In MedTech, breakthroughs rarely fail because the science is wrong. They fail because the product doesn’t translate into the real world. That gap, between technical possibility and practical usability, is where value is either created or lost. The Niji™ platform is a clear example of what happens when that gap is handled properly. Working with

Introduction: The Hidden Lever in MedTech Product Development Every MedTech spin-out starts with energy: fresh thinking, clinical purpose, and an ambition to make a real-world difference. It’s what makes early-stage innovation so rewarding. But there’s one conversation we aim to have early with every founder we meet: Your regulatory strategy will