by Alexander Habermeier | Mar 30, 2026 | News
Every year, tens of thousands of promising medical technologies that could save or improve patients’ lives are delayed by regulatory complexity. Guideways, the AI company built to solve this problem, today launches its agentic AI platform to help medical device teams...
by Alexander Habermeier | Mar 26, 2026 | Blog
In my recent open letter to founders, “The MedTech Valley of Death”[8], I made a blunt assertion. Eliminating unforced regulatory errors to secure a 30 percent faster FDA clearance is the ultimate survival lever for an early-stage MedTech CEO. But...
by Alexander Habermeier | Mar 6, 2026 | Blog, News
By Alexander Habermeier What does building ambitious health technology look like when regulatory approval is part of the equation from day one? On February 12th, during the Guideways Launch Event in Utrecht, we gathered a group of innovators who are moving the needle...
by Alexander Habermeier | Feb 22, 2026 | Blog
By Alexander Habermeier There is a brutal reality in the current medical device ecosystem that nobody wants to talk about during pitch meetings. Out of every ten brilliantly engineered devices (devices just like yours) eight or nine are dying before reaching patients...