Avio Insights

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 new corridors, tech enabled chronic care is often still negotiated one payer and contract at a time.  The Advancing Chronic Ca

In the spirit of the season, here’s our lighthearted (but accurate!) Regulatory Naughty & Nice List—a guide to the behaviors that keep your startup on the right side of compliance, and the pitfalls that can land you in hot cocoa–worthy trouble.

To help you ring in a more compliant, efficient, and inspection-ready new year, we’ve created the MedTech Naughty & Nice List from a Quality perspective—a festive reminder of what you’re doing right and what may earn you a lump of coal… or worse, a 483.