Medical Devices Fund
The Medical Devices Fund is a competitive technology development and commercialisation program.
Applications for round 10 of the Medical Devices Fund closed at 5pm on Tuesday 1 March 2022.
If you submitted an application and did not receive a confirmation of receipt email by Thursday 3 March, please contact us urgently via email moh-ohmrgrants@health.nsw.gov.au or call 02 9391 9228.
Online information session
An online information session was held on Tuesday 15 February 2022.
The session explored the key requirements of a successful application. Speakers included the Chair of the Expert Panel, Panel Members and previous recipients. Questions from the session will be uploaded below under ‘frequently asked questions’ shortly.
Please see the slides that were presented during the session:
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MDF online information session slides
PDF - 662 KB
About the Medical Devices Fund
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 $70 million for 40 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.
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Apply now
In the 2022-23 financial year the Medical Devices Fund has over $8 million available.
Applications for round 10 opened on 21 December 2021 and will close on 1 March 2022.
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Preliminary Application Form - Round 10
DOCX - 890 KB
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Business Model Canvas
DOCX - 139 KB
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Application kit and guidelines
PDF - 490 KB
Before you apply
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.
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Medical Devices Fund Application Kit and Guidelines
PDF - 132 KB
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 Panel to determine eligibility, review the opportunity and assess the quality of the 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. This stage is by invitation only.
Watch the following video to understand the Medical Devices Fund eligibility criteria.
Watch the following video to understand what evidence and/or trial information you need to provide.
Watch the following video to understand what you need to address from an IP perspective.
Watch the following video to understand what you need to address in your regulatory plan.
Watch the following video to understand the importance of having a reimbursement strategy.
Watch the following video to understand the importance of building a well-rounded team.
Watch the following video to understand the Medical Devices Fund Business Canvas Model as part of your application.
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Medical Devices Fund online information session slides - 4 February 2021
PDF - 352 KB
Principles of the Fund
The following principles apply to the Medical Devices Fund:
- The project must be capable of potentially:
- improving patient care and/or health wellbeing
- generating, economic, social and/or environmental benefits to NSW.
- Funding will be open, competitive and merit-based, while maintaining commercial-in-confidence requirements.
- 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.
- 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).
- The fund will not support activities which are deemed to be research.
- 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.
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 Health and Medical Research.
Reporting and accountability
The Expert Panel reports to the Minister for Health and Medical Research through the Secretary or their delegate.
Membership
Membership to the Expert Panel will be by appointment by the Minister for Health and 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 Panel
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 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 Panel.
About the Expert Panel
Professor Hugh Durrant-Whyte (Chair)
Professor Hugh Durrant-Whyte is the NSW Chief Scientist and Engineer. He is known for his pioneering work on probabilistic methods for robotics and is an expert in autonomous robots. Professor Durrant-Whyte previously held a senior research post at the University of Sydney (as director of the Centre for Translational Data Science) and before that was the head of National ICT Australia, which is now embedded in the CSIRO as Data61. He was also named NSW scientist of the year in 2010.
Professor Gemma Figtree
Professor Figtree is a Professor in Medicine at the University of Sydney and is an interventional cardiologist at Royal North Shore Hospital. She works in the field of oxidative signalling and translational cardiovascular research. Professor Figtree is committed to improving the care for patients who have heart attacks and discoveries in her laboratory have been published in leading journals. Professor Figtree is supported by a Heart Foundation Future Leader Fellowship and a NHMRC Career Development Fellowship.
Dr John Parker
Dr Parker is the Founder and CEO of Saluda Medical. Dr Parker founded the Implant Systems team at NICTA that developed the closed loop feedback technology. He has over 20 years of experience in medical devices, including 13 years at Cochlear Limited, where he served in the role of Chief Technology Officer / executive member of the board of directors.
Mark Phelps
Mr Phelps is the Head of Business Development- Mergers and acquisitions, Investments, Partnerships at Cochlear Limited. This role is responsible for developing and coordinating strategic growth initiatives to improve the end-to-end customer experience across major markets; working with clinical partners, country GM’s and functional heads to coordinate the development and execution of new clinical care models based on connectivity and digitisation of data flows.
Kelly Constable
Ms Constable is a senior business executive offering 20 years of life science experience, including eight recent years leading the commercialisation of breakthrough digital/mobile applications in the healthcare arena. She has a proven track record driving innovation within a top global biotech organization, including formation of two entrepreneurial digital start-ups. Demonstrated ability to “own” the full concept-to-launch development process for digital solutions to empower healthcare stakeholders, improve patient outcomes, increase market access, and reduce bottom-line healthcare delivery costs.
Dr Laura Faulconer
Dr Laura Faulconer is a CXO, investor and director. She has 12 years’ experience navigating the complexities of taking IP-rich technologies to market. From founder to investor, COO and Associate Professor teaching entrepreneurship, she is passionate about supporting interesting opportunities that either see the world through a unique lens or bend but not break the laws of physics.
A/Prof Payal Mukherjee
A/Prof Payal Mukherjee is an adult and paediatric Ear, Nose and Throat (ENT) surgeon with special skills in advanced ear surgery. Following her ENT training in Sydney, she attained further sub-specialty post-fellowship training in otology, Cochlear implantation and lateral skull base surgery in Oxford and London. As well as treating general ENT diseases such as glue ears, tonsillitis, snoring and rhinosinusitis, her areas of expertise include hearing and balance disorders such as Meniere’s disease and Otosclerosis.
A/Prof Mukherjee is also a senior lecturer of surgery at The University of Sydney and the ENT lead for research at the RPA Institute of Academic Surgery. She is an executive member of the NSW regional committee of the Royal Australasian College of Surgeons; and is a committee member of a research group called the Meniere’s research fund, of the Sydney Medical School.
Frequently asked questions
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Submitting your application
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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.
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About the application
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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.
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Eligibility criteria
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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, visit our website for previously funded CRC projects.
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.
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Funding purposes
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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.
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Assessing the grant
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How would potential venture capital investment impact the fund's decision?
The application will not be advantaged nor 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.
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What happens if I am successful in receiving a grant?
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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.
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Reimbursement
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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.
About previous recipients
Watch the 2021 Medical Devices Fund recipients tell their stories below, or read about them in the news section of this website.
Search the directory for project summaries by topic areas of interest, find and follow the latest health and medical innovations or search for the brochures of previous Medical Devices Fund recipients.
Updated 3 months ago