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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. Your key connections and networks are one of your greatest resources.

It is also important you understand how others have tried to meet this need through systematic literature review, patents and competitor searchers. 

RESOURCES

You can begin by assessing who you are already connected to and who you will need to connect with using a stakeholder map.

The Bridging Business and Science programme is supported by two interns from the University of Auckland Master of Bioscience Enterprise programme who will work with you for four weeks to assess the size of your potential market(s) and competitors. Please contact us to access this programme.

 
 

2. Connect with Experts

Connect with any of our expert groups

DESCRIPTION

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. You can connect with clinical experts, end-users, community and commercial experts through our networks listed below. Please contact us here if you are interested.

Identifying and understanding your user is key. To aid with thinking about some of the key considerations for your user and all those who will come in contact, a customer journey map or customer empathy map can be helpful. 

RESOURCES

A Customer Journey Map can be used to understand the needs, wants and pain points of users and identify where the improvements can be made.  

A Customer Empathy Map can be used to depict the behaviours of users in the current workflow.

 

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

A Lean canvas is used as a one-page business plan to quickly understand your product and how it will be offered to users.

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).

As a New Zealand University-based research group, you have access to your Tech Transfer office. The teams work to assist you through the intellectual property of your idea and product. Find your office below.

RESOURCES

 

UniServices at the University of Auckland

AUT Ventures at Auckland University of Technology

Wellington Univentures at Victoria University of Wellington

IP and Commercialisation at the University of Canterbury

Otago Innovation at the University of Otago

Massey Ventures at Massey University

WaikatoLink at Waikato University

Two user-centred design workshops will be hosted in 2023; one in Auckland and one virtually. If you would like to confirm a place now, please contact us.

5. Quality and Regulatory Management

Understanding quality management and regulatory strategy

DESCRIPTION

Quality management and regulations for medical devices and digital health are key for ensuring the safety of your product and your end-user. 

 

If you would like project-specific assistance, we have expert open hours available at no cost for NZ university research groups, and the opportunity to have a free seat on our Greenlight Guru QMS license. Contact us if you would like access.

RESOURCES

Demystifying Quality and Regulatory workshop hosted by two local experts to build capability and a general understanding of the requirements during medical device development.

Software as a Medical Device Regulations workshop hosted by the Johner Institute as a complementary workshop for those developing SaMD products.

 
 

6. 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

 

7. 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 - in development

- Adverse Event Form (including SAEs) - in development

Site Checklist - in development

 

8. 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'.

RESOURCES

After considering each of the previous steps, put all information together in a Business Model Canvas. This template also includes marketing, costing and revenue, which are important to think about when becoming a start-up. 

When you do spin-out your company to become an early-stage start-up, make sure you contact the Healthtech Activator to access significant support.

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