Ensuring therapeutic outcomes

Healthtech entrepreneurs are driven by a vision to improve the health of others. Substantiating therapeutic claims with comprehensive data from clinical trials and studies is a major focus for innovators in this field.

This process, known as clinical validation, needs to meet the requirements of regulators and customers (such as healthcare providers).

Preclinical studies

Preclinical studies or trials refer to investigations that aim to test the safety of a new medicine or device and are a requirement before engaging in human clinical trials.

Preclinical studies may include in vitro (cell- or tissue-based) or in vivo (animal-based) approaches, depending on the requirements of regulators, and may in some cases provide sufficient evidence without needing human trials (e.g., lower risk devices may just need safety and performance testing for market approval).

The intended therapeutic claims and related risk profile of the product determine the extent of evidence required. The table below briefly references some key international standards and guidelines from the US Food and Drug Administration (FDA) for devices and medicines.

Key resources for preclinical standards and guidelines

Drugs (Medicines)
  • ISO 10993-1: 2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process- See Annex A for risk assessment table with the required endpoints
  • ISO 14971:2019 - Medical devices — Application of risk management to medical devices
  • FDA - The Device Development Process - See Step 1 - Device Discovery and Concept

Many healthtech startups outsource the development of their preclinical evidence and it is important to seek expert advice early, but the above standards and guidelines provide an overview of the requirements for preclinical work. Once sufficient preclinical evidence is provided on safety, human clinical trials may be the next step.

Clinical trials in New Zealand

Learn more about conducting clinical trials in New Zealand by clicking on the button below.

Clinical trials in New Zealand

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.

Download the clinical validation process diagrams

The clinical trials process is explored in greater detail in the fictional example case studies included in the following section.

A scientist working with samples in a lab.

Case studies

To illustrate some clinical trial 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).

Phase I Pharmaceutical: Psoriasis Treatment

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.

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Class II Medical Device: Diabetes Monitoring

Learn more about the clinical investigation process for a wearable diabetes monitoring device, with links to further reading on the discussed topics.

Download PDF

Clinical trials in Australia

Find out more about undertaking clinical trials in Australia.

A scientist working with samples in a test tube.

Find out more

Clinical validation is a crucial part of the healthtech innovation journey. Undertaking clinical trials is complex and highly regulated; in addition, the clinical trials landscape is constantly evolving. To support healthtech innovators and businesses – of all types and stages – stay up to date with what’s happening in this area, we’ve rounded up the following series of reports, articles and resources.

Latest Resources

Browse more resources on our Articles & Reports page:

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