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Female scientist conducting laboratory testing on their medical device

Test and Refine

Verify prototype performance with bench or laboratory testing to show that it does what is intended.

 

End-user studies are then needed to confirm the acceptability and usability of your solution. To provide this proof, the clinical trial design must consider safety, feasibility, target population, key endpoints, sample size, data collection, and statistical analysis. You will also need to obtain ethics and locality approval for studies conducted in human volunteers/patients.

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For clinical trials conducted in Aotearoa New Zealand, Medsafe offers a range of information.

Events

A clinician speaking to start-up, The Insides Company at a Te Tītoki Mataora showcase

TIKI Tour Showcase

Te Tītoki Mataora | MedTech Research Translator hosts regular Technology Innovation and Knowledge Interchange (TIKI) tours. These are an opportunity for researchers to showcase their prototype to healthcare professionals to gain their feedback and insights. Sign up to our mailing list to find out when registrations open or take a look at the events page.

Resources

Good Clinical Research Practice Handbook

The World Health Organisation's guide to international guidelines for good clinical research practice.

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Download

Ethics Application Guide

A guide to support the processes of ethics applications for your health research in Aotearoa New Zealand.

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Download

Data Management Plan

To provide an outline on how any data that is produced, collected or processed during your project will be handled during and after it's completion.

Download

Manual of Operations and Procedures

This acts an an inclusive manual for assuring uniformity of all tasks related to clinical trials and other relevant research. 

Download

Statistical Analysis Plan

A document to detail the statistical methods that will be used to analyse data in a clinical trial or other research study.

Download

Training Log

To keep track of research and staff members that have completed the necessary training and provide documentation in case of audits or compliance checks.

Download

Participant Information Sheet and Consent Form

A template to assist the development of your participant information sheet.

Download

Adverse Event Form

To record information about any adverse events that happen to a participant in a clinical trial or medical study.

Download

Site Signature and Delegation of Responsibilities Log

An important document that records study personnel and outlines their respective roles and responsibilities.

Download

Mātauranga Māori

To effectively partner and engage with Māori communities, first attend the Whaia te Tika workshop series, followed by the Kaupapa Māori research ideation one-on-one office hours assistance to refine your approach.

Pacific Engagement

To effectively partner and engage with Pacific communities, attend the Vaka Moana workshop and speak to the Pacific Engagement module leads about your project.
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