This talk will draw examples from case studies to exemplify how the journey towards business agility can look like when developing highly regulated software & hardware medical technology products. A huge challenge for this industry is how to ensure swiftness of innovation availability to help patients and yet ensuring that the products are compliant. There are great opportunities here to use agility to address exactly this challenge. We will highlight both how the compliance aspects and the HW development was addressed, what challenges we faced (such as varying regulations in the EU and the US) and how we tried to address them. Another factor that we want to share is how to drive change within a large corporate structure, the importance of working with agility of strategy and leadership simultaneously as various parts of the product development and what that can look like.