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Medical Devices Fund

The Medical Devices Fund is a competitive technology development and commercialisation program.

Key dates

  • 25-FEB

    Preliminary applications close

HEARLab® is an innovation of the HEARing CRC and National Acoustics Laboratories

The Medical Devices Fund aims to provide support to individuals, companies, public and private hospitals, medical research institutes, universities and the medical devices industry, to take local innovation to market.

It also seeks to increase the uptake of NSW medical devices by the health system where they are cost effective and contribute to improved patient outcomes.

Since the first round in 2013, recipients of the NSW Medical Devices Fund have been awarded more than $50 million for 31 technologies. The fund invests in the development and commercialisation of medical devices and related technologies in NSW, with some past recipients later gaining high-profile investors.

Apply now

In the 2019-20 financial year the Medical Devices Fund has over $8 million available.

Applications close Monday 25 February.

Stage 1: Preliminary Application
  • Preliminary Application Form

    DOCX - 751 KB

Please submit one copy of the application electronically to MOH-OHMRGrants@health.nsw.gov.au

Before you apply

Applications are called for once a year, and there is a two stage application process. To be eligible to be invited to submit a Full Application, applicants must first submit a preliminary application.

  • Preliminary Application – this is an early screening document of no more than 8 pages that allows the Medical Devices Fund Expert Group to determine eligibility, review the opportunity and assess the quality of the application.
  • Full Application – the Medical Devices Fund Expert Group will determine if a Preliminary Application will proceed to a Full Application. This is a more detailed document of 15-20 pages that covers all aspects of the opportunity. This stage is by invitation only.

Application guidelines

Information about eligibility, selection criteria, assessment process and other guidelines is outlined further below in the Medical Devices Application Kit and Program Guidelines.

  • Medical Devices Application Kit and Guidelines

    DOCX - 730 KB

Principles of the Fund

The following principles apply to the Medical Devices Fund:

  1. The project must be capable of potentially:
    • improving patient care and/or health wellbeing
    • generating, economic, social and/or environmental benefits to NSW.
  2. Funding will be open, competitive and merit-based, while maintaining commercial-in-confidence requirements.
  3. Funding can be used for purposes including:
    • proof-of-concept, prototyping and piloting studies
    • manufacturing samples for product trials
    • conducting market and product assessments
    • engaging a consultant to locate other national and international trials and research relevant to the product under development
    • and conducting clinical assessments.
  4. The fund will support a cross-section of products across a range of applications throughout the medical device product life-cycle (technical device concept demonstrated to marketing).
  5. The fund will not support activities which are deemed to be research.
  6. 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.

Application guidelines

Medical device definition

The Medical Devices industry is defined as including those companies and organisations that develop, produce or supply devices or parts of devices that are regulated as medical devices by the TGA. The Therapeutic Goods Act 1989, as amended, defines a medical device as:

  1. any instrument, apparatus, appliance, 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:
    1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
    3. investigation, replacement or modification of the anatomy or of a physiological process; or
    4. control 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; or
  2. an accessory to such an instrument, apparatus, appliance, material or other article.

For the purposes of the Medical Devices Fund, the definition of a medical device includes those technologies that have a patient application which will impact the health system that are not considered to be drugs. These include technologies such as ‘omics’ technologies, apps, virtual technologies, remote diagnostics and nanotechnologies.

Applicants

The Medical Devices Fund can be accessed by eligible NSW organisations with innovative medical devices/technologies supported by intellectual property. Eligible organisations include public and private hospitals, medical research institutes, universities, start-ups and established small to medium enterprises.

An applicant must be:

  • a financially viable company or commercial enterprise based in NSW (e.g. location of manufacturing jobs, headquarters based in NSW, NSW investment,) and be able to provide evidence that the proposal connects and benefits NSW; have an Australian Business Number (ABN); typically with an annual turnover of less than $25 million; and is a legal entity; or
  • an individual who agrees to form such an entity so that NSW Government can enter into legally binding funding agreements; or
  • a NSW public research organisation applying through its appropriate technology transfer office, or the Chief Executive Officer or equivalent of the research organisation.

Projects

Projects throughout the medical device product life-cycle will be considered from a minimum Technology Readiness Level 3. A risk mitigation approach to funding will be undertaken as it is acknowledged that funding for a medical device at the technical proof of concept phase is a much higher risk from the point of view of return on investment than funding for a market ready product.

To be considered for the Medical Devices Fund, the project:

  • must satisfy the definition of a medical device
  • must seek to progress a medical device along the commercialisation pathway
  • must be innovative (i.e. new to market, or new to world)
  • should have the potential to assist health delivery in NSW
  • must have been developed in NSW and derive health, economic, social and/or environmental benefit to NSW

Application process

Applications are called for once a year, and there is a two stage application process. To be eligible to be invited to submit a Full Application, applicants must submit a preliminary application.

  • Preliminary Application – this is an early screening document of no more than 8 pages that allows the Medical Devices Fund Expert Panel to determine eligibility, review the opportunity and assess the quality of the application. The mandatory self-assessment must be submitted with the preliminary application.
  • Full Application – the Medical Devices Fund Expert Panel will determine if a Preliminary Application will proceed to a Full Application. This is a more detailed document of 15-20 pages that covers all aspects of the opportunity. Applicants may be required to present the proposal or be interviewed. This stage is by invitation only.

Assessment process

The Medical Devices Fund sub-group will conduct an initial review of the Preliminary Applications and will provide the Expert Panel with advice regarding the eligibility and quality of the applications against the agreed criteria.

The Medical Devices Fund Expert Panel will take this advice into consideration when reviewing the applications and determine which applications will proceed to Full Application. The Medical Devices Fund Expert Group reserves the right to refer proposals to the Secretariat for further discussion and development with applicants. It will convene at most three times a round depending on suitable applications to review.

All applications and supporting material will be treated commercial-in-confidence. If applications progress to Full Application an independent clinical expert review will be undertaken. An independent financial review will also be undertaken. Advice will also be sought from other relevant commercialisation experts, science and technical experts as required. All parties will be required to agree to the same confidentiality undertaking when reviewing applications.

Selection criteria

The Medical Devices Fund Expert Panel will evaluate grant applications against information and evidence provided in relation to the following selection criteria. The application will be assessed against the extent to which it meets the Selection Criteria below.

Applicant

  1. A NSW-based organisation supportive of the technology applying for funding.
  2. The organisation’s interest/involvement in the opportunity must have initially been derived from the activities of their researcher(s)/employee(s).
  3. The organisation must benefit from the Medical Devices Fund investing in the opportunity. However, the benefit need not be financial.
  4. The organisation researcher(s)/employee(s) to have some ongoing role in the development of the technology.
  5. The organisation will derive financial benefit if the technology is commercialised.
  6. The organisation receiving some of the funding to complete project activities.
  7. The organisation will gain recognition/kudos if the technology is commercialised and will benefit from publications relating to the work to be funded.

Project

  1. Demonstrate the potential state, national and/or international significance of the medical device and show how it will improve people’s health and well-being.
  2. Demonstrate how the medical device will potentially deliver economic, social and/or environmental benefits for NSW.
  3. Demonstrate how the medical device will result in: a. Improved clinical outcomes
  4. Improved practice efficiency or effectiveness.
  5. Improved ease of use.
  6. Improved quality.
  7. Improved safety.

All submissions will be assessed against the Australian regulatory requirements for medical devices (TGA).

Sufficient information and evidence must be provided by the applicants to enable the Medical Devices Fund Expert Panel to undertake a diligent review of the applications without the need to source significant further data/information to evaluate the submission.

Reporting and accountability requirements

Successful applicants will be required to sign a Funding Agreement that outlines the State’s obligations in relation to the flow of funds and the grant recipient’s obligations in relation to reporting and accountability.

All information provided in support of Medical Devices Fund applications may be subject to external audit under the Funding Agreement.

Organisations will be awarded funding for one term at a time. The organisation must fulfil its obligations as set out in the Funding Agreement to receive funds for subsequent years within the funding period.

An authorised signatory from research organisations awarded grants under the Medical Devices Fund will be required to sign the Funding Agreement with the State before funds are made available.

Further information

Further information is available in the Medical Devices Fund Application Kit and Program Guidelines.

Terms of reference

Background

The Medical Devices Fund will help encourage and support investment in the development and commercialisation of medical devices in NSW, to accelerate the development of medical devices by removing barriers to commercialisation, and to leverage other funding. The innovations supported by the Fund will be rigorously and transparently assessed by an Expert Panel and have the potential to impact on health outcomes, be cost effective, and be of economic benefit to NSW. 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.

Purpose

The Medical Devices Fund will help encourage and support investment in the development and commercialisation of medical devices in NSW. In doing this it will:

  • building on existing state and federal programs and initiatives
  • encourage linkages between NSW device companies, research hubs, commercialisation offices and domestic and offshore investors in medical devices
  • streamline clinical assessments and trials of innovative medical devices to assist greater uptake of NSW innovations by the NSW health system, and drive sales and exports to other markets
  • build on the previous investment in the Medical Research Commercialisation Fund (MRCF) as a source of expert advice and significant investment
  • align with Commercialisation Australia processes
  • foster collaboration with NSW Trade and Investment, for commercialisation expertise, technical assistance and complementary programs.
  • identify and support teams or individuals who are likely to be successful.

The Medical Devices Fund Expert Panel will review applications for investment in the development and commercialisation life-cycle of medical devices and make funding recommendations with a view to creating outcomes which are of health and economic benefit to NSW.

Approval of the Expert Panel’s recommendations for grants will be in line with existing delegations for Deputy Secretary, Secretary and Minister for Medical Research.

Reporting and accountability

The Expert Panel reports to the Minister for Health and Minister for Medical Research through the Secretary or their delegate.

Membership

Membership to the Expert Panel will be by appointment by the Minister for Health and Minister for Medical Research. It will include individuals who are distinguished experts, who collectively have skills, experience and expertise in; scientific research, medical devices commercialisation, financial management and consumer advocacy. The number of members will be at the discretion of the Minister. The Minister will appoint the Chair of the Expert Group.

If further expertise is required to assist with the assessment of an application, it will be sourced by the panel on a case-by-case basis. This will include advice from Medical Research Commercialisation Fund and NSW Trade and Investment.

Tenure

Appointment of Expert Panel members and Chair will be up to 3 years with the option to extend for a further period of up to 3 years, at the discretion of Minister for Health and Minister for Medical Research, but the appointment must not exceed 6 years in total.

Code of conduct

All members will abide by and display behaviour consistent with NSW Health Code of Conduct.

Conflicts of interest

Members must declare conflict of interest matters in regard to applications. Management of conflict of interest will be undertaken by the Chair and the Office for Health and Medical Research (Secretariat).

Confidentiality

All members will treat meeting proceedings, discussions and recommendations and all documents tendered as commercial-in-confidence.

Employment checks

Appointment is conditional on a satisfactory outcome of a National Criminal Record check and a NSW Department of Premier and Cabinet Lobby Register check. (Employment Screening Policy PD2008_029)

Remuneration

The Expert Panel will be remunerated sitting fees: Chair at $342 full day or $171 half day and Member $207 full day or $104 half day as per the Department of Premier’s and Cabinet Guidelines for NSW Boards and Committee members: Appointments and Remuneration. This excludes minor out of pocket expenses as per Ministry of Health policy directive.

Secretariat

The Office for Health and Medical Research will provide all the administrative support for the Medical Devices Fund processes and the Expert Group.

Current and previous recipients

Download the details of successful projects for each round including company details, watch videos about devices, or use the directory to search successful projects and project summaries by topic areas of interest.

Updated 1 month ago