Understanding the regulatory landscape

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.

Meeting US regulatory requirements

The US Food and Drug Administration (FDA) is the federal regulator for healthtech in the US. As the world’s largest healthcare market, the US will be a focus for many Kiwi healthtech companies, which will need to understand how to negotiate the US regulatory environment.

To further understand how the FDA might define your innovation, what accompanying regulatory frameworks might apply, how the FDA’s requirements might be met and who can assist, these touchpoint maps – covering a range of healthtech sectors – will help.

To learn more about FDA requirements around clinical trials, read this:

Regulation in action

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.

Case studies

Health IT – Disease Management App

Health IT – Disease Management App

Learn more about how the Diabetologic team, which is developing a smartphone app that helps diabetic and pre-diabetic patients control their lifestyle and improve diabetic control, is rolling out its service to patients in the US.
DOWNLOAD PDF
Medical Device Access to the US Market

Medical Device Access to the US Market

Learn more about a medical device company that wants to sell a topical adhesive in the US market as a consumer skin/wound adhesive, after achieving a CE mark in Europe for the same product.
DOWNLOAD PDF
Wearable Device for Oxygen Saturation

Wearable Device for Oxygen Saturation

Learn more about an early-stage medical device company that wants to sell a total ankle replacement device for primary or revision surgery in the US market. The company previously achieved a CE mark in Europe for the same product and the next step in commercialisation is to obtain 510(k) clearance to market the product in the US.
DOWNLOAD PDF
Total Ankle Replacement Device

Total Ankle Replacement Device

Learn more about OxyResp, which is developing a wearable device that measures a person’s circulating oxygen saturation and is wanting to access the US market.
DOWNLOAD PDF