Insights & Analysis

Medical Device Intelligence

Regulatory updates, market analysis, and due diligence insights from the front lines of medical device investing.

FDA's New 510(k) Guidance: 5 Critical Changes for 2025

The FDA's updated 510(k) guidance introduces significant changes to predicate device selection and clinical data requirements. Here's what founders and investors need to understand.

Read More

The Predicate Trap: Why 510(k) Strategy Kills More Deals Than You Think

We've seen it too many times: a promising device company builds their entire regulatory strategy on a predicate that was never appropriate.

Read More

AI in Medical Devices: Separating Hype from Investment-Grade Innovation

Every pitch deck now features "AI-powered" somewhere. But which AI medical device plays are actually defensible? We break down the regulatory realities.

Read More

Anatomy of a Failed Device Launch: Lessons from a $40M Write-Off

An anonymized deep-dive into how a well-funded surgical device company missed every adoption signal. The warning signs were there at Series A.

Read More

EU MDR Update: What the Latest Extensions Mean for US Companies

The EU MDR timeline continues to shift. We analyze the latest guidance and what it means for US device companies planning European market entry.

Read More

Reimbursement Red Flags: The Questions VCs Forget to Ask

Clinical efficacy means nothing if payers won't cover it. We outline the reimbursement diligence framework that separates fundable opportunities.

Read More

Need Custom Analysis?

Our team provides bespoke research and due diligence reports for specific deals and market opportunities.

Contact Us
Schedule Call