Clinical Translation and Commercialisation – Medtech Program

 

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What is the Clinical Translation and Commercialisation – Medtech Program?

The Clinical Translation and Commercialisation – Medtech Program provides grants up to $1.5M for medical device projects that have commercial potential and to support their translation through early clinical trials. 

 

Background

The Clinical Translation and Commercialisation – Medtech program, delivered by MTPConnect, is offered under the 2020 Early Stage Translation and Commercialisation Support Grant of the Medical Research Future Fund’s Medical Research Commercialisation Initiative. 

The $19.75 million program will identify and nurture high-quality medical device projects that have commercial potential and support their translation through early clinical trials.  The program is focused on Australian small to medium-sized enterprises (SMEs) and aims to boost commercialisation of home-grown medical products.

Projects must focus on the development of a medical device for human use, the purpose of which is to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body. Funding will only be awarded to projects where the device’s capability has already been validated with research and/or preclinical studies.

 

Objective

The Clinical Translation and Commercialisation – Medtech Program aims to support early clinical development of medical devices with commercial potential. 

While product development, manufacture and testing will be considered eligible activities, all projects must include clinical testing of devices. 

For applications relating to development of an in vitro diagnostic (IVD), the minimum requirement for eligibility under this program will be the conduct of a clinical performance study using biobank samples or samples from recruits into a study as part of the project plan.

 The Clinical Translation and Commercialisation – Medtech Program will:

  • Deliver consultation and commercialisation advice to guide project development and assessment
  • Facilitate 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.

 

Funding

Funding of between $250,000 and $1.5 million is available per project across two funding rounds (FY2022 and FY2023).

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Clinical Translation and Commercialisation - Medtech Program

 

How to get the Clinical Translation and Commercialisation – Medtech Program grant

You will need to demonstrate:

  • the potential to improve the health and wellbeing of Australians
  • how CTCM funds will accelerate the production and commercialisation of a medical device technology in Australia within a 24-month period
  • a commitment to Australian manufacturing
  • the potential to advance the medical technologies sector in Australia and economic and workforce development
  • how you will form partnerships or stimulate collaboration across disciplines and between the research, industry and technology sectors to maximise entrepreneurship.

 

Eligible Expenditure

Examples of eligible expenditure include, but are not limited to:

  • project consumables directly attributable to the delivery of project outcomes
  • salaries (whole FTEs or fractional) directly attributable to the delivery of project outcomes. The maximum salary claimable per person, including packaged components (superannuation) is limited to $175,000 per financial year. On a case-by-case basis, where it can be adequately justified, CTCM funding may support salaries greater than $175,000 per financial year
  • Commonwealth funded positions can be considered eligible to count towards an in-kind contribution. However, the Commonwealth funded position cannot also draw a salary from funds awarded through this grant opportunity for the same activity
  • labour expenditure for leadership staff (e.g., founder, CEO, CSO, CMO) is considered eligible, provided there are direct, demonstrated and monitored links to project objectives and outcomes. Salaries for leadership staff will be limited to 10 per cent of the total amount of eligible labour expenditure claimable per person (i.e., maximum $17,500). On a case-by-case basis, where it can be adequately justified, CTCM funding may support leadership salaries greater than $17,500 per financial year
  • labour on-costs are eligible. Examples of labour on-costs are employer paid superannuation, payroll tax, workers compensation insurance and leave entitlements (including paid maternity leave, sick leave, long service leave and recreation leave). These costs must be reasonable, appropriate and separately identified in the project budget
  • accessing specialist professional services including regulatory consultants, manufacturing and product development firms, clinical research organisations, technology evaluation, process evaluation, key opinion leaders or strategic stakeholders
  • accessing IP expertise as a service, freedom to operate search costs and provisional and PCT
    drafting and filing costs (or costs associated with comparable stages of IP protection e.g., trade marks, designs, copyright circuits etc.)
  • 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. Justification for purchase and why the applicant(s) cannot support the expense must be provided
  • 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 that this work cannot otherwise be performed in Australia and is critical to the success of the project. If proposed international activities and expenditure exceeds 10 per cent of the total CTCM project funding (grant funding plus co-contribution), the Department of Health must provide its approval (which will be managed by MTPConnect)
  • essential travel within Australia directly related to project activities
  • essential travel overseas on a case-by-case basis directly related to project activities

 

Eligible Applicants

For a proposal to be deemed eligible for CTCM Project Funding it must meet the following criteria:

  • The lead applicant must:
    • be a registered Australian based business
    • be incorporated in Australia
    • have an Australian Business Number (ABN).
    • have less than 200 employees.
  • Demonstrated capacity to match the co-contribution requirement.
  • The applicant’s project must involve the development of a medical device.
  • The applicant must provide evidence of technical and/or commercial feasibility of their product.
  • The applicant 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 activities of the Research Project and to translate, implement or commercialise their product(s)/solution(s).
  • Applicants must meet any applicable timing, formatting, system or other similar administrative requirements from MTPConnect during the application process.

It is understood that the lead applicant may not be the group manufacturing the device prototypes or final product design. To accommodate this scenario, partnerships and collaborations with Australian medical device manufacturers are allowed. A partner is not a mandatory requirement and is not considered an advantage or a disadvantage.

If a manufacturing partner is named, that partner must satisfy the following eligibility criteria. The partner must:

  • be an Australian registered business
  • be incorporated in Australia
  • have an ABN
  • establish and operate the manufacturing facility in Australia
  • be ISO13485 accredited, achieve accreditation within the project activity period, or operate a quality management system aligned to ISO13485.

Other partner organisations can include, but are not limited to:

  • 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.

A partner or collaborator is not required to provide an additional matched cash co-contribution; however, any cash or in-kind co-contribution will be considered favourably.

 

Timing

Round 2 Expressions of Interest open 9 September 2022.

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Call 1300 658 508

Clinical Translation and Commercialisation - Medtech Program

Application Process

1. Expression of Interest
Phase I EOI: All eligible projects are to be submitted as a non-confidential EOI. EOIs 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 the project team. EOIs will be evaluated by the CTCM Selection Panel using selection criteria published in this guidelines document. The most meritorious EOIs, as determined by the Selection Panel, will be invited to progress to Phase II. The merits of an application are based on how well it meets the selection criteria and how it compares to other eligible applications. 
The application form includes 5,000+ words plus an attachment.
 
 
2. Consultation
Phase II Consultation: Applicants who reach Phase II will be assigned a CTCM partner – MTAA, MDPP, or CI – for consultations which will be held via videoconference. Confidential Disclosure Agreements will be entered into with applicants whose projects move beyond the EOI stage to allow for a complete review and assessment of projects. Consultations will provide an opportunity for applicants to address Selection Panel feedback on their EOI, have a two-way due diligence conversation with the assigned CTCM partner on the technical aspects of the project and its commercial potential or translatability and allow for financial vetting with respect to any co-contributions. Time will be provided for the applicant to ask general questions on commercialisation as well. The outcome of the consultation and due diligence evaluation will be assessed by the CTCM Selection Panel. The most meritorious applications, as determined by the CTCM Selection Panel post Phase II consultation, will be invited to progress to Phase III and submit a full proposal. 
 
 
3. Full Proposal
Phase III Full Proposal: Full Proposal applications will expand on the EOI application to provide a more comprehensive outline of the project. 
Full proposal applications will be reviewed by the CTCM Investment Panel; an independent, national and international panel of research, industry and investment experts, against the selection criteria articulated in the Guidelines. The CTCM Investment Panel will make recommendations for funding award to the most meritorious full proposals. Funding recommendations must be approved by the CTCM Steering Committee. 
 

 

More Information

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Clinical Translation and Commercialisation - Medtech Program

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