Author: Frank Jaskulke

Commercialization

Exploring Medtech Tailwinds: Insights from the Avio Medtech & Forj Medical CEO Roundtable
ByFrank Jaskulke February 5, 2026May 28, 2026

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. The conversation centered on three themes shaping today’s innovation and investment landscape: Opportunities emerging from heightened Medicare Advantage (MA) plan scrutiny Strategic…

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Regulatory

The MedTech Quality Naughty & Nice List
ByFrank Jaskulke January 6, 2026May 28, 2026

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 ahead. For MedTech startups, this season is a perfect moment to take a lighthearted (but honest) look at your Quality…

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Leadership

A New Flight Plan for Tech Enabled Chronic Care
ByFrank Jaskulke January 6, 2026May 28, 2026

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 living off grants, one off contracts, or fragile RPM codes instead of scaling nationally. Even as value based care has opened…

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Regulatory

Is FDA Breakthrough Device Status Still Worth It? 2025 Real-World Pros, Cons, and Surprises
ByFrank Jaskulke October 7, 2025May 28, 2026

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…

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Investments

Talking with Corporate Strategics – Timing and IP Protection
ByFrank Jaskulke August 8, 2025May 28, 2026

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…

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Leadership

Leadership Skills for MedTech Founders and CEOs
ByFrank Jaskulke August 8, 2025May 28, 2026

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…

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Investments

5 Strategies for Optimizing Medical Device Startup Fundraising Success
ByFrank Jaskulke July 11, 2025May 28, 2026

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…

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Commercialization

Burning Down Technical Risk: A Critical Step for Medical Device Startups
ByFrank Jaskulke July 11, 2025May 28, 2026

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…

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Uncategorized

Navigating Challenges in the Medical Device Startup Landscape
ByFrank Jaskulke July 11, 2025April 18, 2026

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…

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News

SIME Diagnostics wins 2nd Annual Avio Pitch Contest
ByFrank Jaskulke June 20, 2025May 28, 2026

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…

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