The prototype works. The technology has been demonstrated. The clinical need is clear. The team is excited. So why do so many promising MedTech innovations never become successful commercial products? Because proving that something can work is very different from proving that it can be manufactured, regulated, adopted, supported and sold at scale

Artificial intelligence is moving rapidly into healthcare. Regulation is moving with it. For MedTech companies, that creates a fundamental question: Are you designing an AI product and then asking how to get it through regulation, or are you designing a product that can succeed within the healthcare system from day one? There is an important