Insights
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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 stalls when the leadership model that helped launch the company becomes the very thing holding it back. That’s the hard…
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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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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. 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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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 treat fundraising like a disciplined sales process, not a one-shot performance. They understand that investors are customers, capital is the…
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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 a robust Quality Management System and utilizes its processes to build a device that is safe and effective. For early-stage…
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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 steady: leadership — at both the executive and board level — defines whether a company navigates the storm or gets…
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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 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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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 ahead. For MedTech startups, this season is a perfect moment to take a lighthearted (but honest) look at your Quality…
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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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🎄 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 critical. Great documentation protects your company, accelerates your regulatory path, and helps you scale. Poor documentation? It slows you down,…
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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…
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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 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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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 Consulting and led by executive coach Nirav Sheth, explored what distinguishes competent founders from truly effective and resilient leaders. If…
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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 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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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 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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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 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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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 drawn to ventures that solve real problems in growing markets. Identify a clear, unmet clinical need and demonstrate how your…
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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 contest, held June 16-17, 2025. This annual pitch contest, now in its second year, is a collaborative effort powered…
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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 the template we use when building decks for clients and own ventures. You can download the template below. A couple…
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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 was accompanied by a significant shift in investment patterns: larger rounds were flowing to fewer companies. This investment boom occurred…
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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 the past 30 years, but its appeal has been enhanced by recent shifts in the tax landscape. The presentation covers…
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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, which awards $20,000 in non-dilutive funding, will take place live at the Medtech MVP Conference on June 16, 2025, in…
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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. Conduct Thorough Market Research A deep understanding of your target market is essential. Conduct market research to gather insights into:…
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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 for a medical device to cause harm to patients or fail to meet its intended purpose. Investors are cautious about…
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Avio Medtech Consulting Strengthens Board with the Addition of Carmen Volkart
FOR IMMEDIATE RELEASE April 14, 2025 Avio Medtech Consulting Strengthens Board with the Addition of Carmen Volkart ST. PAUL, MN – Avio Medtech Consulting, the innovators’ consultants, announces the addition of Carmen Volkart to its Board of Directors. Ms. Volkart has over 30 years of experience as a senior executive and independent board director in…
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Why Investors Say No: Recap and Video Link
Why do investors say no? And say no so often? The Avio team has interviewed over 100 VCs and angels and organized their responses into a presentation, along with suggestions you can use to improve your odds. The presentation was given as a webinar, which you can watch here An AI-generated (and human-edited) summary of…
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Balancing Innovation and Well-Being: Mental Health Strategies for Medtech Founders
You’re driven, visionary, and a risk-taker. And startups are lonely, prone to failure, high stress, and high impact on your mental health. And if your mental health declines, so will your business. Your team, your family, and you will feel it. Here are three strategies to help: 1. Prioritize Self-Care: Mindfulness and Meditation: Incorporate mindfulness practices into…
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2024 Medical Device Investment Data: A Brighter Exit Path, A Challenging Funding Road
Avio’s friends at Nocturnal wrote a great post on medtech funding in 2024 and what that could mean for 2025. Avio’s take? The pickup in M&A and (brief) return of IPOs are positives. Challenges with NIH funding, the FDA, and economic uncertainty are negatives. But you knew that already! What to do? Spend small money…
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Chief Executive Officer or Chief Consultant Wrangler?
As a medical device startup founder, you’re intimately familiar with juggling. One moment, you’re pitching to investors, the next, you’re deep in regulatory documents, and somehow, are also expected to lead product development, build a team, and craft your go-to-market strategy. Then comes the inevitable realization: you need specialized expertise. Enter consultants. While they bring…
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Market Authorization vs. Market Adoption: Strategic Choices for Medical Device Startups
Market authorization is not market adoption, yet many confuse them. Being able to legally sell your device (market authorization) is different from customers buying your device (market adoption). Focusing on market authorization can seem rational. Investors and strategics see FDA clearance or approval as a major milestone, making it alluring to focus resources on reaching…
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What are the Three Key Criteria Investors Seek in Medical Device Startups?
When investing in medical device startups, investors evaluate many factors to assess the potential for success, mitigate risks, and maximize their return. Here are three key criteria and how you can improve your odds. 1. Team Quality Team quality is arguably the most critical factor investors evaluate. Investors are betting that YOU can execute on…
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When the Super Bowl Didn’t Stop the FDA, Morari and Avio Didn’t Stop Either
Avio Medtech Consulting client Morari Medical recently received FDA clearance to market their lead product, MOR, a device to enhance sexual performance and delay ejaculation. When a challenging and time-sensitive issue arose, the Avio team was Morari’s committed co-pilot! “The Avio team brought significant value to Morari’s product journey, especially in guiding us through the…
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Why Investors Say “No” to Medical Device Startups: Key Considerations for Funding
Raising money for a medical device startup is difficult. Avio’s team interviewed over 100 venture capitalists (VCs) to understand why they decline to invest. While there are always exceptions, understanding these common pitfalls can increase your chances of success. Before we discuss the factors, let’s discuss the math. Most venture funds will invest in between…
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Medtech Startups Compete for $20,000 in Non-Dilutive Funding at the Avio + Medtech MVP Pitch Contest
Minneapolis, MN—Avio Medtech Consulting and Cambridge VIP, a division of the Cambridge Innovation Institute, announce today that they are partnering for the second year on a pitch contest that awards medical device startups $20,000 in non-dilutive funds and critical investor connections. Contest Highlights Emerging medtech startups with innovative solutions in medical devices, diagnostics, and software…
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How do you get to market faster with less dilution?
Avio Medtech Consulting and Accelermed Partner to Stop Commercial Failures ST. PAUL, Minnesota – Medtech startups are hard, failure is common, but the work matters enough that entrepreneurs persist. Avio Medtech and Accelermed are partnering to put the odds more in the entrepreneur’s favor in a critical area: early commercial planning. Avio and Accelermed today…
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5 Reflections on 5 Years
50% of small businesses don’t make it to 5 years. And medical device startups like the ones Avio serves have an even higher failure rate. We count ourselves fortunate to have made it 5 years radically advancing the medtech development process with 100+ client partners. What’s next? Doing more better. First, it’s worthwhile to pause…
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10 Common Mistakes Medtech Startups Make (And How to Avoid Them)
Check out the recording of a webinar from Avio Medtech’s Frank Jaskulke on 10 of the most common mistakes medtech startups make – and what you can do about it. Link here: 10 Common Mistakes Medtech Startups Make (And How to Avoid Them) Want to bring your product to market faster with less equity dilution?…
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How to Love “No”: Resilience in the Face of Rejection
Medical innovation is hard, fraught with failure and inevitable rejection. No is likely to be the most common answer you receive. Bouncing back from these challenges, learning from them, and persevering are hallmarks of successful entrepreneurs. Here are three strategies to cultivate resilience and navigate setbacks: 1. Embrace a Growth Mindset: Reframe Failures as Learning…
