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Clinical Translation

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TOOLS AND TEMPLATES

1. Qualify Clinical Need

What is the problem you want to solve?

DESCRIPTION

Consulting with relevant healthcare workers, patients and communities will help you determine the nature and significance of the problem to be solved. It is important you understand how others have tried to meet this need through systematic literature review, patents and competitor searchers. 

RESOURCES

In development

 
 

2. Connect with Experts

Connect with our Expert Advisory Group

DESCRIPTION

You can connect with experts in the field to discuss the feasibility of developing and testing your idea through our Expert Advisory Group. Talking about your ideas with clinicians, engineers, marketers and commercialisation experts from an early-stage is important to ensure your solution will meet the need identified. 

RESOURCES

Expert Advisory Group

Requests can be submitted here. Please include the assistance that you are seeking and a brief description of your product and clinical need.

More resources are in development

3. Solution Ideation

Brainstorming with Key Players

DESCRIPTION

Identify and engage with end-users and key stakeholders to develop potential novel solutions to meet the clinical need. Consider indigenous solutions through engagement with Māori communities and the Mātauranga Māori module by contacting us directly. 

RESOURCES

Lean canvas - In development

The Mātauranga Māori Module aims to build and improve the capacity for researchers to work with māori communities by offering cultural competency workshops, Manaaki sessions and one-on-one assistance.

The Pacific Engagement Module is working to increase engagement between Pacific communities and the Aotearoa NZ healthtech sector by offering Pacific cultural responsiveness workshops and annual fono to initiate collaborations.

4. Building a prototype solution

Bring your solution to life

DESCRIPTION

Build a prototype that has novelty and can be tested in the laboratory. Consider the design, materials and usability, and identify what class of medical device you fall into (FDA).

RESOURCES

In development

 
 

5. Verification Testing of Prototype

Bench testing to show it works

DESCRIPTION

Verify prototype performance with bench or laboratory testing to show that it does what is intended and obtain pre-clinical proof of principle data. 

RESOURCES

In development

 

6. Clinical Validation and User Experience

Getting clinical evidence

DESCRIPTION

End-user studies are 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. 

RESOURCES

For trials in New Zealand, MedSafe offers a range of information.

Methodology for the clinical development of medical devices - Guide

Ethics application and how to submit them - in development

IDEAL Framework reference - in development

Data Collection

- Concomitant Medication Log Template

- Adverse Event Form (including SAEs)

Site Checklist - in development

 

7. Clinical Implementation

Using the product

DESCRIPTION

The goal for your product is to meet the clinical need in the real world. This will require commercialisation of the product, including manufacture, regulatory approval, sales and marketing. Success will be determined by the uptake of your product by healthcare workers and potentially becoming the new 'standard of care'. A series of resources for your commercialisation journey has been developed by the commercial translation module and can be accessed here.

 

Module Leads

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