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Navigating the Medtech Maze: Insights from 5 Founders on Regulatory Momentum
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...
The MedTech Valley of Death: Why a 30% Faster FDA Clearance is your best lever for survival
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...
Navigating FDA Medical Device Regulations Without Losing Regulatory Intent
Compliance vs. regulatory intent In highly regulated industries, there is a temptation to treat FDA guidance as a checklist. However, experienced reviewers know that regulatory intent matters more than rote compliance. The FDA’s guidance on clinical decision support...
Why Navigating FDA Medical Device Regulations Fails Long Before Submission
Most regulatory problems are locked in early Medical device executives often focus on the moment of submission, yet many delays stem from decisions made months or years earlier. The FDA’s average 510(k) submission now exceeds 1.000 pages, even though it is the...