Insights
Finalists for Prize at 2026 Medtech MVP Conference Announced
Minneapolis, MN, May 19, 2026, — Avio Medtech Consulting, in partnership with the Destination Medical Center Fredrikson, F&N Med and Mobius Medical, announces that three finalists have been selected for the 2026 Avio Medtech MVP Pitch Contest. The contest,…
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…
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…
Scaling Medtech Requires a New Kind of CEO
We recently hosted a webinar with Nirav Sheth, Executive and Team Performance Coach and Founder of Stratosphere, LLC. Here are some takeaways. In medtech, growth rarely fails because of the product alone. More often, it…
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…
Exploring Medtech Tailwinds: Insights from the Avio Medtech & Forj Medical CEO Roundtable
At Forj Medical’s Energy Park Drive campus, the third Avio Medtech & Forj Medical CEO Roundtable recently convened a select group of startup leaders and executives for an open dialogue on the current tailwinds strengthening the medtech growth environment…
Stop Pitching, Start Selling: How Medtech Founders Raise Capital Faster
Raising capital in medtech has never been harder—and yet some founders consistently move faster, close better rounds, and stay in control of their company’s story. They are not “better pitchers.” They are better sellers. They…
Your FDA Inspection Playbook: How to Prepare with Confidence
For MedTech startups, an FDA inspection can be one of the most defining moments in the journey to market. It’s not just about passing an audit — it’s about demonstrating that your organization has established…
Rethinking Medtech Leadership: Foresight, Adaptability, and Humanity in the Boardroom
In medtech, turbulence isn’t an exception — it’s the norm. Market cycles shift, capital tightens, regulatory frameworks evolve, and reimbursement realities change faster than most startups can adapt. Yet amid this uncertainty, one truth holds…
A New Flight Plan for Tech Enabled Chronic Care
Bringing your device to market has never been a straight shot from runway to cruising altitude. FDA clearance is necessary but doesn’t guarantee demand or adoption. Without a clear reimbursement path, your innovation can end up…
The MedTech Quality Naughty & Nice List
What Santa (and the FDA) Want You to Know This Holiday Season The holidays are a time for reflection—on what we’ve built, what we’ve neglected, and what we promise to do better in the year…
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…
🎄 The Medtech Product Documentation Naughty & Nice List
A Startup-Friendly Guide to Staying on the Right Side of Regulatory Expectations In the world of medtech innovation, documentation isn’t the glamorous part of bringing a device to life, but it is one of the most…
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,…
Is FDA Breakthrough Device Status Still Worth It? 2025 Real-World Pros, Cons, and Surprises
Key Takeaway While FDA’s Breakthrough Device Designation program has grown to nearly 1,200 designations as of 2025, significant concerns about its value proposition have emerged, particularly considering recent FDA staffing cuts. For many companies, especially…
Leadership Skills for MedTech Founders and CEOs
In today’s fast-paced world, leading a MedTech startup presents unique challenges. It requires more than just technical skills or innovative ideas. The recent webinar, “Leadership Skills for MedTech Founders and CEOs,” presented by Avio MedTech…
Talking with Corporate Strategics – Timing and IP Protection
When to Engage with Strategic Partners Build Relationships Early, Without Immediately Seeking Funding Establishing relationships with strategic investors early in your company’s development can be highly beneficial, even if you’re not immediately seeking investment. These…
Navigating Challenges in the Medical Device Startup Landscape
The world of medical device startups is never simple. FDA layoffs, NIH cuts, disruptions at CMS, and fluctuating tariffs have caused the stock market to be unpredictable. Lately, the conditions for running a medical device…