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 featuring Matthieu Kirkland, Head of Regulatory and Quality at Avio Medtech, Nate Downing, Managing Attorney at Gardner Law, and Pablo Morales, CEO at Morales MedTech Advisors—tackled what every medtech startup is asking: how do we move forward when the rules keep changing?

In 2025, the FDA has seen more disruption than any point in its modern history—massive federal workforce cuts, sweeping executive orders, and an unpredictable cycle of policy reversals that would make even the most seasoned regulatory professionals dizzy. For startups trying to bring innovative devices to market, it’s not just about compliance anymore—it’s about strategic navigation.

💬 Key Takeaways from Avio Medtech’s Matthieu Kirkland

1. Remember the Human Side of the FDA

   
   

   “The FDA isn’t a faceless agency—it’s a group of people,” Matthieu reminded the audience. “And right now, those people are under immense pressure.”

   
   

   Successful interactions today depend on empathy and clarity. Treating every exchange as a partnership—not a transaction—goes a long way toward productive reviews and timely responses.

   
   

2. Focus on Mission-Critical Interactions

   
   

   With reduced staff and shifting priorities, the FDA is concentrating its efforts on mission-critical activities like IDEs and MDUFA performance metrics. Matthieu’s advice: make sure your submissions and meeting requests are just as mission-critical.

   
   

   Avio helps startups strategically time and position their submissions—ensuring every FDA touchpoint counts.

   
   

3. Prepare for the Floodgates to Open

   
   

   As parts of the government reopen and rehire, the agency is bracing for a deluge of delayed submissions. Matthieu cautioned companies to be smart about timing. “If your filing isn’t urgent, it might pay to wait—or be laser-focused to reduce burden on both sides.”

   
   

   For emerging medtech teams, this is where Avio’s regulatory foresight becomes invaluable: we help plan, sequence, and prioritize submissions to minimize delays and maximize impact.

⚙️ What This Means for Medtech Startups

The regulatory landscape has always evolved—but 2025 is rewriting the playbook. Startups now face a mix of opportunity and uncertainty. Those who adapt, plan, and communicate strategically will move faster, even through chaos.

That’s where Avio Medtech comes in. Our regulatory team works hand-in-hand with startups to:

• Build submission strategies aligned with shifting FDA focus areas

• Craft clear, human-centered communication that resonates with reviewers

• Anticipate and navigate policy volatility with confidence and foresight

Because in a year where even the FDA feels like a startup, having an experienced regulatory partner isn’t optional—it’s essential.

About Avio Medtech Avio Medtech helps emerging medical technology companies accelerate from concept to commercialization. Our regulatory and quality experts bring clarity, strategy, and structure to the most complex stages of device development—so innovators can focus on innovation.