Getting ready for a strategic: a toolkit for medtech startups
Strategics can become partners, investors or acquirers. Learn what they look for and how your medtech startup can prepare, from regulatory strategy to IP.
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Scrappy is not the same as cheap
Every dollar you spend is a trade-off. A dollar spent on one thing is a dollar that is not available for the next. Some of that money costs ownership. When it does, overspending means founders and early investors give up a bigger share of what they built through dilution. That is why the instinct to…
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10 MORE mistakes medtech startups make — and how to avoid them
In our previous article, we explored ten common mistakes medtech startups make while developing and commercializing a medical device. This article continues that conversation with mistakes 11 through 20—additional challenges that can create avoidable delays, costs and barriers to adoption. Bringing a medical device to market requires much more than a strong product and a clear clinical need….
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FDA clearance is taking longer: How smart medtech startups are adapting
FDA timelines are getting longer. That changes how medtech startups should build. For medtech founders, FDA clearance has always mattered. But the latest reporting on device review timelines reinforces something we are feeling across the industry: getting to market is taking longer, even as approvals continue to rise. That matters because regulatory timing is no longer just a compliance issue — it is a business…
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FDA Pathways, Simplified
If you are building a medtech company, one of the first big questions you may have is: what FDA pathway applies to my medical device? The applicable regulatory pathway may affect your timeline, evidence plan, budget and go-to-market strategy, so understanding it early can save real time and money. The good news is that most…
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FDA & CMS New Programs: What Medtech Startups Need to Know
FDA and CMS just launched two new programs — RAPID and TEMPO — to help innovative medical devices reach patients faster. For startups, this could mean shorter gaps between FDA approval and Medicare coverage, or better ways to build real-world evidence. The catch? These programs only work if you understand them early and plan accordingly….
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What FDA and CDRH Staffing Pressures Mean for Medtech Startups
The regulatory environment for medical devices is becoming more constrained, and that is starting to affect how medtech startups interact with FDA. As workloads continue to rise inside CDRH, the practical result for sponsors is not just slower response times — it is a shift in the nature of engagement itself. More questions are being…
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FDA Clears the Runway for Wearables and AI: What Medtech Innovators Need to Know
The regulatory ground under wearable and AI-enabled devices is shifting—and for once, it’s in a direction many innovators will welcome. In early 2026, FDA issued updated guidance on low‑risk wellness products (including many wearables) and on clinical decision support (CDS) software, easing premarket requirements for certain functions while clarifying where full device regulation still applies….
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The Regulatory Naughty & Nice List: A Holiday Guide for MedTech Startups
Because Santa isn’t the only one checking twice… your regulatory team is too. The holiday season has a way of making all of us reflect—on what we’ve built, what we’ve learned, and what we might need to tighten up going into the new year. For medtech startups, it’s also the perfect moment to pause and…
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FDA, WTF, Now What?
Navigating the New Regulatory Reality with Avio Medtech When the U.S. FDA becomes the headline instead of the gatekeeper, you know the medtech world is in for a ride .At this year’s MD&M Midwest Conference, the panel “FDA, WTF, Now What?”—moderated by Frank Jaskulke, Vice President of Business Development and Sales at Avio Medtech, and…
