Avio Insights

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...

Frank Jaskulke

14 minutes ago5 min read

Talking with Corporate Strategics – Timing and IP Protection

Medical device entrepreneurs face critical decisions about when to approach large strategic companies and how to protect their intellectual property throughout these engagements.

Frank Jaskulke

Aug 82 min read

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...

Frank Jaskulke

Jul 254 min read