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…
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 those pursuing 510(k) clearance, the program may no longer deliver meaningful benefits and could potentially increase regulatory burden. Current State…
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 Consulting and led by executive coach Nirav Sheth, explored what distinguishes competent founders from truly effective and resilient leaders. If…
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 relationships develop over time, and early engagement allows you to align long-term interests and facilitate smoother future transactions. By engaging…
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 startup have become even more challenging. So, what can you do to thrive in this environment? Avio’s Insights for Medical…
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 achieving long-term success. 1. Invest in Research and Development Allocate sufficient resources to research and development (R&D) to ensure your…
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 drawn to ventures that solve real problems in growing markets. Identify a clear, unmet clinical need and demonstrate how your…
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 contest, held June 16-17, 2025. This annual pitch contest, now in its second year, is a collaborative effort powered…
“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 the template we use when building decks for clients and own ventures. You can download the template below. A couple…
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 was accompanied by a significant shift in investment patterns: larger rounds were flowing to fewer companies. This investment boom occurred…