This chapter looks at the challenges of regulatory requirements in the health technology sector. It also looks at how different companies have entered the sector and the evolution of their sales and business models. It also describes the most common commercialization scenarios and how business models relate to regulatory requirements in the sector. Finally, the main challenges faced by companies operating in the health technology sector are presented. This chapter is partly based on survey data collected in 2017 from Finnish companies in the sector. The survey was conducted at a time when new medical device regulations were about to come into force.