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April 3, 2026
Two startups hit major problems at the same time. One had a technical failure—the device didn’t perform as expected.
The other had a regulatory issue—the FDA questioned their pathway and evidence.
April 2, 2026
The acquisition was almost done. Term sheet agreed.
Due diligence complete.
Press release draft ready. Then one issue surfaced: “Regulatory alignment needs clarification.”
April 1, 2026
A startup made it all the way through partner meetings, technical validation, and market analysis. Then diligence started. Two weeks later, the deal slowed.
Four weeks later, the valuation dropped.
Six weeks later, the lead investor walked away.
March 31, 2026
A founder walked investors through a polished pitch: Strong problem
Clear solution
Large market
Impressive prototype Then came the slide titled “Regulatory Strategy.” It had three bullets: 510(k) pathway
No clinical trials expected
Timeline: 12 months
