Healthtech is a highly regulated sector, with new innovations requiring extensive research, development and clinical testing to validate not only the intended health benefits, but to meet the often extensive and complex requirements of regulators.
To add to the complexity for healthtech firms looking to sell their innovation offshore, regulatory requirements can differ around the world.
Given this complexity, it’s essential that healthtech innovators understand the regulatory environment of their potential markets and develop a pathway to meet regulatory requirements in conjunction with their product development and other strategies.
The nature of innovation is that it is ‘new’. That means it can be difficult to understand what different regulatory frameworks might apply to the technology you’re developing, what specific requirements need to be met, and how.
To illustrate some regulatory pathways, we’ve put together some case studies of fictional New Zealand companies developing a range of healthtech innovations aimed at the US market.