Insights
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…
Burning Down Technical Risk: A Critical Step for Medical Device Startups
Technical risk, the potential for technological challenges or failures that could hinder development or commercialization, is a significant concern for medical device startups. Proactively addressing and mitigating technical risk is essential to attracting investors and…
5 Strategies for Optimizing Medical Device Startup Fundraising Success
The medical device landscape is full of innovation. However, securing funding can feel like navigating through a stormy sky. Avio Medtech is your co-pilot, guiding you through the turbulence. Sharpen Your Value Proposition Investors are…
SIME Diagnostics wins 2nd Annual Avio Pitch Contest
Startups are the lifeblood of medtech innovation, and this week, we celebrate a standout achievement: SIME Diagnostics has been named the winner of the $20,000 cash prize at the Medtech MVP Venture & Partnering Conference…
Pitch Deck Elements & Template
“Can you look at my pitch deck?” We’ve all asked the question. Your pitch deck is critically important…and just a stack of text and images. At Avio, we don’t believe in gatekeeping, so we’re sharing…
Market Investment Overview: Medtech Investment Insights for Q1 2025
The first quarter of 2025 saw notable momentum in medtech venture funding. A total of $3.7 billion was invested in 117 funding rounds, reflecting a 9% year-over-year growth compared to Q1 2024. However, this growth…
Recap: Qualified Small Business Stock: A Guide for Founders and Early-Stage Investors
Missed the webinar? The recording is now available! Qualified Small Business Stock (QSBS) under Section 1202 of the Internal Revenue Code offers unparalleled tax-saving opportunities for founders and their investors. QSBS has been available for…
Finalists for $20,000 prize at Medtech MVP Conference Announced
Minneapolis, MN — Avio Medtech Consulting, in partnership with Mobius Medical, Fredrikson & Byron, and the Destination Medical Center, announces three finalists have been selected for the highly anticipated Avio Medtech MVP Pitch Contest. The contest,…
Burning Down Market Risk: A Strategic Approach for Medical Device Startups
Market risk, the uncertainty surrounding market demand, competition, and economic factors, is a significant challenge for medical device startups. Developing strategies to mitigate market risk is crucial to attract investors and achieve long-term success. 1…
Mitigating Risk: Crucial for Medical Device Startups Seeking Investment
Addressing and mitigating the risks of medtech development is crucial to attract investors. These risks can be categorized into three main areas: clinical, technical, and market. 1. Clinical Risk Clinical risk refers to the potential…