Clinical trial research funding from $250,000 and up to $1.5 million to nurture early stage clinical development and help realise commercial potential of medical devices.
Current status of program
CLOSED
To register your interest in future rounds or discuss alternative grant opportunities please contact us here.
What is the Clinical Translation and Commercialisation – Medtech program?
The Clinical Translation and Commercialisation – Medtech (CTCM) program is a funding opportunity offered under the 2020 Early Stage Translation and Commercialisation Support Grant of the Medical Research Future Fund’s (MRFF) Medical Research Commercialisation Initiative.
The program is administered by MTPConnect with the objective of identifying and nurturing high-quality medical device projects with commercial potential and support their transition through early clinical trials.
The program is focused on Australian small to medium-sized enterprises (SMEs) and aims to increase commercialisation of Australian developed medical products through providing financial assistance, consultation, educational support and access to infrastructure for clinical stage translation.
CTCM level of support
Grant
- Between $250,000 and up to $1.5 million per project
Co-contribution
- Co-contribution (applicant : fund) is relative to the funding request, as follows
- $250,000 – $500,000 1:4
- $500,001 – $1,000,000 1:2
- $1,000,001 – $1,500,000 1:1
- Additional in-kind or cash contributions are viewed favourably
CTCM important dates
- This program is currently closed
- Register your interest here with GrantHelper
CTCM important details that you will need to know
CTCM objectives
The Clinical Translation and Commercialisation – Medtech (CTCM) program will:
- deliver consultation and commercialisation programs to guide project development and assessment
- enable access to broader NCRIS and other critical engineering, fabrication and prototyping facilities to accelerate translation of early-stage discoveries
- emphasise collaboration, partnering and consultation to nurture the next generation of health and medical research innovators and provide ongoing SME education
- employ a process of continuous evaluation, based on established commercial principles, to optimise the potential for project success and maximise return on investment
Through supporting the clinical development of innovative and high-quality medical devices, the CTCM program aims to improve the health and wellbeing of Australians. At the same time it contributes to assisting projects to generate commercial returns and create high-paying jobs in the medical device and medical products sector.
Organisations eligible for CTCM support
Applicants are required to demonstrate:
- a lead applicant:
- registered as an Australian based business
- incorporated in Australia
- with an ABN
- with less than 200 employees
- capacity to match the co-contribution requirement
- a project involving the development of a medical device*
- evidence of technical and/or commercial feasibility of their product
- control or have the legal right to access and use the relevant know-how and/or existing and/or potential IP necessary to undertake the project and to translate, implement or commercialise their product(s)/solution(s)
- ability to meet any administrative requirements from MTPConnect during the application process
* For the purposes of this program, medical devices are defined by section 41BD of the Therapeutic Goods Act 1989 and further informed by the Therapeutic Goods (Articles that are Medical Devices) Specification 2014.
Partnerships
- Applicants who do not manufacture medical devices can partner with a medical device manufacturer who:
- is an Australian registered business
- is incorporated in Australia
- has an ABN
- established and operates the manufacturing facility in Australia
- is ISO13485 accredited, achieves accreditation within the project activity period, or operates a quality management system aligned to ISO13485.
- Such applicants can include:
- universities
- medical research institutes
- clinical organisations or health care providers
- health systems
- consumer groups
- private research entities
- commercial entities
- not-for-profit organisations
- other end users
- Partnerships are not mandatory
- Partner cash or in-kind contributions are not mandatory but will be considered favourably
Projects eligible for CTCM support
Applicants in Round 1 were required to demonstrate:
- a lead applicant:
- registered as an Australian based business
- incorporated in Australia
- with an ABN
- with less than 200 employees
- capacity to match the co-contribution requirement
- a project involving the development of a medical device*
- evidence of technical and/or commercial feasibility of their product
- control or have the legal right to access and use the relevant know-how and/or existing and/or potential IP necessary to undertake the project and to translate, implement or commercialise their product(s)/solution(s)
- ability to meet any administrative requirements from MTPConnect during the application process
* For the purposes of this program, medical devices are defined by section 41BD of the Therapeutic Goods Act 1989 and further informed by the Therapeutic Goods (Articles that are Medical Devices) Specification 2014.
Partnerships
- Applicants who do not manufacture medical devices can partner with a medical device manufacturer who:
- is an Australian registered business
- is incorporated in Australia
- has an ABN
- established and operates the manufacturing facility in Australia
- is ISO13485 accredited, achieves accreditation within the project activity period, or operates a quality management system aligned to ISO13485.
- Such applicants can include:
- universities
- medical research institutes
- clinical organisations or health care providers
- health systems
- consumer groups
- private research entities
- commercial entities
- not-for-profit organisations
- other end users
- Partnerships are not mandatory
- Partner cash or in-kind contributions are not mandatory but will be considered favourably
Costs eligible for CTCM support
Examples of eligible expenditure include, but are not limited to:
- project consumables
- salaries directly related to project outcomes, limited to $175,000 per financial year per person, including packaged components and labour on-costs
- labour expenditure for leadership staff (e.g., founder, CEO, CSO, CMO) linked to project objectives and outcomes and limited to $17,500 per person
- accessing specialist professional services and IP expertise
- access to specialist equipment, hardware and software essential to the research
- purchase of equipment that is essential to research, capped at $80,000 in total
- prototyping and development of a Minimum Viable Product
- market research/testing and engaging with major customers and end-users including clinical trials
- data procurement and efforts to obtain regulatory approval
- international activity expenditure where it can be justified
- essential travel within Australia directly related to project activities
- essential travel overseas on a case-by-case basis directly related to project activities
Examples of ineligible expenditure include but are not limited to:
- rent or other property fees
- salaries, activities, equipment or supplies that are already being supported through any other source of funding
- service or repair costs for eligible equipment purchases made with CTCM funding
- purchase of computers, except where necessary for the project
- advertising and recruitment, and contract negotiations
- conference attendance and associated travel (except when pre-approved)
- communications costs (mobiles, telephone calls)
- institutional overheads and administrative costs
- activities that are the usual requirement of business
Applying for CTCM
Applications for the Clinical Translation and Commercialisation – Medtech (CTCM) program are assessed in a multi-step process:
- Phase I: non-confidential Expressions of Interest (EOI)
- Phase II: consultation interview via video-conference
- Phase III: Full Proposal submission
EOI applications and full proposals are completed online via SmartyGrants portal.
Book a no obligation discovery session with GrantHelper to increase your chances of success.
Information to prepare for the CTCM application
Information required for the Clinical Translation and Commercialisation – Medtech (CTCM) program EOI will include:
- source and amount of the co-contribution to the project
- product description, including Technical Readiness Level and stakeholder feedback
- evidence of unmet medical need and value proposition
- market analysis
- business model and IP and commercialisation strategies, including target market
- project plan, including risk management
- project team details and available resources
The EOI will be treated as non-confidential therefore do not include any sensitive or enabling information.
CTCM assessment criteria
Assessment criteria for the Clinical Translation and Commercialisation – Medtech program are as follows:
| Ref | Criteria | Weighting |
| 1 | Challenge and solution – addresses an unmet need – has a competitive advantage – represents a value proposition – commitment to Australian manufacturing | 20% |
| 2 | Technical merit – innovative design features – preclinical studies data – safety profile of device – feedback from clinician / payers – stakeholder engagement /device desirability – scalability and barriers to adoption | 20% |
| 3 | Project plan – clear activities, deliverables and outcomes – path towards translation milestone – focused and appropriate timeframes – key risks and mitigation strategies identified – appropriate and realistic budget | 20% |
| 4 | Translation and commercialisation – IP protection and exclusivity – clinical development plan is feasible – credible regulatory pathway – justified relevant market segment or end-user – feasible commercialisation / business model – investor attractiveness – market demand and willingness to pay | 20% |
| 5 | Team and capabilities – experience and proven track record – diverse team of expertise – access to requisite infrastructure | 20% |
CTCM resources
- Source
- Guidelines
- Example EOI
- Slides (R2 info session)
- Recording (R2 info session)
- Apply here
How to get the CTCM
Your project must involve the development of a medical device. The primary innovation in the applicant’s project must be in the hardware, with some software development permitted. Any project where the primary innovation lies in the software will be deemed ineligible.
Activities supported will include, but are not limited to, product development and testing, clinical trial activity and regulatory support. Ideas and concepts, with no technical validation at the time of application, and preclinical studies, are out of scope for this funding. Projects to develop research tools (e.g., databases or animal models) in isolation are not eligible. Non-human health programs are not eligible. There must be evidence of experimental research that has been undertaken that validates the problem or the potential of the product/solution. You must demonstrate understanding of the market/end-user.
Your organisation must control or have the legal right to access and use the relevant know-how and/or existing and/or potential intellectual property (IP) that will be necessary to undertake the proposed project activities and to translate, implement or commercialise their product(s)/solution(s).
View the CTCM round 2 information session slides or view the information session recording. It is essential to read and understand the guidelines and sample EOI form.
EOI applications will need to clearly articulate the challenge and solution, outline completed and/or planned technical, commercial and implementation activities (substantiated with non-confidential data) and describe the strengths of a diverse project team with a proven track record.
A strong proposal will:
- demonstrate the potential to improve the health and wellbeing of Australians
- demonstrate how CTCM funds will accelerate the production and commercialisation of a medical device technology in Australia within a 24-month period
- demonstrate a commitment to Australian manufacturing, where possible
- demonstrate the potential to advance the medical technologies sector in Australia and economic and workforce development
- consider and demonstrate sustainable practices in the product design, production, packaging, and marketing
Proposals that deliver outcomes aligned with the MMI (Modern Manufacturing Initiative) and its National Medical Products Roadmap will be favoured and strongly encouraged.
For tips on preparing an application view MTPConnect on-demand webinar ‘Show Me The Money: Preparing Successful Commercialisation Funding Applications (scroll down to 18 Nov 2020)‘ or listen to the podcast version.
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CTCM grant recipients
The CTCM program has invested $7.2 million in five cutting edge medical technology projects through the Clinical Translation and Commercialisation Medtech (CTCM) program on 21 October 2022.
CTCM Projects Round 1 Funding Awarded to:
- ARIA Research Pty Ltd, NSW, $1,500,000 award for ARIA Non-Invasive Bionic Vision System Clinical Trial and Pilot
- Eudaemon Technologies Pty Ltd, NSW, $1,500,000 award for Clinical Trial of the Next Generation Condom
- LBT Innovations Ltd, SA, (ASX Listed) $1,500,000 award for APAS Compact – Development of a desktop device for automated microbiology culture plate reading and reporting
- Navi Medical Technologies Pty Ltd, VIC, $1,239,187 award for Safer care for critically ill children: clinical translation of a new medical device to place and monitor paediatric central vascular catheters
- OncoRes Medical, WA, $1,500,000 award for the commercialisation of a diagnostic imaging system for cancer surgery
CTCM Round 2 applications are currently under assessment.
