Supplement, Revision, or New Device?
Is the change to your medical device a supplement or a new device, and why you should care One of the companies I’m supporting has a configurable product that can currently monitor symptom worsening for medical conditions. Their business model is to add other medical conditions to the platform as they are able to validate […]
The Clinical Evaluation Report — Start it Early!
The CER is a critical component of your technical documentation, and a good one to start as early in your product development and evaluation. Read on to learn why.
Risk Class I SaMD
Risk Class I used to be the sweet spot for SaMD—quick approval, minimal review, and low cost. But today, very few software products qualify as Risk Class I. Read on to learn about the MDR’s up-classification and the FDA’s de-regulation of these products, and what might (MIGHT) still count as a Risk Class I medical device.
U.S. Healthcare 101
Here is my overview of the US healthcare system, which I developed because so many founders have basic questions about how healthcare in the U.S. works. Worse is that so many choose not to launch in the U.S, becuase of how complex its healthcare system is.
Well, the U.S. healthcare system is complicated, but it’s this complexity that creates opportunities for creative problem-solvers with innovative solutions. Read on to learn about the special opportunities that exist in the U.S.
Digital Health Regulatory Pathways Master Class Lesson #6
Whether you launch in the U.S. or an EU country will depend on a lot of factors that go beyond the regulatory pathway itself. That said, it’s still important to think about regulatory strategy and pathways at the outset, so read on for my tips for guiding you through which regulatory pathway you should consider based on the risk class and other characteristics of your device.
Digital Health Regulatory Pathways Master Class Lesson #5
You’ve identified your product as a medical device, classified its risk, and scoped documentation and clinical requirements—now it’s time for the strategic decision: which regulatory pathway and market should you target first? It’s definitely not an easy decision, but this post gives you handy tips for helping you make this very important decision.
Digital Health Regulatory Pathways Master Class Lesson #4
Your device’s risk class isn’t just a regulatory label—it’s the foundation of your entire strategy. Whether you’re pursuing FDA clearance or EU MDR certification, classification determines your pathway, documentation, costs, and timelines. In this post, we unpack how risk classes work, why SaMD and AI products often get bumped into higher categories, and how an early classification can save your startup time and money.
Digital Health Regulatory Pathways Master Class Lesson #3
U.S. and EU medical device regulations may look similar from the outside—but for startups, they couldn’t be more different. The FDA relies on centralized review and leaner pathways like 510(k), while the EU’s MDR requires extensive documentation and Notified Body audits, even for lower-risk devices. In this post, we break down the core contrasts, why they matter for your launch strategy, and how they can shape your time to market and budget.
Digital Health Regulatory Pathways Master Class Lesson #2
For digital health founders, one of the first (and trickiest) questions is: does my product even count as a medical device? The answer determines whether you’ll face FDA approval, EU MDR review, or no regulation at all. In this guide, we break down the legal definitions, show examples of software that does and doesn’t qualify, and explain why getting this right early can save you costly delays and rework later.
Digital Health Regulatory Pathways Master Class Lesson #1
Launching a digital health product? Your regulatory strategy can determine whether you get to market quickly—or stall before you even start. In this founder-friendly series, we cut through FDA and EU MDR jargon to show you how risk classes, approval pathways, and early planning shape your product’s cost, timeline, and investor appeal.