It also addresses earlier concerns on the misinterpretation of the data,…
Pear Therapeutics, once a leader in prescription digital therapeutics (PDT or DTx), has recently filed for bankruptcy. In this blog post, we’ll explore the history of the company, its milestones, and the reasons behind its unforeseen downfall, while also shedding light on its competitors in the digital therapeutics market. Pear Therapeutics: History Established in 2013…