Medical Devices Fund

How many pages can be attached to the preliminary application?
There is no limit to how many pages can be attached. However, only high-level detail should be attached in the preliminary application stage. There will be an opportunity to provide further detail if the application proceeds to the full application stage.

Does the video submitted in the application need to be professionally developed?
No, the video should be professional in nature, but it does not matter if it’s designed and filmed professionally or filmed on a smartphone. The structure and format are at the applicant’s discretion. However, it must be submitted as part of the preliminary application.

What is the purpose of the video and how long should it be?
The video is an opportunity to introduce yourself and the technology to the Panel and explain the product and its impact in more detail. It should be no longer than three (3) minutes.

If the file size of the attachments is too big, is it ok to send a series of emails?
Yes, that is fine, please make sure you title the number of emails clearly e.g., email 1/3, 2/3, 3/3.

Is there a preferred format for the email Subject Title?
Yes, this should follow the same format as outlined on the preliminary application form: ‘MDF2023_organisationname_preliminary application’

Do you accept hand delivery of a video on USB to the Office of Health and Medical Research?
We prefer the video to be submitted electronically. If this is not at all possible then we recommend mailed USB’s. If you would like to hand deliver a USB, please let the OHMR know and an expected date and time you will be delivering it.

What information should be included about funding received to date?
All types of private and public funding should be included in the application. This includes grants received through competitive grants schemes and other government programs (State and Federal).

How detailed should the project timeline and costs be? Do you need cashflow or sales?
Information provided in the preliminary application should be high level detail. However, it recommended to submit any relevant information you have available. You will have the opportunity to submit a detailed timeline and costs if the application proceeds to the full application stage. It is recommended that you submit your cashflow and sales.

Are long term subcontractors or consultants regarded as part of the project team?
The Expert Panel understands that an applicant may need to source a skillset from outside the team or who are based outside NSW and as such subcontractors and/or consultants should be listed as part of the project team.

Is there are requirement that clinicians engaged are within NSW?
It is recommended that you engage a clinician who understands the NSW Health system - and this typically would be a clinician from within the system in NSW. This clinician should be able to advocate that the product will solve an unmet clinical need.

Can the referees be part of the project team?
We recommend that referees are external to the project team.

What do I need to include in clinical and technical feasibility attachments?
You will need to include information on the technical proof of concept, assessment of risk classification including risk management and monitoring. All laboratory, preclinical and any early clinical studies and outcomes should also be submitted. There is a short video on our website which explains this in further detail. Please scroll through the videos underneath the ‘Before you apply' section.

Can the funds be used for Patent costs?
Yes, funding can include patent costs.

For start-ups who are short on capital, what is the expected percentage of contribution towards capital costs of progressing their project milestones?
There is no requirement for matched funding.

Are start-ups at the pre-revenue stage at a disadvantage because they have relatively minimal financial documentation? How might they still present a competitive application?
The majority of applications are at the pre-revenue stage so this will not disadvantage your application. We suggest you submit as much financial information as possible. Sales revenue and financial details should be included if relevant.

Do the pictures of early prototype devices have to match those of the intended end product if design changes are underway?
Submit photos of the prototype currently. This does not have to be the end design in changes are underway.

What is meant by "key geographical target markets" in the application form under Section 2, Question 5? What evidence should we provide?
How and where do you intend to protect your intellectual property? Evidence would include any patents filed or other forms of intellectual property protection that have been filed or granted.

CEO/Vice Chancellor/Director’s Declaration states that "this application may be circulated to third parties as required by the secretariat or the MDF Expert Panel." Can you please clarify who these third parties may be? Will the complete application be circulated to third parties or only the lay description of the device (non-commercial in confidence), and summary of the project?
As part of the MDF review process, third party experts may be engaged. Before any applicant is shared with any third parties, confidentiality form and a statement of interest and affiliations must be completed.

Who is eligible to apply to the Medical Devices Fund?
NSW based public and private hospitals, medical research institutes, universities, individuals, start-ups and established SME’s.

An applicant can be: a) a financially viable company or commercial enterprise with the parent company based and headquartered in NSW who can provide evidence that the proposal connects and benefits NSW, has an Australian Business Number, an annual turnover of less than $25 million, and is a legal entity; b) an individual based in NSW who agrees to form such an entity so that NSW Government can enter into legally binding funding agreements; or c) a NSW public research organisation applying through its appropriate technology transfer office, or the CEO, or the equivalent of the research organisation.

Does the majority of business need to be focused in Australia? Would the Fund consider global commercial business cases?
While all activities do not need to occur in Australia and in order to be viable there needs to a global focus, the parent company must be based and headquartered in NSW. There must be strong evidence that the product will benefit NSW.

Are mobile applications (apps) considered a medical device and are they eligible?
Software (including mobile apps) is considered a medical device and is eligible if it’s fits the TGA definition of a medical device in section 41BD of the Therapeutics Goods Act 1989. This means there needs to be a strong clinical need for the technology. Mobile apps which are simply sources of information or tools to manage a healthy lifestyle are not considered a medical device. For examples of mobile applications previously funded visit our website.

Do you need sales /cashflow to be eligible?
No, the Fund understands that many applicants are pre-revenue. Sales revenue and financial details should be included if relevant.

Can a completed CRC project now moving forward and apply to the Fund for commercialisation?
Yes, you can find previously funded CRC projects under the 'About previous recipients' section.

Can the product development happen in collaboration with a University in a different State?
Yes, as long as the IP originated in NSW, the office is headquartered in NSW, the product is developed in NSW and the health, economic, social and/or environmental benefits flow back to NSW.

Is AI (artificial intelligence) for detecting early epidemics can be considered for this funding? Do IVDs, for example blood tests, which address the limitations of conventional tools to detect/diagnose diseases qualify to apply for the grant?
In order to be eligible for the Fund, the technology must meet the definition of a medical device in the MDF guidelines, this definition is based on the TGA definition of a medical device. The Therapeutic Goods Act 1989, as amended, defines a medical device as: (a) any instrument, apparatus, appliance, software, implant, reagent, material, or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: i. diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease; ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; iii. investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state; iv. control or support of conception, and that does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means; v. in vitro examination of a specimen derived from the human body for a specific medical purpose (b) an accessory to such an instrument, apparatus, appliance, software, implant, reagents, material, or other article.

Projects throughout the medical device product life-cycle will be considered from a minimum Technology Readiness Level 3 (Technical proof of concept demonstration). Note that evidence must be provided to support the Technology Readiness Level.

Are patient organisations/charities eligible to make an application under the medical devices fund or is funding only available to hospitals, medical research centres etc.
The MDF has funded companies, local health districts and universities to date. Charities and patient organisations would need to be looked at on a case-by-case basis and the MDF would have to be comfortable that the organisation is the right model for commercialisation and that there is an appropriate plan to commercialise.

Can an applicant be a non-for-profit hospital?
Yes – this can fall under ‘public and private hospitals’ in section 2.1 in the application kit and guidelines

Can the applicant apply with a provisional patent?
Yes – As long as the IP pathway is clearly outlined in the application.

What is the funding level available?
The Medical Devices Fund has a total funding pool of approximately $8.2 million per annuum. The minimum grant available is $500,000 and the maximum is $5 million.

What activities can be funded through the Medical Devices Fund?
Projects throughout the medical device product life-cycle will be considered from a minimum Technology Readiness Level 3 (technical proof of concept demonstrated).
Funding can be used for: proof of concept, prototyping and piloting studies; manufacturing samples for product trials; conduct market and product assessments; regulation costs; engaging a consultant to locate other national international research relevant to the product under development and; conducting clinical assessments/trials.

To what extent must the device be validated as commercially viable? Is it feasible to use the fund support to perform business model development and validation?
A portion of the funds can be dedicated to business model development and validation. The Medical Devices Fund Expert Panel will have sufficient flexibility to tailor funding support according to what it believes is required to assist the development and commercialisation of a medical device.

Our product isn't novel, but the current technology is prohibitively expensive, does the fund cover devices that innovate the technology but not the problem?
To be considered for the Medical Devices Fund, the project must be innovative i.e. new to market or new to world.

Can funding be used to achieve interoperability between our device and larger treatment equipment?
Yes, absolutely.

Can funding be used to engage NSW Health commercial services such as Research Imaging NSW (RINSW)?
The fund typically does not fund other NSW Health funded services. However, funding programs administered by organisations such as MTPConnect will fund RINSW.

Is it best to ask for a smaller amount (e.g., to complete two milestones) or larger amount (e.g., to complete all four milestones)?
This is up to the applicant. The Expert Panel will assess if the milestones and the timelines are realistic and achievable.

If you are successful, the Expert Panel will have sufficient flexibility to tailor funding support according to what it believes is required to assist the development and commercialisation of a medical device.

Given that the fund has a finite amount to distribute, do we reduce our chance of success, by asking for a larger amount?
No, the amount of funding requested will not impact the funding recommendation made by the Expert Panel.

However, the funding requested must be justified throughout the application.

Is the Funding Amount Requested negotiable, up or down, during the Full Application Stage?
If you are invited to submit a full application, you may amend the funding requested from the Preliminary Application to the Full Application.

Can you please provide clarification on repayment to the MoH i.e., once the recipient earns a profit through the commercialisation of the device?
Unless there is a company restructure, upon commercial success of a project, repayment of the grant is triggered. Commercial success of the project is defined as cumulative EBITDA of over $500,000. Repayment of the grant is calculated at 30% of cumulate EBITDA after the success trigger until the grant is repaid.

How would potential venture capital investment impact the fund's decision?
The application will not be advantaged or disadvantaged if is receiving venture capital investment. The Expert Panel expects applicants to pursue some level of venture capital or private equity at some point.

How are partnerships with universities viewed by the fund vs standalone commercial entities?
The Medical Devices Fund has provided funding to organisations/individuals in partnerships in universities. However, it is encouraged that relevant collaborative agreements are in place when you apply.

What test is applied to assess company’s financial viability?
Financial experts are engaged to undertake a financial evaluation and assessment on applications invited to submit a full application. The financial evaluation is based on the proposed business model (projected cash flow and commercialisation strategy), project milestones, Statement of Comprehensive Income, Statement of Financial Position, Statement of Cash Flows, notes to the financial statement (where relevant).

Does the amount of funding requested impact the funding recommendation made by the Expert Panel?
No, the funding requested must be justified throughout the application. The Expert Panel will assess if the funding requested is realistic and if the stated timelines are achievable.

How is repayment decided to the Medical Devices Fund?
Unless there is a company restructure, upon commercial success of a project, repayment of the grant is triggered. Commercial success of the project is defined as cumulative EBITDA of over $500,000. Repayment of the grant is calculated at 30% of cumulate EBITDA after the success trigger until the grant is repaid.

Can the interest rate for repayment be a fixed rate?
The interest rate is based on Annual Nominal CPI.

Can the funds be used to match a Minimal Viable Product grant or an Accelerator Commercialisation grant?
As a government grant, the Medical Devices Fund typically will not be accepted as matching funding by those programs. However, you can and are encouraged to apply to the Medical Devices Fund if you have received either grant.

Does the fund expect any equity participation in the business?
No, it does not, this is one of the unique features of the Medical Devices Fund.

How does the fund view an approach to stagger grant requests? E.g. 1 million this year, 1 million another?
The total amount of Funds payable is paid in one lump sum in the financial year for which you received the grant. If you would like to apply for a second grant at a later stage, you will need to submit a new application.

Does NSW Health have a standardised health economic modelling process and if so where can we access it?
NSW Health currently does not have a standardised health economic modelling process. OHMR can refer you to relevant service providers to assist.

How detailed do health economic studies need to be i.e. quality of life, societal benefit? or only for the payer?
It is recommended to provide as much detail as possible on the health economic studies.