Since its first round in 2013, more than $70 million has been disbursed from the NSW Medical Devices Fund to support more than 40 technologies.
The NSW Medical Devices Fund is a competitive technology development and commercialisation program with over $8.2 million per year currently available, with grants ranging between $500,000 and $5 million. The 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.
Applications for the NSW Medical Devices Fund are generally made on a yearly basis and are subject to a two-stage application process. The Preliminary Application (of no more than 8 pages) is analysed by the Medical Devices Fund Expert Panel to determine if it will proceed to a Full Application.
For the Preliminary Application, a 3-minute video must also be provided and address the following aspects:
- The problem the device solves and the type of patient it helps;
- The market dynamics (e.g., market size, growth rates, key trends);
- The specifics of the project for which funding is requested and how it will assist with commercialising the device;
- The impact the device will have on the health system;
- The proposed business model.
The Technology Readiness Level (TRL) at the start of the project and expected TRL level at the end of the intended project must be stated in the application. The device must be at a minimum TRL 3 to be eligible.
Questions are asked about your business’s IP portfolio, including plans to build and protect this portfolio in key geographical target markets, and you must describe the impact that the device will have on the health system in NSW, Australia and Globally.
Although the NSW Ministry of Health requires repayment of the grant once the recipient earns a profit through the commercialisation of the device benefitted from funding, the NSW Medical Devices Fund has no requirement for matched funding (unlike many similar grants), so it is highly competitive. Also, due to the large size of the grants disbursed, there are usually only two or three recipients per year. Some examples of projects funded by the NSW Medical devices Fund include:
- AtomoRapid: $1.8 million awarded in 2015 to support development and validation of a digitally integrated and e-health enabled version of the AtomoRapid HIV Self Test, which is a small handheld blood testing device that accurately and efficiently diagnoses HIV, malaria, dengue fever and hepatitis without additional equipment.
- Inventia Life Science: awarded $3.6 million in 2021 to facilitate clinical trials in humans with their Ligō Robot, which 3D-prints new skin cells and biomaterials that patients need to promote wound healing and re-create a new layer of normal skin.
Medical Device Definition
The definition in the NSW Medical Devices Fund guidelines 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.
Principles of the Fund
The following principles apply to the NSW 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.
Although applications for the NSW Medical Devices Fund are generally made on a yearly basis, you can be preparing your documentation in advance, as changes in requirements from year to year are minimal. More information (including Guidelines and the online Application form) can be found at the NSW Medical Devices Fund webpage.
If you’re an innovative New South Wales business and want the best advice to keep moving onward and upward, contact Fullstack Advisory so you can leverage our expertise and knowledge of all the grants, incentives, rebates, and other opportunities available.
