Healthtech entrepreneurs are driven by a vision to improve the health of others. Substantiating therapeutic claims with credible and comprehensive scientific data is a major focus for innovators in this field.
Clinical validation, through the likes of clinical studies and trials, needs to be undertaken to do this, and in a way that also meets the requirements of regulators and customers (such as healthcare providers).
You can learn more about conducting clinical trials on the Clinical Trials in New Zealand website.
For an overview of the general steps involved in the first in-human clinical trials of a pharmaceutical or the clinical investigation steps for a medical device, you can download example process diagrams below.
The clinical validation process is explored in greater detail in the fictional example case studies included in the following section.
To illustrate some clinical validation journeys with links to supporting material, we've put together two fictional case studies for example health innovations in collaboration with the New Zealand Association of Clinical Research (NZACRes), Te Tītoki Mataora and the National Institute of Health Innovation (NIHI).
Learn more about how a new treatment for psoriasis could navigate the Phase I clinical trial process, with links to further reading on the discussed topics.
Learn more about the clinical investigation process for a wearable diabetes monitoring device, with links to further reading on the discussed topics.